Access to Primary CareNCT05484609
Access to Primary Care for People With Opioid Use Disorder
A study testing OUD scenario and Diabetes scenario in people with Access to Primary Care, run by Women's College Hospital at 1 site in Canada.
Trial summary
Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Access to Primary Care
- What is being tested?
- OUD scenario and Diabetes scenario
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 30 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- physicians with an active, unrestricted, independent practice in Ontario with a self-reported specialty in Family Medicine
Who cannot join
- physicians with restricted practices (e.g., could not prescribe opioids)
- physician not in independent practice (i.e., physicians in training)
- physicians whose practice address is in a community with a population less than 10,000, unless they are close (less than 50km) to a community with a population greater than 20,000.
- physicians who do not provide primary care
- physicians who require a health card number prior to offering a new patient appointment
- physicians who require an in person visit prior to offering a new patient appointment
- physicians who we are unable to reach after five phone calls and do not have voicemail
- physicians who work at same practice address as another randomly-selected physician included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Access to Primary Care for People With Opioid Use Disorder: a Randomized Controlled Audit Study
Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. The reasons are unclear, but may be related to patient factors, system barriers and provider factors, including discrimination.
Research goal: Our primary goal is to determine if discrimination by primary care physicians plays a role in poor access to primary care for those in treatment for OUD. The answers will help researchers and policy-makers find ways to improve access to primary care for this vulnerable population.
Read more
Research question: Are people in treatment for OUD less likely to be offered a new patient appointment with a physician compared to those in treatment for diabetes? Overall study design: In this randomized controlled trial (RCT), the investigators will make unannounced phone calls to primary care physicians' practices to ask for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes, or a patient in treatment for OUD. Our outcome measure is an unconditional offer of a new patient appointment with the physician contacted or with another physician at the same practice. In an secondary analysis the investigators will determine the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment.
Participants: Randomly-selected primary care physicians in Ontario. Data analysis methods: The investigators will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.
Read the detailed description
Study context
According to the World Health Organization (WHO) primary health care is a "highly effective and efficient way to address the main causes and risks of poor health and wellbeing today" (1). Primary care is particularly important for vulnerable populations as it appears to mitigate effects from factors like low socioeconomic status (2-4). This appears to be true for those with opioid use disorder (OUD): in previous work, enrolment to a primary care physician was associated with higher rates of cancer screening and diabetes monitoring for those in treatment for OUD (5).
In universal health care systems, like Canada's, everyone is entitled to primary health care, regardless of health conditions or financial status. Our previous work, however, indicates that Ontarians in treatment for OUD are less likely to have access to primary care than others. Only 43% of people in treatment for OUD were enrolled with a primary care physician compared to 73% of matched controls (5). Our findings are consistent with an American study that reported poor access to primary care for those in treatment for OUD (6). These findings are concerning. Not only are those with OUD a vulnerable population with complex health needs, their numbers are also growing. OUD currently affects 15.5 million people worldwide (7), with Canada and the United States (U.S.) having the highest burden of disease (8).
Barriers to primary care for those with OUD have been poorly studied. Patient factors, such as difficulty attending appointments, and system barriers, like transportation costs, may affect access (9). Provider factors appear to play a role as well. A qualitative interview study in Ontario found that provider discrimination and stigma towards those with substance use disorder presented a barrier to accessing primary care (9). Other studies support this finding, showing that many providers, just like the general public, have stigma towards those with substance use disorder (10,11). It is possible that negative attitudes lead providers to discriminate against people with OUD when deciding whether to offer a new patient appointment.
Study rationale and goal
Our study goal is to determine if discrimination by physicians is a barrier to accessing primary care for those with OUD.
Research questions
- Are people in treatment for OUD less likely to be offered a new patient appointment compared to people in treatment for diabetes?
- What is the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment?
Methods
The investigators will conduct a randomized controlled trial (RCT), using a similar approach to Olah et al that looked at access to primary care for those of low socio-economic status (14). They will make unannounced phone calls to primary care physicians in Ontario asking for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician. In the secondary exploratory analyses, the investigators will also assess the impact of the model of care (team vs not), gender, rural vs urban, and years in practice.
Population The investigators will use information on the College of Physicians and Surgeon of Ontario (CPSO) website to identify all physicians in Ontario who have an active, independent, unrestricted practice with a self-reported speciality in family medicine (20).
Sample size calculation The objective of our study is to compare the proportion of patients offered a new patient appointment in each of the arms of the study. Our team consensus was that a 10% difference in the proportion of new patient appointments would be clinically meaningful. In a similar study design, Olah et al found that 23.5 % of those with diabetes were offered an appointment from a physician in Ontario (14). For our sample size calculation, the investigators assumed that 23% of those with diabetes and 13% of those in treatment for OUD would be offered a new appointment. At 80% power, 5% type-1 error level, to detect 10% difference in the proportion of new appointments offered between opioid (13%) and diabetes (23%) groups, would require 231 physicians with each scenario. However, previous studies using this approach found that up to one third of physicians were excluded at the time of making the phone call (because physician worked in a walk-in clinic or had a practice that was not primary care; or because of no response after five phone calls) (14,18). Therefore, the study should include 308 physicians in each arm.
To create our sample, the investigators will create a database using publicly-available information on the CPSO website. They will include all physicians who have an active, unrestricted, independent practice with speciality in Family Medicine. They will also record the physician's address(es), postal code, phone number(s), date of registration for independent practice and gender in our database. Physicians will only be identified in the database by a unique identifier. All these data items are collected by the CPSO. They will then group the physicians by primary practice address and then randomly select (using a random number generator), one physician from the list of physicians who work at the same site. The investigators will exclude other physicians from the same practice address.They will then use a random number generator to randomly select a statistical determined sample of physicians. We will randomly assign them to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician.
Scenarios The investigators will train a research assistant (RA) in the clinical scenario and pilot-test the interaction with a simulated receptionist giving different responses (see Appendix 1: Sample Script). To reduce confounding, they will have the same RA make all the phone calls. The RA will contact each physician to request an appointment, for one of the two clinical scenarios. The investigators will exclude physicians at the time of making the phone call if the physician's receptionist reports that the clinic is a walk-in, or that the physician does not offer primary care (14). They will also exclude practices at the time of making the call if they request an in person visit or health card number prior to making an offer of a new patient appointment. The investigators will attempt to reach a physician up to five times over a six-week period. For offices with voicemail, they will leave a message with the script but continue to make up to five phone calls to speak with someone in person. The investigators will accept call-backs up to six weeks after the initial phone call. They will exclude practices where they are not able to speak to anyone or leave a voicemail after five phone calls. They will only request an appointment once from a physician. If the physician's clinic offers an appointment, they will call the next day and cancel it. The investigators will continue sampling until they reach our target number of physicians.
Data analysis The investigators will use descriptive statistics to report on the population. To answer our research question, they will compare the proportion of patients offered a primary care appointment (a binary outcome) across the randomized groups. They will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.
The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.
For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.
The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.
For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.
- Conditions
- Access to Primary Care
- Being tested
- OUD scenario, Diabetes scenario
- Keywords
- primary care, access to health care, opioid use disorder, addictions, health services
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OUD scenarioOther
The patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of a patient with opioid use disorder undergoing methadone treatment with an addiction physician.
Diabetes scenarioOther
The patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of patient with diabetes in treatment with an endocrinologist.
| Study group | Role | What they receive |
|---|---|---|
| OUD scenario | Experimental | Not described Receives: Other: OUD scenario |
| Diabetes scenario | Active comparator | Not described Receives: Other: Diabetes scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with an offer of a new patient appointment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Access to Primary CareStudies of the same condition, open and under way.
- 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
- 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Spithoff, Women's College Hospital
- Investigators
- Sheryl M Spithoff, MD MSc, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484609
- Sponsor's protocol ID
- 410012447
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
Spithoff S, Mogic L, Hum S, Moineddin R, Meaney C, Kiran T. Examining Access to Primary Care for People With Opioid Use Disorder in Ontario, Canada: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233659. doi: 10.1001/jamanetworkopen.2022.33659.
PubMed 36178686
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Access to Primary Care for People With Opioid Use Disorder: a Randomized Controlled Audit Study
- ClinicalTrials.gov ID
- NCT05484609
- Acronym / sponsor ID
- 410012447
- Conditions
- Access to Primary Care
- Keywords
- primary care, access to health care, opioid use disorder, addictions, health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 2 Aug 2022 (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.
Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. The reasons are unclear, but may be related to patient factors, system barriers and provider factors, including discrimination.
Research goal: Our primary goal is to determine if discrimination by primary care physicians plays a role in poor access to primary care for those in treatment for OUD. The answers will help researchers and policy-makers find ways to improve access to primary care for this vulnerable population.
Research question: Are people in treatment for OUD less likely to be offered a new patient appointment with a physician compared to those in treatment for diabetes? Overall study design: In this randomized controlled trial (RCT), the investigators will make unannounced phone calls to primary care physicians' practices to ask for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes, or a patient in treatment for OUD. Our outcome measure is an unconditional offer of a new patient appointment with the physician contacted or with another physician at the same practice. In an secondary analysis the investigators will determine the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment.
Participants: Randomly-selected primary care physicians in Ontario. Data analysis methods: The investigators will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.
Detailed description
Study context
According to the World Health Organization (WHO) primary health care is a "highly effective and efficient way to address the main causes and risks of poor health and wellbeing today" (1). Primary care is particularly important for vulnerable populations as it appears to mitigate effects from factors like low socioeconomic status (2-4). This appears to be true for those with opioid use disorder (OUD): in previous work, enrolment to a primary care physician was associated with higher rates of cancer screening and diabetes monitoring for those in treatment for OUD (5).
In universal health care systems, like Canada's, everyone is entitled to primary health care, regardless of health conditions or financial status. Our previous work, however, indicates that Ontarians in treatment for OUD are less likely to have access to primary care than others. Only 43% of people in treatment for OUD were enrolled with a primary care physician compared to 73% of matched controls (5). Our findings are consistent with an American study that reported poor access to primary care for those in treatment for OUD (6). These findings are concerning. Not only are those with OUD a vulnerable population with complex health needs, their numbers are also growing. OUD currently affects 15.5 million people worldwide (7), with Canada and the United States (U.S.) having the highest burden of disease (8).
Barriers to primary care for those with OUD have been poorly studied. Patient factors, such as difficulty attending appointments, and system barriers, like transportation costs, may affect access (9). Provider factors appear to play a role as well. A qualitative interview study in Ontario found that provider discrimination and stigma towards those with substance use disorder presented a barrier to accessing primary care (9). Other studies support this finding, showing that many providers, just like the general public, have stigma towards those with substance use disorder (10,11). It is possible that negative attitudes lead providers to discriminate against people with OUD when deciding whether to offer a new patient appointment.
Study rationale and goal
Our study goal is to determine if discrimination by physicians is a barrier to accessing primary care for those with OUD.
Research questions
- Are people in treatment for OUD less likely to be offered a new patient appointment compared to people in treatment for diabetes?
- What is the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment?
Methods
The investigators will conduct a randomized controlled trial (RCT), using a similar approach to Olah et al that looked at access to primary care for those of low socio-economic status (14). They will make unannounced phone calls to primary care physicians in Ontario asking for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician. In the secondary exploratory analyses, the investigators will also assess the impact of the model of care (team vs not), gender, rural vs urban, and years in practice.
Population The investigators will use information on the College of Physicians and Surgeon of Ontario (CPSO) website to identify all physicians in Ontario who have an active, independent, unrestricted practice with a self-reported speciality in family medicine (20).
Sample size calculation The objective of our study is to compare the proportion of patients offered a new patient appointment in each of the arms of the study. Our team consensus was that a 10% difference in the proportion of new patient appointments would be clinically meaningful. In a similar study design, Olah et al found that 23.5 % of those with diabetes were offered an appointment from a physician in Ontario (14). For our sample size calculation, the investigators assumed that 23% of those with diabetes and 13% of those in treatment for OUD would be offered a new appointment. At 80% power, 5% type-1 error level, to detect 10% difference in the proportion of new appointments offered between opioid (13%) and diabetes (23%) groups, would require 231 physicians with each scenario. However, previous studies using this approach found that up to one third of physicians were excluded at the time of making the phone call (because physician worked in a walk-in clinic or had a practice that was not primary care; or because of no response after five phone calls) (14,18). Therefore, the study should include 308 physicians in each arm.
To create our sample, the investigators will create a database using publicly-available information on the CPSO website. They will include all physicians who have an active, unrestricted, independent practice with speciality in Family Medicine. They will also record the physician's address(es), postal code, phone number(s), date of registration for independent practice and gender in our database. Physicians will only be identified in the database by a unique identifier. All these data items are collected by the CPSO. They will then group the physicians by primary practice address and then randomly select (using a random number generator), one physician from the list of physicians who work at the same site. The investigators will exclude other physicians from the same practice address.They will then use a random number generator to randomly select a statistical determined sample of physicians. We will randomly assign them to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician.
Scenarios The investigators will train a research assistant (RA) in the clinical scenario and pilot-test the interaction with a simulated receptionist giving different responses (see Appendix 1: Sample Script). To reduce confounding, they will have the same RA make all the phone calls. The RA will contact each physician to request an appointment, for one of the two clinical scenarios. The investigators will exclude physicians at the time of making the phone call if the physician's receptionist reports that the clinic is a walk-in, or that the physician does not offer primary care (14). They will also exclude practices at the time of making the call if they request an in person visit or health card number prior to making an offer of a new patient appointment. The investigators will attempt to reach a physician up to five times over a six-week period. For offices with voicemail, they will leave a message with the script but continue to make up to five phone calls to speak with someone in person. The investigators will accept call-backs up to six weeks after the initial phone call. They will exclude practices where they are not able to speak to anyone or leave a voicemail after five phone calls. They will only request an appointment once from a physician. If the physician's clinic offers an appointment, they will call the next day and cancel it. The investigators will continue sampling until they reach our target number of physicians.
Data analysis The investigators will use descriptive statistics to report on the population. To answer our research question, they will compare the proportion of patients offered a primary care appointment (a binary outcome) across the randomized groups. They will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.
The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.
For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.
The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.
For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| OUD scenario | Experimental | Other: OUD scenario |
| Diabetes scenario | Active comparator | Other: Diabetes scenario |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- physicians with an active, unrestricted, independent practice in Ontario with a self-reported specialty in Family Medicine
Key exclusion criteria (8 listed)
- physicians with restricted practices (e.g., could not prescribe opioids)
- physician not in independent practice (i.e., physicians in training)
- physicians whose practice address is in a community with a population less than 10,000, unless they are close (less than 50km) to a community with a population greater than 20,000.
- physicians who do not provide primary care
- physicians who require a health card number prior to offering a new patient appointment
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 |
|---|---|---|
| OUD scenarioThe patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of a patient with opioid use disorder undergoing methadone treatment with an addiction physician. | Other | OUD scenario |
| Diabetes scenarioThe patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of patient with diabetes in treatment with an endocrinologist. | Other | Diabetes scenario |
Primary outcome
Proportion of participants with an offer of a new patient appointment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 36178686Spithoff S, Mogic L, Hum S, Moineddin R, Meaney C, Kiran T. Examining Access to Primary Care for People With Opioid Use Disorder in Ontario, Canada: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233659. doi: 10.1001/jamanetworkopen.2022.33659.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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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.
Sheryl M Spithoff, MD MSc principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OUD scenario and Diabetes scenario in people with Access to Primary Care, run by Women's College Hospital 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with an offer of a new patient appointment (time frame: Baseline). 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 NCT05484609, which also lists 1 linked publication.
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 2 Aug 2022.