Background Healthcare services are mainly organised around single health conditions and need reconfiguration to meet the needs of people with multiple long-term conditions (multimorbidity). Typically, people are offered annual reviews for each of their long-term conditions separately. In a randomised controlled trial, a comprehensive computerised template based on a personalised care model increased the person-centredness of multimorbidity reviews in primary care, but there were implementation challenges. We sought to understand and address the challenges of implementing a template to support personalised primary care for people with multimorbidity (PP4M).Objectives To explore the extent of implementation and factors influencing uptake of the PP4M intervention. To understand factors influencing implementation and normalisation of the template.Design Convergent parallel mixed methods within a non-randomised hybrid implementation-effectiveness study. Normalisation Process Theory (NPT) informed design, data collection and analysis.Setting Primary care (general practices) in three English regions.Participants Quantitative: Patients aged 18 years or over and had at least three types of long-term conditions (routine data collection); staff involved in using the template in implementation practices (Normalisation MeAsure Development (NoMAD) questionnaire).Qualitative: Staff at implementation practices.Intervention A multimorbidity computerised template to support personalised annual reviews. NPT-informed implementation package delivered to implementation practices included: process mapping, software support and training.Data collection Routine medical record data; NoMAD questionnaires and qualitative interviews in implementation practices.Primary/secondary outcomes Measures of reach, fidelity, acceptability and sustainability.Analysis Quantitative data: descriptive statistics, logistic regression and difference-in-difference models. Qualitative data analysis conducted using NPT coding manual.Results In practices that received an NPT-informed implementation package, use of the template increased more, across patients with a range of demographics and health conditions, than in those that did not receive the implementation package (OR 2.86 (95% CI 2.34 to 3.49)). The implementation package successfully triggered NPT processes of coherence and cognitive participation, and, to a lesser extent, collective action and reflexive monitoring. Contextual factors, including a lack of staff generalist skills and disease-specific incentives, impeded engagement and sustained implementation.Conclusions Focusing on the processes of normalisation as mechanisms of implementation facilitated development of an implementation strategy with potential to trigger those mechanisms, but did not sufficiently address contextual factors. Implementation strategies to support personalised care must consider wider system and practice level contextual factors, such as incentives and staff training.Trail registration number https://doi.org/10.1186/ISRCTN40295449 (2022–08-03, retrospectively registered.)

Background:Polypharmacy is a major challenge for patient safety and effective resource use. High-quality evidence supporting polypharmacy management is lacking. Aim:To develop, optimise and evaluate a primary care complex intervention for reducing medically defined potentially inappropriate prescribing among patients experiencing polypharmacy. Methods:Phase 1: Qualitative interviews and focus groups with patients and professionals explored views/experiences of existing National Health Service Scotland interventions, informing development of core intervention components. Phase 2: An external pilot-feasibility study was conducted in five general practitioner practices to optimise the Improving Medicines use in People with Polypharmacy in Primary care intervention. A formative mixed-methods process evaluation examined intervention implementation, alongside evaluating trial processes and collecting data to inform phase 3. Phase 3: A pragmatic, open-label two-arm parallel cluster-randomised trial was conducted in English general practice. The intervention (19 practices) comprised a structured, collaborative and patient-centred approach to medication review, supported by informatics, clinician training, performance feedback and financial incentivisation. The comparator was usual care (18 practices). Up to 50 adults receiving ≥ 5 regular medications, with ≥ 1 indicator of potentially inappropriate prescribing, were reviewed per practice over 6 months. Primary outcome was number of potentially inappropriate prescribing indicators at 26-week follow-up. Secondary outcomes included patient-reported measures and service use. Cost-effectiveness and cost-utility analyses were conducted (primary economic outcome quality-adjusted life-years). A mixed-methods process evaluation (patient surveys, patient/clinician interviews, audio-recorded observations) explored implementation. Results:Phase 1: Intervention component design was informed by findings related to elements of the medication review, informatics and clinician training. Phase 2: Core intervention elements were successfully implemented in the pilot, although clinical delivery was hampered by disruptions due to the coronavirus disease pandemic. Phase 3: Participants were recruited between January and June 2022 (intervention N = 891, usual care N = 836), median age 73 years, 49% female, with median four long-term conditions and eight medications. No improvement in the primary outcome was observed (mean difference potentially inappropriate prescribing count - 0.007; 95% confidence interval -0.21 to 0.199). Treatment burden was slightly improved, and subgroup analysis suggested potential improvements in less complex patients. The process evaluation found general practitioners and pharmacists valued and benefitted from the model of interprofessional collaboration, which strengthened working relationships and provided an opportunity for knowledge sharing and joint decision-making that supported management of clinical uncertainty. Most patients (73.2%) reported satisfaction with the review, with satisfaction strongly associated with perceptions of shared decision-making. There was no evidence of cost-effectiveness, although the economic evaluation did not quantify the aforementioned benefits or other broader factors of potential interest to decision-makers. Limitations:Key limitations include concurrent changes in usual care, potentially insensitive outcome measures and limited study-population generalisability. Interpretation:A complex medication optimisation intervention did not reduce potentially inappropriate prescribing in patients with polypharmacy. Findings strongly support revisiting current medication optimisation policy, with one-off structured reviews, even when enhanced with digital healthcare solutions and clinical pharmacy investment, not guaranteed to improve key clinical outcomes. Nevertheless, the positive patient and clinician findings are important: protected time for interprofessional collaborative working, plus effective integration of shared decision-making within patient-facing reviews, may facilitate improved patient care more broadly. Future work:Research should develop new patient-centred outcomes and identify higher-risk patients. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 16/118/14.

BACKGROUND:General practice nurses in England often manage long-term conditions, with more people now living with multiple conditions (MLTC). Evidence on the effectiveness and delivery of person-centred care for MLTC is limited, and the nurse's role - including necessary training - remains underexplored. AIM:To identify and characterise general practice nurses' experiences of undertaking person-centred multiple long-term condition reviews in England. DESIGN & SETTING:Secondary analysis of qualitative data gathered from general practice staff in England. METHOD:Two-part review consultations for people with three or more long-term conditions (rather than separate single-condition reviews as per usual care) in sixteen English general practices, part of a larger implementation project (PP4M). Empirical qualitative data (healthcare staff interviews and researcher fieldnotes) and theoretical approaches (chronic care model, normalisation process theory) analysed abductively. RESULTS:Two overarching themes identified:Healthcare professionals' understanding of MLTC reviews' purpose. Challenges and opportunities for nurses delivering MLTC reviews.Some nurses utilised reviews as data-gathering exercises, facilitating collection of nationally set, quality-driven, financial incentives linked to single-conditions. Other nurses used reviews as opportunities for meaningful discussion of complex problems, leading to action.MLTC reviews allowed nurses a new way of thinking. Some found this empowering, others found it challenging. CONCLUSION:General practice nurses are central to MLTC care. They value organisational support for training in person-centred MLTC management, but it remains unclear how best to achieve necessary training. Further research is needed on skills and training required for all healthcare professionals caring for people with MLTC.

BACKGROUND:Primary care is in urgent need of more effective and efficient ways of managing the care of people living with multiple long-term conditions (MLTCs; multimorbidity). Personalised care organised around an individual's needs and conditions, taking account of individual context and priorities and supporting self-management, may offer an improved approach. AIM:To explore the impact of a computerised template to support personalised care for patients with MLTCs within the context of routinely applied general practice. DESIGN & SETTING:A convergent mixed-methods evaluation design. General practices were recruited from three areas of England: Bristol, Southampton, and Staffordshire. METHOD:A computerised template for the review of MLTCs was made available to all general practices subscribing to a commercial template supplier. Implementation practices were supported to conduct personalised multimorbidity reviews. We used routine clinical data from implementation and control practices, a before-and-after patient questionnaire, and qualitative interviews with general practice staff and patients to evaluate the impact of the intervention. RESULTS:Thirty-two general practices were recruited, of which half were implementation practices. Using the multimorbidity template has potential to improve quality of care and patient benefit with no increase in consultation numbers. Patients received a more complete assessment of their needs with a clearer focus on the problems that matter most to them. Conducting multimorbidity reviews can increase burden on nursing staff and consideration is required as to the organisation of reviews and appropriate training for nursing staff. CONCLUSION:Use of the multimorbidity template needs to be supported by staff training, adequate practice capacity, support for system reorganisation, and attention to incentives to facilitate its benefits.

BACKGROUND:Polypharmacy is a major and growing challenge for patient safety and health outcomes, and associated with inefficient use of resources. Management requires balancing therapeutic benefits and risks, aligned with clinical and patient priorities. High-quality evidence supporting current guidance for the management of polypharmacy is scarce. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) study was to examine whether a complex intervention could reduce potentially inappropriate prescribing among patients experiencing polypharmacy in primary care. METHODS:A pragmatic, open-label, two-arm, parallel cluster-randomised trial was conducted in UK general practices providing National Health Service primary medical care. Practices were required to use the EMIS electronic health records system and have more than 4000 registered patients. For inclusion in the study, participants were required to be aged 18 years or older, prescribed at least five regular medications (ie, medicines recorded in the clinical system as repeat prescriptions, and thus available for recurrent ordering by patients without having to see a clinician) irrespective of when the drug was last issued, and with at least one indicator of potentially inappropriate prescribing identified by an informatics tool. Practices were randomly allocated to deliver the polypharmacy intervention or continue usual care. The complex intervention comprised a structured, collaborative, and patient-centred approach to medication review, supported by informatics, clinician training, performance feedback, and financial incentivisation. In each practice, adults receiving five or more regular medications, with at least one indicator of potentially inappropriate prescribing, were reviewed over a 6-month period. The primary outcome was number of indicators of potentially inappropriate prescribing at 26 weeks' follow-up, analysed on an intention-to-treat basis. The trial was registered with the ISRCTN registry (90146150) and is complete. FINDINGS:Between Jan 26, 2022, and June 20, 2022, 37 general practices were recruited. 33 745 patients were potentially eligible, and 11 022 of these were randomly sampled for study inclusion. 1471 were excluded after general practitioner screening, 9551 were invited to participate, and 1950 provided consent and were randomly assigned (944 patients from 18 practices assigned to usual care and 1006 patients from 19 practices assigned to the intervention). 1727 participants were enrolled in the trial (836 in the usual care group and 891 in the intervention group). Participants' median age was 73 years (IQR 66-79), 881 (51%) were male and 846 (49%) were female, and they had a median of four long-term conditions and a median of eight medications. There was no evidence of a difference in the primary outcome of number of potentially inappropriate prescribing indicators at the 26-week follow-up between the intervention and control groups after adjustment for pre-randomisation baseline (mean 2·3 in each group; difference in means -0·007 [95% CI -0·21 to 0·20]; p=0·95). There were 13 deaths and 99 people with one or more unplanned admissions in the intervention group, and 12 deaths and 91 people with one or more unplanned admissions in the control group. None of the admissions or deaths were deemed to be related to the intervention. INTERPRETATION:A complex medication optimisation intervention did not reduce potentially inappropriate prescribing in patients with polypharmacy. The findings are at odds with the current policy drive for digital health-care solutions, investment in clinical pharmacy staff, and promotion of structured medication reviews. Effective use of such strategies should be revisited accordingly. FUNDING:National Institute for Health and Care Research.

BACKGROUND:The aim of this project is to evaluate public contributors' experiences of their involvement in qualitative data analysis workshops during an on-going research project titled 'Personalised Primary care for Patients with Multiple long-term conditions'. METHODS:Four qualitative data analysis workshops were designed and conducted between August and December 2023. We used the Cube evaluation framework (henceforth referred to as the Cube) to evaluate the workshops. The Cube suggests four domains for successful PPI (voice, agenda, change, contribute).Within Workshops One, Two and Three public contributors had to login to an account to access the Cube; this was modified in Workshop Four following feedback from public contributors. FINDINGS:Across the four workshops the Cube was completed 11 times. Across all four workshops, public contributors thought that their voice was heard, that there were diverse ways to contribute and that they led the agenda. Public contributors thought that researchers responded to their questions and issues, when necessary. CONCLUSION:This evaluation has shown that public contributors can gain new skills and lead qualitative data analysis discussions.

Patient and public involvement (PPI) is increasingly seen as essential to health service research. There are strong moral and ethical arguments for good quality PPI. Despite the development of guidance aimed at addressing the inconsistent reporting of PPI activities within research, little progress has been made in documenting the steps taken to undertake PPI and how it influences the direction of a study. Without this information, there are minimal opportunities to share learnings across projects and strengthen future PPI practices. The aim of this paper is to present details on the processes and activities planned to integrate PPI into the qualitative research component of a mixed-methods, multi-site study evaluating the implementation of a smart template to promote personalised primary care for patients with multiple long-term conditions. This proposal describes the processes and activities planned to integrate PPI into the development and piloting of qualitative data collection tools (topic guides for both practice staff and patients) and a tailored data analysis package developed for PPI members incorporating broad concepts and specific methods of qualitative data analysis. Outputs relating to PPI activity may include clear, concise and suitably worded topic guides for qualitative interviews. Piloting of the topic guides via mock interviews will further develop researchers’ skills including sensitisation to the experiences of participants being interviewed. Working with PPI members when analysing the qualitative data aims to provide reciprocal learning opportunities and may contribute to improving the overall rigour of the data analysis. The intent of publishing proposed PPI activities within this project is to inform the future delivery of high quality PPI. Patient and public involvement (PPI) improves healthcare research, however, there is little published evidence of proposed PPI activities within a research study. The aim of this article is to describe the proposed PPI activities which are to be integrated into a study implementing a smart template to promote personalised care for people with multiple long-term conditions within primary care in the United Kingdom. The proposal describes the ways in which PPI members will be included within the data collection and analysis phases of a research study which includes interviews with primary care staff and patients. PPI members will be asked to develop questions for these interviews and to take part in a mock interview whereby a researcher interviews a PPI member. The proposal also provides details on qualitative data analysis workshops which will be specifically developed for PPI members. The impact of PPI activities could include clear, concise and suitably worded questions used within the interviews. Piloting of these questions via mock interviews may enable researchers to further develop their interviewing skills. It is anticipated that involving PPI members when analysing qualitative data will provide opportunities for reciprocal learning and lead to rich interpretations of the data, inclusive of the PPI members’ perspectives. Publishing a record of planned PPI activities and potential impacts demonstrates the rationale and considerations made by the team to ensure that involvement in this study is meaningful and has potential benefits for all involved. The team hopes this proposal will support others with the planning and delivery of PPI activities. In future publications, we will reflect on the learnings, challenges, and outcomes from the PPI activities detailed in this proposal.

Introduction: Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. Methods: This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. Ethics and dissemination: The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. ISRCTN Registration: 90146150 (28/03/2019)

Objectives During 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. Design Mixed-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. Setting Thirty-three UK general practices in three areas. Participants The 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. Results Staff 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. Conclusions Implementation 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

Background: People with multimorbidity experience impaired quality of life, poor health and a burden from treatment. Their care is often disease-focused rather than patient-centred and tailored to their individual needs. Objective: To implement and evaluate a patient-centred intervention to improve the management of patients with multimorbidity in general practice. Design: Pragmatic, cluster randomised controlled trial with parallel process and economic evaluations. Practices were centrally randomised by a statistician blind to practice identifiers, using a computer-generated algorithm. Setting: Thirty-three general practices in three areas of England and Scotland. Participants: Practices had at least 4500 patients and two general practitioners (GPs) and used the EMIS (Egton Medical Information Systems) computer system. Patients were aged ≥ 18 years with three or more long-term conditions. Interventions: The 3D (Dimensions of health, Depression and Drugs) intervention was designed to offer patients continuity of care with a named GP, replacing separate reviews of each long-term condition with comprehensive reviews every 6 months. These focused on individualising care to address patients’ main problems, attention to quality of life, depression and polypharmacy and on disease control and agreeing treatment plans. Control practices provided usual care. Outcome measures: Primary outcome – health-related quality of life (assessed using the EuroQol-5 Dimensions, five-level version) after 15 months. Secondary outcomes – measures of illness burden, treatment burden and patient-centred care. We assessed cost-effectiveness from a NHS and a social care perspective. Results: Thirty-three practices (1546 patients) were randomised from May to December 2015 [16 practices (797 patients) to the 3D intervention, 17 practices (749 patients) to usual care]. All participants were included in the primary outcome analysis by imputing missing data. There was no evidence of difference between trial arms in health-related quality of life {adjusted difference in means 0.00 [95% confidence interval (CI) –0.02 to 0.02]; p = 0.93}, illness burden or treatment burden. However, patients reported significant benefits from the 3D intervention in all measures of patient-centred care. Qualitative data suggested that both patients and staff welcomed having more time, continuity of care and the patient-centred approach. The economic analysis found no meaningful differences between the intervention and usual care in either quality-adjusted life-years [(QALYs) adjusted mean QALY difference 0.007, 95% CI –0.009 to 0.023] or costs (adjusted mean difference £126, 95% CI –£739 to £991), with wide uncertainty around point estimates. The cost-effectiveness acceptability curve suggested that the intervention was unlikely to be either more or less cost-effective than usual care. Seventy-eight patients died (46 in the intervention arm and 32 in the usual-care arm), with no evidence of difference between trial arms; no deaths appeared to be associated with the intervention. Limitations: In this pragmatic trial, the implementation of the intervention was incomplete: 49% of patients received two 3D reviews over 15 months, whereas 75% received at least one review. Conclusions: The 3D approach reflected international consensus about how to improve care for multimorbidity. Although it achieved the aim of providing more patient-centred care, this was not associated with benefits in quality of life, illness burden or treatment burden. The intervention was no more or less cost-effective than usual care. Modifications to the 3D approach might improve its effectiveness. Evaluation is needed based on whole-system change over a longer period of time. Trial registration: Current Controlled Trials ISRCTN06180958. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 7, No. 5. See the NIHR Journals Library website for further project information.

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.

Plain English summary Including 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. Abstract Background Patient 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?’ Methods Fourteen 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. Results Meeting attendance averaged nine PPI contributors and three to four researchers. The involvement log and meeting notes recorded a wide range of activities and impact including changes to participant documentation, advice on qualitative data collection, contribution to data analysis and dissemination advice. Three themes were identified from the questionnaires: impact on the study, including keeping the research grounded in patient experience; impact on individuals, including learning from group diversity and feeling valued; and an environment that facilitated participation. The size of the group influenced impact. Researchers and PPI contributors described a rewarding interaction that benefitted them and the research. Conclusions PPI was wide-ranging and had impact on the trial, contributors and researchers. The group environment facilitated involvement. Feedback and group interactions benefitted individuals. The insights gained from this study will postitively influence the researchers’ and contributors’ future involvement with PPI.

National Institute for Health Research.

Objectives Recent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current ‘usual primary care’ for multimorbidity, against which the 3D intervention was tested. Design Analysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff. Setting Primary care in the UK. Participants Patients with multimorbidity (n=5253) and 154 practice staff. Primary and secondary outcome measures Using surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients. Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma. Results Participating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care. Conclusion This trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention. Trial registration number ISRCTN06180958; Post-results.