Jordhøy 2000.
| Study characteristics | ||
| Methods | Cluster‐randomised trial; clusters stratified into pairs according to the number of inhabitants older than 60 years, and if area was urban or rural. Norway. Originally 8 clusters, 2 urban districts with the smallest number of inhabitants > 60 years were merged with larger ones. 6 participants withdrew from the study. |
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| Participants | People with incurable malignant disease, life expectancy 2–9 months (estimated at referral) and aged > 18 years Median days survival: intervention group 99 days; control group 127 days People with haematological malignant disorders other than lymphomas were excluded from the trial Median age: intervention group: 70 years (range 38–90); control group: 69 years (37–93) Sex: intervention group: 132/235 (56%) men; control group: 98/199 (49%) men Living alone: intervention group: 70/235 (30%); control group: 71/199 (36%) Relatives in the same neighbourhood: intervention group: 214/235 (91%); control group: 179/199 (90%) Receiving home help at the time of recruitment: intervention group: 26/235 (11%); control group: 45/199 (23%) Number recruited from March 1995 to November 1997: 434/707 referred patients were included; intervention group: 235; control group: 199 Numbers of participants per cluster: cluster 1: intervention group: 134; control group: 116; cluster 2: intervention group: 77; control group: 65; cluster 3: intervention group: 24; control group: 18 |
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| Interventions | Intervention group: hospital‐based intervention co‐ordinated by the Palliative Medicine Unit with community outreach. The intervention had been operational for 2 years and 8 months. The Palliative Medicine Unit provided supervision and advice and joined visits at home. The community nursing office determined the type and amount of home care and nursing home care offered. Multidisciplinary, involving palliative‐care team, community team, participants and families. Specialist palliative‐care nurses provided care in the home with a family physician and palliative‐care consultants (n = 3). Physiotherapy, nutrition and social care available. Access to a priest. 24‐hour care was limited, with the smallest urban district not having access to 24‐hour care. Educational programme for community staff including bedside teaching and 6–12 hours of lectures every 6 months. Access to informal help: intervention group: 187/235 (80%); control group: 140/199 (70%). Control group: conventional care shared among the hospital departments and the community. |
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| Outcomes | Time at home, place of death, admissions to hospital, health‐related quality of life, admission to nursing home, survival Follow‐up: maximum 2 years |
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| Notes | Healthcare system: the Norwegian Public Health Service, which provides hospital and community care. The intervention was linked to the Trondheim University Hospital. The Norwegian Public Health Service provided hospital and community care. 8 community healthcare districts participated: 6 districts of Trondheim city (population 141,000) and 2 neighbouring rural communities (Malvik: population 10,000, and Melhus: population 13,000). Community services in all the districts were similar, including family physicians, home care nursing and nursing homes. 1 family physician manpower‐year serves around 1500 inhabitants. A mean of 30 manpower‐years of home care nurses' or nurse assistants' time were available per 1000 inhabitants aged > 67 years. All except the smallest urban district provided 24‐hour home care service. However, night service was limited to short visits or telephone consultations. Number of nursing home beds (short and long term) was restricted to 20 beds per 100 inhabitants aged > 80 years. In each district, home care and nursing home services are co‐ordinated at a common community nursing office, which decided the type and amount of service that a referred patient was offered. Hospital services for all 8 districts were provided by Trondheim University Hospital. Palliative Medicine Unit had 12 inpatient beds, an outpatient clinic and a consultant team that worked in and out of the hospital, including 2 palliative‐care nurses, a social worker, a priest, a nutritionist and a part‐time physiotherapist. 3 full‐time physicians were employed during the study. The team only worked daytime hours. Funding: The Norwegian Cancer Society, The Swedish Cancer Society and The Norwegian Medical Association Fund for Quality Improvement. Conflict of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Comment: details of the randomisation schedule not provided. Eligible patients were assigned treatment according to the district (cluster) in which they lived. |
| Allocation concealment (selection bias) | High risk | Comment: cluster‐randomised trial of 8 local community healthcare districts stratified into pairs according to the number of inhabitants aged > 60 years and whether the areas were rural or urban. To achieve balanced stratification the 2 small urban districts were merged with larger ones, for a total of 3 paired clusters. |
| Baseline characteristics | Unclear risk | Comment: some differences for place of residence (living in a villa/apartment or semi‐detached house), receipt of home nursing, weeks from diagnosis to inclusion. |
| Baseline outcome measurements | Unclear risk | Comment: main outcomes were dying at home, hospital or a nursing home. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: blinding not possible, reliable measures of outcome used. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome data reported for all participants. |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported. |
| Protection against contamination | Low risk | Comment: intervention was not available to control groups. |
CHF: congestive heart failure; COPD: chronic obstructive pulmonary disease; GP: general practitioner ; HMO: health maintenance organisation ; n: number of participants; RGN: registered general nurse; SD: standard deviation.