Gortner 1990.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: The TFU was aimed to monitor recovery, to reinforce risk‐factor reduction, coach toward activity and to provide reassurance. AIM OF STUDY: whether in‐patient education and telephone monitoring during convalescence enhanced perceptions of cardiac efficacy and reported activity. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: patient and their family members were approached the day before surgery and invited to participate in the study. Randomization occurred following transfer from the ICU and was carried out according to cluster randomized design. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY first‐time and repeat cardiac surgery patients between 30 and 75 years of age undergoing CABG or valve replacement EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? unclear. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: adequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: "Randomization occured following transfer from the intensive care unit and was carried out according to a cluster randomization design (Donner et al. 1981). In this procedure, a a group or cluster of subjects is formed and then is assigned as a group, using computer‐generated random numbers, to experimental or control conditions. Cluster size was randomly determined, and usually was eight to ten patients...Random assignments were made in accordance with plans drawn by W. Hauck, the consulting statistician; the sequence of randomization was not revealed to research assistants." (p. 1134). METHOD OF CONCEALMENT OF ALLOCATION: as above. BLINDING: ·PARTICIPANTS: no ·PROVIDER/S: no ·OUTCOME ASSESSOR/S: no INTENTION TO TREAT ANALYSIS: not stated BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes STATISTICAL METHODS AND THEIR APPROPRIATENESS: t‐test/ancova/multiple regression CONSUMER INVOLVEMENT: not stated
Participants	DESCRIPTION : cardiac patients / surgery patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 156. RANDOMISED TO INTERVENTION: 75. RANDOMISED TO CONTROL: 77. INCLUDED IN ANALYSIS INTERVENTION GROUP: 71. INCLUDED IN ANALYSIS CONTROL GROUP: 77. AGE: RANGE OR MEAN (SD): 58. GENDER (% MALE): 80. ETHNICITY: 42% caucasian, PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: cardiovascular disease, OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: CABG and/or valve replacement. OTHER SOCIAL/DEMOGRAPHIC DETAILS:
Interventions	DETAILS OF INTERVENTION: Both groups were provided with routine information on recovery. The experimental group additionally received a slide programme and brief counseling session before discharge. After discharge the experimental group was followed by weekly telephones from a NURSE for 4 weeks and biweekly telephone between 4th and 8th week after discharge. DETAILS OF CONTROL: usual care, CO‐INTERVENTION? yes. DETAILS OF CO‐INTERVENTIONS: routine information on recovery, consisting of a booklet and slide program. DELIVERY OF INTERVENTION Frequency: 6. First time at day 1 week after discharge. Period: 8 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: poor since outcome assessment coincides with intervention. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 3 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): Mood state / Profile of Mood States (McNair 1971) / yes / telephone interview / 4, 12 and 24 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Activity level / self‐developed / no / patient's self‐report during telephone interview / 4, 8, 12 and 24 weeks. Self‐efficacy / Jenkins Self‐Efficacy Scale (Jenkins 1988) / yes / telephone interview / at discharge, 4, 8, 12 and 24 weeks after discharge. C.Other consumer oriented outcomes (e.g. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (e.g. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR: yes. ·POWER CALCULATION? ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate