Mendoza 2009.
Study characteristics | ||
Methods | Parallel randomised trial Study conducted between May 2006 and March 2007. |
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Participants | Setting: Spain Patients in A&E with acute decompensation of chronic heart failure Inclusion criteria: > 65 years of age, with heart failure for at least 12 months prior to study, NYHA functional class II or III prior to acute episode, all‐day supervision available, telephone, < 10 kilometres from hospital Age > 65 years, mean age 79. 29% female in hospital arm, 51% female in hospital at home arm Number recruited (between May 2006 and March 2007): hospital at home: 37; hospital: 34 |
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Interventions | Admission avoidance hospital at home; patients admitted from emergency departments, hospital outreach model. Hospital at home nurse visited within 12 to 24 hours of admission to hospital at home and then daily visits. Care available between 8 a.m. and 9 p.m.; patients called emergency services outside these hours. Hospital specialist visited daily or every other day, depending on patient’s condition. Control group: admitted to hospital |
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Outcomes | Mortality, readmission, functional status, general health status, length of stay, costs | |
Notes | Follow‐up: 1 year after discharge Funding: Caja Vital Kutxa (Spain) Conflicts of interest: none declared Ethical approval: approved by the hospital ethical committee This author contributed IPD for a previous update of this review (Shepperd 2016a). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation described as "externally generated sequence." |
Allocation concealment (selection bias) | Low risk | Random sequence hidden from the physician until patient had consented to participate |
Baseline outcome measurements (selection bias) | Low risk | Baseline outcome measurements done prior to intervention for functional status and general health status; no relevant differences found |
Baseline characteristics (selection bias) | Low risk | Baseline characteristics of the study and control groups are reported and are similar |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel not possible |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | A trained researcher, independent of the health care provided, assessed functional status (Barthel Index), health‐related quality of life (SF‐36) |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Low risk for death, readmission |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 9 of 80 did not complete the study (2 in hospital at home group, 7 in hospital group) |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to allocate low or high risk |