Levine 2020.
Study characteristics | ||
Methods | Parallel pilot randomised trial Study conducted between June 2017 and January 2018; follow‐up ended on 17 February 2018. |
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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 residential or rehabilitation facility or who were at high risk for clinical deterioration were excluded. Number recruited: hospital at home: 43; usual care: 48 (all randomised) Median age (IQR): T: 80 (19), C: 72 (23) Female: T: 15/43 (35%), C: 18/48 (38%) Patients were generally frail and chronically ill and used hospital care frequently. |
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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. Care was available 24/7 from the attending physician. Control group: usual hospital care; sleep was monitored using the same skin patch as the intervention group. |
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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 Center for Population Health and internal departmental funds (USA) Conflicts of interest: "Dr. Levine reports grants from Biofourmis outside the submitted work. Dr. Blanchfield reports consulting income from Verily, GreyBird Ventures, and Atlas5D outside the submitted work. Dr. Schnipper reports grants from Mallinckrodt Pharmaceuticals and Portola Pharmaceuticals outside the submitted work." Ethical approval: approved by local ethical committee Trial registry: NCT03203759 The study was stopped early after enrolling 91 patients (76% of intended sample) "in light of local operational needs to quickly increase home hospital capacity after positive interim outcomes were presented to hospital leadership”. 63% of patients approached and possibly eligible refused to participate. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | An outside statistician generated the randomization using SAS (SAS Institute). Randomization was stratified by infection, heart failure, chronic obstructive pulmonary disease or asthma, and other diagnosis; block sizes between 4 and 6 were randomly selected, |
Allocation concealment (selection bias) | Low risk | Comment: allocation was concealed via sealed opaque envelopes. |
Baseline outcome measurements (selection bias) | Low risk | Comment: the primary outcome was the direct cost of an acute care episode, data were obtained from the electronic record |
Baseline characteristics (selection bias) | Unclear risk | Comment: a few differences between groups, with the largest difference being for the numbers who recorded having a home health aide at baseline: HAH 17/43 (40%) vs control 10/48 (21%) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: patients, study staff and physicians were not blinded to allocation status. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: unclear risk of bias for unblinded assessment of physical activity, patient experience, and quality during the acute care episode |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Comment: the primary outcome was the direct cost of an acute care episode; secondary outcomes were health care use, physical activity, patient experience, safety (medication and delirium), and quality of care during the acute care episode |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: “If patients could not be reached 30 days after discharge (8 total patients, 1 in the home group and 7 in the control group), we used EHR data alone to estimate health care use and readmission rates and did not measure patient experience.” (page 79) |
Selective reporting (reporting bias) | Low risk | Comment: outcomes are consistent between trial registry and published results. |