HomelessnessNCT04012697
Peer Support for Homelessness in the Emergency Department
A study testing Peer Support in people with Homelessness and Health Behavior, run by McMaster University at 1 site in Canada.
Trial summary
Peer support workers with lived experience of homelessness will provide advocacy, supportive counselling, assistance with navigating the system, and role-modeling for people experiencing homelessness in emergency departments in the Niagara region of Ontario, Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness, Health Behavior, Health Care Utilization
- What is being tested?
- Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Canadian citizen or permanent resident
- Resident of Ontario in the past 12 months
- Age 18 or over
- Absolute homeless (e.g., living outside, including but not limited to abandoned buildings, vehicles, transit stations; residing in shelters; residing in hotel/motel rooms)
- Hidden homeless (e.g., living with others, residing in transitional housing)
Who cannot join
- Not a Canadian citizen or permanent resident of Canada
- Not a resident of Ontario for the majority of the past 12 months
- Under the age of 18
- Does not meet criteria for absolute or hidden homelessness (see: Inclusion Criteria)
- Refusal to disclose housing, citizenship, or residential status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Peer Support Workers in the Emergency Department for People Experiencing Homelessness in the Niagara Region of Ontario, Canada
Peer support workers with lived experience of homelessness will provide advocacy, supportive counselling, assistance with navigating the system, and role-modeling for people experiencing homelessness in emergency departments in the Niagara region of Ontario, Canada. Previous research has demonstrated that people experiencing homelessness experience barriers to care and poor health outcomes, including increased risk of dying, and are frequent users of the emergency department for physical and mental health needs. The benefits of peer support have been studied in hospital psychiatric units and with people experiencing homelessness, but no studies have yet explored the potential impact of peer support workers on homelessness in the emergency department. The investigators plan to do a 12-month randomized study of peer support workers compared to usual care in the emergency department, and evaluate outcomes such as physical health, mental health, addictions, and behaviours, as well as cost-effectiveness and changes in how people experiencing homelessness seek health care. The investigators hope that the findings of this study will provide additional knowledge and evidence for future efforts to improve care for people experiencing homelessness.
Read the detailed description
Homelessness is strongly associated with an increased prevalence of chronic physical and mental health morbidity, leading to lower health-related quality of life and increased hospital readmissions compared to the general population. People experiencing homelessness have reported experience of discrimination and unwelcome treatment, neglect and rejection, lack of compassion from their health care providers and feeling as though their perceptions are disregarded. Alongside many daily barriers such as substance use, lack of housing, and food insecurity, these issues also negatively influence the desire to seek health care among people experiencing homelessness.
A national strategy to determine the extent and nature of homelessness, 'Point-in-Time Counts' were conducted in over 60 communities across Canada in 2018 to provide a snapshot of the experiences and needs of people experiencing homelessness. The Niagara 'Point-in-Time' Count collected 408 surveys from people experiencing homelessness, with 57 percent of participants reporting a mental health issue, 36.2 percent reporting an addiction, and 33.9 percent reporting a medical condition. Respondents also reported an ongoing need for mental health services (54.3 percent), addiction services (29.2 percent), and medical services (26.9 percent). Of note, 219 participants reporting a collective 663 visits to the emergency department in the preceding 12 months. People experiencing homelessness are much more likely than housed people to access emergency departments for concerns with mental health, although this may not be an ideal environment to provide recovery-based mental health care.
The placement of peer support workers in the emergency department may help overcome barriers to health care for people experiencing homelessness. Peer support is defined as a supportive relationship between a worker and a peer who share the commonality of a lived experience, with the peer support worker able to model recovery and use a recovery-oriented, person-centered approach with their peer. Increasing positive interactions in a clinical care setting could address the lack of trust perceived by people experiencing homelessness towards health care providers, helping to counteract negative perceptions of health care and increasing the likelihood that people experiencing homelessness will seek care in the future.
The benefits of a peer support worker include feelings of empowerment and hope, increased sense of acceptance and empathy, improved satisfaction, and reduced feelings of stigma. Peer support workers in mental health services lead to reduced admissions, as well as earlier discharge when utilized following admission to hospital. Two recent reviews investigated the effectiveness of peer support services in individuals with severe mental illness. Consistently, they found that peers are at least as effective in providing services as non-peers in the same roles. Additionally, there are certain unique elements that can only be provided by peer support workers. Three randomized controlled trials reported better treatment engagement, fewer hospitalizations and hospital days, and lower rates of non-attendance compared to treatment as usual when peer support workers were added to a care team. When peer support workers served as patient advocates and community connectors for people with multiple psychiatric hospitalizations, the number of hospitalizations and days spent in hospital decreased. Furthermore, participants reported a decrease in depressive symptoms and increase in hope, self-care, and sense of well-being. The researchers noted that the active ingredient in these interventions seemed to be the instillation of hope through self-disclosure, role modeling, and empathy paired with conditional regard. Upon comparing and contrasting the core competencies of case managers and peer support workers, it was noted that the unique duties of peer support workers seemed to center around empowering clients via normalization, participating in personal development as a role model, and encouraging clients' educational growth.
However, despite promising findings in a diversity of clinical care settings, there has been relatively limited research and few high quality studies of the effectiveness of peer support workers and their outcomes with people experiencing homelessness. People experiencing homelessness typically have complex comorbid mental illnesses, and they should theoretically benefit from peer support services via the sharing of lived experiences. An exploratory review of the literature on peer support and homelessness found 10 studies totaling 1341 participants that collectively reported improved overall quality of life, significant increases in social support, reduced rates of substance use, decreased homelessness, and better physical and mental health for the recipients of peer support. Although promising, six of the included studies were longitudinal, two were cross-sectional, and two were quasi-experimental. There was also significant heterogeneity in the delivery of peer services across studies, including peer support from mentors, peer support as part of a larger intervention, and peer support groups.
Within the emergency department, there has been minimal research on peer support or similar interventions. Of 11 studies examined in a meta-analysis of the effectiveness of emergency department interventions for frequent users, case management was found to be the most frequently used. For people experiencing homelessness, case management demonstrated increased contact with health services, reduced lengths of admission, decreased emergency department visits for mental health problems, and reduced substance use, but only equivocal findings for physical and mental health. An example of an emergency department program that is similar to peer support can be found in a randomized trial of compassionate care for people experiencing homelessness. This study from 1995 found that compassionate contact from trained volunteers led to a 33% relative reduction in the overall frequency of visits per month and a significant reduction in the time until a first repeat visit; however, health outcomes were not evaluated.
Although there are several types of emergency department interventions, there is overall a lack of evidence about program effectiveness. Very few studies are randomized controlled trials, most studies with high-risk individuals are of low quality, and stronger evidence on cost-effectiveness is necessary for all program types. Furthermore, the quality of care and health outcomes for people experiencing homelessness may be improved through peer support, but evidence in this area is underdeveloped and in need of studies with robust experimental measures. To fill this gap in knowledge, this study will evaluate a program of peer support for people experiencing homelessness who seek care in the emergency departments of a mid-sized Canadian regional municipality. The research questions for the study are as follows:
- What, if any, are the changes in health service use (e.g., emergency department visits, hospitalizations) following receipt of peer support in the emergency department?
- What, if any, are the changes to health status, health-related quality of life, substance use, or behaviours, following engagement with a peer support worker?
- Is peer support in the emergency department a cost-effective intervention?
- Does receiving peer support in the emergency department lengthen the interval of time before a clinically significant outcome such as a repeat visit to the emergency department or increased morbidity?
- What are the mechanisms of peer support in the emergency department that may contribute to differences observed in the outcomes between the intervention and usual care groups?
- Being tested
- Peer Support
- Keywords
- Survival analysis, Quantitative analysis, Patient-reported outcomes, Randomized-controlled trial, Homelessness, Health services research, Administrative health data, Peer support
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportBehavioural
Participants randomized to the intervention group will be seen by the peer support worker during their stay in the emergency department. The goal of the peer support worker's practice is to address the participant's wellness from a holistic point of view that includes their relationships, connections to the community, general well-being, and sense of empowerment, with an overall focus on quality-of-life goals (Sunderland et al., 2013). The peer support worker will provide a multi-faceted intervention, which aims to foster a peer-to-peer relationship encompassing elements of empathic communication, brief supportive counseling, advocacy for non-medical needs in hospital, liaising and collaborating with medical and nursing staff, motivational interviewing, and connection with programs in the community.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support | Experimental | Peer support services from a peer support worker in the emergency department. Receives: Behavioral: Peer Support |
| Usual care | No intervention | Usual care in the emergency department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hospitalizations, measured using administrative health data
The primary outcome of the study includes the number of hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of days spent in hospital, measured using administrative health data
The primary outcome of the study includes the number of days spent in hospital. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of emergency department visits, measured using administrative health data
The primary outcome of the study includes the number of emergency department visits. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hours spent in the emergency department at each visit, measured using administrative health data
The primary outcome of the study includes the number of hours spent in the emergency department at each visit. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of procedures performed in the emergency department, measured using administrative health data
The primary outcome of the study includes the number of procedures performed in the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in procedures performed during hospitalizations, measured using administrative health data
The primary outcome of the study includes the number of procedures performed during hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in proportions from the pre-intervention 12-month baseline to the post-intervention 12-month period in diagnoses at the time of discharge from the emergency department, measured using administrative health data
The primary outcome of the study includes the diagnosis at time of discharge from the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in mortality, measured using administrative health data
The primary outcome of the study includes mortality. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in overdose presentations, measured using administrative health data
The primary outcome of the study includes overdose presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in psychiatric presentations, measured using administrative health data
The primary outcome of the study includes psychiatric presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Change in proportion from pre-intervention 12-month baseline to post-intervention 12-month period in composition of presenting complaints to the emergency department, measured using administrative health dat
The primary outcome of the study includes the composition of presenting complaints to the emergency department and potential differences over time in the proportions of different presentations (e.g., physical health vs. mental health, Canadian Triage and Acuity Scale (CTAS) levels). This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Measured: 12 months pre-study enrollment and 12-months post-study enrollment
Secondary outcomes (10)
Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 6 months
The CSI is a 14-item self-report measure of psychiatric symptoms (Boothroyd \& Chen, 2008). Respondents report the frequency of various psychiatric symptoms as experienced over the past month on a 5-point Likert scale. Scores range from 0 to 56, with higher scores indicating report of more frequent psychiatric symptoms. The CSI has been psychometrically validated with a sample of people who were experiencing homelessness, living precariously, at risk for homelessness, or had prior history of homelessness (Conrad et al., 2001). The CSI was found to have excellent internal consistency with a Cronbach's alpha of 0.90 and a test/retest intraclass correlation coefficient of 0.79 with this population. The CSI is intended to evaluate change in persons with moderate and high severity psychological symptoms or emotional distress, and is sensitive to change in symptomatology over time. Administration of the questionnaire requires approximately 5 minutes.
Measured: 6 months
Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 12 months
The CSI is a 14-item self-report measure of psychiatric symptoms (Boothroyd \& Chen, 2008). Respondents report the frequency of various psychiatric symptoms as experienced over the past month on a 5-point Likert scale. Scores range from 0 to 56, with higher scores indicating report of more frequent psychiatric symptoms. The CSI has been psychometrically validated with a sample of people who were experiencing homelessness, living precariously, at risk for homelessness, or had prior history of homelessness (Conrad et al., 2001). The CSI was found to have excellent internal consistency with a Cronbach's alpha of 0.90 and a test/retest intraclass correlation coefficient of 0.79 with this population. The CSI is intended to evaluate change in persons with moderate and high severity psychological symptoms or emotional distress, and is sensitive to change in symptomatology over time. Administration of the questionnaire requires approximately 5 minutes.
Measured: 12 months
Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 6 months
The GAIN-SS is a 24-item self-report measure which assesses psychopathology and crime/violence across various dimensions and screens for people who are likely to have diagnoses or require clinical services (Dennis, Chan, \& Funk, 2006). The total score contributes to a Total Disorder Screener (TDScr), with four, 5- to 7-item subset screeners including the Internalizing Disorder Screener (IDScr), Externalizing Disorder Screener (EDScr), Substance Disorder Screener (SDScr), and Crime/Violence Screener (CVScr). The GAIN-SS is internally consistent with a Cronbach's alpha of 0.89 and good discriminant validity for each of the sub-screeners. The Total Disorder Screener has over 90% sensitivity and specificity with a ROC of 0.97 with a cut point of 3 or more. For the sub-screeners, scores can be divided into three groupings of 0 (low), 1-2 (moderate), and 3-5 (high), with the lower cut point of 1+ featuring 90% sensitivity and the upper cut point of 3+ featuring 90% specificity.
Measured: 6 months
Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 12 months
The GAIN-SS is a 24-item self-report measure which assesses psychopathology and crime/violence across various dimensions and screens for people who are likely to have diagnoses or require clinical services (Dennis, Chan, \& Funk, 2006). The total score contributes to a Total Disorder Screener (TDScr), with four, 5- to 7-item subset screeners including the Internalizing Disorder Screener (IDScr), Externalizing Disorder Screener (EDScr), Substance Disorder Screener (SDScr), and Crime/Violence Screener (CVScr). The GAIN-SS is internally consistent with a Cronbach's alpha of 0.89 and good discriminant validity for each of the sub-screeners. The Total Disorder Screener has over 90% sensitivity and specificity with a ROC of 0.97 with a cut point of 3 or more. For the sub-screeners, scores can be divided into three groupings of 0 (low), 1-2 (moderate), and 3-5 (high), with the lower cut point of 1+ featuring 90% sensitivity and the upper cut point of 3+ featuring 90% specificity.
Measured: 12 months
Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 6 months
The EQ-5D is a 5-item generic measure of health status that provides a descriptive profile for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. Health is defined across five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which encompass a broad range of different disease areas, specialties, and types of care. Each dimension offers the following five levels: No problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. The EQ-5D-5L offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions).
Measured: 6 months
Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 6 months
The Visual Analogue Scale is a 20-cm scale for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. This instrument offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions).
Measured: 6 months
Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 12 months
The EQ-5D is a 5-item generic measure of health status that provides a descriptive profile for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. Health is defined across five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which encompass a broad range of different disease areas, specialties, and types of care. Each dimension offers the following five levels: No problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. The EQ-5D-5L offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions).
Measured: 12 months
Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 12 months
The Visual Analogue Scale is a 20-cm scale for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. This instrument offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions).
Measured: 12 months
Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 6 months
The SF-12 is a 12-item questionnaire that has been investigated and utilized for measuring health status among people experiencing homelessness (Larson, 2002). It features categorical questions that assess limitations in role functioning as a result of physical and emotional health, as well as numerous Likert scale responses including a 3-point scale to assess limitations in physical activity and physical role functioning, a 5-point scale for pain and another for overall health, and a 6-point scale to assess mental health, vitality, and social functioning. The SF-12 produces a summary score each for mental health and physical health, which are able to differentiate between diagnostic groups and levels of severity of illness. Internal consistency in a sample of people experiencing homelessness demonstrated a Cronbach's alpha of 0.82 for physical health and 0.79 for mental health.
Measured: 6 months
Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 12 months
The SF-12 is a 12-item questionnaire that has been investigated and utilized for measuring health status among people experiencing homelessness (Larson, 2002). It features categorical questions that assess limitations in role functioning as a result of physical and emotional health, as well as numerous Likert scale responses including a 3-point scale to assess limitations in physical activity and physical role functioning, a 5-point scale for pain and another for overall health, and a 6-point scale to assess mental health, vitality, and social functioning. The SF-12 produces a summary score each for mental health and physical health, which are able to differentiate between diagnostic groups and levels of severity of illness. Internal consistency in a sample of people experiencing homelessness demonstrated a Cronbach's alpha of 0.82 for physical health and 0.79 for mental health.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2020
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for HomelessnessStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled superiority trial with parallel intervention and usual care groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Niagara Community Foundation, United Way Niagara, Niagara Poverty Reduction Network, Quest Community Health Centre
- Responsible party
- Sponsor
- Investigators
- Suneel Upadhye, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012697
- Sponsor's protocol ID
- 7048
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Academy of Peer Services. (n.d.). Retrieved December 23, 2018, from https://www.academyofpeerservices.org/
Acosta O, Toro PA. Let's ask the homeless people themselves: a needs assessment based on a probability sample of adults. Am J Community Psychol. 2000 Jun;28(3):343-66. doi: 10.1023/A:1005105421548.
PubMed 10945121Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
PubMed 21689565Amato S, Nobay F, Amato DP, Abar B, Adler D. Sick and unsheltered: Homelessness as a major risk factor for emergency care utilization. Am J Emerg Med. 2019 Mar;37(3):415-420. doi: 10.1016/j.ajem.2018.06.001. Epub 2018 Jun 2.
PubMed 29891125Barker SL, Maguire N. Experts by Experience: Peer Support and its Use with the Homeless. Community Ment Health J. 2017 Jul;53(5):598-612. doi: 10.1007/s10597-017-0102-2. Epub 2017 Feb 7.
PubMed 28176210Boothroyd RA, Chen HJ. The psychometric properties of the Colorado Symptom Index. Adm Policy Ment Health. 2008 Sep;35(5):370-8. doi: 10.1007/s10488-008-0179-6. Epub 2008 Jun 17.
PubMed 18561020Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.
PubMed 29872845Bungay V. Health care among street-involved women: the perpetuation of health inequity. Qual Health Res. 2013 Aug;23(8):1016-26. doi: 10.1177/1049732313493352. Epub 2013 Jun 12.
PubMed 23761930Cameron, A & Trivedi, P. (2005). Microeconometrics: Methods and applications. Cambridge: Cambridge University Press. Retrieved from https://ebookcentral.proquest.com.
Conrad KJ, Yagelka JR, Matters MD, Rich AR, Williams V, Buchanan M. Reliability and validity of a modified Colorado Symptom Index in a national homeless sample. Ment Health Serv Res. 2001 Sep;3(3):141-53. doi: 10.1023/a:1011571531303.
PubMed 11718206Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, Ashby D, Emsley R, Fergusson DA, Walters SJ, Wilson ECF, Maclennan G, Stallard N, Rothwell JC, Bland M, Brown L, Ramsay CR, Cook A, Armstrong D, Altman D, Vale LD. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(1):606. doi: 10.1186/s13063-018-2884-0.
PubMed 30400926Cousins, C. (2018). Niagara Counts. Retrieved from Niagara Knowledge Exchange: http://www.niagaraknowledgeexchange.com/wp-content/uploads/sites/2/2018/07/2018-07-24-Niagara-Counts-2018.pdf
Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.
PubMed 22654945de Vet R, van Luijtelaar MJ, Brilleslijper-Kater SN, Vanderplasschen W, Beijersbergen MD, Wolf JR. Effectiveness of case management for homeless persons: a systematic review. Am J Public Health. 2013 Oct;103(10):e13-26. doi: 10.2105/AJPH.2013.301491. Epub 2013 Aug 15.
PubMed 23947309Dennis ML, Chan YF, Funk RR. Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults. Am J Addict. 2006;15 Suppl 1(Suppl 1):80-91. doi: 10.1080/10550490601006055.
PubMed 17182423
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Peer Support Workers in the Emergency Department for People Experiencing Homelessness in the Niagara Region of Ontario, Canada
- ClinicalTrials.gov ID
- NCT04012697
- Acronym / sponsor ID
- 7048
- Keywords
- Survival analysis, Quantitative analysis, Patient-reported outcomes, Randomized-controlled trial, Homelessness, Health services research, Administrative health data, Peer support
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 19 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Niagara Community Foundation, United Way Niagara, Niagara Poverty Reduction Network, Quest Community Health Centre
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peer support workers with lived experience of homelessness will provide advocacy, supportive counselling, assistance with navigating the system, and role-modeling for people experiencing homelessness in emergency departments in the Niagara region of Ontario, Canada. Previous research has demonstrated that people experiencing homelessness experience barriers to care and poor health outcomes, including increased risk of dying, and are frequent users of the emergency department for physical and mental health needs. The benefits of peer support have been studied in hospital psychiatric units and with people experiencing homelessness, but no studies have yet explored the potential impact of peer support workers on homelessness in the emergency department. The investigators plan to do a 12-month randomized study of peer support workers compared to usual care in the emergency department, and evaluate outcomes such as physical health, mental health, addictions, and behaviours, as well as cost-effectiveness and changes in how people experiencing homelessness seek health care. The investigators hope that the findings of this study will provide additional knowledge and evidence for future efforts to improve care for people experiencing homelessness.
Detailed description
Homelessness is strongly associated with an increased prevalence of chronic physical and mental health morbidity, leading to lower health-related quality of life and increased hospital readmissions compared to the general population. People experiencing homelessness have reported experience of discrimination and unwelcome treatment, neglect and rejection, lack of compassion from their health care providers and feeling as though their perceptions are disregarded. Alongside many daily barriers such as substance use, lack of housing, and food insecurity, these issues also negatively influence the desire to seek health care among people experiencing homelessness.
A national strategy to determine the extent and nature of homelessness, 'Point-in-Time Counts' were conducted in over 60 communities across Canada in 2018 to provide a snapshot of the experiences and needs of people experiencing homelessness. The Niagara 'Point-in-Time' Count collected 408 surveys from people experiencing homelessness, with 57 percent of participants reporting a mental health issue, 36.2 percent reporting an addiction, and 33.9 percent reporting a medical condition. Respondents also reported an ongoing need for mental health services (54.3 percent), addiction services (29.2 percent), and medical services (26.9 percent). Of note, 219 participants reporting a collective 663 visits to the emergency department in the preceding 12 months. People experiencing homelessness are much more likely than housed people to access emergency departments for concerns with mental health, although this may not be an ideal environment to provide recovery-based mental health care.
The placement of peer support workers in the emergency department may help overcome barriers to health care for people experiencing homelessness. Peer support is defined as a supportive relationship between a worker and a peer who share the commonality of a lived experience, with the peer support worker able to model recovery and use a recovery-oriented, person-centered approach with their peer. Increasing positive interactions in a clinical care setting could address the lack of trust perceived by people experiencing homelessness towards health care providers, helping to counteract negative perceptions of health care and increasing the likelihood that people experiencing homelessness will seek care in the future.
The benefits of a peer support worker include feelings of empowerment and hope, increased sense of acceptance and empathy, improved satisfaction, and reduced feelings of stigma. Peer support workers in mental health services lead to reduced admissions, as well as earlier discharge when utilized following admission to hospital. Two recent reviews investigated the effectiveness of peer support services in individuals with severe mental illness. Consistently, they found that peers are at least as effective in providing services as non-peers in the same roles. Additionally, there are certain unique elements that can only be provided by peer support workers. Three randomized controlled trials reported better treatment engagement, fewer hospitalizations and hospital days, and lower rates of non-attendance compared to treatment as usual when peer support workers were added to a care team. When peer support workers served as patient advocates and community connectors for people with multiple psychiatric hospitalizations, the number of hospitalizations and days spent in hospital decreased. Furthermore, participants reported a decrease in depressive symptoms and increase in hope, self-care, and sense of well-being. The researchers noted that the active ingredient in these interventions seemed to be the instillation of hope through self-disclosure, role modeling, and empathy paired with conditional regard. Upon comparing and contrasting the core competencies of case managers and peer support workers, it was noted that the unique duties of peer support workers seemed to center around empowering clients via normalization, participating in personal development as a role model, and encouraging clients' educational growth.
However, despite promising findings in a diversity of clinical care settings, there has been relatively limited research and few high quality studies of the effectiveness of peer support workers and their outcomes with people experiencing homelessness. People experiencing homelessness typically have complex comorbid mental illnesses, and they should theoretically benefit from peer support services via the sharing of lived experiences. An exploratory review of the literature on peer support and homelessness found 10 studies totaling 1341 participants that collectively reported improved overall quality of life, significant increases in social support, reduced rates of substance use, decreased homelessness, and better physical and mental health for the recipients of peer support. Although promising, six of the included studies were longitudinal, two were cross-sectional, and two were quasi-experimental. There was also significant heterogeneity in the delivery of peer services across studies, including peer support from mentors, peer support as part of a larger intervention, and peer support groups.
Within the emergency department, there has been minimal research on peer support or similar interventions. Of 11 studies examined in a meta-analysis of the effectiveness of emergency department interventions for frequent users, case management was found to be the most frequently used. For people experiencing homelessness, case management demonstrated increased contact with health services, reduced lengths of admission, decreased emergency department visits for mental health problems, and reduced substance use, but only equivocal findings for physical and mental health. An example of an emergency department program that is similar to peer support can be found in a randomized trial of compassionate care for people experiencing homelessness. This study from 1995 found that compassionate contact from trained volunteers led to a 33% relative reduction in the overall frequency of visits per month and a significant reduction in the time until a first repeat visit; however, health outcomes were not evaluated.
Although there are several types of emergency department interventions, there is overall a lack of evidence about program effectiveness. Very few studies are randomized controlled trials, most studies with high-risk individuals are of low quality, and stronger evidence on cost-effectiveness is necessary for all program types. Furthermore, the quality of care and health outcomes for people experiencing homelessness may be improved through peer support, but evidence in this area is underdeveloped and in need of studies with robust experimental measures. To fill this gap in knowledge, this study will evaluate a program of peer support for people experiencing homelessness who seek care in the emergency departments of a mid-sized Canadian regional municipality. The research questions for the study are as follows:
- What, if any, are the changes in health service use (e.g., emergency department visits, hospitalizations) following receipt of peer support in the emergency department?
- What, if any, are the changes to health status, health-related quality of life, substance use, or behaviours, following engagement with a peer support worker?
- Is peer support in the emergency department a cost-effective intervention?
- Does receiving peer support in the emergency department lengthen the interval of time before a clinically significant outcome such as a repeat visit to the emergency department or increased morbidity?
- What are the mechanisms of peer support in the emergency department that may contribute to differences observed in the outcomes between the intervention and usual care groups?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled superiority trial with parallel intervention and usual care groups.
| Arm | Type | Receives |
|---|---|---|
| Peer Support | Experimental | Behavioral: Peer SupportPeer support services from a peer support worker in the emergency department. |
| Usual care | No intervention | –Usual care in the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Canadian citizen or permanent resident
- Resident of Ontario in the past 12 months
- Age 18 or over
- Absolute homeless (e.g., living outside, including but not limited to abandoned buildings, vehicles, transit stations; residing in shelters; residing in hotel/motel rooms)
- Hidden homeless (e.g., living with others, residing in transitional housing)
Key exclusion criteria (5 listed)
- Not a Canadian citizen or permanent resident of Canada
- Not a resident of Ontario for the majority of the past 12 months
- Under the age of 18
- Does not meet criteria for absolute or hidden homelessness (see: Inclusion Criteria)
- Refusal to disclose housing, citizenship, or residential status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer SupportParticipants randomized to the intervention group will be seen by the peer support worker during their stay in the emergency department. The goal of the peer support worker's practice is to address the participant's wellness from a holistic point of view that includes their relationships, connections to the community, general well-being, and sense of empowerment, with an overall focus on quality-of-life goals (Sunderland et al., 2013). The peer support worker will provide a multi-faceted intervention, which aims to foster a peer-to-peer relationship encompassing elements of empathic communication, brief supportive counseling, advocacy for non-medical needs in hospital, liaising and collaborating with medical and nursing staff, motivational interviewing, and connection with programs in the community. | Behavioural | Peer Support |
Primary outcome
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hospitalizations, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of days spent in hospital, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of days spent in hospital. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of emergency department visits, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of emergency department visits. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hours spent in the emergency department at each visit, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of hours spent in the emergency department at each visit. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of procedures performed in the emergency department, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of procedures performed in the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in procedures performed during hospitalizations, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the number of procedures performed during hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in proportions from the pre-intervention 12-month baseline to the post-intervention 12-month period in diagnoses at the time of discharge from the emergency department, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the diagnosis at time of discharge from the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in mortality, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes mortality. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in overdose presentations, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes overdose presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in psychiatric presentations, measured using administrative health data
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes psychiatric presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
Change in proportion from pre-intervention 12-month baseline to post-intervention 12-month period in composition of presenting complaints to the emergency department, measured using administrative health dat
Time frame: 12 months pre-study enrollment and 12-months post-study enrollment
The primary outcome of the study includes the composition of presenting complaints to the emergency department and potential differences over time in the proportions of different presentations (e.g., physical health vs. mental health, Canadian Triage and Acuity Scale (CTAS) levels). This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.
10 secondary outcomes
Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 6 months
Time frame: 6 months
Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 12 months
Time frame: 12 months
Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 6 months
Time frame: 6 months
Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 12 months
Time frame: 12 months
Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 6 months
Time frame: 6 months
Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 6 months
Time frame: 6 months
Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 12 months
Time frame: 12 months
Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 12 months
Time frame: 12 months
Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 6 months
Time frame: 6 months
Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- BackgroundAcademy of Peer Services. (n.d.). Retrieved December 23, 2018, from https://www.academyofpeerservices.org/
- Background: PubMed 10945121Acosta O, Toro PA. Let's ask the homeless people themselves: a needs assessment based on a probability sample of adults. Am J Community Psychol. 2000 Jun;28(3):343-66. doi: 10.1023/A:1005105421548.
- Background: PubMed 21689565Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
- Background: PubMed 29891125Amato S, Nobay F, Amato DP, Abar B, Adler D. Sick and unsheltered: Homelessness as a major risk factor for emergency care utilization. Am J Emerg Med. 2019 Mar;37(3):415-420. doi: 10.1016/j.ajem.2018.06.001. Epub 2018 Jun 2.
- Background: PubMed 28176210Barker SL, Maguire N. Experts by Experience: Peer Support and its Use with the Homeless. Community Ment Health J. 2017 Jul;53(5):598-612. doi: 10.1007/s10597-017-0102-2. Epub 2017 Feb 7.
- Background: PubMed 18561020Boothroyd RA, Chen HJ. The psychometric properties of the Colorado Symptom Index. Adm Policy Ment Health. 2008 Sep;35(5):370-8. doi: 10.1007/s10488-008-0179-6. Epub 2008 Jun 17.
- Background: PubMed 29872845Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.
- Background: PubMed 23761930Bungay V. Health care among street-involved women: the perpetuation of health inequity. Qual Health Res. 2013 Aug;23(8):1016-26. doi: 10.1177/1049732313493352. Epub 2013 Jun 12.
- BackgroundCameron, A & Trivedi, P. (2005). Microeconometrics: Methods and applications. Cambridge: Cambridge University Press. Retrieved from https://ebookcentral.proquest.com.
- Background: PubMed 11718206Conrad KJ, Yagelka JR, Matters MD, Rich AR, Williams V, Buchanan M. Reliability and validity of a modified Colorado Symptom Index in a national homeless sample. Ment Health Serv Res. 2001 Sep;3(3):141-53. doi: 10.1023/a:1011571531303.
- Background: PubMed 30400926Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, Ashby D, Emsley R, Fergusson DA, Walters SJ, Wilson ECF, Maclennan G, Stallard N, Rothwell JC, Bland M, Brown L, Ramsay CR, Cook A, Armstrong D, Altman D, Vale LD. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(1):606. doi: 10.1186/s13063-018-2884-0.
- BackgroundCousins, C. (2018). Niagara Counts. Retrieved from Niagara Knowledge Exchange: http://www.niagaraknowledgeexchange.com/wp-content/uploads/sites/2/2018/07/2018-07-24-Niagara-Counts-2018.pdf
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneel Upadhye, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support in people with Homelessness and Health Behavior, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hospitalizations, measured using administrative health data (time frame: 12 months pre-study enrollment and 12-months post-study enrollment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012697, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.