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.

Condition	Intervention	Phase
Coronary Artery Disease	Procedure: Peer Support	Phase I

Further study details as provided by University of Toronto:

Primary Outcomes: Health-related quality of life (SF-36v2-acute form)
Secondary Outcomes: * Pain (McGill Pain Questionnaire-Short Form); * Interference with Activities (Brief Pain Inventory-Interference Subscale); * Function (Human Activity Profile); * Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)
Expected Total Enrollment:  100

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 purpose of this pilot trial is to test all procedures for an adequately powered randomized controlled trial (RCT). An 8-week pre-post test RCT design with stratification for sex will enrol individuals undergoing CABG surgery at a single site in Southeastern Ontario. Participants (N=100) will include men and women, who are having first time non-emergency CABG surgery and are judged ready for discharge to home. Participants will be randomized to either a usual care (n=50) or an intervention group (usual care plus peer support)(n=50). Participants randomly assigned to the intervention group will receive individualized education and support via telephone, throughout the 8-week recovery period, by peers who possess knowledge derived from the shared experience of having CABG surgery.

A research assistant, blinded to group allocation, will collect outcome data 9-weeks following discharge. The primary endpoint for the trial is HRQOL [SF-36v2 (acute form)]. Secondary outcomes include pain [McGill Pain Questionnaire-Short Form (MPQ-SF)], and related interference with activities [Brief Pain Inventory-Interference Subscale (BPI-I)]. The Human Activity Profile (HAP) will be used to measure function and the Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure depressive symptoms.

Data analyses will include descriptive statistics. The variance and distributional properties of all outcomes will be estimated in order to inform the sample size and methods of analysis for the larger trial. To identify possible factors that form stratification factors in the larger trial, treatment effects will be compared by subgroups. Exploratory analyses will be conducted to determine an optimal analysis approach for the larger trial.

Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00275340

Monica J. Parry, PhD (C)      613-634-0636    parrym@kgh.kari.net
Judy Watt-Watson, PhD      416-978-2850    j.watt.watson@utoronto.ca

Canada, Ontario
      University of Toronto, Toronto,  Ontario,  M5T 1P8,  Canada

Study chairs or principal investigators

Monica J. Parry, PhD (C),  Principal Investigator,  Faculty of Nursing, University of Toronto   

Study ID Numbers:  15880
Last Updated:  January 10, 2006
Record first received:  January 10, 2006
ClinicalTrials.gov Identifier:  NCT00275340
Health Authority: Canada: Ethics Review Committee
ClinicalTrials.gov processed this record on 2006-01-17