Acute Coronary Syndrome, Chronic Stable Heart Failure, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Keywords
cardiac rehabilitation, peer mentorship, healthcare utilization, continuity of cardiac care
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.
Interventions
BEHAVIORALCardiac Rehabilitation Peer Mentorship
Sponsors
Stony Brook University
York University
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Rehabilitation Enrollment | 12 weeks after patient is discharged from hospital | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Rehabilitation Referral | 12 weeks after patient has been discharged from hospital | A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Rehabilitation Enrollment in Site Closer to Home | 8 weeks after patient is discharged from hospital | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Rehabilitation Peer Mentorship 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 before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.
Cardiac Rehabilitation Peer Mentorship | 46 |
| Usual Care 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. | 47 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Cardiac Rehabilitation Peer Mentorship | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 16.5 | 62.6 years STANDARD_DEVIATION 13.1 | 62.7 years STANDARD_DEVIATION 14.8 |
| Region of Enrollment Canada | 46 participants | 47 participants | 93 participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 64 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 weeks after patient is discharged from hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Rehabilitation Peer Mentorship | Cardiac Rehabilitation Enrollment | 20 participants |
| Usual Care | Cardiac Rehabilitation Enrollment | 15 participants |
Secondary
Cardiac Rehabilitation Referral
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Rehabilitation Peer Mentorship | Cardiac Rehabilitation Referral | 31 participants |
| Usual Care | Cardiac Rehabilitation Referral | 27 participants |
Other Pre-specified
Cardiac Rehabilitation Enrollment in Site Closer to Home
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Rehabilitation Peer Mentorship | Cardiac Rehabilitation Enrollment in Site Closer to Home | 17 participants |
| Usual Care | Cardiac Rehabilitation Enrollment in Site Closer to Home | 13 participants |