A randomised controlled trial, cost-effectiveness and process evaluation of the implementation of self-management for chronic gastrointestinal disorders in primary care, and linked projects on identification and risk assessment

Thompson, David G; O’Brien, Sarah; Kennedy, Anne; Rogers, Anne; Whorwell, Peter; Lovell, Karina; Richardson, Gerry; Reeves, David; Bower, Peter; Chew-Graham, Carolyn; Harkness, Elaine; Beech, Paula

Abstract

Background
Chronic gastrointestinal disorders are major burdens in primary care. Although there is some evidence that enhancing self-management can improve outcomes, it is not known if such models of care can be implemented at scale in routine NHS settings and whether or not it is possible to develop effective risk assessment procedures to identify patients who are likely to become chronically ill.

Objectives
What is the clinical effectiveness and cost-effectiveness of an intervention to enhance self-management support for patients with chronic conditions when translated from research settings into routine care? What are the barriers and facilitators that affect the implementation of an intervention to enhance self-management support among patients, clinicians and organisations? Is it possible to develop methods to identify patients at risk of long-term problems with functional gastrointestinal disorders in primary care? Data sources included professional and patient interviews, patient self-report measures and data on service utilisation.

Design
A pragmatic, two-arm, practice-level cluster Phase IV randomised controlled trial evaluating outcomes and costs associated with the intervention, with associated process evaluation using interviews and other methods. Four studies around identification and risk assessment: (1) a general practitioner (GP) database study to describe how clinicians in primary care record consultations with patients who experience functional lower gastrointestinal symptoms; (2) a validation of a risk assessment tool; (3) a qualitative study to explore GPs’ views and experiences; and (4) a second GP database study to investigate patient profiles in irritable bowel syndrome, inflammatory bowel disease and abdominal pain.

Setting
Salford, UK.

Participants
People with long-term conditions and professionals in primary care.

Interventions
A practice-level intervention to train practitioners to assess patient self-management capabilities and involve them in a choice of self-management options.

Main outcome measures
Patient self-management, care experience and quality of life, health-care utilisation and costs.

Results
No statistically significant differences were found between patients attending the trained practices and those attending control practices on any of the primary or secondary outcomes. The intervention had little impact on either costs or effects within the time period of the trial. In the practices, self-management tools failed to be normalised in routine care. Full assessment of the predictive tool was not possible because of variable case definitions used in practices. There was a lack of perceived clinical benefit among GPs.

Limitations
The intervention was not implemented fully in practice. Assessment of the risk assessment tool faced barriers in terms of the quality of codting in GP databases and poor recruitment of patients.

Conclusions
The Whole system Informing Self-management Engagement self-management (WISE) model did not add value to existing care for any of the long-term conditions studied.

Future work
The active components required for effective self-management support need further study. The results highlight the challenge of delivering improvements to quality of care for long-term conditions. There is a need to develop interventions that are feasible to deliver at scale, yet demonstrably clinically effective and cost-effective. This may have implications for the piloting of interventions and linking implementation more clearly to local commissioning strategies.

Trial registration
Current Controlled Trial ISRCTN90940049.

Funding
This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 6, No. 1. See the NIHR Journals Library website for further project information.

Citation

Thompson, D. G., O’Brien, S., Kennedy, A., Rogers, A., Whorwell, P., Lovell, K., …Beech, P. A randomised controlled trial, cost-effectiveness and process evaluation of the implementation of self-management for chronic gastrointestinal disorders in primary care, and linked projects on identification and risk assessment. Programme Grants for Applied Research, 6(1), 1-154. https://doi.org/10.3310/pgfar06010

• Journal Article Type: Article
• Deposit Date: Jun 20, 2023
• Journal: Programme Grants for Applied Research
• Print ISSN: 2050-4322
• Electronic ISSN: 2050-4330
• Publisher: NIHR Journals Library
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Issue: 1
• Pages: 1-154
• DOI: https://doi.org/10.3310/pgfar06010
• Keywords: General Chemical Engineering
• Additional Information: Free to read: This content has been made freely available to all.