title: Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice: the 3D study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ISRCTN06180958.
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Cindy
authors.identifier: 0000-0002-1256-1820
authors.initials: C
authors.lastname: Mann
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Shaw
authors.affiliation: Division of Population Health Sciences, University of Dundee, Dundee, UK.
authors.forename: Bruce
authors.initials: B
authors.lastname: Guthrie
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Wye
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Mei-See
authors.identifier: 0000-0003-4948-5670
authors.initials: MS
authors.lastname: Man
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Sandra
authors.identifier: 0000-0003-0782-3117
authors.initials: S
authors.lastname: Hollinghurst
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Brookes
authors.affiliation: Centre for Primary Care, University of Manchester, Manchester, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.affiliation: Department of General Practice and Primary Care, University of Glasgow, Glasgow, UK.
authors.forename: Stewart
authors.initials: S
authors.lastname: Mercer
authors.affiliation: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
authors.forename: Chris
authors.identifier: 0000-0002-4378-3960
authors.initials: C
authors.lastname: Salisbury
mesh_terms: D002908:Chronic Disease / Q000453:epidemiology*; D002985:Clinical Protocols; D016000:Cluster Analysis; D019033:Delivery of Health Care, Integrated / Q000458:organization & administration* / Q000592:standards; D005260:Female; D058006:General Practice / Q000458:organization & administration / Q000592:standards; D006801:Humans; D008297:Male; D000076322:Multimorbidity; D017063:Outcome Assessment, Health Care; D018802:Patient-Centered Care / Q000458:organization & administration* / Q000592:standards; D020399:Practice Management / Q000458:organization & administration* / Q000592:standards; D036301:Qualitative Research; D058996:Quality Improvement; D011788:Quality of Life; D006113:United Kingdom / Q000453:epidemiology
keywords: Family Practice; Multimorbidity; Patient-centred care; Process evaluation; Protocol