Colitis, UlcerativePRICENCT02931799
Prevention of Readmissions at IBD Centres of Excellence
A study testing Nurse Follow-Up, Electronic Monitoring and Post-Discharge Questionnaire in people with Colitis, Ulcerative and Crohn Disease, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased risk of repeat hospitalizations within the same calendar year. Given that hospital readmissions represent a significant burden to patients and the health care system, a standardised pathway for IBD patients discharged from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Nurse Follow-Up, Electronic Monitoring and Post-Discharge Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- IBD diagnosis of UC or CD
- Hospitalization for diagnosis or exacerbation of IBD
Who cannot join
- Inability to provide informed consent
- No internet access
- Death during hospitalization
- History of surgical management for IBD
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Nguyen Geoffrey, MD, PhD, 416-586-4800 ext. 2819, geoff.nguyen@utoronto.ca
Geoffrey Nguyen, MD, PhD
About this study
Official title: Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence
Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased risk of repeat hospitalizations within the same calendar year. Given that hospital readmissions represent a significant burden to patients and the health care system, a standardised pathway for IBD patients discharged from the hospital can have a significant impact on reducing readmission rates, healthcare utilization and patient satisfaction. The primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway, involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD readmission rates.
Read the detailed description
Background: Hospital readmission rates are a key issue in health policy as they place a large burden on the healthcare system. Readmissions are a preventable source of health care expenditure and in some cases, represent an opportunity for quality improvement. Lack of standardization in hospital discharge processes, and deficiencies in the transition of care after discharge, predispose patients to an increased risk of illness, hospital utilization and healthcare costs. Previously identified issues in discharge planning include timely transmission of discharge summaries to primary care providers and lack of communication between providers and patients with respect to discharge medications and follow-up appointments.
Rationale: Various post-discharge interventions have been effective in reducing hospital readmission rates and increasing patient satisfaction. However, in patients with flares of Inflammatory Bowel Disease (IBD), there is limited evidence to suggest which processes of care are protective against readmissions. IBD patients are frequently hospitalized, with over 22% of patients hospitalized within the first 2 years of diagnosis. Moreover, readmission rates are high in the IBD population, with over 20% of patients readmitted within the same calendar year of their initial hospitalization. Alongside increased healthcare expenditure, hospitalizations in the IBD population are associated with a number of nosocomial complications including venous thromboembolism and infection.
Specific Aim: The primary aim of this study is to determine whether standardized IBD post-discharge pathway, involving regular follow-up with an advanced practice nurse and electronic monitoring through a web-based application, decreases the risk of IBD readmissions when compared to the usual standard of care.
Study Design: All IBD inpatients with a diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) will be approached to participate in this parallel group randomized control trial. Patients randomized to the control arm will be discharged with the usual post-discharge standard of care. Patients randomized to the intervention arm will receive the usual post-discharge standard of care, in addition to organised follow-up with an advance practice nurse and electronic monitoring through a web-based application.
- Being tested
- Nurse Follow-Up, Electronic Monitoring, Post-Discharge Questionnaire, Standard of Care
- Keywords
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Gastroenterology, Quality Improvement, Post-Discharge
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Follow-UpBehavioural
Organized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-discharge; to monitor patients' health status with respect to their IBD.
Electronic MonitoringOther
Patients will be provided access to a web-based application entitled: 'Health Promise'. The application will generate surveys every 3 days, where patients will self-report their IBD symptoms, quality of life and medication adherence on three separate scales:
- PRO-2 Scale for patients with Crohn's Disease
- 6-Point Mayo Score for patients with Ulcerative Colitis
- Morisky Medication Adherence Scale (MMAS-4)
The survey responses will be monitored by an IBD advanced practice nurse, to triage patients for outpatient follow-up.
Post-Discharge QuestionnaireOther
Patients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis; and Patient Satisfaction with the 'Health Promise' application.
Post-Discharge QuestionnaireOther
Patients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis.
Standard of CareOther
Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge
| Study group | Role | What they receive |
|---|---|---|
| Nurse Follow-Up and Electronic Monitoring | Experimental | Not described Receives: Behavioral: Nurse Follow-Up; Other: Electronic Monitoring; Other: Post-Discharge Questionnaire; Other: Standard of Care |
| Minimal Intervention | Active comparator | Not described Receives: Other: Post-Discharge Questionnaire; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Discharge Readmission
Occurrence of post-discharge readmissions will be recorded for all patients enrolled in the study. Post-discharge readmissions will be defined as any IBD readmission subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge readmission rates will be compared between study arms.
Measured: Within 30 days of initial hospital discharge
Secondary outcomes (5)
Post-Discharge Occurrence of Venous Thromboembolism
Occurrence of post-discharge venous thromboembolism will be recorded for all patients enrolled in the study. Post-discharge occurrence of venous thromboembolism will be defined as any event of venous thromboembolism subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge rates of venous thromboembolism will be compared between study arms.
Measured: Within 30 days of initial hospital discharge
Patient Satisfaction with Health Care in IBD
Patient satisfaction with health care in IBD as measured by CACHE will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for Patient Satisfaction with Health Care in IBD will be compared between study arms.
Measured: 30 days post-discharge
IBD related Quality of Life
IBD related Quality of Life as measured by IBDQ will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for IBD related Quality of Life will be compared between study arms.
Measured: 30 days post-discharge
Disease Activity
Disease Activity as measured by PRO-2 for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for disease activity will be compared between study arms.
Measured: 30 days post-discharge
Patient Satisfaction with 'Health Promise'
Patient satisfaction with the 'Heath Promise' application will be collected from patients enrolled in the experimental arm, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean score for patient satisfaction the 'Health Promise' application will be interpreted.
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start1 Oct 2018 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Canada
- Responsible party
- Sponsor
- Investigators
- Geoffrey Nguyen, MD, PhD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931799
- Sponsor's protocol ID
- PRICE
- Acronym
- PRICE
- Status last verified
- Sep 2018
- First submitted
- 11 Oct 2016
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casellas F, Ginard D, Vera I, Torrejon A; GETECCU. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68. doi: 10.1097/MIB.0b013e31827febd1.
PubMed 23429448Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004 May;10(3):261-9. doi: 10.1097/00054725-200405000-00014.
PubMed 15290922Hazratjee N, Agito M, Lopez R, Lashner B, Rizk MK. Hospital readmissions in patients with inflammatory bowel disease. Am J Gastroenterol. 2013 Jul;108(7):1024-32. doi: 10.1038/ajg.2012.343.
PubMed 23820989Vest JR, Gamm LD, Oxford BA, Gonzalez MI, Slawson KM. Determinants of preventable readmissions in the United States: a systematic review. Implement Sci. 2010 Nov 17;5:88. doi: 10.1186/1748-5908-5-88.
PubMed 21083908Makaryus AN, Friedman EA. Patients' understanding of their treatment plans and diagnosis at discharge. Mayo Clin Proc. 2005 Aug;80(8):991-4. doi: 10.4065/80.8.991.
PubMed 16092576Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med. 2003 Aug;18(8):646-51. doi: 10.1046/j.1525-1497.2003.20722.x.
PubMed 12911647Nguyen GC, Bollegala N, Chong CA. Factors associated with readmissions and outcomes of patients hospitalized for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1897-1904.e1. doi: 10.1016/j.cgh.2014.02.042. Epub 2014 Mar 26.
PubMed 24681074Bernstein CN, Nabalamba A. Hospitalization, surgery, and readmission rates of IBD in Canada: a population-based study. Am J Gastroenterol. 2006 Jan;101(1):110-8. doi: 10.1111/j.1572-0241.2006.00330.x.
PubMed 16405542Nguyen GC, Sam J. Rising prevalence of venous thromboembolism and its impact on mortality among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Sep;103(9):2272-80. doi: 10.1111/j.1572-0241.2008.02052.x. Epub 2008 Aug 5.
PubMed 18684186Nguyen GC, Kaplan GG, Harris ML, Brant SR. A national survey of the prevalence and impact of Clostridium difficile infection among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Jun;103(6):1443-50. doi: 10.1111/j.1572-0241.2007.01780.x. Epub 2008 May 29.
PubMed 18513271
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence
- ClinicalTrials.gov ID
- NCT02931799
- Acronym / sponsor ID
- PRICE / PRICE
- Keywords
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Gastroenterology, Quality Improvement, Post-Discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Canada
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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.
Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased risk of repeat hospitalizations within the same calendar year. Given that hospital readmissions represent a significant burden to patients and the health care system, a standardised pathway for IBD patients discharged from the hospital can have a significant impact on reducing readmission rates, healthcare utilization and patient satisfaction. The primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway, involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD readmission rates.
Detailed description
Background: Hospital readmission rates are a key issue in health policy as they place a large burden on the healthcare system. Readmissions are a preventable source of health care expenditure and in some cases, represent an opportunity for quality improvement. Lack of standardization in hospital discharge processes, and deficiencies in the transition of care after discharge, predispose patients to an increased risk of illness, hospital utilization and healthcare costs. Previously identified issues in discharge planning include timely transmission of discharge summaries to primary care providers and lack of communication between providers and patients with respect to discharge medications and follow-up appointments.
Rationale: Various post-discharge interventions have been effective in reducing hospital readmission rates and increasing patient satisfaction. However, in patients with flares of Inflammatory Bowel Disease (IBD), there is limited evidence to suggest which processes of care are protective against readmissions. IBD patients are frequently hospitalized, with over 22% of patients hospitalized within the first 2 years of diagnosis. Moreover, readmission rates are high in the IBD population, with over 20% of patients readmitted within the same calendar year of their initial hospitalization. Alongside increased healthcare expenditure, hospitalizations in the IBD population are associated with a number of nosocomial complications including venous thromboembolism and infection.
Specific Aim: The primary aim of this study is to determine whether standardized IBD post-discharge pathway, involving regular follow-up with an advanced practice nurse and electronic monitoring through a web-based application, decreases the risk of IBD readmissions when compared to the usual standard of care.
Study Design: All IBD inpatients with a diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) will be approached to participate in this parallel group randomized control trial. Patients randomized to the control arm will be discharged with the usual post-discharge standard of care. Patients randomized to the intervention arm will receive the usual post-discharge standard of care, in addition to organised follow-up with an advance practice nurse and electronic monitoring through a web-based application.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Follow-Up and Electronic Monitoring | Experimental | Behavioral: Nurse Follow-Up, Other: Electronic Monitoring, Other: Post-Discharge Questionnaire, Other: Standard of Care |
| Minimal Intervention | Active comparator | Other: Post-Discharge Questionnaire, Other: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- IBD diagnosis of UC or CD
- Hospitalization for diagnosis or exacerbation of IBD
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- No internet access
- Death during hospitalization
- History of surgical management for IBD
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 |
|---|---|---|
| Nurse Follow-UpOrganized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-discharge; to monitor patients' health status with respect to their IBD. | Behavioural | Nurse Follow-Up and Electronic Monitoring |
| Electronic MonitoringPatients will be provided access to a web-based application entitled: 'Health Promise'. The application will generate surveys every 3 days, where patients will self-report their IBD symptoms, quality of life and medication adherence on three separate scales: * PRO-2 Scale for patients with Crohn's Disease * 6-Point Mayo Score for patients with Ulcerative Colitis * Morisky Medication Adherence Scale (MMAS-4) The survey responses will be monitored by an IBD advanced practice nurse, to triage patients for outpatient follow-up. | Other | Nurse Follow-Up and Electronic Monitoring |
| Post-Discharge QuestionnairePatients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis; and Patient Satisfaction with the 'Health Promise' application. | Other | Nurse Follow-Up and Electronic Monitoring |
| Post-Discharge QuestionnairePatients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis. | Other | Minimal Intervention |
| Standard of CareDischarge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge | Other | Minimal Intervention, Nurse Follow-Up and Electronic Monitoring |
Primary outcome
Post-Discharge Readmission
Time frame: Within 30 days of initial hospital discharge
Occurrence of post-discharge readmissions will be recorded for all patients enrolled in the study. Post-discharge readmissions will be defined as any IBD readmission subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge readmission rates will be compared between study arms.
5 secondary outcomes
Post-Discharge Occurrence of Venous Thromboembolism
Time frame: Within 30 days of initial hospital discharge
Patient Satisfaction with Health Care in IBD
Time frame: 30 days post-discharge
IBD related Quality of Life
Time frame: 30 days post-discharge
Disease Activity
Time frame: 30 days post-discharge
Patient Satisfaction with 'Health Promise'
Time frame: 30 days post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background: PubMed 23429448Casellas F, Ginard D, Vera I, Torrejon A; GETECCU. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68. doi: 10.1097/MIB.0b013e31827febd1.
- Background: PubMed 15290922Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004 May;10(3):261-9. doi: 10.1097/00054725-200405000-00014.
- Background: PubMed 23820989Hazratjee N, Agito M, Lopez R, Lashner B, Rizk MK. Hospital readmissions in patients with inflammatory bowel disease. Am J Gastroenterol. 2013 Jul;108(7):1024-32. doi: 10.1038/ajg.2012.343.
- Background: PubMed 21083908Vest JR, Gamm LD, Oxford BA, Gonzalez MI, Slawson KM. Determinants of preventable readmissions in the United States: a systematic review. Implement Sci. 2010 Nov 17;5:88. doi: 10.1186/1748-5908-5-88.
- Background: PubMed 16092576Makaryus AN, Friedman EA. Patients' understanding of their treatment plans and diagnosis at discharge. Mayo Clin Proc. 2005 Aug;80(8):991-4. doi: 10.4065/80.8.991.
- Background: PubMed 12911647Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med. 2003 Aug;18(8):646-51. doi: 10.1046/j.1525-1497.2003.20722.x.
- Background: PubMed 24681074Nguyen GC, Bollegala N, Chong CA. Factors associated with readmissions and outcomes of patients hospitalized for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1897-1904.e1. doi: 10.1016/j.cgh.2014.02.042. Epub 2014 Mar 26.
- Background: PubMed 16405542Bernstein CN, Nabalamba A. Hospitalization, surgery, and readmission rates of IBD in Canada: a population-based study. Am J Gastroenterol. 2006 Jan;101(1):110-8. doi: 10.1111/j.1572-0241.2006.00330.x.
- Background: PubMed 18684186Nguyen GC, Sam J. Rising prevalence of venous thromboembolism and its impact on mortality among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Sep;103(9):2272-80. doi: 10.1111/j.1572-0241.2008.02052.x. Epub 2008 Aug 5.
- Background: PubMed 18513271Nguyen GC, Kaplan GG, Harris ML, Brant SR. A national survey of the prevalence and impact of Clostridium difficile infection among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Jun;103(6):1443-50. doi: 10.1111/j.1572-0241.2007.01780.x. Epub 2008 May 29.
- 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.
Geoffrey Nguyen, MD, PhD principal investigator
Mount Sinai Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Follow-Up, Electronic Monitoring and Post-Discharge Questionnaire in people with Colitis, Ulcerative and Crohn Disease, run by Mount Sinai Hospital, Canada 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoffrey Nguyen, MD, PhD (416-586-4800 ext. 2819, geoff.nguyen@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Discharge Readmission (time frame: Within 30 days of initial hospital discharge). 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 NCT02931799, which also lists 10 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 10 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.