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. Author manuscript; available in PMC: 2014 May 27.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD009231. doi: 10.1002/14651858.CD009231
Methods Randomised controlled trial
Participants Age:
Mean age 74 year SD 12.0
Sex:
51% men (n = 151)
49% women (n = 146)
Ethnicity
37% belonged to an ethnic minority group
18% were 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 chronic obstructive pulmonary disease (COPD) (21%); congestive heart failure (CHF) (33%) or cancer with a life-expectancy of 12 months or less (47%); participants visited the emergency department or hospital at least once within the previous year; and scored 70% or less on the Palliative Performance Scale. Life expectancy was assessed by the primary care physician who responded to the question ‘Would you be surprised if this patient died in the next year?’
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: T = 155, C = 155. In the intervention group 8/155 died before receiving palliative care, while in the control group 5/155 withdrew from the study. This left 297 available for analysis

Interventions Multi-disciplinary team which included a physiotherapist, occupational therapist, speech therapist, dietician, 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 service 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 was used to measure overall satisfaction with services, perception of service providers and likelihood of positive recommendations of services to others. Palliative Performance Scale was used to measure severity of illness
Data were also collected retrospectively from health maintenance organisation (HMO) service utilisation databases at each site, from time patient enrolled in study until time of death or end of study period. 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 office 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

Notes Healthcare system: US healthcare system, not for profit HMOs. Two-group model, closed panel, non-profit HMOs providing integrated healthcare services in Hawaii and Colorado. The Colorado site has more than 500 physicians representing all medical specialities and sub specialities 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 spans the 6-county Denver metropolitan area. The Hawaii site is located in Oahu and serves 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 provide care. In contrast to Colorado, the HMO provides all outpatient and most inpatient care, and it also has an internal home health agency

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection bias) Low risk Group assignment was determined by blocked randomisation using a computer-generated random number chart, stratified according to study site

Allocation concealment (selection bias) Low risk Once eligibility was determined, the intake clerk contacted the evaluators, who randomly assigned patients to the palliative care intervention or usual care

Blinding (performance bias and detection bias) High risk
All outcomes

Incomplete outcome data (attrition bias) All outcomes Low risk 8/155 died in the intervention group before the intervention was delivered; 5/155 withdrew from the control group
During the course of the study (maximum follow-up time at 120 days) 75% (n = 225) participants died

Baseline measures Low risk Palliative Performance Scale, demographic data

Protection against contamination Low risk Both groups had access to hospice care, the control group did not have access to the intervention (an interdisciplinary home-based healthcare programme)