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. 2021 Mar 15;2021(3):CD009231. doi: 10.1002/14651858.CD009231.pub3

Brumley 2007.

Study characteristics
Methods Randomised trial, USA
Participants Age: mean 74 years, SD 12.0
Sex: 51% men (n = 151), 49% women (n = 146)
Ethnicity: 37% ethnic minority group; 18% Asian/Pacific Islanders, 13% Hawaiian, 4% Latino, 2% other
Place of residence: 66% lived in their own home or apartment; 8% lived in the home of a family member; 74% resided with a family member, primarily a spouse or a child; 26% lived alone
Condition: late‐stage COPD (21%), CHF (33%) or cancer (47%) and a life expectancy of ≤ 12 months; participants visited the emergency department or hospital at least once within the previous year; and scored ≤ 70% on the Palliative Performance Scale. The primary care physician assessed life expectancy, responding to the question 'Would you be surprised if this patient died in the next year?' Mean days survival were: intervention group 196 (SD 164) days, control group 242 (SD 200) days.
Number recruited: 718 referred to the study, 408/718 excluded: 196 did not meet eligibility criteria, 67 were eligible for and admitted to hospice care, 59 refused, 38 died before enrolment, 26 were part of another research project and 22 moved out of the area or could not be contacted. 310 terminally ill participants were randomly allocated: intervention group: 155; control group: 155. 8/155 in the intervention group died before receiving palliative care, while 5/155 in the control group withdrew from the study. 297 remained available for analysis.
Interventions Intervention group: multidisciplinary team including a physiotherapist, occupational therapist, speech therapist, dietitian, social worker, bereavement co‐ordinator, counsellor, chaplain, pharmacist, palliative‐care physician and a specialist nurse trained in symptom control and biopsychosocial interventions. The specialist nurse provided education, discussed goals of care and the expected course of the disease and expected outcomes, as well as the likelihood of success of various treatment and interventions. 24‐hour care was available if required.
The in‐home palliative care service for terminally ill patients was co‐ordinated by a core team of physician, specialist nurse, and social worker who managed care across settings and provided assessment, evaluation, planning, care delivery, follow‐up, monitoring and continuous reassessment of care. The service was not time‐limited and was provided until death or transfer to a hospice.
Control care: followed Medicare guidelines, services included home health services, acute care services, primary care services, and hospice care.
Outcomes Reid‐Gundlach Satisfaction with Services instrument used to measure overall satisfaction with services, perception of service providers and likelihood of positive recommendations of services to others.
Palliative Performance Scale used to measure severity of illness.
Data were also collected retrospectively from HMO service utilisation databases at each site, from time participant enrolled in study until time of death or end of study. Medical service use data: costs for all standard medical care and costs associated with the palliative‐care programme. Service data: number of emergency department visits, physician clinic visits, hospital days, skilled nursing facility days, home health and palliative visits, palliative physician home visits and days in hospice. Service costs calculated using actual costs for contracted medical services (Colorado) and proxy cost estimates for all services provided within the HMO.
Follow‐up: 30, 60, 90 and 120 days.
Notes Healthcare system: US healthcare system, not‐for‐profit HMOs. 2‐group model, closed panel, non‐profit HMOs providing integrated healthcare services in Hawaii and Colorado. The Colorado site had > 500 physicians representing all medical specialities and subspecialities in 16 separate ambulatory medical offices spread across a greater metropolitan area. The HMO contracts with outside providers for emergency department, hospital, home health and hospice care to serve its 477,000‐person membership, which spanned the 6‐county Denver metropolitan area. The Hawaii site was in Oahu and served approximately 224,000 members, with 12 medical offices in Oahu, 3 in Maui and 3 on the Big Island. A medical group of 317 physicians provided care. In contrast to Colorado, the HMO provided all outpatient and most inpatient care, and it also had an internal home health agency
Funding: Kaiser Permanente Garfield Memorial Fund, authors reported being employed by the Permanente Medical Group, or being funded through a contract or consultancy with Garfield Memorial Fund.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: group assignment used block randomisation using a computer‐generated random number chart, stratified according to study site.
Allocation concealment (selection bias) Low risk Comment: once eligibility was determined, the intake clerk contacted the evaluators who randomly assigned participants to the palliative‐care intervention or usual care.
Baseline characteristics Low risk Comment: Palliative Performance Scale, demographic data similar between groups.
Baseline outcome measurements Low risk Comments: groups were similar for most baseline outcome measures; there were small differences for the baseline measure of satisfaction with services (Table 1).
Blinding (performance bias and detection bias)
All outcomes Unclear risk Comment: participants and clinical staff were aware of the intervention; the researchers employed research assistants who were blinded to the group assignments and collected data by telephone.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: 8/155 participants died in the intervention group before the intervention was delivered; 5/155 withdrew from the control group.
Selective reporting (reporting bias) Unclear risk Comment: no information.
Protection against contamination Low risk Comment: both groups had access to hospice care; the control group did not have access to the intervention (an interdisciplinary home‐based healthcare programme).