Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial
Introduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a...
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BMJ Publishing Group
2021-01-01
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| Series: | BMJ Open |
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| author | Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate |
| author_facet | Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate |
| author_sort | Lieve Van den Block |
| collection | DOAJ |
| description | Introduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a pilot randomised controlled trial (RCT) with a process evaluation that aims to assess the feasibility and preliminary effectiveness of the Frailty+ intervention.Methods and analysis We will conduct a pilot RCT in Flanders, Belgium. Frail older people who are discharged to home from hospital will be identified and recruited. Seventy-six will be randomly assigned either to the control group (standard care) or the intervention group (Frailty+ intervention alongside standard care). Data will be collected from patients and family carers. At the core of the Frailty+ intervention is the provision of timely short-term specialised palliative care facilitated by a nurse from the specialised palliative home care service over a period of 8 weeks. We will assess feasibility in terms of recruitment, randomisation, acceptability of the intervention, retention in the programme and data completion. The primary outcome for assessing preliminary effectiveness is a mean score across five key symptoms that are amenable to change (ie, breathlessness, pain, anxiety, constipation, fatigue), measured at baseline and 8 weeks post-baseline. The process evaluation will be conducted in the intervention group only, with measurements at 8–11 weeks post-baseline to evaluate implementation, mechanisms of change and contextual factors.Ethics and dissemination The study has been approved by the ethics committee of University Hospital Ghent. Results will be used to inform the design of a full-scale RCT and will be published in a peer-reviewed, open access journal.Trial registration number ISRCTN39282347; Pre-results. |
| format | Article |
| id | doaj-art-a29b72a89fb94d5c85a9cdf8f46d1b47 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a29b72a89fb94d5c85a9cdf8f46d1b472024-11-18T11:25:10ZengBMJ Publishing GroupBMJ Open2044-60552021-01-0111110.1136/bmjopen-2020-043663Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trialLieve Van den Block0Kim de Nooijer1Lara Pivodic2Peter Pype3Nele Van Den Noortgate4End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, BelgiumEnd-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, BelgiumEnd-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, BelgiumEnd-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, BelgiumEnd-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, BelgiumIntroduction There is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a pilot randomised controlled trial (RCT) with a process evaluation that aims to assess the feasibility and preliminary effectiveness of the Frailty+ intervention.Methods and analysis We will conduct a pilot RCT in Flanders, Belgium. Frail older people who are discharged to home from hospital will be identified and recruited. Seventy-six will be randomly assigned either to the control group (standard care) or the intervention group (Frailty+ intervention alongside standard care). Data will be collected from patients and family carers. At the core of the Frailty+ intervention is the provision of timely short-term specialised palliative care facilitated by a nurse from the specialised palliative home care service over a period of 8 weeks. We will assess feasibility in terms of recruitment, randomisation, acceptability of the intervention, retention in the programme and data completion. The primary outcome for assessing preliminary effectiveness is a mean score across five key symptoms that are amenable to change (ie, breathlessness, pain, anxiety, constipation, fatigue), measured at baseline and 8 weeks post-baseline. The process evaluation will be conducted in the intervention group only, with measurements at 8–11 weeks post-baseline to evaluate implementation, mechanisms of change and contextual factors.Ethics and dissemination The study has been approved by the ethics committee of University Hospital Ghent. Results will be used to inform the design of a full-scale RCT and will be published in a peer-reviewed, open access journal.Trial registration number ISRCTN39282347; Pre-results.https://bmjopen.bmj.com/content/11/1/e043663.full |
| spellingShingle | Lieve Van den Block Kim de Nooijer Lara Pivodic Peter Pype Nele Van Den Noortgate Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial BMJ Open |
| title | Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial |
| title_full | Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial |
| title_fullStr | Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial |
| title_full_unstemmed | Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial |
| title_short | Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial |
| title_sort | timely short term specialised palliative care service intervention for frail older people and their family carers in primary care study protocol for a pilot randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/1/e043663.full |
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