Riegel 2002.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to reduce resource use (readmissions, hospital days, costs). AIM OF STUDY: to assess the effectiveness of a standardized telephonic case‐management intervention in decreasing resource use in patients with chronic heart failure. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: physicians known to admit patients with heart failure were matched by specialty (cardiology, internal medicine), practice size and number of HF admissions in the prior year. After matching, physicians were randomized to the intervention or usual care group. Although it was the physicians who were randomized, patients were the unit of analysis for this study. It was not feasible to randomize patients in the same physician practice to different groups because of the possibility that the physicians would modify care in the control group to mimic aspects of the intervention. Physicians were not informed of the group to which they were assigned. A total of 281 physicians were randomized. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: confirmed diagnosis of heart failure as the primary reason for their hospital visit/ speak English or Spanish. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: cognitive impairment or psychiatric illness/ severe renal failure requiring dialysis/ terminal disease// discharge to a long term care setting/ previous enrolment in a HF disease program. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: unclear. 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: no. STATISTICAL METHODS AND THEIR APPROPRIATENESS: anova/logistic regression/linear regression. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: cardiac patients. GEOGRAPHIC LOCATION: USA. SETTING:discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 573. RANDOMISED TO INTERVENTION: 130. RANDOMISED TO CONTROL: 112 . INCLUDED IN ANALYSIS INTERVENTION GROUP: 130. INCLUDED IN ANALYSIS CONTROL GROUP: 112. AGE: RANGE OR MEAN (SD): 72 (12). GENDER (% MALE): 49. ETHNICITY: 25% Spanish speaking. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: heart failure (49% ischemic, 20% hypertensive). OTHER HEALTH PROBLEM/S: 41% low comorbidity, 20% high comorbidity (68% hypertension, 35% COPD, 42% diabetes, 28% renal disease). TREATMENT RECEIVED/RECEIVING: medication (62% digoxin, 54% ACE‐inhibitor, 86% diuretic,…). OTHER SOCIAL/DEMOGRAPHIC DETAILS: 56% single.
Interventions	DETAILS OF INTERVENTION: Telephonic case management by a registered nurse was provided using a decision support software program; the software program uses automated tool for setting priorities for patient education, data collection and documentation; best practices are supported by the program. The intervention group was phoned within 5 days after discharge and thereafter at a frequency guided by the software and case manager judgment based on patient symptoms, knowledge and needs. Patients received an average of 17 calls at decreasing levels of intensity, length and frequency over the 6 month follow‐up period; printed educational material was mailed every month to the patients. DETAILS OF CONTROL: usual care, not standardized. CO‐INTERVENTION? unclear. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 14. First time at day 5 after discharge. Period: 6 months. PROVIDERS: nurse. INTERVENTION QUALITY: large range. 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, ..): 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, ..): Readmission / self‐developed / unclear / hospital record / 3 and 6 months. Costs / self‐developed / no / hospital record / 3 and 6 months.
Notes	·CHANGES IN TRIAL PROTOCOL: Riegel 2002 (in journal Disease Management & Health Outcomes) is subanalysis for Spanish speaking patients. ·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