Roebuck 1999.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to reduce anxiety and depression. AIM OF STUDY: the study tests the hypothesis that telephone follow‐up from the ward will reduce patients' anxiety and depression levels in the early post‐discharge period. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: patients admitted during a 21‐day consecutive period were enrolled to a defined group. After completion of this period, no patients were enrolled for 7 days to prevent patient overlap if their discharge was delayed. The process was then repeated with the patients being enrolled to the alternative group. Patients were asked for consent and enrolled into the study on the day they were given a planned discharge date. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: have undergone elective coronary artery bypass grafting or valve replacement. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: unable to give consent/ could not communicate in English/ history of mental illness/ have undergone emergency cardiac surgery. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: inadequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: A convenience sampling model utilizing alternative block selection was used. METHOD OF CONCEALMENT OF ALLOCATION: not specified. 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: Mann‐Whitney U test. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: cardiac patients / surgery patients. GEOGRAPHIC LOCATION: UK. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 78. RANDOMISED TO INTERVENTION: 45. RANDOMISED TO CONTROL: 31. INCLUDED IN ANALYSIS INTERVENTION GROUP: 42. INCLUDED IN ANALYSIS CONTROL GROUP: 31. AGE: RANGE OR MEAN (SD): unclear. GENDER (% MALE): unclear. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: coronary heart and/or valve disease. OTHER HEALTH PROBLEM/S: not specified. TREATMENT RECEIVED/RECEIVING: CABG‐surgery or valve replacement. OTHER SOCIAL/DEMOGRAPHIC DETAILS: not given.
Interventions	DETAILS OF INTERVENTION: patients in the intervention group received standard discharge advice/information plus 2 additional follow‐up calls from a nurse. Contact was made at 7 and 21 days after discharge. On contact, the callers introduced themselves and patient identity was confirmed. Patients were invited to discuss how they had been since their last contact with the ward and encouraged to raise any concerns or difficulties they had experienced since that time. DETAILS OF CONTROL: standard advice included the patient being offered a selection of information leaflets, a personal exercise plan and an individual discussion with their named nurse over concerns and discharge medications. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 2. First time at day 7 after discharge. Period: 3 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 2 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, ..): Anxiety / Hospital anxiety and depression scale (Zigmond, 1983) / yes / postal questionnaire / 5 weeks after discharge. Depression / Hospital anxiety and depression scale (Zigmond, 1983) / yes / postal questionnaire / 5 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·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?	High risk	C ‐ Inadequate