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Cardiac Rehabilitation Peer Mentorship

Primary Purpose

Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiac Rehabilitation Peer Mentorship
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Percutaneous Coronary Intervention focused on measuring cardiac rehabilitation, peer mentorship, healthcare utilization, continuity of cardiac care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any condition indicated for cardiac rehabilitation: Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft +/- valve surgery or procedure (e.g., TAVI), heart transplant, ventricular assist device, heart failure, arrhythmia, rhythm device (i.e. implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemaker), congenital heart disease, minor non-disabling stroke or transient ischemic attack (i.e., can ambulate), peripheral vascular disease
  • Proficiency in English language

Exclusion Criteria:

  • Any musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines
  • Being discharged to long-term care
  • Inability to ambulate (i.e. walk unaided at 2mph)

Sites / Locations

  • Toronto General Hospital
  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac Rehabilitation Peer Mentorship

Usual Care

Arm Description

Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral, and arrange a time to call the patient/participant at home to find out about their CR progress. One week post-discharge the peer mentor will mail a card to the patient to remind them of the planned call. Two weeks post-discharge the peer mentor will call the patient at home to determine if they were referred and if they are planning to attend CR. If any barriers are stated by patient the peer mentors will work with the patient to develop possible solutions. Patients can request up to two additional phone calls from the mentors.

Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.

Outcomes

Primary Outcome Measures

Cardiac Rehabilitation Enrollment
A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.

Secondary Outcome Measures

Cardiac Rehabilitation Referral
A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.

Full Information

First Posted
July 28, 2014
Last Updated
November 30, 2015
Sponsor
University Health Network, Toronto
Collaborators
Stony Brook University, York University
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1. Study Identification

Unique Protocol Identification Number
NCT02204449
Brief Title
Cardiac Rehabilitation Peer Mentorship
Official Title
Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Stony Brook University, York University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship from a volunteer cardiac rehabilitation peer mentor, and a control group, in which they will receive usual care. Patients in both groups will be tracked to determine if they are referred to cardiac rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac rehabilitation.
Detailed Description
The current study will be a randomized controlled trial in which cardiac inpatients will be randomized to either receive the intervention (cardiac rehabilitation peer mentorship) or be in the control group (receive usual care). After consent is obtained cardiac patients in the intervention group will be visited, at the hospital bedside, by trained volunteer cardiac rehabilitation peer mentors (i.e., individuals who have completed cardiac rehabilitation) who will provide the patients with information on cardiac rehabilitation as well as encourage the patients to obtain a referral from their healthcare provider. During this visit the cardiac rehabilitation peer mentor will also obtain agreement from the patient to call the patient at home two weeks after their discharge. Those in the control group will not be visited by cardiac rehabilitation peer mentors. One week after discharge the cardiac rehabilitation peer mentors will mail the patients in the intervention a get-well soon card reminding the patient of the visit, giving them more information about the cardiac rehabilitation program, and reminding them of their future scheduled phone call. Two weeks after patients' discharge cardiac rehabilitation peer mentors will call the patients in the intervention group. At this point they will assess how the patient is doing, if they were referred to cardiac rehabilitation and if they enrolled. Any possible barriers the patients have to attending cardiac rehabilitation will also be discussed. Eight weeks post-discharge, patient referral and enrolment will be ascertained by a research assistant blinded to random assignment. Statistical analyses will be conducted to determine any differences between the two groups as well as to determine any differences between men and women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure, Coronary Artery Disease
Keywords
cardiac rehabilitation, peer mentorship, healthcare utilization, continuity of cardiac care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Rehabilitation Peer Mentorship
Arm Type
Experimental
Arm Description
Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral, and arrange a time to call the patient/participant at home to find out about their CR progress. One week post-discharge the peer mentor will mail a card to the patient to remind them of the planned call. Two weeks post-discharge the peer mentor will call the patient at home to determine if they were referred and if they are planning to attend CR. If any barriers are stated by patient the peer mentors will work with the patient to develop possible solutions. Patients can request up to two additional phone calls from the mentors.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Rehabilitation Peer Mentorship
Primary Outcome Measure Information:
Title
Cardiac Rehabilitation Enrollment
Description
A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.
Time Frame
12 weeks after patient is discharged from hospital
Secondary Outcome Measure Information:
Title
Cardiac Rehabilitation Referral
Description
A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.
Time Frame
12 weeks after patient has been discharged from hospital
Other Pre-specified Outcome Measures:
Title
Cardiac Rehabilitation Enrollment in Site Closer to Home
Description
A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.
Time Frame
8 weeks after patient is discharged from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any condition indicated for cardiac rehabilitation: Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft +/- valve surgery or procedure (e.g., TAVI), heart transplant, ventricular assist device, heart failure, arrhythmia, rhythm device (i.e. implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemaker), congenital heart disease, minor non-disabling stroke or transient ischemic attack (i.e., can ambulate), peripheral vascular disease Proficiency in English language Exclusion Criteria: Any musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines Being discharged to long-term care Inability to ambulate (i.e. walk unaided at 2mph)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Grace, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27000785
Citation
Ali-Faisal SF, Benz Scott L, Johnston L, Grace SL. Cardiac rehabilitation referral and enrolment across an academic health sciences centre with eReferral and peer navigation: a randomised controlled pilot trial. BMJ Open. 2016 Mar 21;6(3):e010214. doi: 10.1136/bmjopen-2015-010214.
Results Reference
derived

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Cardiac Rehabilitation Peer Mentorship

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