Methods	RCT, one centre Recruitment period: July 1999 to April 2001 Duration of follow up: 90 days
Participants	Country: USA Participants: 146 patients (74 males, 50 %) in comparison group, 141 (82 males, 58%) in intervention group. Actual age of study subjects: mean 70.7 years (SD 11.8) Male sex: 54% Ethnicity: not given Severity of heart failure in study subjects: (At enrolment) NYHA class, n (%): controls I 35 (26%), II 47 (36%), III 46 (35%), IV 4 (3%) intervention group I 10 (7%), II 76 (55%), III 50 (36%), IV 3 (2%). (At enrolment) LV dysfunction: control group normal to mild 29 (21%), moderate 26 (19%), moderate-severe 22 (16%), severe 58 (43%), intervention group normal to mild 27 (20%), moderate 15 (11%), moderate-severe 20 (15%), severe 73 (54%) Study inclusion criteria: All patients admitted to the hospital with clinical signs and symptoms of CHF and: either moderate-to-severe left ventricular dysfunction or, radiographic evidence of pulmonary congestion and symptomatic improvement following diuresis. At risk for early readmission for CHF, defined as one or more of the following: “ history of CHF; “‘documented knowledge of deficits of treatment plan or disease process’; “potential or ongoing lack of adherence to treatment plan; “previous CHF admission; “living alone; “four or more hospitalisations in the last five years. Study exclusion criteria: Discharge to a long term care facility. Planned cardiac surgery. Cognitive impairment. Anticipated survival of fewer than three months. Long-term haemodialysis.
Interventions	Duration of intervention: 12 weeks Intervention Group: ‘Case management’ Before discharge: Education by study nurse case manager. Early discharge planning and co-ordination of care by case manger including: arranging for consultations are required with physical therapy and occupational therapy; facilitating communication between hospital team and patient and family; submitting progress reports to primary care physicians; involving patient and family in developing care plan; collaborating with home health agencies and providing information and emotional support to patient and family. Patients received a educational booklet; weight logs; medication lists and a guide for measuring sodium intake also weigh scales and pill boxes as required After discharge: Letter to patient’s doctors informing them of participation in the study and outlining the case management programme. Scheduled telephone calls by case manager to patient at home at 1-3 days after discharge, then weekly for first month followed by fortnightly for next two months. Patients were also able to contact the case manager during weekday office hours. At six weeks post discharge the patient’s responsible physicians were contacted if their patients were not on medications or doses as outlined in the treatment plan Telephone calls covered symptoms and adherence to all aspects of treatment plan, resources available, next appointment time with primary care provider, reinforced education plan with patient and family and provided an opportunity for patients and family to ask questions. In the event of symptoms of worsening heart failure ‘appropriate triage’ was arranged and additional phone calls made to patients The education plan was consistent with education guidelines and covered: disease process of CHF; diet and fluid intake recommendations; medications and dosing plan; self-monitoring of signs and symptoms of CHF; activity recommendations; cardiac risk factor modification; prognosis and counselling Comparison Group: usual care Standard care ‘typical of a tertiary care hospital’ including opportunity for social services evaluation, dietician consultation etc and home care service on discharge. Post discharge care conducted by the patient’s own local physician
Outcomes	Primary endpoint: All cause readmissions during 90 days after discharge. Secondary endpoints: Adherence to the treatment plan. Patient satisfaction, dosages of : angiotensin-converting enzyme inhibitors; angiotensin recptor blockers; and beta blockers, overall cost of medical care Also looked at: Cause for readmission Length of stay Number of CHF readmissions Cumulative number of hospital days Number of days to first readmission Analysis done on intention to treat basis?: no*.
Notes	Data source: published data and information from author*. Generalisability: 589 patients thought to have heart failure admission were screened; 454 (77%) were eligible for the study; 74 (16%) refused consent; 13 (3%) patient’s physicians refused consent; 80 (18%) were not randomised for logistical reasons including patient discharged before consented; and 287 (63%, 49% of those screened) of these were randomised Consort flow chart: supplied Rationale for sample size: not given explicitly, but does say that they were seeking to show a 50% reduction in 90 day readmission rates Other points: Reasons for exclusions (135 patients): discharged to long term care 32%; planned cardiac surgery 31%; cognitive impairment 21%; expected survival <3 months 10%; haemodialysis 6% Adherence to treatment survey instrument not validated. Generation of randomisation sequence and allocation concealment: They used a block randomisation in order to balance out the workload of the case manager so she would not have a chance of getting more than five patients in a row. They used 10 envelopes: five for each group and let the patient choose an envelope to determine what group they were in. When 10 Patients had picked the 10 envelopes they started again with 10 envelopes. Patients were recruited in order of their admission date and time. “Hence this was not a blinded study for participants or researchers.”* Care giver performance bias comment: possible because hospital teams would know who was receiving intervention. Risk of attrition bias: low, although 19 patients (13%) not followed up in usual care group (9 lost to follow up; 9 withdrew consent; 1 ‘no longer met criteria’) compared to 6 (4%) lost to follow up in intervention group. Risk of detection bias: possible, clinical research co-coordinator enrolled patients in study out come data collected by clinical research co-coordinator (usual care group) and case manager (intervention group)
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	No	C - Inadequate