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Background Patient and public involvement (PPI) is recognized as a key component of clinical practice guideline development with important implications for guideline implementability. The impact of PPI on guidelines, however, has not been rigorously assessed. Better understanding of the impact of PPI must start with guideline question formation, which drives all subsequent development steps. The aim of this study was to investigate the effect of PPI on guideline question formation and validate a conceptual model of patient and public contributions to guidelines. Methods For development of a clinical practice guideline on the topic of using amyloid positron emission tomography in the diagnosis of dementia, we convened two parallel guideline development groups, one with and one without patient representatives. Participating physicians were randomized to group assignment. Each group developed Population, Intervention, Comparator, Outcome, Time (PICOT) questions and identified key benefits and harms to incorporate in guideline development. Analysis included a descriptive comparison of proposed PICOT questions, benefits, and harms between groups and a qualitative analysis of discussion themes from audio recordings of the question development retreats. Results Proposed guideline questions, benefits, and harms were largely similar between groups, but only the experimental group proposed outcomes relating to development of cognitive impairment at specific time points and rate of progression. The qualitative analysis of the discussions occurring during guideline question development demonstrated key differences in group conduct and validated the proposed conceptual model of patient and public contributions to guidelines. PPI influenced the conduct of guideline development, scope, inclusion of patient-relevant topics, outcome selection, and planned approaches to recommendation development, implementation, and dissemination with implications for both guideline developers and the guideline development process. Conclusions Evidence of how PPI impacts guideline development underscores the importance of engaging patient stakeholders in guideline development and highlights developer- and guideline-specific outcomes of PPI, both of which have implications for guideline implementation. It also raises the question of whether guidelines developed without such input are acceptable for use. PPI should be considered an essential element of trustworthy guideline development for purposes of development and funding.

BackgroundThe ‘Productive Ward: Releasing Time to Care’ programme is a quality improvement (QI) intervention introduced in English acute hospitals a decade ago to: (1) Increase time nurses spend in direct patient care. (2) Improve safety and reliability of care. (3) Improve experience for staff and patients. (4) Make changes to physical environments to improve efficiency.ObjectiveTo explore how timing of adoption, local implementation strategies and processes of assimilation into day-to-day practice relate to one another and shape any sustained impact and wider legacies of a large-scale QI intervention.DesignMultiple methods within six hospitals including 88 interviews (with Productive Ward leads, ward staff, Patient and Public Involvement representatives and senior managers), 10 ward manager questionnaires and structured observations on 12 randomly selected wards.ResultsResource constraints and a managerial desire for standardisation meant that, over time, there was a shift away from the original vision of empowering ward staff to take ownership of Productive Ward towards a range of implementation ‘short cuts’. Nonetheless, material legacies (eg, displaying metrics data; storage systems) have remained in place for up to a decade after initial implementation as have some specific practices (eg, protected mealtimes). Variations in timing of adoption, local implementation strategies and contextual changes influenced assimilation into routine practice and subsequent legacies. Productive Ward has informed wider organisational QI strategies that remain in place today and developed lasting QI capabilities among those meaningfully involved in its implementation.ConclusionsAs an ongoing QI approach Productive Ward has not been sustained but has informed contemporary organisational QI practices and strategies. Judgements about the long-term sustainability of QI interventions should consider the evolutionary and adaptive nature of change processes.

SummaryTo improve the quality of care and reduce the healthcare costs of elderly patients with a hip fracture, surgeons and geriatricians collaborated intensively due to the special needs of these patients. After treatment at the Centre for Geriatric Traumatology (CvGT), we found a significant decrease in the 1-year mortality rate in frail elderly patients compared to the historical control patients who were treated with standard care.IntroductionThe study aimed to evaluate the effect of an orthogeriatric treatment model on elderly patients with a hip fracture on the 1-year mortality rate and identify associated risk factors.MethodsThis study included patients, aged 70 years and older, who were admitted with a hip fracture and treated in accordance with the integrated orthogeriatric treatment model of the CvGT at the Hospital Group Twente (ZGT) between April 2008 and October 2013. Data registration was carried out by several disciplines using the clinical pathways of the CvGT database. A multivariate logistic regression analysis was used to identify independent risk factors for 1-year mortality. The outcome measures for the 850 patients were compared with those of 535 historical control patients who were managed under standard care between October 2002 and March 2008.ResultsThe analysis demonstrated that the 1-year mortality rate was 23.2 % (n = 197) in the CvGT group compared to 35.1 % (n = 188) in the historical control group (p < 0.001). Independent risk factors for 1-year mortality were male gender (odds ratio (OR) 1.68), increasing age (OR 1.06), higher American Society of Anesthesiologists (ASA) score (ASA 3 OR 2.43, ASA 4–5 OR 7.05), higher Charlson Comorbidity Index (CCI) (CCI 1–2 OR 1.46, CCI 3–4 OR 1.59, CCI 5 OR 2.71), malnutrition (OR 2.01), physical limitations in activities of daily living (OR 2.35), and decreasing Barthel Index (BI) (OR 0.96).ConclusionAfter integrated orthogeriatric treatment, a significant decrease was seen in the 1-year mortality rate in the frail elderly patients with a hip fracture compared to the historical control patients who were treated with standard care. The most important risk factors for 1-year mortality were male gender, increasing age, malnutrition, physical limitations, increasing BI, and medical conditions. Awareness of risk factors that affect the 1-year mortality can be useful in optimizing care and outcomes. Orthogeriatric treatment should be standard for elderly patients with hip fractures due to the multidimensional needs of these patients.

BackgroundIndividuals with sickle cell disease (SCD) experience poor clinical outcomes while transitioning from paediatric to adult care. Standards for SCD transition are needed. We established a Quality Improvement (QI) Collaborative that aimed to improve the quality of care for all young adults with SCD by establishing a standardised SCD transition process. This study evaluates the implementation of the Six Core Elements (6CE) of Health Care Transition, which was a fundamental component of the cluster-randomised Sickle Cell Trevor Thompson Transition Project (ST3P-UP) study.MethodsA central QI team trained 14 ST3P-UP study sites on QI methodologies, 6CE and Got Transition’s process measurement tool (PMT). Site-level QI teams included a transition coordinator, clinic physicians/staff, patients/parents with SCD and community representatives. Sites completed the PMT every 6 months for 54 months and monthly audits of 10 randomly-selected charts to verify readiness/self-care assessments and emergency care plans.ResultsOf a possible 100, the aggregate mean (±SD) PMT score for paediatric clinics was 23.9 (±13.8) at baseline, 95.9 (±6.0) at 24 months and 98.9 (±2.1) at 54 months. The aggregate mean PMT score for adult clinics was 15.0 (±13.5) at baseline, 88.4 (±11.8) at 24 months and 95.8 (±6.8) at 54 months. The overall QI Collaborative PMT score improved by 402%. At baseline, readiness/self-care assessments were current for 38% of paediatric and 20% of adult patients; emergency care plans were current for 20% of paediatric and 3% of adult patients. Paediatric clinics had one median readiness assessment shift (76%) and four median emergency care plan shifts (65%, 77%, 79%, 84%). Adult clinics experienced three median self-care assessment shifts (58%, 63%, 70%) and two median emergency care plan shifts (57%, 70%).ConclusionsThe ST3P-UP QI Collaborative successfully embedded the 6CE of Health Care Transition into routine care and increased administration of assessments and emergency care plans for transition-aged patients with SCD.

Background Women Veterans’ numerical minority, high rates of military sexual trauma, and gender-specific healthcare needs have complicated implementation of comprehensive primary care (PC) under VA’s patient-centered medical home model, Patient Aligned Care Teams (PACT). Objective We deployed an evidence-based quality improvement (EBQI) approach to tailor PACT to meet women Veterans’ needs and studied its effects on women’s health (WH) care readiness, team-based care, and burnout. Design We evaluated EBQI effectiveness in a cluster randomized trial with unbalanced random allocation of 12 VAMCs (8 EBQI vs. 4 control). Clinicians/staff completed web-based surveys at baseline (2014) and 24 months (2016). We adjusted for individual-level covariates (e.g., years at VA) and weighted for non-response in difference-in-difference analyses for readiness and team-based care overall and by teamlet type (mixed-gender PC-PACTs vs. women-only WH-PACTs), as well as post-only burnout comparisons. Participants We surveyed all clinicians/staff in general PC and WH clinics. Intervention EBQI involved structured engagement of multilevel, multidisciplinary stakeholders at network, VAMC, and clinic levels toward network-specific QI roadmaps. The research team provided QI training, formative feedback, and external practice facilitation, and support for cross-site collaboration calls to VAMC-level QI teams, which developed roadmap-linked projects adapted to local contexts. Main Measures WH care readiness (confidence providing WH care, self-efficacy implementing PACT for women, barriers to providing care for women, gender sensitivity); team-based care (change-readiness, communication, decision-making, PACT-related QI, functioning); burnout. Key Results Overall, EBQI had mixed effects which varied substantively by type of PACT. In PC-PACTs, EBQI increased self-efficacy implementing PACT for women and gender sensitivity, even as it lowered confidence. In contrast, in WH-PACTs, EBQI improved change-readiness, team-based communication, and functioning, and was associated with lower burnout. Conclusions EBQI effectiveness varied, with WH-PACTs experiencing broader benefits and PC-PACTs improving basic WH care readiness. Lower confidence delivering WH care by PC-PACT members warrants further study. Trial Registration The data in this paper represent results from a cluster randomized controlled trial registered in ClinicalTrials.gov (NCT02039856).

Women Veterans with co-morbid medical and mental health conditions face persistent barriers accessing high-quality health care. Evidence-based quality improvement (EBQI) offers a systematic approach to implementing new care models that can address care gaps for women Veterans. This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans with complex mental health needs. Following a 12-site (8 EBQI, 4 control) cluster randomized study to evaluate EBQI effectiveness, we conducted an in-depth case study analysis of one women's health clinic that used EBQI to improve integrated primary care-mental health services for women Veterans. Our study sample included providers, program managers, and clinic staff at a women Veteran's health clinic that, at the time of the study, had one Primary Care and Mental Health Integration team and one women's health primary care provider serving 800 women. We analyzed interviews conducted 12 months, 24 months, and 4 years post-implementation and call summaries between the clinic and support team. We conducted qualitative thematic analysis of interview and call summary data to identify EBQI elements, clinic characteristics, and reported challenges and successes within project development and execution. The clinic harnessed core EBQI elements (multi-level stakeholder engagement, data-driven progress-monitoring, PDSA cycles, sharing results) to accomplish pre-defined project goals, strengthen inter-disciplinary partnerships, and bolster team confidence. Clinic characteristics that facilitated implementation success included prior QI experience and an organizational culture responsive to innovation, while lack of pre-existing guidelines and limited access to centralized databases posed implementation challenges. Successful practice transformation emerges through the interaction of evidence-based methods and site-specific characteristics. Examining how clinic characteristics support or impede EBQI adaptation can facilitate efforts to improve care within integrated health systems.

Background Improving the quality and safety of perioperative care is a global priority. The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was a stepped-wedge cluster randomised trial of a quality improvement (QI) programme to improve 90-day survival for patients undergoing emergency abdominal surgery in 93 hospitals in the UK National Health Service. Methods The aim of this process evaluation is to describe how the EPOCH intervention was planned, delivered and received, at both cluster and local hospital levels. The QI programme comprised of two interventions: a care pathway and a QI intervention to aid pathway implementation, focussed on stakeholder engagement, QI teamwork, data analysis and feedback and applying the model for improvement. Face-to-face training and online resources were provided to support senior clinicians in each hospital (QI leads) to lead improvement. For this evaluation, we collated programme activity data, administered an exit questionnaire to QI leads and collected ethnographic data in six hospitals. Qualitative data were analysed with thematic or comparative analysis; quantitative data were analysed using descriptive statistics. Results The EPOCH trial did not demonstrate any improvement in survival or length of hospital stay. Whilst the QI programme was delivered as planned at the cluster level, self-assessed intervention fidelity at the hospital level was variable. Seventy-seven of 93 hospitals responded to the exit questionnaire (60 from a single QI lead response on behalf of the team); 33 respondents described following the QI intervention closely (35%) and there were only 11 of 37 care pathway processes that > 50% of respondents reported attempting to improve. Analysis of qualitative data suggests QI leads were often attempting to deliver the intervention in challenging contexts: the social aspects of change such as engaging colleagues were identified as important but often difficult and clinicians frequently attempted to lead change with limited time or organisational resources. Conclusions Significant organisational challenges faced by QI leads shaped their choice of pathway components to focus on and implementation approaches taken. Adaptation causing loss of intervention fidelity was therefore due to rational choices made by those implementing change within constrained contexts. Future large-scale QI programmes will need to focus on dedicating local time and resources to improvement as well as on training to develop QI capabilities. EPOCH trial registration ISRCTN80682973 https://doi.org/10.1186/ISRCTN80682973 Registered 27 February 2014 and Lancet protocol 13PRT/7655.

Background Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Methods Design: Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Setting: Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Intervention: Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Control: Professionals established priorities among themselves, without patient involvement. Participants: A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. Outcomes: The primary outcome was the level of agreement between patients’ and professionals’ priorities. Secondary outcomes included professionals’ intention to use the selected quality indicators, and the costs of patient involvement. Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals’ intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Conclusions Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. Trial registration The Netherlands National Trial Register #NTR2496 .

Background Health care practice needs to be underpinned by high quality research evidence, so that the best possible care can be delivered. However, evidence from research is not always utilised in practice. This study used the Promoting Action on Research Implementation in Health Services (PARIHS) framework as its theoretical underpinning to test whether two different approaches to facilitating implementation could affect the use of research evidence in practice. Methods A pragmatic clustered randomised controlled trial with embedded process and economic evaluation was used. The study took place in four European countries across 24 long-term nursing care sites, for people aged 60 years or more with documented urinary incontinence. In each country, sites were randomly allocated to standard dissemination, or one of two different types of facilitation. The primary outcome was the documented percentage compliance with the continence recommendations, assessed at baseline, then at 6, 12, 18, and 24 months after the intervention. Data were analysed using STATA15, multi-level mixed-effects linear regression models were fitted to scores for compliance with the continence recommendations, adjusting for clustering. Results Quantitative data were obtained from reviews of 2313 records. There were no significant differences in the primary outcome (documented compliance with continence recommendations) between study arms and all study arms improved over time. Conclusions This was the first cross European randomised controlled trial with embedded process evaluation that sought to test different methods of facilitation. There were no statistically significant differences in compliance with continence recommendations between the groups. It was not possible to identify whether different types and “doses” of facilitation were influential within very diverse contextual conditions. The process evaluation (Rycroft-Malone et al., Implementation Science. doi: 10.1186/s13012-018-0811-0) revealed the models of facilitation used were limited in their ability to overcome the influence of contextual factors. Trial registration Current Controlled Trials ISRCTN11598502 . Date 4/2/10. The research leading to these results has received funding from the European Union’s Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 223646.