SummaryBackgroundThe management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach. Our hypothesis was that the patient-centred, so-called 3D approach (based on dimensions of health, depression, and drugs) for patients with multimorbidity would improve their health-related quality of life, which is the ultimate aim of the 3D intervention.MethodsWe did this pragmatic cluster-randomised trial in general practices in England and Scotland. Practices were randomly allocated to continue usual care (17 practices) or to provide 6-monthly comprehensive 3D reviews, incorporating patient-centred strategies that reflected international consensus on best care (16 practices). Randomisation was computer-generated, stratified by area, and minimised by practice deprivation and list size. Adults with three or more chronic conditions were recruited. The primary outcome was quality of life (assessed with EQ-5D-5L) after 15 months' follow-up. Participants were not masked to group assignment, but analysis of outcomes was blinded. We analysed the primary outcome in the intention-to-treat population, with missing data being multiply imputed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN06180958.FindingsBetween May 20, 2015, and Dec 31, 2015, we recruited 1546 patients from 33 practices and randomly assigned them to receive the intervention (n=797) or usual care (n=749). In our intention-to-treat analysis, there was no difference between trial groups in the primary outcome of quality of life (adjusted difference in mean EQ-5D-5L 0·00, 95% CI −0·02 to 0·02; p=0·93). 78 patients died, and the deaths were not considered as related to the intervention.InterpretationTo our knowledge, this trial is the largest investigation of the international consensus about optimal management of multimorbidity. The 3D intervention did not improve patients' quality of life.FundingNational Institute for Health Research.

Objective. To explore the opinions of patients and health professionals about the provision of health care for people with osteoarthritis (OA) and possible service improvements. Methods. Qualitative methods were used to explore the opinions of patients and health professionals about existing OA care and possible changes in service provision. Sixteen patients with hip or knee OA took part in focus groups, and 12 health professionals from primary and secondary care were interviewed. Focus groups and interviews were audiorecorded, transcribed, and anonymized. Transcripts were analyzed using the Framework method. Results. The views of the patients and health professionals generally concurred. They felt that OA should receive more attention and better consistency of care. More information and education about the condition, diet, exercise, aids, and resources was needed at the time of diagnosis. Patients wanted more time, better continuity, and proactive followup from general practitioners, with less variation in accessing joint replacement. Participants suggested access on demand to an "OA specialist" in primary care and the use of a management model comparable to other long-term conditions. Both patients and health professionals wanted better support for self-management to help patients manage their condition more effectively and appropriately. Conclusion. Patients and health professionals perceived similar problems with OA care. More proactive care and improved information, especially for those with early OA, might achieve better outcomes. Access to a primary care OA specialist might provide better continuity of care, enable patients to meet their needs for information, support, and self-management, as well as improve appropriate referral to other resources.

Plain English summaryIncluding patient and public involvement (PPI) in health research is thought to improve research but it is hard to be clear exactly how it helps. This is because PPI takes many forms, is sometimes only token and is not always reported clearly. This makes it difficult to combine the evidence so that clear conclusions can be reached about the ingredients of successful PPI and what PPI achieves. Previous research that has tried to combine the evidence has led to several guidelines for researchers to use in setting up and reporting PPI.This paper was written jointly by researchers and PPI contributors as a reflection on our experiences. The aim was to add to the evidence, by giving detail about the use of PPI in a large randomised controlled trial and the effect it had. We were guided by published PPI reporting guidelines. The effects on the trial are shown in a table of changes made because of suggestions from the PPI group. A survey was used to ask PPI contributors and researchers about their experience and effects they had noticed. Three themes were noted: impact on the trial, the effect of involvement on individual researchers and group members, and group environment. The PPI work affected the trial in many ways, including changes to documents used in the trial and advice on qualitative data collection methods and analysis. Individuals reported positive effects, including enjoying being in the group, gaining confidence, and learning how to share views.AbstractBackgroundPatient and public involvement (PPI) is believed to enhance health care delivery research, and is widely required in research proposals. Detailed, standardised reporting of PPI is needed so that strategies to implement more than token PPI that achieves impact can be identified, properly evaluated and reproduced. Impact includes effects on the research, PPI contributors and researchers. Using contributor and researcher perspectives and drawing on published guidelines for reporting PPI, we aimed to reflect on our experience and contribute evidence relevant to two important questions: ‘What difference does PPI make?’ and ‘What’s the best way to do it?’MethodsFourteen people living with multiple long-term conditions (multimorbidity) were PPI contributors to a randomised controlled trial to improve care for people with multimorbidity. Meetings took place approximately four times a year throughout the trial, beginning at grant application stage. Meeting notes were recorded and a log of PPI involvement was kept. At the end of the trial, seven PPI contributors and four researchers completed free-text questionnaires about their experience of PPI involvement and their perception of PPI impact. The responses were analysed thematically by two PPI contributors and one researcher. The PPI group proposed writing this report, which was co-authored by three PPI contributors and two researchers.ResultsMeeting attendance averaged nine PPI contributors and three to four researchers. The involvement log and meeting notes recorded a wide range of ac...

ObjectivesDuring a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.DesignMixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.SettingThirty-three UK general practices in three areas.ParticipantsThe trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.ResultsStaff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from ‘tick-box’ to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.ConclusionsImplementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.Trial registration number ISRCTN06180958

BackgroundComputer templates for review of single long-term conditions are commonly used to record care processes, but they may inhibit communication and prevent patients from discussing their wider concerns.AimTo evaluate the effect on patient-centredness of a novel computer template used in multimorbidity reviews.Design and settingA qualitative process evaluation of a randomised controlled trial in 33 GP practices in England and Scotland examining the implementation of a patient-centred complex intervention intended to improve management of multimorbidity. A purpose-designed computer template combining long-term condition reviews was used to support the patient-centred intervention.MethodTwenty-eight reviews using the intervention computer template and nine usual-care reviews were observed and recorded. Sixteen patient interviews, four patient focus groups, and 23 clinician interviews were also conducted in eight of the 12 intervention practices. Transcripts were thematically analysed based on predefined core components of patient-centredness and template use.ResultsDisrupted communication was more evident in intervention reviews because the template was unfamiliar, but the first template question about patients’ important health issues successfully elicited wide-ranging health concerns. Patients welcomed the more holistic, comprehensive reviews, and some unmet healthcare needs were identified. Most clinicians valued identifying patients’ agendas, but some felt it diverted attention from care of long-term conditions. Goal-setting was GP-led rather than collaborative.ConclusionIncluding patient-centred questions in long-term condition review templates appears to improve patients’ perceptions about the patient-centredness of reviews, despite template demands on a clinician’s attention. Adding an initial question in standardised reviews about the patient’s main concerns should be considered.