Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice: the 3D study

Cindy Mann (Lead / Corresponding author), Alison Shaw, Bruce Guthrie, Lesley Wye, Mei-See Man, Sandra Hollinghurst, Sara Brookes, Peter Bower, Stewart Mercer, Chris Salisbury

    Research output: Contribution to journalArticle

    15 Citations (Scopus)
    162 Downloads (Pure)

    Abstract

    Introduction: As an increasing number of people are living with more than 1 long-term condition, identifying effective interventions for the management of multimorbidity in primary care has become a matter of urgency. Interventions are challenging to evaluate due to intervention complexity and the need for adaptability to different contexts. A process evaluation can provide extra information necessary for interpreting trial results and making decisions about whether the intervention is likely to be successful in a wider context. The 3D (dimensions of health, drugs and depression) study will recruit 32 UK general practices to a cluster randomised controlled trial to evaluate effectiveness of a patient-centred intervention. Practices will be randomised to intervention or usual care.

    Methods and Analysis: The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and the effect of context. As part of the intervention, quantitative data will be collected to provide implementation feedback to all intervention practices and will contribute to evaluation of implementation fidelity, alongside case study data. Data will be collected at the beginning and end of the trial to characterise each practice and how it provides care to patients with multimorbidity. Mixed methods will be used to collect qualitative data from 4 case study practices, purposively sampled from among intervention practices. Qualitative data will be analysed using techniques of constant comparison to develop codes integrated within a flexible framework of themes. Quantitative and qualitative data will be integrated to describe case study sites and develop possible explanations for implementation variation. Analysis will take place prior to knowing trial outcomes.

    Ethics and Dissemination: Study approved by South West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via a final report, peer-reviewed publications and practical guidance to healthcare professionals, commissioners and policymakers.

    Trial Registration Number: ISRCTN06180958.

    Original languageEnglish
    Article numbere011260
    Number of pages11
    JournalBMJ Open
    Volume6
    Issue number5
    DOIs
    Publication statusPublished - 4 May 2016

    Fingerprint Dive into the research topics of 'Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice: the 3D study'. Together they form a unique fingerprint.

  • Cite this