Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial.

BACKGROUND: Breastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The 'Breastfeeding - a good start together' intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022-2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention. METHODS: The study was guided by the Medical Research Council's guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). RESULTS: Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families' chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers' context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high. CONCLUSIONS: Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts. TRIAL REGISTRATION: Clinical Trials: NCT05311631. First posted April 5, 2022.

Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation.

AIM: To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster-randomised FICUS trial. DESIGN: A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory. METHODS: This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3-6 months) and mid-implementation (9-12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid-implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases). FINDINGS: Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study-related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case-based, integrated findings yielded two implementation pathways, namely early and protracted adopters. CONCLUSION: Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs. REPORTING METHOD: Good reporting of a Mixed-Methods Study (GRAMMS). PATIENT OR PUBLIC CONTRIBUTION: Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team.

Health and wellbeing of survivors of sexual violence and abuse attending sexual assault referral centres in England: the MESARCH mixed-methods evaluation.

Background: One million people in England and Wales experience sexual violence and abuse each year, with nearly half experiencing serious sexual offences; around 30,000 survivors access sexual assault referral centres. Objectives: This research was commissioned by National Institute for Health and Care Research to evaluate access, interventions and care pathways for survivors, especially those provided through sexual assault referral centres. Design, setting, participants: The sexual assault referral centres care pathway was investigated through six sub-studies. There were two Cochrane Reviews (4274 participants). Seventy-two providers and 5 survivors were interviewed at eight sites; the children and young people study involved 12 participants from two sexual assault referral centres. A cohort study involving three-wave data collection over 1 year (21 sites; 2602 service users screened, 337 recruited) used a multilevel modelling framework to explore risk factors for burden of post-traumatic stress disorder symptoms at baseline and change at 1 year. We analysed costs and outcomes and conducted a narrative analysis (41 survivors). We worked closely with survivors and prioritised the safety/welfare of participants and researchers. Results: Cochrane Reviews identified large effects from psychosocial interventions for post-traumatic stress disorder and depression. Sexual assault referral centres delivered a high-quality frontline service for survivors but groups experiencing domestic abuse and some ethnic and cultural minorities were under-represented. The qualitative research emphasised inter-agency collaboration for survivor benefit. The cohort study identified a risk 'triad' of adverse childhood experiences, poor mental health and economic deprivation, which was associated with baseline trauma burden. There were important improvements in trauma symptoms a year later. These improvements were unrelated to different sexual assault referral centre models. Costs and other outcomes were also similar across models. Harmful policing and justice practices/procedures were identified by 25% of participants. In this context, trauma-competent interviewing techniques, regular/timely updates and conveying case decisions with care signalled good practice. Limitations: The cohort study lacked a comparison group, reducing confidence in the finding that access to sexual assault referral centres explained the reduction observed in post-traumatic stress disorder. Conclusions and future work: Barriers to access call for concerted efforts to implement trauma-informed universal health services. The risk 'triad' underscores the value of holistic approaches to care at sexual assault referral centres and timely follow-on care. Poor mental health was the main barrier to service access beyond sexual assault referral centres. The persistence of trauma symptoms a year after accessing sexual assault referral centres signals urgent need for tackling counselling wait-lists, expanding support options and commitment to lifelong care. Multidisciplinary evaluation of sexual assault referral centres for better health provides a foundation for advancing trauma-informed practices in the context of sexual violence and abuse. Study registration: This study is registered as ISRCTN30846825 https://doi.org/10.1186/ISRCTN30846825. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/117/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 35. See the NIHR Funding and Awards website for further award information.

Around 30,000 survivors of rape, sexual assault and sexual abuse access sexual assault referral centres in England each year. Sexual assault referral centres provide support, health care and, if people wish, can gather evidence for a criminal investigation. Sexual assault referral centres also open routes to other care/support. We intended to understand the benefits of sexual assault referral centres and ways to improve care. We interviewed 72 professionals to understand how they worked together. We followed up 335 survivors over 1 year after visiting a sexual assault referral centre. We gathered the views of 12 children and young people and 41 people from minority and disadvantaged backgrounds. We examined existing research to gather evidence of the benefit of care/support. We worked with survivors to confirm the safety and relevance of our research. Participants were positive about sexual assault referral centres and Independent Sexual Violence Advisors, reporting very low harms (1% viewed sexual assault referral centre services as harmful to them). They were also satisfied with charities offering counselling, helplines and advocacy (4% harms). The research gathered mixed feedback about the National Health Service and police, with more harm being reported (15% and 25%, respectively). We found gaps in NHS care for those with complex trauma and long-term mental health problems. Post-traumatic stress disorder affected 70% of participants, with the highest being observed for those with adverse childhood experiences, poor mental health and economic struggles (a risk 'triad'). Improvements occurred 1 year later, although half of participants still had trauma symptoms. We identified new treatments (e.g. yoga) as potential alternatives to traditional interventions. Sexual assault referral centres offer excellent care to survivors but should be accessible to a wider group of people. Identifying, supporting and careful referral of those with the risk triad mentioned may aid recovery after sexual violence and abuse. The research suggests that the NHS and policing/justice needs to ensure that they provide good care more often.

Development and Evaluation of the Telehealth in Motor Neuron Disease System: The TIME Study Protocol.

BACKGROUND: For more responsive care provision for motor neuron disease and caregivers, a digital system called Telehealth in MND-Care (TiM-C) was created. TiM-C sends regular symptom questionnaires to users; their responses are sent to health care professionals (HCPs). To enable people with motor neuron disease to participate in research studies more easily, a parallel platform was developed from TiM-C, called Telehealth in MND-Research (TiM-R). TiM-R can advertise studies, collect data, and make them available to MND researchers. OBJECTIVE: This study has 4 work packages (WPs) to facilitate service approval, codevelop the TiM systems, and evaluate the service. Each WP aims to understand (1) what helps and hinders the approval of the TiM-C system as a National Health Service; (2) what aspects of MND care and research are currently unmet and can be addressed through the TiM-C and TiM-R systems; (3) how TiM-C influences MND care, from the perspective of people with motor neuron disease, their caregivers, and HCPs; and (4) the costs and benefits associated with TiM-C. METHODS: WP1 will use semistructured interviews with 10-15 people involved in the approval of TiM-C to understand the barriers and facilitators to governance processes. WP2 will use individual and group interviews with 25-35 users (people with motor neuron disease, caregivers, HCPs, MND researchers, and industry) of TiM-C and TiM-R to understand the current unmet needs of these user groups and how TiM services can be developed to meet these needs. WP3 will use a process evaluation involving 5 elements; local context, engagement, user experiences, service impact, and mechanisms of action. A range of methods, including audits, analysis of routine data, questionnaires, interviews, and observations will be used with people with motor neuron disease, caregivers, and HCPs, both those using the system and those who declined the service when invited. WP4 will use data collected through the process evaluation and known costs to conduct a cost-consequence and budget impact analysis to explore the cost-benefit of the TiM-C service. Most data collected will be qualitative, with thematic and framework analysis used to develop themes from transcripts and observations. Descriptive statistics or t tests and chi-square tests will be used to describe and analyze quantitative data. RESULTS: This study has received ethical approval and has begun recruitment in 1 site. Further, 13 specialist MND centers will adopt TiM-C and the TIME study, beginning in July 2024. The study will conclude in November 2026 and a final report will be produced 3 months after the completion date. CONCLUSIONS: This study will facilitate the implementation and development of TiM-C and TiM-R and fully evaluate the TiM-C service, enabling informed decision-making among health care providers regarding continued involvement and contribute to the wider literature relating to how technology-enabled care services can affect clinical care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57685.

Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial.

BACKGROUND: We previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice. METHODS: We conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework. RESULTS: The questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers. CONCLUSIONS: We found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03970356. Registered on May 31, 2019.

M-SAKHI - Mobile health solutions to help community providers promote maternal and infant nutrition and health: a description of development of the Program Impact Pathway using Theory of Change.

OBJECTIVE: Behaviour Change Communication (BCC) intervention programmes often lack documentation of successful processes. This manuscript aims to describe the development of Program Impact Pathway (PIP) using Theory of Change (ToC) approach for a mHealth BCC intervention titled 'Mobile Solutions Aiding Knowledge for Health Improvement (M-SAKHI)' aimed at reducing stunting in infants at 18 months of age. DESIGN: The PIP was developed using ToC to design the intervention and plan its implementation. Literature review and data from previous pilots helped to identify health service gaps that needed to be addressed by the PIP of this intervention. SETTING: M-SAKHI was implemented in 244 villages under governance of forty primary health centres of Nagpur and Bhandara districts of eastern Maharashtra in central India. PARTICIPANTS: The study investigators and the public health stakeholders participated in developing the PIP. M-SAKHI evaluation study recruited 2501 pregnant women who were followed up through delivery until their infants were 18 months old. RESULTS: The PIP was developed, and it identified the following pathways for the final impact: (1) improving maternal and infant nutrition, (2) early recognition of maternal and infant danger signs, (3) improving access and utilisation to healthcare services, (4) improving hygiene, sanitation and immunisation practices, and (5) improving implementation and service delivery of community health workers through their training, monitoring and supervision in real time. CONCLUSION: This paper will illustrate the significance of development of PIP for M-SAKHI. It can aid other community-based programmes to design their PIP for nutrition-based BCC interventions.

Implementation of the four habits model in intermediate care services in Norway: a process evaluation.

BACKGROUND: Intermediate care (IC) services bridge the transition for older patients from the hospital to the home. Despite the goal of involving individuals in their recovery process, these services often become standardised, leading to communication breakdowns. While evidence-based practices, such as the Four Habits Model (4HM), for effective communication are crucial for enhancing high-quality healthcare, research suggests their integration into routine practice remains limited. In this study, we aimed to investigate the implementation process of the 4HM through a two-day course that engaged healthcare professionals and managers in IC. METHODS: We conducted a process evaluation employing qualitative and quantitative methods: (i) individual interviews with three managers and two course participants pre-course, (ii) two focus group interviews with course participants (N = 11) and individual interviews with the same three managers post-course, and (iii) the NoMAD questionnaire (Normalisation MeAsure Development) administered four months later to assess the short- and long-term impact on course participants (N = 14). Reflexive thematic analyses were guided by Normalisation Process Theory (NPT), which offers insight into how new interventions become routine practices. The analysis of the NoMAD involved descriptive statistics. RESULTS: We identified four themes in the qualitative data: (i) Decoding Interactions: Making Sense of the 4HM in IC services, (ii) Fostering Change: Legitimising 4HM Through Staff Engagement, (iii) Harmonising Practice: Integrating 4HM into Complex Situations, and (iv) Embedding Value: Normalising the 4HM into Everyday Work. These themes illustrate the normalisation process of the 4HM course within IC, establishing standard practices. Healthcare professionals and managers highlighted the urgent need to integrate communication skills based on the 4HM into daily care. They noted positive changes in their communication habits following the course. The consistent findings from the NoMAD questionnaire underscore the sustainability of implementing the 4HM programme, as participants continue to utilise it in their clinical practice beyond the initial four-month period. CONCLUSION: The 4HM course programme was deemed feasible for expansion within IC services. Both managers and staff found its focus on addressing communication breakdowns and readiness for change sensible. The study findings may benefit the stakeholders involved in IC service routines, potentially improving services for older patients and relatives.

Bridging the gap: a qualitative process evaluation from the perspectives of healthcare professionals of an audit-and-feedback-based intervention to improve transition to adult care for young people living with type 1 diabetes.

BACKGROUND: The transition from pediatric to adult care is a vulnerable time for young people living with type 1 diabetes (T1D). Bridging the Gap (BTG) is an audit-and-feedback (AF) intervention aimed at improving both transitions-in-care processes and diabetes management in the year following transition. As part of BTG, we conducted a qualitative process evaluation to understand: (a) what was implemented and how; and (b) the contextual factors (micro-, meso- and macro-) that affected implementation, outcomes and study processes. METHODS: Using qualitative descriptive methodology, interviews were conducted with 13 healthcare professionals (HCPs) delivering diabetes care to transitioning youth. Participants were asked about their experiences of BTG study processes and feedback tools, the quality improvement (QI) initiatives implemented at their site, and potential spread and scale. Interviews also explored the impacts of COVID-19 on transition care and study processes and results. RESULTS: Five key themes were identified. Participants' reflections on the BTG study design indicated they appreciated its flexible, site-specific approach to QI, which they saw as crucial to the success of their initiatives. Engagement with feedback reports and other study resources provided comparative, site-specific data. Participants described the challenges posed by the COVID-19 pandemic and its impacts on patients, care provision and study implementation. Their site-specific QI initiatives resulted in changes to their transition practices. Finally, participants commented on how BTG and its processes fostered a community of practice (CoP) between sites, resulting in new opportunities to collaborate and share experiences. CONCLUSIONS: BTG resulted in a CoP among practitioners delivering transition care to youth with T1D, which could be scaled up to promote a learning health system in pediatric diabetes care. Qualitative process evaluation is a useful tool for understanding how contextual factors affect the implementation and outcomes of complex QI interventions.

The effect of two speech and language approaches on speech problems in people with Parkinson's disease: the PD COMM RCT.

Background: Speech impairments are common with Parkinson's disease (reported prevalence 68%), increasing conversational demands, reliance on family and social withdrawal. Objective(s): The PD COMM trial compared the clinical and cost-effectiveness of two speech and language therapy approaches: Lee Silverman Voice Treatment LOUD and National Health Service speech and language therapy for the treatment of speech or voice problems in people with Parkinson's disease to no speech and language therapy (control) and against each other. Design: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Participants were randomised in a 1 : 1 : 1 ratio to control, National Health Service speech and language therapy or Lee Silverman Voice Treatment LOUD via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Mixed-methods process and health economic evaluations were conducted. Setting: United Kingdom outpatient and home settings. Participants: People with idiopathic Parkinson's disease, with self-reported or carer-reported speech or voice problems. We excluded people with dementia, laryngeal pathology and those within 24 months of previous speech and language therapy. Interventions: The Lee Silverman Voice Treatment LOUD intervention included maximum effort drills and high-effort speech production tasks delivered over four 50-minute therapist-led personalised sessions per week, for 4 weeks with prescribed daily home practice. National Health Service speech and language therapy content and dosage reflected local non-Lee Silverman Voice Treatment speech and language therapy practices, usually 1 hour, once weekly, for 6 weeks. Trained, experienced speech and language therapists or assistants provided interventions. The control was no speech and language therapy until the trial was completed. Main outcome measures: Primary outcome: Voice Handicap Index total score at 3 months. Secondary outcomes: Voice Handicap Index subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICEpop Capabilities Measure for Older Adults; Parkinson's Disease Questionnaire - Carers; resource utilisation; and adverse events. Assessments were completed pre-randomisation and at 3, 6 and 12 months post randomisation. Results: Three hundred and eighty-eight participants were randomised to Lee Silverman Voice Treatment LOUD (n = 130), National Health Service speech and language therapy (n = 129) and control (n = 129). The impact of voice problems at 3 months after randomisation was lower for Lee Silverman Voice Treatment LOUD participants than control [-8.0 (99% confidence interval: -13.3, -2.6); p = 0.001]. There was no evidence of improvement for those with access to National Health Service speech and language therapy when compared to control [1.7 (99% confidence interval: -3.8, 7.1); p = 0.4]. Participants randomised to Lee Silverman Voice Treatment LOUD reported a lower impact of their voice problems than participants randomised to National Health Service speech and language therapy [99% confidence interval: -9.6 (-14.9, -4.4); p < 0.0001]. There were no reports of serious adverse events. Staff were confident with the trial interventions; a range of patient and therapist enablers of implementing Lee Silverman Voice Treatment LOUD were identified. The economic evaluation results suggested Lee Silverman Voice Treatment LOUD was more expensive and more effective than control or National Health Service speech and language therapy but was not cost-effective with incremental cost-effectiveness ratios of £197,772 per quality-adjusted life-year gained and £77,017 per quality-adjusted life-year gained, respectively. Limitations: The number of participants recruited to the trial did not meet the pre-specified power. Conclusions: People that had access to Lee Silverman Voice Treatment LOUD described a significantly greater reduction in the impact of their Parkinson's disease-related speech problems 3 months after randomisation compared to people that had no speech and language therapy. There was no evidence of a difference between National Health Service speech and language therapy and those that received no speech and language therapy. Lee Silverman Voice Treatment LOUD resulted in a significantly lower impact of voice problems compared to National Health Service speech and language therapy 3 months after randomisation which was still present after 12 months; however, Lee Silverman Voice Treatment LOUD was not found to be cost-effective. Future work: Implementing Lee Silverman Voice Treatment LOUD in the National Health Service and identifying alternatives to Lee Silverman Voice Treatment LOUD for those who cannot tolerate it. Investigation of less costly alternative options for Lee Silverman Voice Treatment delivery require investigation, with economic evaluation using a preference-based outcome measure that captures improvement in communication. Study registration: This study is registered as ISRCTN12421382. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 10/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 58. See the NIHR Funding and Awards website for further award information.

Most people with Parkinson's disease develop difficulties with their speech and voice. Communicating becomes difficult. This affects their relationships, work, social life and how they feel about themselves. Our PD COMM trial compared two types of speech and language therapy to find out if they helped the speech and voice problems people with Parkinson's have. We measured changes in the way their voice and speech problems affected their lives and how much therapy cost the National Health Service and families. Everyone taking part had speech or voice problems because of their Parkinson's disease. People could not take part if they had dementia, evidence of laryngeal pathology or previous laryngeal surgery or received speech and therapy for Parkinson's disease in the last 2 years. People who agreed to take part joined one of three groups, which were alike except for the therapy they received. A computer decided which group they joined by chance. National Health Service speech and language therapy Lee Silverman Voice Treatment LOUD No speech and language therapy for 12 months The 388 people who took part came from 41 outpatient clinics in Scotland, England and Wales. Most were older men. The people that received Lee Silverman Voice Treatment LOUD felt better about their speech and voice after 3 months compared to people in the other groups. A year later, they still felt better about it. People that received National Health Service therapy had no benefit compared to people with no access to therapy. Analysis of cost-effectiveness indicated that Lee Silverman Voice Treatment LOUD did not offer value for money and the intervention cost more because more speech and language therapy time was needed to deliver it. Our next question is to ask how we can provide Lee Silverman Voice Treatment LOUD in a way that costs less, for example, using therapy assistants and computer packages or at home. Clear speech and language therapy approaches for people with Parkinson's disease and speech or voice problems should be tested in trials that measure changes in people's lives.

Digital rehabilitation care planning for people with chronic diseases (RehaPro-SERVE): study protocol for a German multicentre randomised controlled trial.

BACKGROUND: Chronic diseases are a significant and growing problem of our time. They impair the ability to work and increase the risk of early retirement. To support the return to work, rehabilitation services can be applied for in Germany. Currently, the application system for rehabilitation allows only a limited degree of individualisation of the treatment and is associated with a lack of multidisciplinary communication. To facilitate rehabilitation care planning, we developed a complex intervention. A digital, platform-based case management approach (intervention) will ensure multidisciplinary communication and the tailored selection of medical treatments and/or non-medical support measures. The overall objective is to assess the effectiveness of the intervention compared to treatment as usual (control condition). The German Federal Ministry of Labour and Social Affairs (BMAS) funds the RehaPro-SERVE study (grant number: 661R0053K1). METHODS: This is the protocol for an investigator-initiated, pragmatic, multicentre, randomised and controlled two-arm parallel-group superiority trial with embedded qualitative process evaluation. The study will be conducted in Hesse state, Germany. N = 59 primary care physicians will be recruited and tasked with the recruitment of six eligible patients each. ELIGIBILITY CRITERIA: age 40-60; minimum of 4-week work disability due to musculoskeletal, oncologic or psychological conditions or the post-COVID-19 syndrome within the last 6 months; at high risk for early retirement. In total, n = 352 patients will be randomised with a 1:1 allocation to intervention or control group and stratified by primary care practice using permuted blocks. The primary outcome is the number of days of sick leave during a 12-month period after the assumed completion of treatments (t1 to t2). Secondary outcomes include the number of days of sick leave (self-report), work ability, and health-related quality of life, as well as data from the qualitative process evaluation. DISCUSSION: The results of the study will inform the design of future care services and provide valuable information on multidisciplinary case management in the context of rehabilitation care planning. The results of the qualitative process evaluation will further contribute to the understanding of facilitating and hindering factors. TRIAL REGISTRATION: DRKS-German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021.

Lessons learned from implementing a digital rehabilitation care planning platform to improve care access for patients with work disability: qualitative process evaluation of the RehaPro-SERVE study.

BACKGROUND: Inpatient rehabilitation therapies can be applied for in Germany by patients of working age to support their return to work. However, there are some problems that impede an easy and uncomplicated application process. An interdisciplinary case management approach for rehabilitation care planning was developed to facilitate the access to rehabilitation. Case conferences (CCs) were held with relevant stakeholders and took place on a digital communication platform. We conducted a qualitative process evaluation to understand the implementation of the intervention and to identify contextual factors as well as mechanisms for a successful implementation in the context of primary care. METHODS: The process evaluation included interviews with primary care physicians (PCPs), patients and stakeholders involved in the intervention process. Reflexive thematic analysis was used to analyse the data. Emerging themes were structured according to the Donabedian framework of structure, process and outcomes. RESULTS: A total of 18 interviews were conducted. Important results included the desire for more patient involvement and case management. Patients especially valued the opportunity to receive support from a social worker. Limitations of the platform related to usability and limited opportunities for stakeholder communication. Despite training for PCPs, several problems arose regarding the clarity of the intervention process. Patients were satisfied with their application process and the treatments offered, while PCPs reported an increase in workload. CONCLUSIONS: A digitalisation of the application procedure for rehabilitation and further treatment options is acceptable to patients and personal support of a social worker is particularly valued. However, patients should be included in the CC in terms of a shared decision-making process. The digital platform requires sufficient training and adjustments have to be made to enhance usability and to improve the efficiency of the process for PCPs. Overall, the exchange between the various stakeholders in the CC is considered particularly useful in more complex cases. TRIAL REGISTRATION: DRKS German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021.

Process evaluation of a randomised controlled trial - prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM).

BACKGROUND: Musculoskeletal disorders are commonly treated in primary healthcare and may, if not treated adequately, entail a risk for long-term disability and sickness absence. A team-based rehabilitation intervention (PREVention of Sickness Absence for Musculoskeletal disorders, PREVSAM) was evaluated in a randomised controlled trial. The purpose of this study was to evaluate the process of implementing the PREVSAM model in primary care rehabilitation. METHODS: This process evaluation was conducted alongside the trial, collecting quantitative and qualitative data to evaluate how the PREVSAM model was implemented, mechanisms of impact, and contextual factors. Acceptability, feasibility, appropriateness, adaptations, training and support, resources, recruitment, reach, retention, dose, fidelity, and readiness for change were investigated. Qualitative data were collected from healthcare professionals and patients. RESULTS: Eight of 22 invited rehabilitation clinics (36%) and 28 of 54 healthcare professionals (52%) were included in the PREVSAM trial and this process evaluation. Of 507 eligible patients, 261 (51%) were included. Of those, 134 were randomised to the intervention and 129 (96%) were retained. Twelve healthcare professionals and 15 patients participated in the qualitative evaluations. The model's essential components; individual assessments and structured, team-based rehabilitation with clear division of responsibilities agreed in a joint health plan; were generally delivered according to protocol. The optional components early access to psychological treatment and workplace contact were delivered to a lesser extent. Perceived acceptability, feasibility, and appropriateness of the PREVSAM model were moderate to high. Several contextual barriers, in the form of missing prerequisites, affected the implementation. Qualitative data showed that the model, with its holistic view, was appreciated by both healthcare professionals and patients. CONCLUSIONS: This process evaluation suggests that PREVSAM is acceptable, feasible and appropriate for patients with MSDs reporting psychological risk factors associated with increased risk for sickness absence. While essential components were implemented with fidelity for most patients, optional components were not. This variability reflects the complexity of the model, its mandatory and optional components, contextual barriers, and the person-centred approach meeting individual patient needs. As all model components were not delivered to all patients, the intervention may have been too similar to treatment as usual to detect differences on a group level. A limitation of the study is that half of the participating rehabilitation clinics withdrew prematurely.

Development and Implementation of Mental Healthcare Plans in Three Districts in Ghana: A Mixed-Method Process Evaluation Using Theory of Change.

In Ghana, a severe mental healthcare gap of 95-98% exists due to limited services. Ghana Somubi Dwumadie set out to address this by developing district mental healthcare plans (DMHPs) in three demonstration districts. Following the Programme for Improving Mental Healthcare model, district mental health operations teams were formed and used Theory of Change (ToC) to develop DMHPs. Key elements included training non-specialist health workers and enrolling individuals in relevant healthcare programmes. Evaluation methods included routine data, health facility surveys, and qualitative analysis within the ToC framework. Results showed improved integration of mental health services, enhanced case management through training, and increased service utilisation, shown through 691 service user enrollments. However, there was limited commitment of new resources and no significant improvement in primary care workers' capacity to detect priority mental health conditions. The study concludes that DMHPs, implemented with an integrated approach, can improve mental health service utilisation, contingent on committed leadership, resource availability, and stakeholder engagement.

Patients' and stakeholders' experiences of a personalized self-management SUPport program (P-SUP) for patients with type 2 diabetes mellitus and/or coronary heart disease: a qualitative process evaluation : Maximilian Scholl.

BACKGROUND: Chronic diseases such as type 2 diabetes mellitus and coronary heart disease cause medical, social, and economic burdens worldwide. Disease management programs in Germany mostly lack components to improve patients' self-management and health-promoting lifestyles despite clear guideline recommendations. Therefore, a Personalized Self-Management Support Program (P-SUP) was developed, which includes: (1) peer support groups; (2) telephone coaching; (3) feedback reports and, (4) a web portal. This study aims to explore patients' and implementing stakeholders' experiences in the implementation of P-SUP to identify barriers and facilitators to the implementation of the intervention. METHODS: A qualitative study was conducted using face-to-face focus group interviews with participating patients and telephone-based one-to-one expert interviews with implementing stakeholders, involved in the delivery of the intervention. The transcribed interview reports were analyzed using qualitative content analysis, and the contents were categorized according to Donabedian's Structure-Process-Outcome framework. RESULTS: A total of six themes among patients (N = 35) and five themes among implementing stakeholders (N = 32) represent the experiences. The patient themes were: (1) technical conditions, (2) indoor facilities, (3) group composition, (4) acceptance of digital components, (5) supervision and feedback and (6) impact on lifestyle behavior. The themes among the implementing stakeholders were: (1) multiprofessional approach, (2) human resources, (3) patient acceptance, (4) supervision and feedback and (5) impact on lifestyle behavior. CONCLUSIONS: Multiprofessional interventions such as P-SUP appear to be valuable for patients and implementing stakeholders. Although infrastructural barriers made the implementation of peer support and digital patient education difficult, patients rated the exchange with peers and experts on health-related topics positively. The lack of supervision and feedback during the course of the intervention might be compensated by regular telephone coaching. The findings from this study can be used in future studies to guide researchers and implementing stakeholders and to improve the feasibility and effectiveness of complex interventions in different contexts. TRIAL REGISTRATION: The P-SUP study was registered in the German Clinical Trials Register (DRKS) on 16/07/2020 under the registration number DRKS00020592.

Process evaluation of two large randomized controlled trials to understand factors influencing family physicians' use of antibiotic audit and feedback reports.

BACKGROUND: Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. METHODS: Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. RESULTS: Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. CONCLUSION: Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. TRIAL REGISTRATION: Clinical Trial registration IDs: NCT04594200, NCT05044052.

Process Evaluation of an Ambulance-Delivered Early Intensive Blood Pressure-Lowering Stroke Trial: Design, Rationale, and Reflection.

INTRODUCTION: The fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) is a large-scale, multicenter, prospective, randomized, open-label, blinded endpoint assessment trial, initiated in an ambulance in China, aiming at evaluating the effectiveness and safety of prehospital blood pressure (BP) lowering in patients with suspected acute stroke and elevated BP. A prespecified process evaluation is intended to explore the implementation of the trial intervention, provide support to interpret the trial outcomes and put forward suggestions to scale up the intervention in broader settings in the future. METHODS: This process evaluation is a mixed-methods design, and follows the Normalization Process Theory (NPT) and the UK Medical Research Council (UK MRC) guidance. Fidelity, reach, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting the implementation of prehospital early intensive BP-lowering treatment will be analyzed. Semi-structured interviews with ambulance staff, ward and emergency department clinicians, and nurses are undertaken to explore perceptions of the intervention, contextual factors, and potential suggestions for future implementation in practice. Data from observational records, surveys, conventional monitoring data, on-site records, and case report forms will be analyzed to understand background care and context. CONCLUSION: The process evaluation of INTERACT4 will provide insights for the implementation of prehospital early intensive BP-lowering intervention in different health systems and help better explain the trial results for further scale up.

Increasing adolescents' physical activity levels through a comprehensive school-based physical activity program: study protocol of the cluster randomized controlled trial Active School.

BACKGROUND: The positive effects of regular physical activity on children and adolescents' physical and mental health are well-established. Despite these health benefits, most Swiss adolescents do not meet WHO's recommended level of physical activity, which includes a daily minimum of 60 min of moderate-to-vigorous physical activity. Due to their inclusivity, schools are identified as a key setting to promote physical activity. Recently, the comprehensive school physical activity program (CSPAP), in which teachers as physical activity leaders (PALs) play a crucial role to advance comprehensive school-based physical activity promotion, has been discussed. However, such comprehensive approaches are still lacking in Switzerland, and specific PAL trainings do not exist. Therefore, the aim of this study is to implement and evaluate Active School, a comprehensive school-based physical activity program for Swiss secondary schools with integrated PAL training. METHODS/DESIGN: A cluster randomized controlled trial (RCT) involving 12 secondary schools (6 experimental, 6 waiting control schools) will assess baseline data and effectiveness of Active School at 12 and 24 months. Active School includes five components based on the CSPAP. Each school is encouraged to set individual physical activity goals in this regard. This process is guided by the PALs, who will participate in professional development training before and during Active School implementation. As a primary outcome, students' moderate-to-vigorous physical activity will be assessed via accelerometers. As secondary outcomes, inactivity, light physical activity, step counts, aerobic fitness and coordination will be measured, and students' general wellbeing, learning behavior, and multiple psychosocial measures related to physical activity will be assessed by questionnaires. The effectiveness evaluation is accompanied by a process evaluation that focuses on the implementation outcomes of dose of delivery, reach, feasibility, and sustainability. A mixed methods approach, including ripple effect mapping, will be employed to reconstruct and understand the implementation process. DISCUSSION: This study will be the first to implement and evaluate a CSPAP in the Swiss school system. The specific PAL training and the simultaneous application of effectiveness and process evaluation are considered strengths of the study. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00033362). Date of registration: January 25, 2024. Retrospectively registered.

Using Normalisation Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: the STAMINA lifestyle intervention.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention. METHODS: Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future. RESULTS: Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner. CONCLUSIONS: Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. TRIAL REGISTRATION: (ISRCTN: 46385239 ). Registered on July 30, 2020.

Centering the role of community health workers in social risk screening, referral, and follow-up within the primary care setting.

BACKGROUND: Community health workers (CHWs) remain an underutilized resource in social risk diagnostics in the primary care setting. This process evaluation study seeks to assess the role of CHWs in social risk screening, referral, and follow-up through process mapping to identify barriers to the process for future quality improvement efforts. METHODS: Researchers at the Arizona Prevention Research Center (AzPRC) engaged with two Federally Qualified Health Centers (FQHCs) in two of Arizona's major urban areas to evaluate their internal processes for social risk screening and intervention. The Consolidated Framework for Implementation Research (CFIR) was used to direct a process mapping exercise to visually describe the workflow, gaps, and barriers to identifying and addressing social risk. RESULTS: The process unveiled key areas for health system improvements in the community setting, the organizational setting, and in the implementation of social risk screening, referral, and follow-up. Further, process maps highlight the potential resources needed for effective CHW integration to address social risk in the primary care setting. CONCLUSIONS: Our findings demonstrate the importance of organizational tools, such as process mapping, to assist primary care settings in evaluating internal processes for quality improvement in addressing social risk and in effectively integrating the CHW workforce. Subsequent research will evaluate rates of social risk screening, referral, and follow-up within all of Arizona's FQHCs and propose models for CHW integration to address social risk in primary care and strengthen social risk screening reach and effectiveness.

Use and appreciation of combined computer- and mobile-based physical activity interventions within adults aged 50 years and older: Randomized controlled trial.

Objective: To investigate whether six combined computer- and mobile-based physical activity interventions differ regarding use, attrition, usability and appreciation among adults aged 50 years and older. Methods: The interventions were studied in a randomized controlled trial. Participants were allocated to the computer-based Active Plus or I Move program including a mobile-based activity tracker, or ecological momentary intervention (EMI), or chatbot, or to a waiting list control group. Use and attrition were investigated via log data gathered within the intervention software. Appreciation was assessed via online evaluation questionnaires. ANOVAs and Chi-squares were performed to test for intervention differences on use, attrition and appreciation (p ≤ .05). Results: A total of 954 participants aged 50 years and older with varying health conditions were included. Attrition differed between interventions (χ 2 = 27.121, p < .001) and was the highest in I Move including chatbot (58.4%) and lowest in I Move including activity tracker (33.0%). Appreciation differed between interventions (p < .001) and was the highest for interventions including activity tracker, followed by interventions including EMI and lowest for interventions including chatbot. Technical issues were primarily faced by EMI- and chatbot-participants. EMI-participants reported mainly that they received no or few text messages. Chatbot-participants reported mainly that the step count application was not working properly. Conclusions: The integration of mobile-based activity trackers with computer-based interventions has high potential for increasing use and lowering attrition among adults aged 50 years and older. The process evaluation findings can guide future intervention optimization procedures, other eHealth and mHealth developers and practitioners.