Mixed-methods Process Evaluation Research Articles

Implementation of the children and young people’s health partnership model of paediatric integrated care: a mixed-methods process evaluation

ObjectiveA process evaluation of the Children and Young People’s Health Partnership (CYPHP) model of integrated care for the interpretation of trial findings and building evidence on the implementation of integrated...

Early detection and a treatment bundle strategy for postpartum haemorrhage: a mixed-methods process evaluation.

Postpartum haemorrhage is a leading cause of maternal mortality. A multicountry, cluster-randomised trial (E-MOTIVE) demonstrated a 60% reduction in adverse postpartum haemorrhage outcomes. The E-MOTIVE intervention included early postpartum haemorrhage detection using calibrated blood-collection drapes, followed by a postpartum haemorrhage treatment bundle (ie, uterine massage, oxytocics, tranexamic acid, intravenous fluids, examination and escalation [MOTIVE]), supported by implementation strategies. We report a mixed-methods process evaluation assessing the implementation of the E-MOTIVE intervention in Kenya, Nigeria, South Africa, and Tanzania. In this mixed-methods process evaluation, data sources were observations of health workers providing clinical care to pregnant women and pregnant people during vaginal birth and postpartum haemorrhage at intervention sites, and surveys and qualitative interviews with health workers at intervention and control sites. Intervention sites received the calibrated drapes, MOTIVE bundle, and implementation strategies and control sites used uncalibrated drapes. Primary implementation outcomes included fidelity, adoption, adaptation, acceptability, feasibility, and contamination to the calibrated drape, MOTIVE bundle, and implementation strategies. Between June 1, 2022, and Jan 31, 2023, 2578 births were observed, 295 pregnant women and people had postpartum haemorrhage, 47 qualitative interviews were done, and 889 surveys were completed. Fidelity to calibrated drape use was high (birth observations 2578 [100%] of 2578; survey 451 [98·3%] of 459). Among health workers, calibrated drape acceptability was high; however, they reported barriers to pregnant women's and people's acceptability. Fidelity to postpartum haemorrhage treatment bundle delivery was high (birth observations 286 [96·9%] of 295), with moderate to high fidelity in median time from postpartum haemorrhage diagnosis to final treatment initiation (≤15 min initiation time in 191 [66·8%] of 295 birth observations, 16-20 min in 42 [14·7%] birth observations), and high acceptability and feasibility. Research midwives participated in clinical assessments after birth and bundle delivery in some sites (mixed fidelity). This process evaluation shows generally high levels of fidelity, feasibility, and acceptability of the calibrated drape and treatment bundle across evaluation methods and countries. The E-MOTIVE intervention should be included in national policies, with consideration for health workforce, supplies, and medication issues, which might need addressing for successful implementation. The Bill and Melinda Gates Foundation and the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, a co-sponsored programme of WHO. For the Swahili translation of the abstract see Supplementary Materials section.

The engagement of healthcare providers in implementing the selfBACK randomised controlled trial - A mixed-methods process evaluation.

People with low back pain (LBP) are often recommended to self-manage their condition, but it can be challenging without support. Digital health interventions (DHIs) have shown promise in supporting self-management of LBP, but little is known about healthcare providers' (HCPs) engagement in implementing these. We aimed to examine HCPs' engagement in patient recruitment for the selfBACK app clinical trial and explore their perceptions of the app. In a mixed-methods design, we conducted a process evaluation alongside the selfBACK trial, triangulating quantitative data from trial recruitment logs and a vignette-based survey, and qualitative data from trial procedure documents, interviews with HCPs, and survey free-text responses. From 2019 to 2020, we recruited 57 HCPs from Norway and 39 health clinics in Denmark and collected quantitative and qualitative data in parallel. Results were integrated using displays. Overall, 825 patients were recruited by the HCPs. The vignette-based survey showed high agreement among HCPs (n = 62) with the self-management plans generated by the app (84.1-88.9%) but also highlighted concerns about tailoring and content. Interviews with HCPs (n = 19) revealed challenges with recruitment due to busy schedules, competing tasks, and varying levels of interest and engagement in the study. The study identified factors that impact HCPs' engagement in recruiting patients for the selfBACK trial and highlighted overall positive views of the selfBACK app, although some concerns about the content and tailoring of the app were raised. Understanding HCP motivations and workload is crucial for the successful implementation of DHIs in clinical practice.

Knowledge translation and exercise for degenerative meniscal pathology and early osteoarthritis (KNEE-DEeP): Protocol for a single arm feasibility study

Background The Knowledge Translation and Exercise for Degenerative Meniscal Pathology and Early Knee Osteoarthritis (KNEE-DEeP) intervention was designed to promote greater uptake of evidence-based non-surgical treatments for knee pain attributed to degenerative meniscal pathology and early knee osteoarthritis (OA) in primary care, by tackling barriers at a service, clinician and patient level. Evidence indicates that patients frequently do not access first-line treatments, namely exercise and patient education, prior to specialist referral. The KNEE-DEeP intervention supports general practitioners (GPs) and physiotherapists to enhance their skills and confidence in managing patients with this type of knee pain through professional development workshops. In turn, patients will receive an ‘enhanced consultation’ from their GP and be referred to an early ‘best practice’ physiotherapy session. Physiotherapists will work with patients to develop a collaborative action plan focussing on self-management and exercise. Methods This protocol outlines a single arm non-randomised feasibility study with a mixed method process evaluation. The study intends to recruit 15 GPs, five physiotherapists and 36 patients from general practices in the South-West of Ireland. Eligible patients, will be aged between 35 years and 69 years inclusive, and attend their GP with an episode of non-traumatic knee pain attributed to a degenerative meniscal tear (DMT) or early OA. Physiotherapists and GPs will be trained in intervention delivery. Within two weeks of receiving an ’enhanced consultation‘ from their participating GP, patients will attend the one-hour ‘best practice’ physiotherapy session. Patient data will be collected via online questionnaires at baseline, 12 weeks and 6 months. Qualitative interviews to assess the feasibility and acceptability of the intervention will be conducted with a purposive sample of GPs, physiotherapists and their enrolled patients. Ethics and Dissemination Approved by Clinical Research Ethics Committee of the Cork Teaching Hospitals. Results will be presented in peer-reviewed journals and at international conferences. Registration clinicaltrials.gov (NCT06576557)

Intervention to systematize fall risk assessment and prevention in older hospitalized adults: a mixed methods study

BackgroundFall-prevention interventions are efficient but resource-requiring and should target persons at higher risk of falls. We need to ensure that fall risk is systematically assessed in everyday practice. We conducted a quality improvement (QI) intervention to systematize fall risk assessment and prevention in older adults hospitalized on general internal medicine wards. We evaluated the efficacy of the intervention in a pre-post intervention study and assessed its feasibility and acceptability through a mixed methods process evaluation, which results are reported in here.MethodsThe QI intervention was conducted between 09/2022 and 10/2023 and targeted the nursing staff and residents in two tertiary hospitals of two different language and cultural regions of Switzerland. The intervention comprised an oral presentation, an e-learning, and reminder quizzes. We conducted a process evaluation including 25 interviews and a survey sent to all participants to assess feasibility and acceptability of the intervention. Quantitative data were analyzed descriptively and qualitative data with a mixed deductive and inductive approach. Results were integrated through meta-inferences.ResultsAmong 544 clinicians, 59% completed the e-learning, 74% found the intervention useful, and 25% reported an increase in interprofessional team working. A rewarding system was deemed motivating by 33% of clinicians. Main implementation barrier was the high workload. A concise and clear content as well as regular reminders were perceived as facilitators.ConclusionsA concise and multimodal QI intervention with regular reminders seemed to be feasible and well-accepted. Future QI intervention projects should consider the barriers and facilitators identified in this project to improve quality of care in older hospitalized adults.Trial registrationThe conducted research was not pre-registered.

Pilot study of a ketogenic diet in bipolar disorder: a process evaluation

BackgroundBipolar disorder is a serious mental illness, which requires new strategies for prevention and management. Recent evidence suggests that a ketogenic diet may be an effective intervention. This research aimed to explore the feasibility and acceptability of a ketogenic diet intervention for bipolar disorder, fidelity to its behavioural components and the experiences of the participants and research clinicians involved.MethodsA mixed-methods process evaluation was conducted. Semi-structured telephone interviews were carried out with 15 participants 1–2 months after completing a 6–8 week modified ketogenic diet intervention, and 4 research clinicians from the study team following the completion of data collection. Data were thematically analysed. Fidelity checklists completed by research dietitians were analysed using descriptive count and percentage statistics. Findings are reported post-hoc, following the analysis and publication of the main pilot study findings. Reporting was guided by the COREQ checklist.ResultsFive themes were identified in the qualitative data: (1) ‘Encouraging entry and supporting exit’ (e.g. recognising and managing participants’ varied motives and expectations, including around weight loss and symptom alleviation); (2) ‘Challenging but potentially transformational,’ which reflects that while it can be difficult to initiate and maintain a ketogenic diet day-to-day, many participants perceived physical and psychological benefits (e.g. significant weight loss, mood stability and enhanced ability to focus); (3) ‘Intervention facilitators,’ including a range of behavioural (e.g. goal setting), social (e.g. family and dietitians) and technological (e.g. apps for monitoring) support mechanisms; (4) ‘Intervention barriers’ (e.g. dietary preferences, concerns about the diet and its impact, the testing burden and capacity of the delivery team); and (5) ‘The wider context’ (e.g. the cost of living and sociocultural expectations) was a crucial factor explaining differential experiences. Overall, descriptive analyses indicated moderate-to-good fidelity to the behaviour change components of the study.ConclusionWe provide novel insight into the experiences of people living with bipolar disorder initiating and following a ketogenic diet, as well as those of research clinicians who support the intervention. Future trials may benefit from increased clinical research capacity, better-defined entry and exit routes, additional interpersonal support, and greater understanding of how social and societal factors impact participation.Trial registrationStudy registration number: ISRCTN61613198 (02/03/22).

Migrant Health Country Profile tool (MHCP-t) for transforming health data collection and surveillance in the Middle East and North African (MENA) region: tool development protocol with embedded process evaluation

IntroductionThe Middle East and North Africa (MENA) region is characterised by major health disparities and complex migration flows. Yet, because of a lack of epidemiological data, there is an urgent...

Implementation and evaluation of a novel community-based urban mobile health clinic in Toronto, Ontario.

Despite Canada's single-payer health system, marginalized populations often experience poor health outcomes and barriers to healthcare access. In response, mobile health clinics (MHCs) have been deployed in several cities across Canada. MHCs are wellestablished in the United States; however, little is known about their role and impact in a country with universal healthcare. We describe the implementation of an urban MHC and early learnings from a mixed methods process and outcome-oriented evaluation. In February 2021, Parkdale Queen West Community Health Centre, TELUS Health for Good, and University Health Network's Gattuso Centre for Social Medicine partnered to launch a nurse practitioner‒led, community-based MHC in Toronto, Ontario. The MHC provides low-barrier primary healthcare, harm reduction, and mental health services at five convenient locations. Through an intercept survey (n = 49) and semi-structured interviews (n = 10), we sought to understand the sociodemographic characteristics of clients, their experiences at the MHC, and barriers and facilitators to the MHC in comparison to traditional healthcare settings. Most clients surveyed reported being homeless (61%). Without the MHC, 37% of clients would have accessed care at an emergency department and 18% would not have sought care. Thematic analysis revealed two structural and two relational factors that improved care experiences and care access. We demonstrate that in a single-payer health system, MHCs alleviate major barriers to care access for marginalized populations. Learnings provide context to the most salient factors influencing clients' decisions to seek care at MHCs and can inform how these outreach models are designed.

Implementing a workplace participatory approach to support working caregivers in balancing their work, private life and informal care: results of a process evaluation

BackgroundMany organizations are faced with growing numbers of employees who combine their jobs with informal caregiving responsibilities. To support working caregivers in maintaining a good balance between work, private life and informal care, a workplace participatory approach (PA) intervention was implemented in four Dutch organizations. This study’s aims were to evaluate the degree of PA implementation, contextual factors influencing implementation, and stakeholder experiences with the PA.MethodsA mixed methods process evaluation was conducted alongside a randomized controlled trial among three stakeholder groups: caregiving employees, their supervisors, and trained occupational professionals who acted as PA process facilitators. The implementation frameworks of Steckler and Linnan (2002) and Carrol et al. (2007) were applied to evaluate recruitment, reach, dosage, fidelity and context, as well as stakeholders’ satisfaction, experiences and perceived intervention outcomes. Data were collected after PA implementation (4–7 months) using questionnaires, semi-structured interviews, checklists and research logs.ResultsOf the 57 caregivers in the intervention group, 48 participated in the stepwise intervention. Among them, 20 (42%) completed all seven steps of the PA, and 30 (63%) involved their supervisors. PA implementation and supervisor involvement varied based on personal factors (e.g. a need for balance-related improvements; preference to keep caregiving private), interpersonal factors (e.g. caregiver-supervisor relationship quality), and organizational factors (high work demands; a supportive workplace culture for caregivers). Caregivers, supervisors, and process facilitators reported positive experiences with the PA, finding it valuable for addressing informal caregiving, receiving support and working on balance-related changes in multiple life domains. Some caregivers, however, needed more than the standard 3 PA meetings to identify key issues and implement solutions.ConclusionsStakeholders found the PA helpful in addressing working caregivers’ work-life balance, but PA implementation can be further stimulated by creating a supportive organizational culture in which it is encouraged and safe to discuss informal care. Moreover, to better support working caregivers in the long term, the PA should be viewed as an ongoing and iterative process taking into account their evolving balance and circumstances.Trial registrationCurrent Controlled Trials ISRCTN15363783 (Registration date 21 November 2022; Retrospectively registered).

Powerful together with diabetes, a group-based self-management intervention for patients with type 2 diabetes from lower educational groups: study protocol for a hybrid type 2 evaluation

IntroductionType 2 diabetes mellitus (T2DM) is a major burden on public health worldwide. To reduce adverse events and complications, effective T2DM self-management is required. Self-management and glycaemic control are generally...

The Physical Activity at Work (PAW) Program in Thai Office Workers: Mixed Methods Process Evaluation Study.

An increasing number of multicomponent workplace interventions are being developed to reduce sedentary time and promote physical activity among office workers. The Physical Activity at Work (PAW) trial was one of these interventions, but it yielded an inconclusive effect on sedentary time after 6 months, with a low uptake of movement breaks, the main intervention component. This study investigates the factors contributing to the outcomes of the PAW cluster randomized trial. Following the Medical Research Council's guidance for process evaluation of complex interventions, we used a mixed methods study design to evaluate the PAW study's recruitment and context (how job nature and cluster recruitment affected movement break participation), implementation (dose and fidelity), and mechanisms of impact (assessing how intervention components affected movement break participation and identifying the facilitators and barriers to participation in the movement breaks). Data from accelerometers, pedometers, questionnaires, on-site monitoring, and focus group discussions were used for the evaluation. Linear mixed effects models were used to analyze the effects of different intervention components on the movement breaks. Subsequently, qualitative analysis of the focus group discussions provided additional insights into the relationship between the intervention components. The participation in movement breaks declined after the third week, averaging 12.7 sessions (SD 4.94) per participant per week for the first 3 weeks, and continuing to decrease throughout the intervention. On-site monitoring confirmed high implementation fidelity. Analysis of Fitbit data revealed that each additional movement break was associated with a reduction of 6.20 (95% CI 6.99-5.41) minutes in sedentary time and an increase of 245 (95% CI 222-267) steps. Regarding the mechanisms of impact, clusters with higher baseline sedentary time demonstrated greater participation in movement breaks, while those with frequent out-of-office duties showed minimal engagement. Moreover, clusters with enthusiastic and encouraging movement break leaders were associated with a 24.1% (95% CI 8.88%-39.4%) increase in participation. Environmental and organizational support components using posters and leaders' messages were ineffective, showing no significant change in percentage participation in movement breaks (4.49%, 95% CI -0.49% to 9.47% and 1.82%, 95% CI -2.25% to 5.9%, respectively). Barriers such as high workloads and meetings further hindered participation, while the facilitators included participants' motivation to feel active and the perceived health benefits from movement breaks. Despite high fidelity, the PAW trial did not significantly reduce sedentary time, with limited uptake of movement breaks due to context-related challenges, ineffective environmental support, and high workloads during the COVID-19 pandemic.

Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial

IntroductionThe PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes...

Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study

IntroductionPeople with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for...

Process Evaluation of Teaching Critical Thinking About Health Using the Informed Health Choices Intervention in Kenya: A Mixed Methods Study.

We evaluated the Informed Health Choices secondary school intervention to help students in Kenya think critically about health choices. We conducted this process evaluation to explore if the intervention was implemented as planned, identify factors that facilitated or hindered implementation, potential benefits of the intervention, and how to scale up the intervention beyond the trial. This was a mixed methods process evaluation nested in a cluster-randomized trial of the Informed Health Choices intervention. We analyzed quantitative data from teacher training evaluation forms completed by 39 teachers, 10 lesson evaluation forms completed by 40 teachers allocated to the intervention, and 72 structured classroom observation forms. We conducted a framework analysis of qualitative data from 14 group interviews (with 96 students, 23 teachers, and 18 parents) and 22 individual interviews (with 8 teachers, 5 school principals, 6 curriculum developers, and 3 policymakers). We assessed confidence in our findings from the qualitative analysis using a modified version of Confidence in the Evidence from Reviews of Qualitative Research. Lesson objectives were achieved with minimal adaptations. Factors that might have facilitated the implementation of the intervention include teacher training; perceived value of the intervention by students, teachers, and policymakers; and support from school administration. Time constraints, teachers' heavy workloads, and the lessons not being included in the curriculum or national examination are factors that might have impeded implementation. Both students and teachers demonstrated the ability to apply key concepts that were taught to health choices and other choices. However, they experienced difficulties with 2 of the lessons. Scale-up of this intervention in Kenyan schools is feasible but may depend on adjusting the time allocated to teaching the lessons, modifying the 2 lessons that teachers and students found difficult, and including the lesson objectives and assessment in the national curriculum.

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

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. 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. 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. 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.

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.