Methods	RCT, single centre, pilot study Recruitment: April 1988 to March 1989. Duration of follow up: 90 days from hospital discharge.
Participants	Country: USA Participants: 35 patients (15 males, 43%) in comparison group, 63 (25 males, 40%) in intervention group, (2:1 assignment to intervention or usual care). Actual age of study subjects: mean age 79 years (SD 6). Male sex: 41%. Ethnicity: “white” 50% Actual severity of heart failure in study subjects at recruitment: NYHA class, mean: controls 3.0 (SD 1.0), intervention group 2.7 (SD 1.1) Study inclusion criteria: All patients admitted with CHF identified by: definite radiographic evidence of pulmonary congestion determined independently by both a staff radiologist and a staff cardiologist; or a typical history and physical findings of CHF in conjunction with symptomatic improvement following diuresis. One or more of four independent risk factors for re-admission: four or more hospitalisations in the preceding five years, previous history of CHF, hypercholesterolaemia (<150 mg/dl), R bundle branch block on admitting ECG. Aged over 70 years. Study exclusion criteria: Patients defined as low risk for re-admission based on the absence of each of four independent risk factors for (see above). Death during initial hospitalisation. Residence outside the hospital catchment area. Planned discharge to a nursing home or other chronic care facility. Non-cardiac illness likely to result in non-preventable re-admission (e.g. terminal malignancy). Severe mental incapacity. Psychiatric disturbance. Physician refusal. Logistic and discretionary reasons.
Interventions	Duration of intervention: not clear, during index hospitalisation, plus one week after discharge, plus phone follow up Intervention Group: ‘Comprehensive multidisciplinary treatment strategy’ During index hospitalisation: Daily educational visits by study specialist nurse. Dietician visit with individualised 1.5-2.0 g sodium diet. Medication review by geriatric cardiologist with patient and/or caregivers. Drug regimen rationalised with aim of maximising compliance and minimising side effects and drug interactions. Following this study nurse taught patients about medications and dosing, medication cards and charts provided and information given about potentially serious side effects. Weigh scales (if required), instruction and daily weigh charts provided with instructions when to contact researchers Social worker and the home care team visited patient to facilitate discharge planning and identify and manage potential economic, social or transport problems. Discharge summary to home care team prepared by study nurse. After discharge: Home care team nurse visited within 48 hrs (usually within 24 hours): physical assessment of patient, reinforced teaching, reviewed medication and lifestyle advice, assisted with initiating daily weights. Two further home care team nurse visits in first week. Study nurse phoned patient at home to assess progress and answer questions. Patients encouraged to contact own doctors or study team with problems or questions Educational visits covered: CHF diagnosis, symptoms, treatment, follow up and prognosis using educational booklet developed by the researchers Comparison Group: usual care “Conventional medical care as determined by the patient’s usual physician,” this could include social service evaluation, dietary and medication teaching, home care and all other available hospital services
Outcomes	Primary endpoints: Unplanned re-admissions within 90 days of discharge. Total number of days hospitalised during follow up. Also looked at: Re-admission rates in the moderate risk subgroup compared to the high risk sub group Analysis done on intention to treat basis?: yes*
Notes	Data source: published data and information from author*. Generalisability: Number of patients screened for HF not given, 261 patients fulfilled criteria for CHF, 21 (8%) died during initial hospitalisation, 188 (72%) classified as intermediate or high risk, 67 (36% of 188) excluded, 23 (12% of 188) patient or physician refused, 98 (52% of 188) participated Consort flow chart: not applicable, before 1996. Rationale for sample size: not given, pilot study. Other points: Reasons for exclusions (67/188 patients): residence outside hospital catchment 34%; planned discharge to a nursing home or other chronic care facility 22%; non-cardiac illness likely to result in non-preventable re-admission, mental incapacity or psychiatric disturbance 12%; logistic and discretionary reasons 31% Not clear if some of the patients who died in hospital were originally randomised into the study or not. Generation of randomisation sequence: computer generated list of random numbers* Allocation concealment: “The principal investigator and study statistician were blinded; the patients and nurses were not blinded.”* Risk of care giver performance bias: possible, care providers were not masked. Risk of attrition bias: low. Risk of detection bias: high, “detailed data were collected for all patients by a research nurse and study physician”, although those doing the analyses were masked as to the patient’s allocation*
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	Unclear	B - Unclear