Jordhøy 2000.
| Study characteristics | ||
| Methods |
Design: cluster RCT (patient and caregiver) Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist) |
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| Participants |
Country and regions: Norway, Trondheim, 6 metropolitan and 2 rural areas Recruitment (1995‐1997, 32 months): from hospital departments, particularly gastrointestinal surgery, urological surgery, oncology and gynaecology, lung and gastrointestinal departments of internal medicine (through professionals, lead nurse and researchers screening visits once or twice per week) and primary care professionals in 8 healthcare districts; patients aged > 18 years with incurable cancer, life expectancy 2‐9 months (not stated who estimated) living in 8 community healthcare districts (clusters) stratified into 3 pairs according to number of inhabitants > 60 years and urban/rural status (2 smaller urban districts merged with larger ones) and randomised to intervention or control. Exclusion criteria: haematological malignant disorders other than lymphomas, patient not informed about their diagnosis and that the disease was incurable, participation in other trials with quality of life as outcome, unable to fill in questionnaire Number of patients (randomised): 434 (235 intervention and 199 control) Diseases: cancer (434): gastrointestinal (181), lung (52), breast and female genitals (67), prostate and male genitals (41), kidney or vesica (29), lymphomas (13), skin (12), others (39) Patient characteristics: median age 70 years intervention, 69 years control; 47% female; 32.5% lived alone Number of caregivers (consented): 313 (183 intervention and 130 control) Caregiver characteristics: median age 57.6 years intervention, 53.9 years control; 68.3% female Deaths at end of study: 395 (219 intervention (93%) and 176 control (88%)) Withdrawals/other drop‐outs: 6 intervention and 10 control (reasons not stated) |
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| Interventions | Home palliative care vs. usual care Type: specialist palliative care Service base: palliative medicine unit at University Hospital of Trondheim (12 beds, outpatient clinic and consultant team in and out of hospital) Team: 1 full‐time physician; 2 palliative care nurses, social worker, priest, nutritionist, part‐time physiotherapist; staff worked daytime hours only; weekly meetings Responsibility: consultant nurse was the care co‐ordinator; primary family physician and community nurse maintained as main professional carers Description: new intervention grounded on holistic philosophy, included multidisciplinary approach to the patient's needs and co‐ordination of care; consultant team who co‐ordinated care; initial care plan set up in meeting of patient, caregivers, family physician, community nurse, and consultant nurse or physician from team; follow‐up routine consultations by community staff supervised by team (available for joint home visits); no additional out of hours or on‐call service; service linked the palliative medicine unit to community services under pre‐defined guidelines to keep interaction at optimum level; education programme (including bedside training and 6‐12 hours of lecturers every 6 months on symptoms and difficulties in palliative care); inpatient and outpatient services provided at unit except when required for medical reasons (e.g. surgery or acute intensive care for intercurrent disease) Duration: from enrolment to death or study end (median survival 99 days in the intervention group) Control: usual care shared among University hospital departments and community services according to diagnosis and medical needs (no well‐defined routines existed and poor communication between levels of services had been addressed as general problem); despite minor variations, community services were similar in all districts, including family physicians, HC nursing (nurses and nurse‐assistants) and nursing homes (when extensive need for attention or basic nursing care but not specialised hospital care is required); all except smallest urban district had 24 hours HC; limited night coverage (generally only short visits or telephone consultations); HC and nursing home services co‐ordinated at district level (common community nursing office ‐ decisions based on patient's medical and social needs and current availability of community resources); no specialist palliative care service available other than the intervention |
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| Outcomes | Quality of life (primary outcome) Physical symptoms (pain – primary outcome; breathlessness, nausea/vomiting, constipation, diarrhoea, sleep disturbance, fatigue, appetite loss) Physical function (primary outcome) Psychological well‐being (primary outcome; emotional functioning and psychological stress) Death at home (primary outcome) Death in hospital Death in hospital palliative care unit Death in nursing home Percentage of time spent at home General health and vitality Social functioning Survival Caregiver satisfaction with care Caregiver pre‐bereavement outcomes (quality of life, general health, vitality, physical, psychological and social functioning, bodily pain) Caregiver post‐bereavement outcomes (quality of life, general health, vitality, physical, psychological and social functioning, bodily pain, grief intensity) Assessment points: baseline and monthly until death (or up to 2 years to avoid research burden); satisfaction with care measured 1 month after death; caregivers assessed 1, 3, 6 and 13 months after death Analysis: forwards from enrolment, backwards and forwards from death (caregivers' outcomes) |
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| Resource use/costs | Hospitalisations (admission, number of admissions, mean length of admission, inpatient days, proportion of time in hospital) Care in nursing homes (admission, number of admissions, nursing home days, proportion of time in nursing homes) Time horizon: from enrolment to death or study end; last month before death |
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| Notes |
Power considerations: "Pre‐planned sample size was 200 patients in each group, based on quality of life."; "Because there was uncertainty about the likely difference, the impact of a variety of effect sizes was explored. Between 50 to 75 patients per group would be realistic to detect differences as small as 0.5 SDs in an ordinary randomized clinical trial (RCT), an effect size that is commonly regarded as a moderate change, and for which the EORTC QLQ‐C30 scores are roughly comparable to a change of 10 units. This represented a plausible and realistic effect of the intervention policy. However, for a cluster randomized design, the statistical power will be reduced because of within‐cluster correlation. This can be taken into account by increasing the total number of clusters, or to a lesser extent, by increasing the number of subjects per cluster. In this trial, for practical and economical reasons, participation had to be restricted to the clusters (health care districts) located within close reach from the palliative medicine unit, and it was decided to include 200 patients in each treatment group" Authors discuss issues related to recruitment attrition, and compliance in a methodological paper. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Concealment of allocation (RCT / CCT) | Unclear risk | "Cluster randomised design"; unit of allocation was health district but random process not explicit |
| Follow‐up (RCT / CCT) | Unclear risk | Patients: 153 intervention (65%) and 116 control (58%) follow‐up at 1 month on questionnaire‐based measures (including primary outcomes); 219 intervention (93%) and 176 control (88%) on place of death Caregivers: 113 (49%) intervention and 70 control (36%) 1 month after death |
| Blinding (RCT / CCT) | Unclear risk | Not stated |
| Baseline measurement (RCT / CCT) | Unclear risk | Significant differences in diagnosis (intervention more gastrointestinal/lung, less breast/prostate/kidney/vesica/lymphoma/skin), housing (intervention higher proportion living in villa/apartment), access to informal help (intervention higher) and receipt of HC nursing (intervention lower); unclear if all are in same direction as results. No significant baseline differences in quality of life (1 of primary outcomes) |
| Reliability of outcome measurement (RCT / CCT) | Unclear risk | Questionnaire‐based measures were self completed; source of data on place of death not stated |
| Protection against contamination (RCT / CCT) | Low risk | Health districts randomised |