Hartford 2002.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to reduce anxiety in patients and partners. AIM OF STUDY: to determine the effectiveness of an information and support telephone intervention for reducing anxiety in patients who have undergone CABG surgery and their partners STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: convenience sample. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: first elective CABG without valve replacement/had a partner at home involved in their care/older than 18 years/able to understand and speak english/have a telephone/ able to hear telephone conversations. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: major comorbidity/ psychiatric diagnosis/ generalized anxiety or panic disorder. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: adequate. EPOC‐ QUALITY CRITERIA 2002: B.moderate risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: random number assignment and using opaque envelopes. METHOD OF CONCEALMENT OF ALLOCATION: opaque envelopes. BLINDING: PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square/anova/repeated measures analysis. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: cardiac patients / surgery patients. GEOGRAPHIC LOCATION: Canada. SETTING: discharged home from an acute care setting. NUMBER OF PARTTICIPANTS: ELIGIBLE: 166. RANDOMISED TO INTERVENTION: 81. RANDOMISED TO CONTROL: 68. INCLUDED IN ANALYSIS INTERVENTION GROUP: 63. INCLUDED IN ANALYSIS CONTROL GROUP: 68. AGE: RANGE OR MEAN (SD): 63 (8). GENDER (% MALE): 86. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: cardiovascular disease. OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: CABG. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 98% married, 50% high school, 58% retired.
Interventions	DETAILS OF INTERVENTION: The intervention consisted of information and support to assist patients (and partners) in meeting their needs. Standardized protocols for predefined problems and concerns identified in the literature were developed. The intervention began on the day of discharge; this was followed by 6 telephone calls by NURSE on days 1, 2, 4, 7, 14 and 21 after discharge. The nurse was also on call 24 hours a day. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 6, First time at day 1 day after discharge, Period: 7 weeks, PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 1. 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 / Beck Anxiety Inventory (Beck, 1988) / yes / telephone interview / 2 days and 4 weeks and 8 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: yes. ·POWER CALCULATION? yes. ·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