Axelsson 1998.
Study characteristics | ||
Methods |
Design: cluster CCT (patient) Methodological quality: 2.5/6a (EPOC RCT/CCT checklist) |
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Participants |
Country and regions: Sweden, Östersund, County of Jämtland, metropolitan area (sparsely populated region) Recruitment (1991‐1993, 30 months): mainly from Department of General Surgery at County Hospital of Östersund but also from other departments and other GPs; patients with symptomatic incurable cancer (disease within the realm of general surgery), who wished to stay at home and had a caregiver; patients living within 40 km of the hospital (9 primary care health centres) were allocated to the intervention; controls met all inclusion criteria but the latter (unknown number of primary care health centres) Number of patients (allocated): 72 (57 intervention and 15 control; authors referred to the control group as "reference group") Diseases: cancer (72) Patient characteristics: median age 72 years intervention, 71 years control; 46% female Deaths at end of study: 72 Withdrawals/other drop‐outs: 17 intervention (1 actively dying, 16 who were not matched to a third historical control group, see notes) |
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Interventions | Home palliative care vs. usual care "Palliative Support Service (PSS)" Type: specialist palliative care Service base: Department of General Surgery at County Hospital of Östersund Team: full‐time nurse (15 years' experience of practical cancer care on a surgical ward, trained in pain relief and symptom control, worked weekdays 8 a.m. to 5 p.m.), surgeon (half‐day per week basis); leasing car and mobile telephone; weekly conference to review cases; collaboration with the 9 local primary care centres Responsibility: not stated Description: new programme; nurse role ‐ acted as link between home and hospital, supported patient, caregiver and district nurse, district nurse education on management of infusors, epidural catheters, central venous catheters and other technical devices, administered blood transfusions, low‐dose chemotherapy and parenteral nutrition at home when needed; surgeon role ‐ scrutinised all referrals to select patients for whom support could imply improved palliation and extended time at home, reviewed patients at weekly conference with nurse, occasional home visits if needed (supported by 6 interested colleagues); patient dossier – given to the patient on discharge to improve communication between the hospital and primary healthcare service, included copies of essential information from medical records, with 3 specific fact sheets (1. sheet listed all names and telephone numbers of staff involved, namely surgeon, ward, GP, district nurse, HC assistant, consultant nurse, emergency telephone numbers for nights and weekends; 2. all prescribed drugs, information on effects and administration instructions; 3. exact wording used by doctor informing the patient of their disease and its dissemination, stating clearly whether patient had been informed of a lump, a tumour or a cancer and which metastases the patient knew of, also noted the family member(s) who had received the same information) Duration: median length of stay in intervention 70 days Control: usual care, mainly home care and conventional primary and hospital care |
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Outcomes | Death at home Death in hospital Death in nursing home Percentage of time and days spent at home Survival Assessment points: prospectively for intervention and retrospectively for control group, through medical records |
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Resource use/costs | Hospitalisations (number of admissions, terminal hospitalisation days) Institutional days (in hospital and nursing homes) HC (hours of contact with intervention consultant nurse and surgeon, district nurse, assistant nurse, GP, home service, night sitting) Informal care (days next of kin off work) Time horizon: from enrolment to death; from diagnosis to death (institutional days); last 6 months before death (hospital admissions, institutional days) |
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Notes |
Power considerations: none stated Analysis involved only part of the intervention group, those matched to a third historical control group who died locally prior to service start (1990); patients aged ≥ 58 years were matched for age, diagnosis, place of residence and as far as possible for gender and marital status (younger patients could not be adequately matched). This excluded 16 of 57 eligible patients, resulting in a sample of 41 in the intervention group Longer recruitment for intervention patients (30 months) than for controls (4 months) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Concealment of allocation (RCT / CCT) | High risk | Allocation based on area proximity to service (not random) |
Follow‐up (RCT / CCT) | High risk | 56/72 (78%) |
Blinding (RCT / CCT) | Unclear risk | Not stated |
Baseline measurement (RCT / CCT) | Unclear risk | No significant differences in age, sex distribution, marital status and KPS; however, groups differed in distance to hospital |
Reliability of outcome measurement (RCT / CCT) | Unclear risk | Patient and staff filled sheets in patient's dossier |
Protection against contamination (RCT / CCT) | Low risk | Allocation was by area |