Levine 2018.
Study characteristics | ||
Methods | Parallel pilot randomised trial Study conducted between September and November 2016. |
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Participants | Setting: USA Patients aged >= 18 years, attending the emergency department with a primary diagnosis of any infection, heart failure exacerbation, COPD exacerbation, or asthma exacerbation. Those residing in a facility that provided on‐site medical care or who were at high risk for clinical deterioration were excluded. Number recruited: hospital at home: 9; usual care: 11 Median age (IQR): T: 65 (28), C: 60 (29) Female: T: 2/9 (22%), C: 8/11 (73%) Participants had on average 6 comorbidities and took 9 medications. |
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Interventions | The intervention was tailored to the patient's needs. There was at least 1 daily visit from an attending general internist and 2 daily visits from a home health registered nurse; additional services included medical meals and the services of a home health aide, social worker, physical therapist, and/or occupational therapist. Home services included oxygen and respiratory therapies, radiology, and point‐of‐care blood diagnostics; patients were remotely monitored for heart rate, respiratory rate, telemetry, movement, falls, and sleep via a small skin patch. Control group: usual hospital care; patients were also monitored using the same skin patch. |
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Outcomes | Main outcome: total cost of the hospitalisation Other outcomes: length of stay, readmissions, healthcare use, quality of life, activities of daily living, satisfaction with care |
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Notes | Follow‐up: 30 days Funding: Partners HealthCare Population Health Management; Institutional National Research Service Award; Ryoichi Sasakawa Fellowship Fund (USA) Conflicts of interest: none reported Ethical approval: approved by local ethical committee Trial registry: NCT02864420 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “stratified by condition with randomly selected block sizes between 4 and 6” |
Allocation concealment (selection bias) | Low risk | Quote: “allocation concealment via sealed envelopes” |
Baseline outcome measurements (selection bias) | Unclear risk | Comment: participants allocated to the control group reported more depression symptoms and lower self‐assessed quality of life. There was little or no difference between groups for hospital admission and ED visits in the past 6 months |
Baseline characteristics (selection bias) | Unclear risk | Comment: participants allocated to the control group were younger, more likely to be female and speak English, more educated and less likely to be privately insured. Although these were sub‐threshold values, the sample is very small. |
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 | Low risk | No subjective outcomes. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: “All measures were derived from the EHR, except falls, physical activity, and sleep, which were observed via the skin patch.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: very low attrition. |
Selective reporting (reporting bias) | Unclear risk | Comment: primary and secondary outcomes are the same as per trial registry. There are other outcomes mentioned in the trial registry but not in the publication. |