Ellard, David R., Nichols, Vivien P., Taylor, Stephanie J. C. and Griffiths, Frances (2020) CHESS process evaluation results report. Coventry, UK: University of Warwick.

Preview

PDF WRAP-CHESS-process-evaluation-results-report-Griffiths-2020.pdf - Published Version - Requires a PDF viewer. Download (1831Kb) | Preview

Request Changes to record.

Abstract

Executive Summary

Purpose: The purpose of this report is to present the findings from the CHESS trial process evaluation. These results are being presented to the CHESS Chief Investigator and the CHESS team before the main trial outcomes are presented. These results will form the basis of the process evaluation interpretation of the CHESS outcome as well as a process evaluation paper.
Background: This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches.
Methods: Our process evaluation was guided by the MRC framework and explored components proposed by Steckler and Linnan including Context, Reach, Recruitment, Dose delivered, Dose receive, intervention fidelity and Implementation. We employed a mixed methods approach. Using both quantitative and qualitative data. Quantitatively we explored: Reach/context, recruitment, dose delivered, dose received and fidelity. In addition to this we included the experiences of both participants and intervention facilitators about their involvement in the trial. By bringing together both the qualitative and quantitative results where we explored both early implementation (4-months) and implementation overall; looking for facilitators and barriers.
Results: Reach/Context results show that we reached a diverse population that was representative of national averages in terms of ethnic mix and levels of deprivation, with a good mix of rural and suburban areas. Recruitment proved to be consistent across the study with an average of 2% (31,020) of the populations from the 164 GP practices being identified as potential participants. The study team struggled to recruit all headache types and the study became predominantly populated with those reporting migraine. The research team identified 31,020 people from GP searches and contacted, of these 7% (2178) were interested in CHESS, but of these only 47% (1034) were eligible, 68% (706) were randomised. There is a slight trend towards better recruitment and randomisation in less deprived areas. The study team successfully delivered 42 (2-day) group sessions. A total of 380 participants were invited to attend the two-day group sessions and the 1-2-1 discussions with a nurse. 288 (76%) attended at least part of the two-day course. 92 (24%) were not exposed to the CHESS intervention at all. Of the 288 who did attend the group sessions 227 (79%) attended both days whilst 61 (21%) only attended day one. Of the 288 who took part in groups 261 (91%) had a one-to-one interaction with the nurse. Overall 380/261 (69%) achieved the predefined minimum dose (attended at least some of the course and the 1-2-1 discussion with the nurse). Only 217 (57%) fully adhered to the intervention. In terms of fidelity the intervention was delivered well with adherence being slightly better than competence. (Adherence 0.83% (0.67, 1.00) Competence 70% (0.50, 0.90)).
Interviews with participants gave us an insight into the lives of people who live with chronic headache. 31 participated in the interview study covering both the intervention and control arms. Participants provided their thoughts and feelings about the interventions, both control and active, with generally favourable comments. A sample of participants (n = 117) who were in the intervention arm provided detailed feedback on the 2-day group session and the nurse 1-2-1. Results were generally positive with high levels of satisfaction with the course overall and the facilitators. Venues, relaxation and taster sessions and the mindfulness received less favourable satisfaction scores.
Interviewees were largely positive about the group sessions with them generally liking the group format, however some sessions were more popular than others For example, the lifestyle session, stress and anxiety and sleep sessions and overall felt it were useful to raise awareness of how these may affect headaches. Whilst the Mindfulness and relaxation for headaches Taster activity and the managing setbacks session were not well liked. Comments on the 1-2-1 sessions again were generally positive. Focus groups with the facilitators offered provided views from their perspective.
Fourteen interviewees contributed to a longitudinal examination of their experiences of the trial and its impact on their lives with chronic headache. These showed similarities and differences between the intervention and control arm participants. Again these interviews highlight the complexity of living with chronic headache. In the intervention arm participants described having made, or making, changes to their lives and headache management that could be attributed to CHESS. But equally there is evidence of similar improvements in control participants.
Conclusion: The results of the PE, reveal that the CHESS study was well conducted and it reached out to a diverse population across different geographical settings. Recruitment was successful. However, the PE does highlight that this is a complex population that may be hard to reach. The intervention components (2-day course and 1-2-1 sessions) were delivered with fidelity and, in most cases, were well received. We have results that will help interpret the outcome results from the main trial and we are making a number of recommendations.

Item Type:	Report
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RB Pathology R Medicine > RC Internal medicine
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
Library of Congress Subject Headings (LCSH):	Headache, Headache -- Diagnosis, Chronic pain, Migraine, Tension headache
Publisher:	University of Warwick
Place of Publication:	Coventry, UK
Official Date:	1 December 2020
Dates:	Date Event 1 December 2020 Published 1 December 2020 Created
Number of Pages:	65
Status:	Not Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Description:	Version 1
Date of first compliant deposit:	11 December 2020
Date of first compliant Open Access:	14 December 2020

Request changes or add full text files to a record

Repository staff actions (login required)

View Item

Downloads