Methods	RCT, feasibility study, one centre Recruitment: November 1994 to January 1996. Duration of follow up: mean follow up time 5.0 months (SD 2.0) control group and 5.0 (2.3) in the intervention group
Participants	Country: Sweden Participants: 79 patients in comparison group, 79 in intervention group, males: females in each group not given. Actual age of study subjects: mean 80.3 years (SD 6.8) Male sex: 58% Ethnicity: not given Actual severity of heart failure in study subjects at recruitment: NYHA class: control group mean 3.2 (SD 0.5), intervention group 3.2 (SD 0.5) LVEF on 99 patients (63%): control group mean 38% (SD 25), intervention group 43% (SD 18) Study inclusion criteria: Inpatient on medical ward. Boston criteria score 8. NYHA III or IV at index hospitalisation. Age 65 years or older. Residence in hospital catchment area. Study exclusion criteria: Large MI during preceding 8 weeks (new Q wave or serum CK-MB >100 μkat . l-1). In “need of specialist treatment”. S Serum creatinine >300 μmol . l-1. Needing permanent nursing home care. “Serious or life threatening co-morbidity”. Communication problems.
Interventions	Duration of intervention: 6 months? Intervention Group: ‘Structured care programme based on Nurse-monitored outpatient clinic’ After discharge: Pt and carers offered visit to specialist nurse monitored HF clinic one week after discharge, clinic run in collaboration with the study doctors (who were responsible for pharmacological Rx). Main aim of programme was patient education about their treatment and the symptoms of clinical deterioration. Tailored care plan with individualised treatment goals for each patient. Primary care team continually informed about patient’s situation by HF clinic nurses. Patients had access to clinic nurses during business hours. In emergencies patients seen by clinic nurses and attending doctor Patients given notebook for daily weight monitoring, treatment and information about clinical deterioration. Clinic nurses made regular follow up telephone calls to patients, those not seen regularly in clinic were called monthly Comparison Group: usual care. In general this was GP follow up.
Outcomes	Main endpoints: Proportion of patients aged > 65 years who were eligible for the study. Proportion of patients in the intervention group who did not visit the HF nurses. NYHA functional class. Hospitalisations and hospital days during six month follow up. Deaths. Analysis done on intention to treat basis?: yes
Notes	Data source: published data and information from author* Generalisability: Of 1058 consecutively screened patients with a diagnosis of heart failure and cardiomyopathy and aged 65 years or older, only 160 (17%) met criteria for participating in the study (2 later found not to be eligible) and 22 (12%) of these refused to participate Consort flow chart: not supplied Rationale for sample size: not given, feasibility study Other points: Reasons for exclusions (sub study of 454 excluded patients): 27% had serious communication problems or were otherwise too disabled to attend the out patient clinic, 25% had Boston criteria score <8, 18% NYHA class <III, 8% nursing home care, 7% specialist care, 5% acute MI Generation of randomisation sequence: “randomly permuted blocks with a size of 20 obtained from tables of random numbers.”. Allocation concealment: “consecutively numbered, sealed envelopes containing group assignments”. The envelopes were generated by a doctor but allocated by a nurse Risk of care giver performance bias: high; 20 care likely because the three specialist nurses who staffed the HF clinic also staffed the inpatient ward, 10 care both control and intervention patients’ general practitioners were aware their patients were in the study* and they must have known the allocation group of their patients. Risk of attrition bias: low Risk of detection bias: high, those collecting endpoint data were not masked to patients’ allocation status*
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	Yes	A - Adequate