A proposal to embed patient and public involvement within qualitative data collection and analysis phases of a primary care based implementation study.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

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).

Financing The Infrastructure Of Accountable Communities For Health Is Key To Long-Term Sustainability.

Accountable Communities for Health (ACHs) are collaborative partnerships spanning health, public health, and social services that seek to improve the health of individuals and communities by addressing social determinants of health such as housing, food security, employment, and transportation. ACHs require funding not only for programs and services but also for core infrastructure functions. We conducted a legal and policy review to identify potential funding streams specifically for ACH infrastructure activities. We found multiple and credible options at the federal and state levels and in the public health, health insurance, and philanthropic and private sectors. Such options could support ACH infrastructure directly or through reimbursement for administrative costs associated with programmatic work. Yet we also found that there is no dedicated or explicit source of funding for these critical functions. For sustainable and long-term ACH support, policy makers and program administrators should clarify and define ACH infrastructure functions and, where appropriate, explicitly recognize supporting these functions as an allowable use of funds and facilitate their coordination across program funding streams.

Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

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.

Understanding usual care for patients with multimorbidity: baseline data from a cluster-randomised trial of the 3D intervention in primary care.

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.

Management of multimorbidity using a patient-centred care model: a pragmatic cluster-randomised trial of the 3D approach.

BACKGROUND: The 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. METHODS: We 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. FINDINGS: Between 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. INTERPRETATION: To 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. FUNDING: National Institute for Health Research.

A computer template to enhance patient-centredness in multimorbidity reviews: a qualitative evaluation in primary care.

BACKGROUND: Computer 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. AIM: To evaluate the effect on patient-centredness of a novel computer template used in multimorbidity reviews. DESIGN AND SETTING: A 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. METHOD: Twenty-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. RESULTS: Disrupted 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. CONCLUSION: Including 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.

Reporting and appraising the context, process and impact of PPI on contributors, researchers and the trial during a randomised controlled trial - the 3D study.

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. 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.

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

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.

Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study).

INTRODUCTION: An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice. METHODS AND ANALYSIS: This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years. ETHICS AND DISSEMINATION: This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN06180958; Pre-results.

Evaluation of internal peer-review to train nurses recruiting to a randomized controlled trial--Internal Peer-review for Recruitment Training in Trials (InterPReTiT).

AIM: A discussion and qualitative evaluation of the use of peer-review to train nurses and optimize recruitment practice in a randomized controlled trial. BACKGROUND: Sound recruitment processes are critical to the success of randomized controlled trials. Nurses recruiting to trials must obtain consent for an intervention that is administered for reasons other than anticipated benefit to the patient. This requires not only patients' acquiescence but also evidence that they have weighed the relevant information in reaching their decision. How trial information is explained is vital, but communication and training can be inadequate. DESIGN: A discussion of a new process to train nurses recruiting to a randomized controlled trial. DATA SOURCES: Literature from 1999-2013 about consenting to trials is included. Over 3 months from 2009-2010, recruiting nurses reviewed recruitment interviews recorded during the pilot phase of a single-site randomized controlled trial and noted content, communication style and interactions. They discussed their findings during peer-review meetings, which were audio-recorded and analysed using qualitative methodology. IMPLICATIONS FOR NURSING: Peer-review can enhance nurses' training in trial recruitment procedures by supporting development of the necessary communication skills, facilitating consistency in information provision and sharing best practice. CONCLUSIONS: Nurse-led peer-review can provide a forum to share communication strategies that will elicit and address participant concerns and obtain evidence of participant understanding prior to consent. Comparing practice can improve consistency and accuracy of trial information and facilitate identification of recruitment issues. Internal peer-review was well accepted and promoted team cohesion. Further evaluation is needed.

Assessing function in patients undergoing joint replacement: a study protocol for a cohort study.

BACKGROUND: Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF), which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time. METHODS/DESIGN: Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over time. DISCUSSION: There are a range of tools that can be used to assess function before and after joint replacement, with little information about how these various measures compare in their properties and responsiveness. This study aims to provide this data on a selection of commonly used assessments of function, and explore how they relate to the ICF domains.

Health care provision for osteoarthritis: concordance between what patients would like and what health professionals think they should have.

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 audio-recorded, 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.

Can the application of control theory assist patient management in rheumatoid arthritis?

Supporting patient self-management is an important part of the care of patients with rheumatoid arthritis (RA) but patients vary in their capacity and willingness to manage their illness and may feel overwhelmed by the challenge of controlling the impact on their life. This paper discusses the value and importance of control theory and how it might be applied to enhance patients' self-management. Not only does it offer a means of identifying those who might have greatest difficulty in managing their illness, but it also points the way to effective interventions.

Medicaid at the ten-year anniversary of SCHIP: looking back and moving forward.

The adoption of the State Children's Health Insurance Program (SCHIP) in 1997 spurred widespread efforts to simplify and revitalize Medicaid coverage for children. To an extent often not recognized, these Medicaid improvements were a key factor behind much of the progress that has been made in covering low-income children: These children's uninsurance rate dropped from 22.3 percent in 1997 to 14.9 percent in 2005, and more than 70 percent of those gains can be attributed to Medicaid. The program, however, faces a number of issues that will need to be addressed if the country is to continue to make progress.