Methods	RCT, single centre Recruitment period: October 1997 to September 1998. Duration of follow up: one year.
Participants	Country: USA Participants: 44 patients (29 males, 66%) in comparison group, 44 (21 males, 48%) in intervention group. Actual age of study subjects: median age 74 years, controls mean age 71.6 (SD 10.3), intervention 75.9 (SD 8.7) Males: 57% Ethnic group: ‘74% caucasians’ Actual severity of heart failure in study subjects at recruitment: Mean ejection fraction: control group 37% (SD 16), intervention group 38% (SD 17). NYHA: not given Study inclusion criteria: Age 50 or over Needed to have either admission diagnosis of heart failure or radiological signs of heart failure on admission chest x-ray. Reviewed within three days to verify additional set of criteria derived from NHANES-1 Study exclusion criteria: Patients transferred from other hospitals or nursing homes. Patients with HF secondary to high output states or non-cardiac disease. Patients with another terminal illness (e.g. expected survival < 6/12)
Interventions	Duration of intervention: one year Intervention Group: ‘Education and Support’ After discharge: Initial hour long face to face consultation with experienced cardiac nurse within two weeks of discharge using a teaching booklet (45% of these consultations took place in patient’s home, remainder in hospital clinic). Following this weekly telephone contact for four weeks, bi-weekly for eight weeks then monthly until one year Initial consultation covered five sequential care domains for chronic illness including: patient knowledge of illness; the relation between medication and illness; the relation between health behaviours and illness; knowledge of early signs and symptoms of decompensation, and where and when to obtain assistance. Follow up phone calls reinforced the five care domains but did not modify current regimens or provide recommendations about treatment. However the nurse could recommend that the patient consulted his/her physician when the patient’s condition deteriorated sharply or when the patient had problems, in order to help patients to understand when and how to seek and access care Comparison Group: usual care. All usual care treatments and services ordered by their physicians
Outcomes	Primary endpoint: Re-admission or death. Secondary endpoints: All cause admissions. HF related or other CVD related re-admissions. Cumulative number of days in hospital. Cost of readmission. Analysis done on intention to treat basis? Yes
Notes	Data source: published data and information from author*. Generalisability: 390 consecutive admissions who met clinical criteria for HF screened, 142(36%) eligible and a further 34 eligible but not enrolled, 20 (5%) patient, physician or family refusal to participate, 88 (23% of those screened) enrolled in the study Consort flow chart: not supplied Rationale for sample size: provided, they expected a 40% reduction in readmission or death from 75%. The number required to show this not stated in text Other points: Reasons for exclusions (248 patients): admitted from nursing home 19%; transfer from another acute facility (18%); conditions interfering with interview 18%, elective admission 12%, already enrolled in study 12%; high output state 6%; other terminal disease 4%; terminal or skilled nursing care 4%; enrolled in other studies 3%; no signs/symptoms of HF 3%; other impairing conditions 2%, cardiomyopathy 1 %, age <50 1%, followed by another facility 1%. A further 34 were eligible but not enrolled because of no interview because of death, discharge or other medical reasons 65%, no telephone or residing in another state 35% Generation of randomisation sequence: “computer generated”* Allocation concealment: “It was not blinded”* Comment on risk of care giver performance bias: low, care givers were not informed of patient’s involvement in the study by the researchers*. Risk of attrition bias: Risk of detection bias: low, record examinations to confirm events and classify cause done by a clinician masked to patient’s intervention allocation
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	No	C - Inadequate