Tranmer 2004.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to improve cardiac surgery recovery following hospital discharge, as reflected in improved health related quality of life, decreased symptom distress, improved satisfaction with discharge and follow‐up care and decreased unplanned contacts with the hospital. AIM OF STUDY: The purpose of the study was to determine if the provision of Advanced Practice Nurse (APN) support, delivered via the telephone, improved cardiac surgery recovery following hospital discharge, as reflected in improved health related quality of life, decreased symptom distress, improved satisfaction with discharge and follow‐up care and decreased unplanned contacts with the hospital. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: participants were recruited from the inpatient cardiac surgery unit. Prior to discharge, eligible participants were identified by a research assistant who obtained consent and baseline data. The research assistant informed the APN of consenting patients' discharge. recruited patients were randomized after discharge. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: a) undergone first elective or emergent cardiac surgery, b) no unexpected cardiac complications that necessitated an unexpected stay in ICU, c) oriented to time, place and person, d) no history of acute or chronic psychiatric problems, e) able to read, write and speak English, f) capable of responding over the telephone. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: B.moderate risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: random numbers were generated by a statistical consultant through a computer based randomization schedule and forwarded to the APN who assigned patients. METHOD OF CONCEALMENT OF ALLOCATION: unclear. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: yes. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: t‐test/chi‐square/Mann‐Whitney U test. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: cardiac patients / surgery patients. GEOGRAPHIC LOCATION: Canada. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: unclear. RANDOMISED TO INTERVENTION: 102. RANDOMISED TO CONTROL: 92. INCLUDED IN ANALYSIS INTERVENTION GROUP: 94. INCLUDED IN ANALYSIS CONTROL GROUP: 92. AGE: RANGE OR MEAN (SD): 64. GENDER (% MALE): 76. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: coronary artery disease. OTHER HEALTH PROBLEM/S: COPD in 20%; peripheral vascular disease in 10%, cerebrovascular disease in 145, renal failure in 3.5%. TREATMENT RECEIVED/RECEIVING: CABG. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 16% single.
Interventions	DETAILS OF INTERVENTION: The intervention group received, in addition to the usual care, active and ongoing follow‐up via nurse‐initiated telephone calls from the APN in cardiac surgery at 3 and 5 days following discharge and then weekly for 4 more weeks. During the calls, the APN continued with the plan of care established in the hospital, provided ongoing information and assessment, assisted with self‐management of common symptoms and facilitated referrals to appropriate healthcare resources. Telephone sessions were individually tailored in response to patient's symptoms, concerns and recovery. All sessions, however, were standardized sufficiently to include evaluation of physical and psychological states and incorporated mutual goal setting for the management of symptoms in the recovery period. The initial TFU were approximately 20 to 30 minutes. DETAILS OF CONTROL: usual care: this included preoperative and discharge preparation by the APN, provision of an education booklet and home care follow‐up if necessary. Patients were provided the contact information for the APN and instruction to call with questions or concerns. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 6. First time at day 3 after discharge. Period: 5 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: good. FIDELITY/INTEGRITY: good.
Outcomes	NUMBER OF OUTCOMES: 7 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, ..): Satisfaction / patient satisfaction questionnaire (Shortell 2000) / yes / telephone interview / 1 and 5 weeks after discharge. Mental status / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. Social functioning / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Physical functioning / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. Symptom distress / Memorial symptom assessment scale (Portenoy 1994) / yes / telephone interview / 1 and 5 weeks after discharge. C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / self‐developed / no / telephone interview / 1 and 5 weeks after discharge. ED‐visits / self‐developed / no / telephone interview / 1 and 5 weeks after discharge.
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·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?	Unclear risk	B ‐ Unclear