Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ)

OBJECTIVE: To develop and validate a new scale to assess treatment burden (the effort of looking after one's health) for patients with multimorbidity. DESIGN: Mixed-methods. SETTING: UK primary care. PARTICIPANTS: Content of the Multimorbidity Treatment Burden Questionnaire (MTBQ) was based on a literature review and views from a patient and public involvement group. Face validity was assessed through cognitive interviews. The scale was piloted and the final version was tested in 1546 adults with multimorbidity (mean age 71 years) who took part in the 3D Study, a cluster randomised controlled trial. For each question, we examined the proportion of missing data and the distribution of responses. Factor analysis, Cronbach's alpha, Spearman's rank correlations and longitudinal regression assessed dimensional structure, internal consistency reliability, construct validity and responsiveness, respectively. We assessed interpretability by grouping the global MTBQ scores into zero and tertiles (>0) and comparing participant characteristics across these categories. RESULTS: Cognitive interviews found good acceptability and content validity. Factor analysis supported a one-factor solution. Cronbach's alpha was 0.83, indicating internal consistency reliability. The MTBQ score had a positive association with a comparator treatment burden scale (rs 0.58, P<0.0001) and with self-reported disease burden (rs 0.43, P<0.0001), and a negative association with quality of life (rs-0.36, P<0.0001) and self-rated health (rs-0.36, P<0.0001). Female participants, younger participants and participants with mental health conditions were more likely to have high treatment burden scores. Changes in MTBQ score over 9-month follow-up were associated, as expected, with changes in measures of quality of life (EuroQol five dimensions, five level questionnaire) and patient-centred care (Patient Assessment of Chronic Illness Care). CONCLUSION: The MTBQ is a 10-item measure of treatment burden for patients with multimorbidity that has demonstrated good content validity, construct validity, reliability and responsiveness. It is a useful research tool for assessing the impact of interventions on treatment burden. TRIAL REGISTRATION NUMBER: ISRCTN06180958

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

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 positively influence the researchers’ and contributors’ future involvement with PPI

Making the journey with me : a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness

BACKGROUND: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial. METHODS: Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method. RESULTS: Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users' illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems. CONCLUSION: The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236 . Registered 3(rd) July 2009

Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions:study protocol for two linked randomized controlled trials

As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring

Reaching everyone in general practice?:Feasibility of an integrated domestic violence training and support intervention in primary care

Background Primary care needs to respond effectively to patients experiencing or perpetrating domestic violence and abuse (DVA) and their children, but there is uncertainty about the value of integrated programmes. The aim of the study was to develop and test the feasibility of an integrated primary care system-level training and support intervention, called IRIS+ (Enhanced Identification and Referral to Improve Safety), for all patients affected by DVA. IRIS+ was an adaptation of the original IRIS (Identification and Referral to Improve Safety) model designed to reach female survivors of DVA. Methods Observation of training; pre/post intervention questionnaires with clinicians and patients; data extracted from medical records and DVA agency; semi-structured interviews with clinicians, service providers and referred adults and children. Data collection took place between May 2017 and April 2018. Mixed method analysis was undertaken to triangulate data from various sources to assess the feasibility and acceptability of the intervention. Results Clinicians and service providers believed that the IRIS+ intervention had filled a service gap and was a valuable resource in identifying and referring women, men and children affected by DVA. Despite increased levels of preparedness reported by clinicians after training in managing the complexity of DVA in their practice, the intervention proved to be insufficient to catalyse identification and specialist referral of men and direct identification and referral (without their non-abusive parents) of children and young people. The study also revealed that reports provided to general practice by other agencies are important sources of information about adult and children patients affected by DVA. However, in the absence of guidance about how to use this information in patient care, there are uncertainties and variation in practice. Conclusions The study demonstrates that the IRIS+ intervention is not feasible in the form and timeframe we evaluated. Further adaptation is required to achieve identification and referral of men and children in primary care: an enhanced focus on engagement with men, direct engagement with children, and improved guidance and training on responding to reports of DVA received from other agencies

The foundations framework for developing and reporting new models of care for multimorbidity

PURPOSE Multimorbidity challenges health systems globally. New models of care are urgently needed to better manage patients with multimorbidity; however, there is no agreed framework for designing and reporting models of care for multimorbidity and their evaluation. METHODS Based on findings from a literature search to identify models of care for multimorbidity, we developed a framework to describe these models. We illustrate the application of the framework by identifying the focus and gaps in current models of care, and by describing the evolution of models over time. RESULTS Our framework describes each model in terms of its theoretical basis and target population (the foundations of the model) and of the elements of care implemented to deliver the model. We categorized elements of care into 3 types: (1) clinical focus, (2) organization of care, (3) support for model delivery. Application of the framework identified a limited use of theory in model design and a strong focus on some patient groups (elderly, high users) more than others (younger patients, deprived populations). We found changes in elements with time, with a decrease in models implementing home care and an increase in models offering extended appointments. CONCLUSIONS By encouraging greater clarity about the underpinning theory and target population, and by categorizing the wide range of potentially important elements of an intervention to improve care for patients with multimorbidity, the framework may be useful in designing and reporting models of care and help advance the currently limited evidence base

‘It felt like there was always someone there for us’:supporting children affected by domestic violence and abuse who are identified by general practice

One in five children in the UK are affected by domestic violence and abuse. However, primary care clinicians (GPs and nurses) struggle to effectively identify and support children and young people living in homes where it is present. The IRIS+ (Enhanced Identification and Referral to Improve Safety) training and advocacy support intervention aimed to improve how clinicians respond to children and young people affected by domestic violence and abuse. IRIS+ training was delivered as part of a feasibility study to four general practices in an urban area in England (UK). Our mixed method design included interviews and questionnaires about the IRIS+ intervention with general practice patients, including children and young people as well as with clinicians and advocacy service providers. We collected the number of identifications and referrals by clinicians of children experiencing domestic violence and abuse through a retrospective search of medical and agency records 10 months after the intervention. Forty-nine children exposed to domestic violence and abuse were recorded in medical records. Thirty-five children were referred to a specialist domestic violence and abuse support service over a period of 10 months. Of these, 22 received direct or indirect support. The qualitative findings indicated that children benefitted from being referred by clinicians to the service. However, several barriers at the patient and professional level prevented children and young people from being identified and supported. Some of these barriers can be addressed through modifications to professional training and guidance, but others require systematic and structural changes to the way health and social care services work with children affected by domestic violence and abuse

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 ISRCTN0618095

Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care:a pragmatic cluster randomised controlled trial

Objective Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care. Design Economic evaluation conducted alongside a pragmatic cluster-randomised trial. Setting General practices in three centres in England and Scotland. Participants 797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care. Intervention The 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments. Primary and secondary outcome measures The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost-consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses. Results Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference 126 pound (-739 pound to 991)) pound in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was 18 pound 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of 20 pound 000 per QALY (55.8% at 30 pound 000 per QALY). Conclusions The small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal