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

Research output: Contribution to journalArticle

Original languageEnglish
Article numbere011260
Number of pages12
JournalBMJ Open
Issue number5
Early online date4 May 2016
DateAccepted/In press - 12 Apr 2016
DateE-pub ahead of print - 4 May 2016
DatePublished (current) - May 2016


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.

    Structured keywords

  • ConDuCT-II
  • Centre for Surgical Research

    Research areas

  • process evaluation, protocol, primary care, multimorbidity, patient-centred care

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  • Full-text PDF (final published version)

    Rights statement: This is the final published version of the article (version of record). It first appeared online via BMJ Publishing Group at 10.1136/bmjopen-2016-011260. Please refer to any applicable terms of use of the publisher.

    Final published version, 2 MB, PDF document

    Licence: CC BY-NC


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