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

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

Research output: Contribution to journalArticlepeer-review

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
Original languageEnglish
Pages (from-to)1-154
JournalProgramme Grants Appl Res
Volume6
Issue number1
DOIs
Publication statusPublished - 31 Mar 2018

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