Methods | RCT, single centre Recruitment: July 1996 to June 1997 Duration of follow up:12 months |
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Participants | Country: USA Participants: 17 patients (9 53% males) in comparison group, 17 (8 males 47%) in intervention group, Actual age of study subjects: control group mean 72.8 years (SD 10.7), intervention group 66.9 (SD 8.7). Male sex: 50% Ethnicity: not given Actual severity of heart failure in study subjects at recruitment: NHYA class, n, (%): control group II 4 (24%), III 11 (65%), IV 2 (10%), intervention group II 1 (6%), III 12 (71%), IV 4 (24%). LVEF: not given. Study inclusion criteria:
Study exclusion criteria:
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Interventions | Duration of intervention: 90 days Intervention Group: ‘pharmacist intervention’ During index hospitalisation: “Routine care plus pharmacist and clinical nurse specialist identified patient issues which posed risk for rehospitalisation and determined corrective action.” Before discharge the pharmacist reviewed pathology and treatment of HF, weight monitoring and risk modifications with the patient or caregiver. Patient given information brochure, video, weight log and medication organiser. Pharmacist also recommended medication changes to physicians. After discharge: Pharmacist phoned within three days of discharge, and at 7, 30, and 90 days and 12 months to enquire about any re-admissions, respond to questions, reinforce information give before discharge. Pharmacist’s phone number provided to patients for further support Comparison Group: usual care Routine care and preparation for discharge including: written prescription, physician discharge instructions, nurse review of diet, treatment plans and medications; patients provided with computer generated drug information sheets. At 30, and 90 days and 12 months pharmacist contacted patients to ask about re-admissions |
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Outcomes | Primary endpoint: hospital re-admission for heart failure or death (composite endpoint) Analysis done on intention to treat basis: No* |
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Notes | Data source: published data and information from author* Generalisability: *Of 377 patients whose admission history included HF, 42 refused consent (11%) and 42 (11%) were eligible and provided informed consent (3 patients then became ineligible during index admission, 1 patient lost to follow up). Data on these four patients were excluded Consort flow chart: not supplied Rationale for sample size: not given Other points: Reasons for exclusion (288 patients): unstable coronary disease 78 (27%), pulmonary disease 37 (13%), cardiac arrhythmia 33 (11%), pneumonia 20 (7%). *Heart failure re-admissions were confirmed either by chart documentation or personal communication with the admitting physician. Generation of randomisation sequence: computer generated* Allocation concealment: “Information on patient randomisation was concealed from the patient and all care givers except for the pharmacists involved in the study”. It is not clear who was responsible for allocation Risk of care giver performance bias: low* Risk of attrition bias: low Risk of detection bias: high |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |