Background The Carer Support Needs Assessment Tool intervention (CSNAT-I) has been shown to improve end-of-life care support for informal caregivers. This study investigated the impact of the CSNAT-I on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark.
Methods A stepped-wedge cluster randomised controlled trial with nine clusters (ie, SPC teams). Outcome measures were collected using caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up.
Results A total of 437 caregivers were enrolled (control group, n=255; intervention group, n=182). No intervention effect was found on the primary outcome, caregiver strain at T1 (p=0.1865). However, positive effects were found at T1 and T2 on attention to caregivers’ well-being (p<0.0001), quality of information and communication (p<0.0001), amount of information (T1: p=0.0002; T2: p<0.0001), involvement (T1: p=0.0045; T2: p<0.0001), talking about greatest burdens (p<0.0001) and assistance in managing greatest burdens (p<0.0001). The effect sizes of these differences were medium or large and seemed to increase from T1 to T2. At T1, positive effects were found on distress (p=0.0178) and home care responsibility (p=0.0024). No effect was found on the remaining outcomes.
Conclusion Although no effect was found on caregiver strain, the CSNAT-I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers’ experience of the interaction with healthcare professionals.
Trial registration number NCT03466580.
- supportive care
- home care
- family management
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Correction notice This article has been corrected since it is published.
Funding The study was funded by the Danish Cancer Society (Grant A8861) and the A.P. Moeller and Chastine Mc-Kinney Moeller Foundation (Grant 11692). The sponsors had no role in the study design, data collection, analysis and interpretation of data, in the writing of the paper, or in the decision to submit the paper for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was carried out in accordance with the 1964 Helsinki Declaration and its later amendments. The study was registered at ClinicalTrials.gov (ID: NCT03466580) and was approved by the Danish Data Protection Board (VD-2018-46). The protocol was presented to the Scientific Ethical Committee system (no. H-16042063) and was found not to require formal approval from the committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Any data sharing requires approval from the Danish Data Protection Board.
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