Strengthening China's National Essential Public Health Services Package for hypertension and diabetes care: protocol for an interrupted time series study with mixed-methods process evaluation and health economic evaluation.

BACKGROUND: Despite major primary health care (PHC) reforms in China with the 2009 launch of the National Essential Public Health Service Package, the country experiences many challenges in improving the management of non-communicable diseases in PHC facilities. "EMERALD" is a multifaceted implementation strategy to strengthen the management of hypertension and type-2 diabetes mellitus (T2DM) in PHC facilities. The study aims to: (1) examine the effectiveness of EMERALD in improving hypertension and T2DM management; (2) evaluate the implementation of the interventions; and (3) use the study findings to model the long-term health economic impact of the interventions. METHODS: The EMERALD intervention components include: (1) empowerment for PHC providers through training and capacity building; (2) empowerment for patient communities through multi-media health education; and  (3) empowerment for local health administrators through health data monitoring and strengthening governance of local PHC programs. An interrupted time series design will be used to determine the effectiveness of the interventions based on routinely collected health data extracted from local health information systems. The primary effectiveness outcome is the guideline-recommended treatment rates for people with hypertension and T2DM. Secondary effectiveness outcomes include hypertension and T2DM diagnosis and control rates, and enrolment and adherence rates to the recommended care processes in the National Essential Public Health Service Package. A mixed-methods process evaluation will be conducted to evaluate the implementation of the interventions, including the reach of the target population, adequacy of adoption, level of implementation fidelity, and maintenance. Qualitative interviews with policy makers, health administrators, PHC providers, and patients with hypertension and/or T2DM will be conducted to further identify factors influencing the implementation. In addition, health economic modelling will be performed to explore the long-term incremental costs and benefits of the interventions. DISCUSSION: This study is expected to generate important evidence on the effectiveness, implementation, and health economic impact of complex PHC interventions to strengthen the primary care sector's contribution to addressing the growing burden of non-communicable diseases in China. TRIAL REGISTRATION: The study has been registered on Chinese Clinical Trial Registry at https://www.chictr.org.cn/ (Registration number ChiCTR2400082036, on March 19th 2024).

The SME tool supporting employers of small- and medium-sized enterprises during the return to work of employees on long-term sick leave: study protocol for a randomized controlled trial and for a process evaluation.

BACKGROUND: Returning to work after long-term sick leave can be challenging, particularly in small- and medium-sized enterprises (SMEs) where support may be limited. Recognizing the responsibilities and challenges of SME employers, a web-based intervention (hereafter the SME tool) has been developed. The SME tool aims to enhance the employer's intention and ability to support the sick-listed employee. Based on the Self-Determination Theory, it is hypothesized that this intention is enhanced by intervening in the employer's autonomy, competences, and relatedness targeted at, e.g., communication with sick-listed employee, involvement of other stakeholders, and practical support. This is achieved by means of providing templates, communication videos, and information on legislation. This article describes the design of an effect and process evaluation of the SME tool. METHODS: A randomized controlled trial (RCT) with a 6-month follow-up will be conducted with a parallel-group design with two arms: an intervention group and a control group. Sick-listed employees (≤ 8 weeks) of SMEs (≤ 250 employees) at risk of long-term sick leave and their employers will be recruited and randomly allocated as a dyad (1:1). Employers randomized to the intervention group receive unlimited access to the SME tool, while those in the control group will receive care as usual. The primary outcome is the satisfaction of the employee with the return to work (RTW) support provided by their employer. Secondary outcomes include social support, work performance, and quality of work life at the employee level and self-efficacy in providing RTW support at the employer level. Outcomes will be assessed using questionnaires at baseline and 1, 3, and 6 months of follow-up. Process evaluation measures include, e.g., recruitment and use of and perceived usefulness of the SME tool. Additionally, semi-structured interviews with employers, employees, and occupational physicians will explore the interpretation of the RCT results and strategies for the national implementation of the SME tool. DISCUSSION: The SME tool is hypothesized to be valuable in addition to usual care helping employers to effectively support the RTW of their long-term sick-listed employees, by improving the employers' intention and ability to support. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06330415. Registered on February 14, 2024.

Process evaluation of a New psychosocial goal-setting and manualised support intervention for Independence in Dementia (NIDUS-Family).

INTRODUCTION: We report a mixed-methods process evaluation embedded within a randomised controlled trial. We aimed to test and refine a theory of change model hypothesising key causal assumptions to understand how the New Interventions for Independence in Dementia Study (NIDUS)-Family (a manualised, multimodal psychosocial intervention), was effective relative to usual care, on the primary outcome of Goal Attainment Scaling (GAS) over 1 year. METHODS: In 2021-2022, intervention-arm dyads completed an acceptability questionnaire developed to test causal assumptions. We conducted qualitative interviews with dyads and intervention facilitators, purposively selected for diverse follow-up GAS scores. We collected observational data from intervention session recordings. We thematically analysed data, then integrated qualitative and quantitative data. RESULTS: 174/204 (85.3%) dyads allocated to NIDUS-Family, fully completed it, 18 partially completed, while 12 received no intervention. We interviewed 27/192 (14%) of dyads receiving any sessions, and 9/10 facilitators; and observed 12 sessions. 47/192 (24.5%) of carers completed the acceptability questionnaire. We identified four themes: (A) 'Someone to talk to helps dyads feel supported'; (B) 'NIDUS-Family helps carers change their perspective'; (C) 'Personalisation helps people living with dementia maintain their identity' and (D) 'Small steps help dyads move forward'. CONCLUSION: Key causal pathway mechanisms were: a respectful, trusting and impartial relationship with the facilitator: supporting the development of meaningful goals and support to find manageable solutions. Core implementation factors were delivery of the modules from a consistent facilitator across regular sessions. Core contextual factors influencing these mechanisms were dyadic participation and understanding of abilities.

Process evaluation of a randomised controlled trial intervention designed to improve rehabilitation services for Aboriginal Australians after brain injury: the Healing Right Way Trial.

BACKGROUND: Healing Right Way (HRW) aimed to improve health outcomes for Aboriginal Australians with stroke or traumatic brain injury by facilitating system-level access to culturally secure rehabilitation services. Using a stepped-wedge randomised controlled trial (RCT) design (ACTRN12618000139279, 30/01/2018), a two-pronged intervention was introduced in four rural and four urban hospitals, comprising 1.Cultural security training (CST) for staff and 2.Training/employment of Aboriginal Brain Injury Coordinators (ABIC) to support Aboriginal patients for 6-months post-injury. Three-quarters of recruited patients lived rurally. The main outcome measure was quality-of-life, with secondary outcomes including functional measures, minimum processes of care (MPC); number rehabilitation occasions of service received, and improved hospital experience. Assessments were undertaken at baseline, 12- and 26-weeks post-injury. Only MPCs and hospital experience were found to improve among intervention patients. We report on the process evaluation aiming to support interpretation and translation of results. METHODS: Using mixed methods, the evaluation design was informed by the Consolidated Framework for Implementation Research. Data sources included minutes, project logs, surveys, semi-structured interviews, and observations. Four evaluation questions provided a basis for systematic determination of the quality of the trial. Findings from separate sources were combined to synthesise the emerging themes that addressed the evaluation questions. Three components were considered separately: the trial process, CST and ABIC. RESULTS: The complex HRW trial was implemented to a satisfactory level despite challenging setting factors, particularly rural-urban system dynamics. Patient recruitment constraints could not be overcome. The vulnerability of stepped-wedge designs to time effects influenced recruitment and trial results, due to COVID. Despite relatively high follow-up, including to rural/remote areas, data points were reduced. The lack of culturally appropriate assessment tools influenced the quality/completeness of assessment data. The ABIC role was deemed feasible and well-received. The CST involved complex logistics, but rated highly although online components were often incomplete. Project management was responsive to staff, patients and setting factors. CONCLUSIONS: Despite mostly equivocal results, the ABIC role was feasible within mainstream hospitals and the CST was highly valued. Learnings will help build robust state-wide models of culturally secure rehabilitation for Aboriginal people after brain injury, including MPC, workforce, training and follow-up.

Navigating process evaluation in co-creation: a Health CASCADE scoping review of used frameworks and assessed components.

BACKGROUND: Co-creation is seen as a way to ensure all relevant needs and perspectives are included and to increase its potential for beneficial effects and uptake process evaluation is crucial. However, existing process evaluation frameworks have been built on practices characterised by top-down developed and implemented interventions and may be limited in capturing essential elements of co-creation. This study aims to provide a review of studies planning and/or conducting a process evaluation of public health interventions adopting a co-creation approach and aims to derive assessed process evaluation components, used frameworks and insights into formative and/or participatory evaluation. METHODS: We searched for studies on Scopus and the Health CASCADE Co-Creation Database. Co-authors performed a concept-mapping exercise to create a set of overarching dimensions for clustering the identified process evaluation components. RESULTS: 54 studies were included. Conceptualisation of process evaluation included in studies concerned intervention implementation, outcome evaluation, mechanisms of impact, context and the co-creation process. 22 studies (40%) referenced ten existing process evaluation or evaluation frameworks and most referenced were the frameworks developed by Moore et al (14%), Saunders et al (5%), Steckler and Linnan (5%) and Nielsen and Randall (5%).38 process evaluation components were identified, with a focus on participation (48%), context (40%), the experience of co-creators (29%), impact (29%), satisfaction (25%) and fidelity (24%).13 studies (24%) conducted formative evaluation, 37 (68%) conducted summative evaluation and 2 studies (3%) conducted participatory evaluation. CONCLUSION: The broad spectrum of process evaluation components addressed in co-creation studies, covering both the evaluation of the co-creation process and the intervention implementation, highlights the need for a process evaluation tailored to co-creation studies. This work provides an overview of process evaluation components, clustered in dimensions and reflections which researchers and practitioners can use to plan a process evaluation of a co-creation process and intervention.

Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.

BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention. METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy. RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context. CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness. TRIAL REGISTRATION: Number NCT02765009.

Process evaluation of comprehensive sexuality education programme in Zambia: a focus on contextual factors, mechanisms of impact, quality of development and implementation process.

BACKGROUND: Comprehensive sexuality education (CSE) is critical in addressing negative sexual and reproductive health (SRH) outcomes among adolescents. Yet in many low- and middle-income countries (LMICs) including Zambia, little is known about the impact, realities of CSE implementation, the quality of teaching and the comprehensiveness of the content covered. METHODS: Our approach was informed by a process evaluation incorporating recommendations by the European Expert Group guidance on evaluating sexuality education programmes and the Medical Research Council (MRC) guidelines on process evaluation. The development process and quality of CSE implementation were assessed using eight and six quality criteria respectively. In-depth interviews (IDIs), focus group discussions (FGDs), document analysis and classroom observation were employed to assess contextual factors, implementation process and mechanisms of impact of CSE. In-depth interviews (50) and focus group discussions (2) with seven pupils in each group were conducted among 64 purposefully selected participants. The sample comprised pupils (35), parents (4) and teachers (17) from nine secondary schools (four peri-urban, four urban and one rural), policymakers (4), and religious leaders (4). We employed deductive content analysis to analyse the data. RESULTS: Contextual factors that influenced the implementation of CSE included: (1) piecemeal funding for the CSE programme; (2) lack of monitoring programmes in schools; (3) lack of community engagement; (4) religious and socio-cultural barriers; (5) lack of skills and competency to teach CSE; and (6) insufficient time allocation for CSE. The assessment of the quality of the development of CSE revealed: (1) a lack of sexual diversity; (2) no meaningful participation of pupils in programme implementation; (3) a lack of stakeholder engagement during programme implementation; (4)  lack of gender sensitivity; and (5) lack of human rights approach. Assessment of the quality of the implementation of CSE revealed: (1) no evidence of skill-based CSE teaching; (2) no linkage between CSE and SRH services in the communities; and (3) a lack of incorporation of multiple delivery methods during CSE teaching. The mechanisms of impact of CSE were related to the acceptability and positive changes in pupils' SRH practices. CONCLUSION: The complex influences of contextual factors during CSE implementation highlight the need for contextual analysis during the interventional design. Co-creation of the CSE programme through stakeholder participation could reduce social opposition and enable a culturally sensitive CSE. Comprehensive teacher training, a guiding curriculum as well as setting of appropriate monitoring tools and indicators are likely to enhance the quality of CSE implementation.

Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK.

BACKGROUND: Stepping Stones Triple P (SSTP) is a complex parent-mediated intervention aimed to reduce behaviours that challenge in children with moderate to severe intellectual disabilities, aged 30-59 months. METHODS: To formulate a comprehensive understanding of SSTP implementation in the UK, we conducted a process evaluation collecting stakeholder views and considering intervention fidelity, dose, reach, delivery adaptations, and acceptability. RESULTS: Fidelity and quality of delivery ratings were high. Parents perceived SSTP as valuable, reporting increased parental confidence and understanding of the child's behaviours. However, only 30% of families received an adequate dose of the intervention. Parents who only received treatment as usual described feeling abandoned by current services. Service managers emphasised the importance of availability of resources and therapist training for successful intervention delivery. CONCLUSIONS: SSTP supports effective management of early-onset behaviours that challenge. Further work is needed to ensure equitable access to the intervention across health and social care services. TRIAL REGISTRATION: NCT03086876 - https://www. CLINICALTRIALS: gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1.

Process evaluation of the implementation of the assessment of burden of chronic conditions tool in Dutch primary care - lessons from a qualitative implementation study.

BACKGROUND: The Assessment of Burden of Chronic Conditions (ABCC-)tool is developed to facilitate a personalized approach to care in the patient-healthcare provider (HCP) conversation based on shared decision-making and individualized care plans. An effectiveness study highlighted its effect on the perceived quality of care and patient activation. Successful implementation of novel interventions necessitates an understanding of the user's actual application, user experiences and an evaluation of implementation outcomes. This study aims to evaluate the implementation of the ABCC-tool by HCPs in Dutch primary care. METHODS: This study is the process evaluation of a larger type 1 effectiveness-implementation hybrid trial. Semi-structured interviews with HCPs, who were interventionists in the hybrid trial, were held at three and twelve months after they started using the ABCC-tool. The Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework was used to evaluate implementation outcomes. The Implementation domain was further strengthened with an evaluation of implementation fidelity using Carroll's framework. Inductive coding and thematic analysis were applied to identify relevant participant experiences and implementation outcomes within the RE-AIM framework. RESULTS: Seventeen HCPs (1 general practitioner, 16 practice nurses) participated in the study, representing 39% of potentially eligible participants. Most HCPs applied the tool after finishing their own routines instead of how it is intended to be used, namely from the beginning of the consultation. HCPs reached 2-6 patients. The ABCC-tool was initially adopted, but twelve HCPs stopped using the tool due to COVID-19 related cancellation of consultations. High fidelity was found for applying the questionnaire and visualization. Low fidelity was present for applying shared decision-making, formulating care goals and monitoring progress. HCPs indicated that maintaning the ABCC-tool depended on accompanying training and implementation support. CONCLUSIONS: HCPs applied the ABCC-tool critically different from intended, potentially diminishing its benefits and ease of use. This evaluation stresses the need for a tailored implementation plan that includes more detailed training and guidance on how and when to use the ABCC-tool.

A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa.

BACKGROUND: Combination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples' sexual and reproductive health. Between 2020 and 2022, the Africa Health Research Institute in rural South Africa conducted a 2 × 2 randomised factorial trial among young people aged 16-29 years old (Isisekelo Sempilo) to evaluate whether integrated HIV and sexual and reproductive health (HIV/SRH) with or without peer support will optimise delivery of HIV prevention and care. Using mixed methods, we conducted a process evaluation to provide insights to and describe the implementation of a community-based peer-led HIV care and prevention intervention targeting adolescents and young people. METHODS: The process evaluation was conducted in accordance with the Medical Research Council guidelines using quantitative and qualitative approaches. Self-completed surveys and clinic and programmatic data were used to quantify the uptake of each component of the intervention and to understand intervention fidelity and reach. In-depth individual interviews were used to understand intervention experiences. Baseline sociodemographic factors were summarised for each trial arm, and proportions of participants who accepted and actively engaged in various components of the intervention as well as those who successfully linked to care were calculated. Qualitative data were thematically analysed. RESULTS: The intervention was feasible and acceptable to young people and intervention implementing teams. In particular, the STI testing and SRH components of the intervention were popular. The main challenges with the peer support implementation were due to fidelity, mainly because of the COVID-19 pandemic. The study found that it was important to incorporate familial support into interventions for young people's sexual health. Moreover, it was found that psychological and social support was an essential component to combination HIV prevention packages for young people. CONCLUSION: The results demonstrated that peer-led community-based care that integrates SRH services with HIV is a versatile model to decentralise health and social care. The family could be a platform to target restrictive gender and sexual norms, by challenging not only attitudes and behaviours related to gender among young people but also the gendered structures that surround them.

Process Evaluation of a Work Stress Prevention Approach in Primary Education: Exploring the Added Value of Real-Time Feedback During Implementation.

OBJECTIVE: Participatory organizational-level interventions carry a risk of implementation failure. The current study evaluates the implementation of a work stress prevention approach in primary education and reflects on the use of real-time feedback as implementation strategy to prevent this risk. METHODS: The process evaluation was conducted at four primary schools in the Netherlands. A framework for evaluating organizational-level interventions was applied using mixed methods. RESULTS: Results show the implementation level varied between schools and was hindered by the intervention context, school size, and planning of the approach. Management commitment and employee involvement seemed important factors for successful implementation. Real-time feedback seemed valuable to further improve implementation, but not to prevent implementation failure. CONCLUSIONS: Collecting data on implementation factors before the active phase of the approach, may provide the possibility to anticipate on implementation problems earlier.

Implementing Individually Tailored Prescription of Physical Activity in Routine Clinical Care: A Process Evaluation of the Physicians Implement Exercise = Medicine Project.

BACKGROUND: Although the prescription of physical activity in clinical care has been advocated worldwide, in the Netherlands, "Exercise is Medicine" (E = M) is not yet routinely implemented in clinical care. METHODS: A set of implementation strategies was pilot implemented to test its feasibility for use in routine care by clinicians in 2 departments of a university medical center. An extensive learning process evaluation was performed, using structured mixed methods methodology, in accordance with the Reach, Effect, Adoption, Implementation, and Maintenance framework. RESULTS: From 5 implementation strategies employed (education, E = M tool embedded in the electronic medical records, lifestyle coach situated within the department, overviews of referral options, and project support), the presence of adequate project support was a strong facilitator of the implementation of E = M. Also, the presence of the lifestyle coach within the department seemed essential for referral rate. Although clinicians appreciated the E = M tool, barriers hampered its use in practice. CONCLUSIONS: Specific implementation strategies, tailored to the setting, are effective in facilitating the implementation of E = M with specific regard to education for clinicians on E = M, deployment of a lifestyle coach within a department, and project coordination. Care providers do see a future for lifestyle coaches who are structurally embedded in the hospital, to whom they can easily refer.

Enhancing healthcare process analysis through object-centric process mining: Transforming OMOP common data models into object-centric event logs.

OBJECTIVES: This study aims to enhance the analysis of healthcare processes by introducing Object-Centric Process Mining (OCPM). By offering a holistic perspective that accounts for the interactions among various objects, OCPM transcends the constraints of conventional patient-centric process mining approaches, ensuring a more detailed and inclusive understanding of healthcare dynamics. METHODS: We develop a novel method to transform the Observational Medical Outcomes Partnership Common Data Models (OMOP CDM) into Object-Centric Event Logs (OCELs). First, an OMOP CDM4PM is created from the standard OMOP CDM, focusing on data relevant to generating OCEL and addressing healthcare data's heterogeneity and standardization challenges. Second, this subset is transformed into OCEL based on specified healthcare criteria, including identifying various object types, clinical activities, and their relationships. The methodology is tested on the MIMIC-IV database to evaluate its effectiveness and utility. RESULTS: Our proposed method effectively produces OCELs when applied to the MIMIC-IV dataset, allowing for the implementation of OCPM in the healthcare industry. We rigorously evaluate the comprehensiveness and level of abstraction to validate our approach's effectiveness. Additionally, we create diverse object-centric process models intricately designed to navigate the complexities inherent in healthcare processes. CONCLUSION: Our approach introduces a novel perspective by integrating multiple viewpoints simultaneously. To the best of our knowledge, this is the inaugural application of OCPM within the healthcare sector, marking a significant advancement in the field.

Understanding the processes underpinning IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a process evaluation within a cluster randomised controlled implementation trial.

BACKGROUND: Providing supported self-management for people with asthma can reduce the burden on patients, health services and wider society. Implementation, however, remains poor in routine clinical practice. IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a UK-wide cluster randomised implementation trial that aims to test the impact of a whole-systems implementation strategy, embedding supported asthma self-management in primary care compared with usual care. To maximise opportunities for sustainable implementation beyond the trial, it is necessary to understand how and why the IMP2ART trial achieved its clinical and implementation outcomes. METHODS: A mixed-methods process evaluation nested within the IMP2ART trial will be undertaken to understand how supported self-management was implemented (or not) by primary care practices, to aid interpretation of trial findings and to inform scaling up and sustainability. Data and analysis strategies have been informed by mid-range and programme-level theory. Quantitative data will be collected across all practices to describe practice context, IMP2ART delivery (including fidelity and adaption) and practice response. Case studies undertaken in three to six sites, supplemented by additional interviews with practice staff and stakeholders, will be undertaken to gain an in-depth understanding of the interaction of practice context, delivery, and response. Synthesis, informed by theory, will combine analyses of both qualitative and quantitative data. Finally, implications for the scale up of asthma self-management implementation strategies to other practices in the UK will be explored through workshops with stakeholders. DISCUSSION: This mixed-methods, theoretically informed, process evaluation seeks to provide insights into the delivery and response to a whole-systems approach to the implementation of supported self-management in asthma care in primary care. It is underway at a time of significant change in primary care in the UK. The methods have, therefore, been developed to be adaptable to this changing context and to capture the impact of these changes on the delivery and response to research and implementation processes.

A process evaluation of the NIDUS-Professional dementia training intervention for UK homecare workers.

INTRODUCTION: This process evaluation was conducted in parallel to the randomised controlled feasibility trial of NIDUS-Professional, a manualised remote dementia training intervention for homecare workers (HCWs), delivered alongside an individualised intervention for clients living with dementia and their family carers (NIDUS-Family). The process evaluation reports on: (i) intervention reach, dose and fidelity; (ii) contexts influencing agency engagement and (iii) alignment of findings with theoretical assumptions about how the intervention might produce change. METHODS: We report proportions of eligible HCWs receiving any intervention (reach), number of sessions attended (dose; attending ≥4/6 main sessions was predefined as adhering), intervention fidelity and adherence of clients and carers to NIDUS-Family (attending all 6-8 planned sessions). We interviewed HCWs, managers, family carers and facilitators. We integrated and thematically analysed, at the homecare agency level, qualitative interview and intervention recording data. RESULTS: 32/141 (23%) of eligible HCWs and 7/42 (17%) of family carers received any intervention; most who did adhered to the intervention (89% and 71%). Intervention fidelity was high. We analysed interviews with 20/44 HCWs, 3/4 managers and 3/7 family carers, as well as intervention recordings involving 32/44 HCWs. All agencies reported structural challenges in supporting intervention delivery. Agencies with greater management buy-in had higher dose and reach. HCWs valued NIDUS-Professional for enabling group reflection and peer support, providing practical, actionable care strategies and increasing their confidence as practitioners. CONCLUSION: NIDUS-Professional was valued by HCWs. Agency management, culture and priorities were key barriers to implementation; we discuss how to address these in a future trial.

Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals.

BACKGROUND: Article 14 of the WHO 'Framework Convention on Tobacco Control' recommends, that all oral healthcare providers provide support for tobacco cessation, to all patients. Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, implementation remains low in most high-burden countries like Pakistan. A pragmatic pilot trial of a dentist-delivered behavioural support intervention for smokeless tobacco (ST) cessation, was conducted in dental hospitals in Pakistan. This paper presents the findings of the process evaluation of the trial. METHODS: A mixed-method process evaluation of a multi-centre randomised control pilot trial of dentist-delivered behavioural support intervention ST cessation was conducted. The intervention included three sessions namely: pre-quit, quit and post-quit sessions. The process evaluation involved: semi-structured interviews with trial participants (n = 26, of which dental patients were n = 13 and participating dentists were n = 13 conducted from June-August 2022); and fidelity assessment of audio recordings of the intervention sessions (n = 29). The framework approach was used to thematically analyse the interview data. RESULTS: Overall the trial procedures were well accepted, however, young patients expressed uneasiness over revealing their ST use status. The intervention was received positively by dentists and patients. Dentists identified some challenges in delivering behavioural support to their patients. Of these, some were related to the contents of the intervention whereas, others were related to the logistics of delivering the intervention in a clinical setting (such as workload and space). Acceptability of the intervention resources was overall low amongst young patients as they did not take the intervention resources home due to fear of their family members finding out about their ST use. The intervention was successful in achieving the intended impact (in those who engaged with the intervention), i.e., change in the patients' ST use behaviour. Giving up ST with the aid of behavioural support also had an unintended negative effect i.e., the use of harmful substances (cannabis, cigarettes) to give up ST use. Patients' satisfaction with their dental treatment seemed to influence the intervention outcome. CONCLUSION: While there are many variables to consider, but for the participants of this study, behavioural support for abstinence delivered through dentists during routine dental care, appears to be an acceptable and practical approach in helping patients give up ST use, in a country like Pakistan, where negligible support is offered to ST users.

Implementation of supplemental physiotherapy following hip fracture surgery: a protocol for the process evaluation of a randomised controlled trial.

BACKGROUND: Patient outcomes following low-trauma hip fracture are suboptimal resulting in increased healthcare costs and poor functional outcomes at 1 year. Providing early and intensive in-hospital physiotherapy could help improve patient outcomes and reduce costs following hip fracture surgery. The HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER) trial will compare usual care physiotherapy to intensive in-hospital physiotherapy for patients following hip fracture surgery. The complex environments in which the intervention is implemented present unique contextual challenges that may impact intervention effectiveness. This study aims to complete a process evaluation to identify barriers and facilitators to implementation and explore the patient, carer and clinician experience of intensive therapy following hip fracture surgery. METHODS AND ANALYSIS: The process evaluation is embedded within a two-arm randomised, controlled, assessor-blinded trial recruiting 620 participants from eight Australian hospitals who have had surgery for a hip fracture sustained via a low-trauma injury. A theory-based mixed method process evaluation will be completed in tandem with the HIPSTER trial. Patient and carer semi-structured interviews will be completed at 6 weeks following hip fracture surgery. The clinician experience will be explored through online surveys completed pre- and post-implementation of intensive therapy and mapped to domains of the Theoretical Domains Framework (TDF). Translation and behaviour change success will be assessed using the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework and a combination of qualitative and quantitative data collection methods. These data will assist with the development of an Implementation Toolkit aiding future translation into practice. DISCUSSION: The embedded process evaluation will help understand the interplay between the implementation context and the intensive therapy intervention following surgery for low-trauma hip fracture. Understanding these mechanisms, if effective, will assist with transferability into other contexts and wider translation into practice. TRIAL REGISTRATION: ACTRN 12622001442796.

Developing a questionnaire to evaluate an automated audit & feedback intervention: a Rand-modified Delphi method.

BACKGROUND: Audit and feedback (A&F) is a widely used implementation strategy to evaluate and improve medical practice. The optimal design of an A&F system is uncertain and structured process evaluations are currently lacking. This study aimed to develop and validate a questionnaire to evaluate the use of automated A&F systems. METHODS: Based on the Clinical Performance Feedback Intervention Theory (CP-FIT) and the REFLECT-52 (REassessing audit & Feedback interventions: a tooL for Evaluating Compliance with suggested besT practices) evaluation tool a questionnaire was designed for the purpose of evaluating automated A&F systems. A Rand-modified Delphi method was used to develop the process evaluation and obtain validation. Fourteen experts from different domains in primary care consented to participate and individually scored the questions on a 9-point Likert scale. Afterwards, the questions were discussed in a consensus meeting. After approval, the final questionnaire was compiled. RESULTS: A 34-question questionnaire composed of 57 items was developed and presented to the expert panel. The consensus meeting resulted in a selection of 31 questions, subdivided into 43 items. A final list of 30 questions consisting of 42 items was obtained. CONCLUSION: A questionnaire consisting of 30 questions was drawn up for the assessment and improvement of automated A&F systems, based on CP-FIT and REFLECT-52 theory and approved by experts. Next steps will be piloting and implementation of the questionnaire.

The symptom to assessment pathway for suspected chronic limb-threatening ischaemia (CLTI) affects quality of care: a process mapping exercise.

BACKGROUND: Delays in the pathway from first symptom to treatment of chronic limb-threatening ischaemia (CLTI) are associated with worse mortality and limb loss outcomes. This study examined the processes used by vascular services to provide urgent care to patients with suspected CLTI referred from the community. METHODS: Vascular surgery units from various regions in England were invited to participate in a process mapping exercise. Clinical and non-clinical staff at participating units were interviewed, and process maps were created that captured key staff and structures used to create processes for referral receipt, triage and assessment at the units. RESULTS: Twelve vascular units participated, and process maps were created after interviews with 45 participants. The units offered multiple points of access for urgent referrals from general practitioners and other community clinicians. Triage processes were varied, with units using different mixes of staff (including medical staff, podiatrists and s) and this led to processes of varying speed. The organisation of clinics to provide slots for 'urgent' patients was also varied, with some adopting hot clinics, while others used dedicated slots in routine clinics. Service organisation could be further complicated by separate processes for patients with and without diabetes, and because of the organisation of services regionally into vascular networks that had arterial and non-arterial centres. CONCLUSIONS: For referred patients with symptoms of CLTI, the points of access, triage and assessment processes used by vascular units are diverse. This reflects the local context and ingenuity of vascular units but can lead to complex processes. It is likely that benefits might be gained from simplification.