Mixed-methods Process Evaluation Research Articles

Pilot Implementation of a Primary Care Disease Management Concept for Venous Leg Ulceration: Results of a Mixed-Methods Process Evaluation

Background: Within the project “Ulcus Cruris Care”, a disease management intervention to improve general practice care for patients with venous leg ulcer was developed, comprising online teaching for practice teams, standardized patient education, and case management. Implementation of the intervention was piloted and evaluated via a process evaluation. This study aims to evaluate contentedness with the intervention, implementation effort, implementation determinants, intervention fidelity, and perceived intervention effects using a mixed-methods process evaluation. Methods: The mixed-methods process evaluation explored the views of general practitioners, medical assistants and patients regarding the intervention components. Data were collected through semi-structured telephone interviews and a survey questionnaire. Qualitative data were first analyzed inductively, followed by a deductive–inductive approach based on the Theoretical Domains Framework. Survey data were analyzed descriptively. Results: Participants (n = 21) reported a strong contentedness with the intervention, high intervention fidelity, low implementation effort, and a change in perception of compression therapy as the central treatment element. Healthcare professionals emphasized increased patient education and patient and family involvement. Patients reported feeling better informed and empowered to take an active role in their treatment, primarily due to increased knowledge and skills in compression therapy. As a result, they were more content with their care and reported positive experiences with wound healing since trial participation. Conclusions: The Ulcus Cruris Care intervention can lead to a noticeable change in knowledge and potentially influence practice teams’ approach to venous leg ulcer management, facilitating a significantly more frequent use of compression therapy in VLU care. A confirmatory evaluation of potential effects in a definitive RCT seems warranted.

Process evaluation of an individually tailored complex intervention to improve activities and participation of older nursing home residents with joint contractures (JointConEval): a mixed-methods study

BackgroundOlder people with joint contractures in nursing homes often experience severe restrictions in their activities and participation. The effectiveness of an individually tailored complex intervention to improve residents’ activities and participation by incorporating the biopsychosocial perspective into nursing care using a structured facilitator approach could not be established in the JointConEval cluster-randomised controlled trial. This process evaluation aimed to systematically identify factors influencing implementation and effectiveness.MethodsThe mixed-methods process evaluation analysed recruitment, implementation, mechanisms of impact, and context. Qualitative data was generated in semi-structured focus groups and in individual interviews with facilitators, nursing and social care staff, residents, relatives and guardians. Quantitative data was recorded with facilitators and 20% of nursing and social care staff using standardised documentation forms and questionnaires. Qualitative data was analysed using qualitative thematic content analysis, while the quantitative data was analysed descriptively. An interpretation was performed by combining and comparing the qualitative and quantitative results after the separate analyses.ResultsThe implementation was realised as planned, but the intervention did not always reach the nursing home staff, which hindered the planned change in attitude and behaviour. The attitude of the facilitators was mainly in line with the intervention. However, the intervention reached only half the residents. We identified various key influencing factors related to the context, setting and implementation agents. Nursing homes lacking facilitator support from staff or management or experiencing staff shortages and facing organisational weaknesses had difficulties in achieving the desired behavioural changes and positive primary outcomes.ConclusionsThe complex intervention was delivered as planned with several factors affecting the implementation. A key influencing factor was the organisational structure and leadership of the nursing homes, which had an impact on the behaviour and motivation of the implementation agents. The findings highlight challenges in achieving behavioural changes among nursing staff in the context of long-term care in Germany. We recommend a systematic organisational context analysis for similar complex interventions in long-term care, involving stakeholders and improving leadership participation for more effective implementation.Trial registrationDRKS (German Clinical Trials Register), number DRKS00015185. Registered on 1 August 2018, https://drks.de/search/en/trial/DRKS00015185. Universal Trial Number U1111-1218–1555.

Improving Lynch syndrome detection: a mixed-methods process evaluation of a hybrid type III effectiveness-implementation trial

IntroductionTranslating evidence-based practices into real-world healthcare settings is challenging, particularly in the rapidly evolving field of genomics. A pragmatic two-arm cluster-randomized clinical trial (Hide and Seek Project – HaSP) tested two implementation approaches for improving hereditary cancer referral practices with one key distinction: implementation strategies that were designed 1) explicitly using psychological theory, or 2) using healthcare professional intuition. This mixed-methods process evaluation aimed to provide insights into how and why change occurred by examining contextual determinants, identifying mechanisms of action, and exploring the role of theory.MethodsPost-implementation interviews were conducted with Implementation Leads and clinicians from participating HaSP sites. Transcripts were analysed using a mixed inductive and deductive approach, guided by the updated Consolidated Framework for Implementation Research (2.0). Findings were triangulated with other HaSP process evaluation data sources, including HaSP focus group observations, HaSP research team focus groups, MDT observations, and Implementation Lead project logs. Logic models and case studies were developed to articulate causal processes underlying strategy effectiveness and conditions necessary for implementation success.ResultsEighteen participants from seven HaSP sites were interviewed. Qualitative analysis identified themes related to Lynch syndrome complexity, pandemic disruptions, operational challenges, information technology constraints, multidisciplinary collaboration, cultural determinants, attitudes towards change, the value of theory, adaptations, and implementation support. Within these themes, a total of 39 contextual determinants were identified, with barriers and facilitators spanning 18 CFIR constructs across five domains. Logic models and case studies highlighted a number of mechanisms of action, producing variable clinical outcomes. Process evaluation findings, interpreted together with HaSP trial outcomes, indicate that theory-based implementation strategies may better support Lynch syndrome detection practices compared to intuition-based strategies.ConclusionsThe information gained from this process evaluation deepens understanding of the factors influencing the success of hospital-specific implementation strategies within the HaSP framework. Potential pathways for optimising the effectiveness of the overall HaSP implementation approach have been identified.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001072202. Registered 27 June 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375348&isReview=true.

A randomised controlled feasibility trial of Behavioural activation as a treatment for people with diabetes and depression: (DiaDeM feasibility trial).

There is a lack of evidence on effective treatments for depression in people with T2DM, particularly in Low and Middle-Income Countries (LMICs). This study aims to test the feasibility and acceptability of a culturally adapted Behavioural Activation (BA) intervention (DiaDeM) for people with depression and T2DM in two South Asian LMICs. A multicountry, individually randomised-controlled feasibility trial was conducted from March 2022 to November 2022. We recruited adults from diabetes healthcare facilities in Bangladesh and Pakistan with a diagnosis of depression and T2DM. Consenting individuals were randomised to either optimised usual care or the DiaDeM intervention, which comprised six BA sessions delivered by non-mental health facilitators over six to twelve weeks. Participants were followed up at three and six months post-randomisation. The feasibility and acceptability of recruitment and retention, intervention delivery, and data collection were assessed. A mixed-methods process evaluation was also performed to inform the main trial. The DiaDeM feasibility trial successfully recruited 128 participants, with 85 % retention at six months follow-up. The majority of participants engaged with the intervention, demonstrating good adherence to the Behavioural Activation (BA) sessions. Data completeness for key outcomes, including depression severity and HbA1c levels, was high across all time points (>90 %). The process evaluation showed high acceptability of the intervention, with participants reporting increased motivation and improved management of both T2DM and depression. Good recruitment and retention rates, completeness of data collection, and high acceptability of the intervention showed that it would be feasible to undertake a full-scale trial.

Implementation and evaluation of a navigation program for people with cancer in old age and their family caregivers: study protocol for the EU NAVIGATE International Pragmatic Randomized Controlled Trial

BackgroundCancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, and care. Navigators engage with people to ensure timely access to services and resources. While promising for older people with cancer, these programs are scarce in Europe, and research on their effectiveness and implementation is limited. We describe the protocol of the EU NAVIGATE randomized controlled trial, aimed to evaluate (1) effectiveness and cost-effectiveness of NavCare-EU, an intervention that aims to support older people with cancer throughout their illness trajectory, spanning the continuum of supportive, palliative, and end-of-life care, and (2) the intervention’s implementation processes and feasibility of its integration into different health care systems in Europe, contextual barriers and facilitators for effective and sustainable implementation, and mechanisms involved in reaching the outcomes.MethodsWe will conduct a multisite pragmatic fast-track randomized controlled trial with embedded convergent mixed-method process evaluation in Belgium, Ireland, Italy, Netherlands, Poland, and Portugal. The study targets people with cancer and declining health, 70 years or older, and their close family caregivers. The trial compares the NavCare-EU intervention plus standard care with standard care alone. We will perform a baseline measurement prior to randomization and follow-up measurements at 12 weeks, 24 weeks, and 48 weeks in intervention and control group, and an additional measurement at 72 weeks in the control group. Primary outcomes, measured at 24 weeks are (1) the older person’s global health status/quality of life, a 2-item subscale from EORTC-QLQ-C30 (revised) measuring health-related quality of life, (2) level of social support measured with Medical Outcomes Study Social Support Survey (MOS-SSS scale). The study will include at least 246 older persons with completed global health status/quality of life at 24 weeks.DiscussionThe EU NAVIGATE trial will cross-nationally test the effectiveness and cost-effectiveness of a navigation intervention for older people with cancer and their family caregivers, and its implementation in different health care systems in Europe. As continuity and access to health, social, and community care is a priority for patients and caregivers, the trial is timely and critically needed.Trial registrationClinicaltrials.gov: identifier NCT06110312 (2023/10/31).

Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study

Background High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. The improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. Methods We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. Discussion The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407

Feasibility of a custom-tailored, evidence-based, theory-informed, intervention to prevent burnout and reduce stress for healthcare professionals: protocol for a single-arm trial

BackgroundHealthcare professionals face high levels of occupational stress, time pressure, workload, and poor organizational support. This makes them particularly vulnerable to burnout. The COVID-19 pandemic has further exacerbated this situation. This single-arm, multicenter, mixed-methods feasibility study pilots the LAGOM program: A tailored, evidence-based intervention to prevent burnout and reduce stress among healthcare professionals.MethodsParticipants will include healthcare professionals (N = 30) working at Charité–Universitätsmedizin Berlin and Immanuel Hospital, Berlin. LAGOM focuses on support for individual behavior change and personal resources and also addresses the organizational level. The intervention´s feasibility will be evaluated through a non-randomized feasibility trial with a mixed methods process evaluation. The exploratory primary study aims are to assess the acceptability and feasibility of the (1) evaluation procedures and of the (2) intervention content and structure using study records, standardized questionnaires, protocol checklists, and diaries. Exploratory effectiveness analysis will take place as well. Further, semi-structured interviews (n = 3 to 6) and electrophysiological measurements (n = 20) will be conducted.DiscussionCustom-tailored, well-implemented multi-level interventions are needed to prevent burnout and reduce stress among healthcare professionals. Long-term strategies are warranted to sustainably implement effective programs. This feasibility study helps to refine trial procedures and content of the LAGOM program for a randomized controlled trial to evaluate the intervention’s effectiveness.Trial registrationGerman Clinical Trials Register: DRKS00032014, registered 17th October 2023.

Community mental health for migrant women in Barcelona (“Self-Care Among Women”): Protocol for a mixed-methods process evaluation of a pilot psychological intervention

IntroductionMigrant populations, especially women, are often more susceptible to poor mental health and they face healthcare access barriers. This study aims to develop and evaluate a community-based mental health intervention through a participative research process to promote mental health and prevent psychiatric disorders among migrant women in Barcelona city. The intervention is built upon two evidence-based guidelines: Group Problem Management Plus (Group PM+) and Self-Help Plus (SH+). Methods“Self-Care Among Women” is a mixed-methods process evaluation study for the development of a community-based psychological pilot intervention. A participatory approach will be employed to adapt the content agenda of the community mental health intervention. Process indicators on context, implementation and mechanisms of change will be assessed through an intersectionality lens to explore the way in which the intervention is developed and implemented. The contextual fit, acceptability and feasibility of the proposed psychological intervention will be examined through participants' and facilitators' perceptions of the intervention. Further, women's clinical mental health condition and wellbeing will be assessed before and after the intervention, through standardized and culturally-validated instruments. Ethics and disseminationEthical approval of the research protocol has been obtained by the Research Ethics Committees of Hospital Clínic, Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol) and Parc Sanitari Sant Joan de Déu. Written informed consent will be requested from all research participants for inclusion in the study. The study results will be published in peer-reviewed journals and communicated to congresses.

Remote Patient Monitoring for Managing Interstitial Lung Disease: A Mixed Methods Process Evaluation

Remote Patient Monitoring for Managing Interstitial Lung Disease: A Mixed Methods Process Evaluation

Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol

BackgroundChronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation, or withdrawal. A growing body of evidence suggests that sex and gender aspects influence CNCP management as the experience of pain, the emotions associated with it, and the expression of pain may differ between women and men. In addition, doctor-patient communication is known to be influenced by gender stereotypes. Despite there being evidence on such differences, current guidelines do not consider sex- and gender-sensitive approaches. In order to examine how to adequately address the diversity of the experience and processing of pain in patients of differing sex and gender, the GESCO study aims at developing and pilot testing a sex- and gender-sensitive intervention for patients with CNCP receiving long-term opioid therapy (LTOT) in primary care.MethodsThe development process is designed in accordance with the first two phases of the UK Medical Research Council. Phase I will iteratively explore, develop, and pilot the intervention’s modules using literature searches, interviews, and workshops involving stakeholders and experts. Phase II will pilot-test the novel intervention in a sample of 40 patients with CNCP under LTOT from ten general practices using an effectiveness-implementation hybrid design including a mixed-methods process evaluation focusing on implementation strategy criteria and a single-arm, pre-post comparison to determine preliminary effects in preparation for a larger effectiveness trial. The intervention will combine in-person educational sessions for general practitioners and tools to be used in patient care.DiscussionThe intervention aims to improve CNCP management in primary care by empowering practitioners to reflect on their attitudes towards pain and stereotypes. Besides sex and gender aspects, awareness of other factors that might affect the care process, such as age, social conditions, or culture, is also promoted. The intention is to develop a comprehensive care concept for CNCP that considers aspects relevant for sex- and gender-sensitive care which are transferrable to other health care fields as well.Trial registrationGerman Clinical Trial Register DRKS00029980.

LifeLab Dublin; a process evaluation of a pilot health literacy intervention for socioeconomically disadvantaged adolescents

ABSTRACT Developing health literacy (HL) in youth populations, as a means to improving lifelong health behaviours and outcomes, has garnered increased interest in both research and practice in recent years. This mixed-methods process evaluation examines the acceptability, fidelity and dose delivered of the pilot of LifeLab Dublin: a nine-week, school-based HL intervention for low socioeconomic adolescents. The intervention, which comprised of two, out-of-school, interactive HL experiences in conjunction with seven school-based lessons, took place between September and December in 2021 and involved first-year students (aged 11–13) from one socioeconomically disadvantaged school in Dublin, Ireland. Data sources included focus groups, a questionnaire and self-reflection checklists. Overall, the intervention was perceived positively by the students and teachers, particularly the two interactive out-of-school experiences. The evaluation provided valuable insight into the refinements required to enhance the efficacy of the LifeLab intervention, as well as providing an evidence-base that can be used to inform future school-based HL interventions for low socioeconomic adolescents.

The ASK trial: a randomised controlled feasibility trial and process evaluation of a complex multicomponent intervention to improve AccesS to living-donor Kidney transplantation

Background Following identification of barriers to living-donor kidney transplantation, and subsequent development of a multicomponent intervention, we undertook a feasibility trial of the intervention. Trial design Two-arm, parallel group, pragmatic, individually-randomised, controlled, feasibility trial, comparing the new intervention with usual care, with a mixed-methods parallel process evaluation. Based at two UK hospitals. Participants Individuals were eligible if ≥18 years old, active on the kidney transplant waiting list or had been referred for transplant listing without a contraindication to transplantation. Individuals with a living-donor undergoing surgical assessment were excluded. Intervention i) A meeting between a home educator for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; ii) A standardized letter from a healthcare professional to a candidate’s potential donors; iii) A home-based education and family engagement session undertaken by a living kidney donor and a nurse specialist. Objective To establish the acceptability and feasibility i) of delivering the developed intervention in existing care pathways, and ii) of undertaking a randomised controlled trial of the intervention. Primary outcomes Recruitment and retention. Randomisation Participants were randomly allocated 1:1 to i) the intervention or ii) usual care, stratified by site. Minimisation was used to ensure balance in sex, age group, and socioeconomic strata, with probability weighting of 0.8. Results 183 people were invited to participate. 62 people (34% recruitment) were randomised. 62/62 (100%) completed nurse assessed follow-up at 6 weeks. 51/62 (82%) completed follow-up questionnaires. 3/30 (10%) in the usual care arm and 9/32 (28%) in the intervention arm had individuals ask to be tested for living kidney donation following recruitment to the trial. Conclusions Intervention and trial delivery are feasible and acceptable. Findings have informed the design of an effectiveness and cost-effectiveness trial. Trial registration ISRCTN Registry ISRCTN10989132 https://doi.org/10.1186/ISRCTN10989132. The trial was registered on 6/11/2020.

Health Catch-UP!: a realist evaluation of an innovative multi-disease screening and vaccination tool in UK primary care for at-risk migrant patients

BackgroundMigrants to the UK face disproportionate risk of infections, non-communicable diseases, and under-immunisation compounded by healthcare access barriers. Current UK migrant screening strategies are unstandardised with poor implementation and low uptake. Health Catch-UP! is a collaboratively produced digital clinical decision support system that applies current guidelines (UKHSA and NICE) to provide primary care professionals with individualised multi-disease screening (7 infectious diseases/blood-borne viruses, 3 chronic parasitic infections, 3 non-communicable disease or risk factors) and catch-up vaccination prompts for migrant patients.MethodsWe carried out a mixed-methods process evaluation of Health Catch-UP! in two urban primary healthcare practices to integrate Health Catch-UP! into the electronic health record system of primary care, using the Medical Research Council framework for complex intervention evaluation. We collected quantitative data (demographics, patients screened, disease detection and catch-up vaccination rates) and qualitative participant interviews to explore acceptability and feasibility.ResultsNinety-nine migrants were assessed by Health Catch-UP! across two sites (S1, S2). 96.0% (n = 97) had complete demographics coding with Asia 31.3% (n = 31) and Africa 25.2% (n = 25), the most common continents of birth (S1 n = 92 [48.9% female (n = 44); mean age 60.6 years (SD 14.26)]; and S2 n = 7 [85.7% male (n = 6); mean age 39.4 years (SD16.97)]. 61.6% (n = 61) of participants were eligible for screening for at least one condition and uptake of screening was high 86.9% (n = 53). Twelve new conditions were identified (12.1% of study population) including hepatitis C (n = 1), hypercholesteraemia (n = 6), pre-diabetes (n = 4), and diabetes (n = 1). Health Catch-UP! identified that 100% (n = 99) of patients had no immunisations recorded; however, subsequent catch-up vaccination uptake was poor (2.0%, n = 1). Qualitative data supported acceptability and feasibility of Health Catch-UP! from staff and patient perspectives, and recommended Health Catch-UP! integration into routine care (e.g. NHS health checks) with an implementation package including staff and patient support materials, standardised care pathways (screening and catch-up vaccination, laboratory, and management), and financial incentivisation.ConclusionsClinical Decision Support Systems like Health Catch-UP! can improve disease detection and implementation of screening guidance for migrant patients but require robust testing, resourcing, and an effective implementation package to support both patients and staff.

Innovative approaches to measuring and promoting employee vitality and sustainable employability

Abstract Background Employers find it difficult to develop interventions for vitality and sustainable employability (SE), particularly for employees in low-skilled jobs. Measures based on the employee perspective on SE that would give direction to interventions fall short, and effective programs to improve vitality and SE in this group are lacking. This study aims (1) to get insight into the effect and implementation of an innovative organizational, dialogue-based approach ‘Healthy HR’ (HHR)* to promote job control and SE, and (2) to refine and further validate the Maastricht Instrument for SE (MAISE)-Easy (an HHR tool for needs assessment). Methods (1) An effect evaluation with a pretest-posttest design with a 1 year follow up (N = 71), and a mixed-methods process evaluation were conducted. Data were collected using questionnaires, interviews with employees and employers (N = 26), focus groups (N = 4) and logbooks. (2) A questionnaire containing the MAISE-Easy-items, proxy variables (health and vitality) and demographics was answered by 1223 employees from 7 organizations. Construct validity, reliability and criterion validity were tested through PCA, CFA, Cronbach’s alpha and correlations. Results (1) A higher dose of HHR resulted in better job control and SE (n.s.). HHR had a positive impact on the awareness level of vitality and healthy workplaces of all stakeholders. (2) Reliability, construct and criterion validity of the MAISE-Easy were good, and MAISE-Easy 2.0 was constructed. This tool consists of 8 scales and 20 items divided over 4 areas: (1) Level of SE; (2) Factors affecting my SE; (3) Overall responsibility for SE; and (4) Responsibility for factors affecting my SE. Conclusions MAISE-Easy 2.0 is a valuable, valid and reliable tool in HHR which serves as a needs assessment for SE interventions. The innovative participatory approach HHR can improve job control and SE of employees in low-skilled jobs by giving them an active voice. *doi.org/10.1186/s12889-021-11278-7 Key messages • Healthy HR (HHR) is an effective, organisational dialogue-based approach (online toolkit) to promote job control, vitality and sustainable employability (SE) of employees in low-skilled jobs. • MAISE-Easy-2.0 (Maastricht Instrument for SE) is a new and thoroughly validated HHR tool for needs assessment, which measures SE and the responsibility for SE from the employee perspective.

A Person-Based Web-Based Sleep Intervention Aimed at Adolescents (SleepWise): Randomized Controlled Feasibility Study.

Adolescents are advised to sleep 8-10 hours per night; however, most do not sleep for this recommended amount. Poor adolescent sleep is associated with detrimental health outcomes, including reduced physical activity, risk-taking behaviors, and increased depression and anxiety levels, making this an important public health concern. Existing interventions targeting adolescent sleep are often unsuccessful or their effectiveness unclear, as they are frequently noninteractive, time-consuming, and lack a strong theoretical foundation; highlighting an urgent need for innovative interventions deemed acceptable by adolescents. The main objective of this study was to determine the acceptability, feasibility, and preliminary impact of a web-based person-based sleep intervention (SleepWise) on adolescent sleep quality. Participant incentivization was also explored to understand its impact on engagement, acceptability, and sleep quality. A feasibility trial was conducted to test the feasibility, acceptability, and preliminary impact of SleepWise on adolescent sleep quality, developed based on the person-based approach to intervention development. In total, 90 participants (aged 13-17 years) from further education institutions and secondary schools were recruited for two 2-arm randomized controlled trials. One trial (trial 1) was incentivized to understand the impact of incentivization. Acceptability and sleep quality were assessed via questionnaires, and a mixed methods process evaluation was undertaken to assess participant engagement and experience with SleepWise. Engagement was automatically tracked by SleepWise, which collected data on the date and time, pages viewed, and the number of goals and sleep logs completed per participant. Semistructured interviews were carried out to gain participant feedback. Participants in both trials reported high levels of acceptability (trial 1: mean 21.00, SD 2.74; trial 2: mean 20.82, SD 2.48) and demonstrated similar levels of engagement with SleepWise. Participants in trial 1 viewed slightly more pages of the intervention, and those in trial 2 achieved their set goals more frequently. Improvements in sleep quality were found in both trials 1 and 2, with medium (trial 1) and large (trial 2) effect sizes. A larger effect size for improvement in sleep quality was found in the nonincentivized trial (d=0.87), suggesting that incentivization may not impact engagement or sleep quality. Both trials achieved acceptable recruitment (trial 1, N=48; trial 2, N=42), and retention at 5 weeks (trial 1: N=30; trial 2: N=30). Qualitative findings showed that adolescents lead busy lifestyles, which may hinder engagement; however, participants deemed SleepWise acceptable in length and content, and made attempts at behavior change. SleepWise is an acceptable and potentially efficacious web-based sleep intervention aimed at adolescents. Findings from this study showed that incentivization did not greatly impact engagement, acceptability, or sleep quality. Subject to a full trial, SleepWise has the potential to address the urgent need for innovative, personalized, and acceptable sleep interventions for adolescents. OSF Registries osf.io/yanb2; https://osf.io/yanb2.

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

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. A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory. 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 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. 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. Good reporting of a Mixed-Methods Study (GRAMMS). 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.

A type 1 hybrid multi-site randomized controlled trial protocol for evaluating virtual interview training among autistic transition-age youth

A number of policies mandate that autistic transition-age youth receive employment services to prepare for the workforce before high school graduation. A key limitation to these services is the job interview component, which relies on non-standardized, resource-intensive, staff-led role-plays to help autistic transition-age youth improve their interview skills. The autism community has called for better job interview preparation. To address this gap in services, our team, collaborated with the autism community to adapt the intervention, Virtual Reality Job Interview Training (VR-JIT; effective among adults with serious mental illness), into Virtual Interview Training for Transition Age Youth (VIT-TAY). This adapted intervention was tailored to meet the needs of autistic transition age youth while maintaining the core components of VR-JIT (i.e., an online job interview simulator with four levels of automated feedback and e-learning content). A pilot randomized controlled trial (RCT) demonstrated VIT-TAY's feasibility and initial effectiveness at improving job interview skills, reducing anxiety, and increasing employment rates within six months when added to transition services or pre-employment transition services (Pre-ETS). Thus, the overarching goal of this Hybrid Type 1 effectiveness-implementation study protocol is to conduct a fully-powered RCT of VIT-TAY across 16 schools in various geographical locations. Our specific aims are to 1) Evaluate whether Pre-ETS (or transition services) with VIT-TAY, as compared to Pre-ETS (or transition services) with an active control intervention (i.e., job interview didactics/e-learning with a series of 3–5 min videos of employed autistic adults talking about their career pathways) enhances employment outcomes; 2) Evaluate mechanisms of employment by nine months post-randomization; and 3) Conduct a multilevel, mixed-method process evaluation of the initial implementation of VIT-TAY across settings (e.g., acceptability, feasibility, and barriers and facilitators of implementation).

Effect of a participatory whole-systems approach on mortality in children younger than 5 years in Jigawa state, Nigeria (INSPIRING trial): a community-based, parallel-arm, pragmatic, cluster randomised controlled trial and concurrent mixed-methods process evaluation

In 2019, Nigeria reported the highest mortality rate in children younger than 5 years globally. We aimed to assess a whole-systems approach to improving child mortality in northern Nigeria. We conducted a community-based, parallel-arm, pragmatic, cluster randomised controlled trial in Kiyawa local government area, Jigawa state, Nigeria, and a concurrent mixed-methods process evaluation using ethnography and quantitative implementation monitoring. Trial clusters were population catchment areas of 32 government primary health-care facilities. Compounds were randomly sampled, proportional to cluster size, and all women aged 16-49 years and children younger than 5 years who were permanent residents were eligible for inclusion and recruited as the evaluation population. Children younger than 7 days were recruited but excluded from analysis. Evaluation clusters were allocated to intervention or control via simple randomisation with a 1:1 ratio. Cluster names were written on paper, folded, and placed in a container by community representatives. Different community representatives took out names one by one, with the first half assigned to receive the intervention. The intervention consisted of three components: participatory learning and action (PLA) groups for men and women (including compound heads [ie, the member of the compound that residents deemed most senior]), partnership defined quality scorecard (PDQS), and health-care worker capacity building; it was delivered from March 1, 2021, to Dec 31, 2022. We could not mask participants, field staff, or intervention-delivery staff to cluster allocation but baseline, endline, and follow-up data excluded information on cluster allocation. PLA groups involved separate groups of up to 25 men or women from all villages in the intervention clusters. The primary outcome was all-cause mortality in children aged 7 days to 59 months between Oct 1, 2021, and Sept 20, 2022, referred to as the evaluation period. The trial was prospectively registered (ISRCTN 39213655) and the protocol has been published. We recruited 3800 compounds at baseline, with 12 893 children contributing to analysis of the primary outcome (7316 [56·8%] of 12 893 in the intervention group and 5577 [43·3%] in the control group). 6617 (51·3%) of 12 893 children were male, 6275 (48·7%) were female, and one (<0·1%) child had missing sex data. Sampled compounds randomly came from 388 (91·3%) of 425 villages in the 32 clusters. We conducted verbal autopsies for 1182 deaths, of which 369 (31·2%) were children aged 7 days to 59 months during the evaluation period. Of these 369, 91 (24·7%) were classified as pneumonia deaths. Children contributed a median 361 days (IQR 236-365) to the analysis, with 369 (2·9%) of 12 893 children censored on their date of death, 1545 (12·0%) on their 5th birthday, and 3392 (26·3%) on the date of the most recent follow-up in which their residence or survival status was known. We found no significant decrease in all-cause mortality (hazard ratio 0·95, 95% CI 0·68-1·33; p=0·79) or suspected pneumonia mortality (0·79, 0·43-1·46; p=0·46) in the intervention group. The process evaluation showed low coverage and issues in reach of the intervention, but qualitative data highlighted mechanisms for positive effects on health and relationships. Our intervention did not affect mortality. However, due to the high child mortality in this region, further efforts should be made to adapt our participatory whole-systems approach to use communities of action within compounds. GSK and Save the Children UK. For the Hausa translation of the abstract see Supplementary Materials section.

Mixed methods process evaluation of an advance care planning intervention among nursing home staff.

We developed the ACP+ intervention to support nursing home staff with implementation of advance care planning. While ACP+ was found to improve staff's self-efficacy, it did not change their knowledge about advance care planning. To describe the level of implementation, mechanisms of impact, and contextual factors. Process evaluation embedded in a cluster randomized controlled trial in nursing homes (NCT03521206). Throughout and immediately following the 8-month ACP+ implementation, we collected weekly diaries, post-training surveys, attendance records, facility data, and conducted interviews (n = 32). We applied descriptive statistics and thematic analysis. Management, staff, and ACP+ trainers in seven intervention homes. Although most participants reported they valued ACP+, 33% of eligible staff across nursing homes attended training (range: 6%-69%) and only a few reported they felt ready to engage in actual care planning conversations. Half of all nursing homes adapted parts of the intervention (e.g., more/fewer/shortened training; assigning a coordinating role for practical management). Enough time to consolidate skills, and management support were key for staff engagement in advance care planning, and limited time and staff shortages were significant barriers. Staff reported increased awareness of the importance of advance care planning and felt there was a more systematic way of organizing advance care planning. There was limited staff engagement. Management ownership, clear roles, and collaborative practices may enhance nursing home advance care planning. Accessible and ongoing training for all staff, and ample practical learning opportunities are needed.

Peer-led recovery groups for people with psychosis in South Africa (PRIZE): Results of a randomized controlled feasibility trial.

The aims of this feasibility trial were to assess the acceptability and feasibility of peer-led recovery groups for people with psychosis in a low-resource South African setting, to assess the feasibility of trial methods, and to determine key parameters in preparation for a definitive trial. The design was an individually randomised feasibility trial comparing recovery groups in addition to treatment as usual (TAU) with TAU alone. Ninety-two isiXhosa-speaking people with psychosis and forty-seven linked caregivers were recruited from primary care clinics and randomly allocated to trial arms in a 1:1 allocation ratio. TAU comprised anti-psychotic medication delivered in primary care. The intervention arm comprised six recovery groups including service users and caregivers. Two-hour recovery group sessions were delivered weekly in a 2-month auxiliary social worker (ASW)-led phase, then a 3-month peer-led phase. To explore acceptability and feasibility, a mixed methods process evaluation included 25 in-depth interviews and 2 focus group discussions at 5months with service users, caregivers and implementers, and quantitative data collection including attendance and facilitator competence. To explore potential effectiveness, quantitative outcome data (functioning, relapse, unmet needs, personal recovery, stigma, health service use, medication adherence and caregiver burden) were collected at baseline, 2months and 5months post randomisation. Trial registration: PACTR202202482587686. Qualitative interviews revealed that recovery groups were broadly acceptable with most participants finding groups to be an enjoyable opportunity for social interaction, and joint problem-solving. Peer facilitation was a positive experience; however a minority of participants did not value expertise by lived experience to the same degree as expertise of professional facilitators. Attendance was moderate in the ASW-led phase (participants attended 59% sessions on average) and decreased in the peer-led phase (41% on average). Participants desired a greater focus on productive activities and financial security. Recovery groups appeared to positively impact on relapse. Relapse occurred in 1 (2.2%) of 46 participants in the recovery group arm compared to 8 (17.4%) of 46 participants in the control arm (risk difference -0.15 [95% CI: -0.26; -0.05]). Recovery groups also impacted on the number of days in the last month totally unable to work (mean 1.4days recovery groups vs 7.7days control; adjusted mean difference -6.3 [95%CI: -12.2; -0.3]). There were no effects on other outcomes. Peer-led recovery groups for people with psychosis in South Africa are potentially acceptable, feasible and effective. A larger trial, incorporating amendments such as increased support for peer facilitators, is needed to demonstrate intervention effectiveness definitively.