Cardiac Home Education and Support Trial (CHEST): A Pilot Study

Coronary Artery Disease Clinical Trial

Official title:

A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275340
• Other study ID #: 15880
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2006
• Last updated: June 5, 2009
• Start date: February 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2009
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Peer Support

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Kingston General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related Quality of Life (SF-36v2-Acute Form)		9 weeks	No
Secondary	Pain (McGill Pain Questionnaire-Short Form)		9 weeks	No
Secondary	Interference With Activities (Brief Pain Inventory-Interference Subscale)		9 weeks	No
Secondary	Function (Human Activity Profile)		9 weeks	No
Secondary	Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)		9 weeks	No