Clinical trial NCT00275340: Cardiac Home Education and Support Trial (CHEST): A Pilot Study
Official title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: Pain
Depressive Symptoms
Coronary Artery Bypass
Convalescence
Quality of Life
Human Activities
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Kingston Health Sciences Centre
First posted: 2006-01-11
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.

Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.

Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.

Detailed description: Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. This, combined with reduced hospital length of stays, leaves individuals ill prepared for their recovery after discharge. Individuals experience pain, functional impairment and depressive symptoms; which predispose them to adverse events and impaired health-related quality of life (HRQOL). A home-based peer support program may improve recovery outcomes for individuals following CABG surgery.

The objectives of this pilot trial were to test the feasibility of all procedures, specifically to determine: 1) an estimate of patient and peer recruitment rates, 2) peer compliance and dose of the intervention, 3) peer satisfaction with orientation, 4) peer support activities offered to patients, and 5) patients' satisfaction with peer support. Additionally, exploratory research questions were used to determine indicators of the effects of peer support on HRQOL, pain, pain-related interference with activities, function, depressive symptoms, and enrolment in cardiac rehabilitation. An 8-week pre-post test RCT design enrolled men and women undergoing CABG surgery at a single site in Southeastern Ontario. Patients were randomized to either a usual care or an intervention group. Patients allocated to usual care received preoperative/postoperative education sessions, a preoperative video/information booklet, and preoperative/postoperative visits from in-hospital peer volunteers. In addition to usual care, patients in the intervention group received individualized education and support via telephone for 8 weeks following hospital discharge from trained peer volunteers.

Peer volunteers participated in a 4-hour orientation session. Ninety-three percent of the peers felt adequately prepared for their peer volunteer role and 98% of them initiated calls within 72 hours of the patient's discharge. Peers made an average of 12 calls, less than 30 minutes in duration, to each patient over the 8-week period. Most common support activities provided by the peers included listening to patient concerns, promoting activities, reinforcing rest periods and encouraging achievements. Patients were satisfied with their peer support experience. The intervention group reported improved physical function, role function, less pain and improved cardiac rehabilitation enrolment.

The evidence obtained from this pilot trial suggests that a home-based peer support intervention is feasible following CABG surgery. The information will be used to plan a larger multi-centre trial.

Eligibility criteria: Inclusion Criteria (patients): Men and women who

* are having first-time non-emergency CABG surgery
* are judged ready for discharge
* are being discharged to home \[either their own or to family/friends\]
* have access to and are able to communicate over a telephone
* are able to read, write and understand English

Inclusion Criteria (peers): Men and women who

* have undergone CABG surgery within the last 5 years
* have access to and are able to communicate clearly over a telephone
* are able to read, write and understand English
* have attended a formal cardiac rehabilitation program
* are not associated with the current in-hospital peer volunteer program

Primary outcomes:
measure: Health-related Quality of Life (SF-36v2-acute Form)
timeFrame: 9 weeks
Secondary outcomes:
measure: Pain (McGill Pain Questionnaire-Short Form)
timeFrame: 9 weeks
measure: Interference With Activities (Brief Pain Inventory-Interference Subscale)
timeFrame: 9 weeks
measure: Function (Human Activity Profile)
timeFrame: 9 weeks
measure: Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: Faculty of Nursing, University of Toronto
name: Monica J. Parry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry M, Arthur H, Brooks D, Groll D, Pavlov A. Measuring function in older adults with co-morbid illnesses who are undergoing coronary artery bypass graft (CABG) surgery. Arch Gerontol Geriatr. 2012 May-Jun;54(3):477-83. doi: 10.1016/j.archger.2011.04.013. Epub 2011 Jun 29.
citation: Parry MJ, Watt-Watson J, Hodnett E, Tranmer J, Dennis CL, Brooks D. Cardiac Home Education and Support Trial (CHEST): a pilot study. Can J Cardiol. 2009 Dec;25(12):e393-8. doi: 10.1016/s0828-282x(09)70531-8.