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Process evaluation protocol for the I-WOTCH study : an opioid tapering support programme for people with chronic non-malignant pain
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I-WOTCH team (Including: Nichols, Vivien P., Abraham, Charles, Eldabe, Sam , Sandhu, Harbinder, Underwood, Martin and Seers, Kate). (2019) Process evaluation protocol for the I-WOTCH study : an opioid tapering support programme for people with chronic non-malignant pain. BMJ Open, 9 . e028998. doi:10.1136/bmjopen-2019-028998 ISSN 2044-6055.
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WRAP-process-evaluation-protocol-opioid-tapering-people-pain-Seers-2019.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1125Kb) | Preview |
Official URL: http://dx.doi.org/10.1136/bmjopen-2019-028998
Abstract
Introduction The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved.
Methods and analysis A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a ‘following a thread’ and a mixed methods matrix for the final integrated analysis.
Ethics and dissemination The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RB Pathology | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Chronic pain -- Treatment, Clinical trials, Opioids -- Receptors, Drugs -- Prescribing | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 10 October 2019 | ||||||
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| Volume: | 9 | ||||||
| Article Number: | e028998 | ||||||
| DOI: | 10.1136/bmjopen-2019-028998 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 10 October 2019 | ||||||
| Date of first compliant Open Access: | 10 October 2019 | ||||||
| RIOXX Funder/Project Grant: |
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