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 DG1, O’Brien S2, Kennedy A3, Rogers A3, Whorwell P1, Lovell K4, Richardson G5, Reeves D6, Bower P7, Chew-Graham C8, Harkness E9, Beech P10.

Author information

1 Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester, Manchester, UK

2 Institute of Infection and Global Health, University of Liverpool, Liverpool, UK

3 National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Wessex, University of Southampton, Southampton, UK

4 Division of Nursing, Midwifery & Social Work, School of Health Sciences, University of Manchester, Manchester, UK

5 Centre for Health Economics, University of York, York, UK

6 Centre for Biostatistics, School of Health Sciences, University of Manchester, Manchester, UK

7 Centre for Primary Care, School of Health Sciences, University of Manchester, Manchester, UK

8 Research Institute, Primary Care and Health Sciences, Faculty of Medicine and Health Sciences, Keele University, Keele, UK

9 Division of Informatics, Imaging and Data Sciences, University of Manchester, Manchester, UK

10 Stroke Rehabilitation Unit, Salford Royal Foundation Trust, Salford, UK


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.

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