Mixed-methods Process Research Articles

Process and implementation evaluation of a virtual hospital model of care for low back pain (Back@Home).

Low back pain was the sixth most common reason for an ED visit in 2022-2023 in Australia, one-third of these patients were subsequently admitted to hospital. Therefore, we have assessed whether some patients could be diverted to alternate clinical pathways, via admission to a virtual hospital (rpavirtual), and be cared for remotely in their own homes. Ethics approval was granted for protocols X21-0278 & 2021/ETH10967 and X21-0094 & 2021/ETH00591. We conducted a mixed-method process evaluation, using the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance) to answer key questions regarding the Back@Home model of care. This preliminary evaluation describes a cohort of the first 50 patients who received care between 13 February and 31 July 2023. The service had high levels of reach and adoption, very low levels of ED representation, and no AEs. Virtual care cost a median of AU$2215 (interquartile range = AU$1724-AU$2855) per admission. Patients admitted virtually had the same high satisfaction with care as traditionally admitted patients and reported less pain and better physical function. Preliminary findings suggest that this model of care is a safe, acceptable, and feasible alternative to hospitalisation for non-serious low back pain, in a select cohort of patients meeting inclusion criteria. Further data collection will inform whether Back@Home has had an impact on length of stay or traditional admission rates.

Preliminary Validation of Stigma Measures Among Parents of Children Who Are d/Deaf or Hard of Hearing in the United States and Ghana

Objectives: Parents are integral to the development and overall well-being of their child. Previous research has studied the emotional effects parenting experiences have on parents. However, parents caring for children with disabilities have unique parenting experiences, filled with both victories and challenges. Parenting a child with disabilities can bring additional responsibilities as parents respond to their child’s special needs. Specifically, parents of children who are d/Deaf or hard of hearing (d/DHH) are required to make ongoing life-changing decisions about their child’s life, including mode of communication, medical care, and education. Across the world, many adults who are d/DHH experience stigma. However, less is known about the stigma faced by children who are d/DHH and their parents. Measuring the nature and magnitude of stigma-affecting parents of children who are d/DHH could offer insights into how to additionally support these parents. Nonetheless, there is a gap in validated scales to measure stigma among parents of children who are d/DHH. In response, we developed and preliminarily validated five measures of stigma among parents of children who are d/DHH. Design: Measures were developed through a mixed-method process: (1) a scoping literature review, (2) a modified Delphi process consisting of two group discussions (n = 3, n = 4) and two individual discussions with parents of children who are d/DHH from high-income countries (HICs) and low- and middle-income countries (LMICs), (3) cognitive interviews with parents of children who are d/DHH in the United States (U.S.) (n = 5) and Ghana (n = 5), and (4) a pretest of the survey in the U.S. (n = 28) and Ghana (n = 30). Modifications to the measures were made after each stage. This article focuses on evaluating the psychometric performance of the developed measures. Parents were recruited in the U.S. (n = 100) and Ghana (n = 173). Convenience sampling was used in both countries. In Ghana, survey administration was in-person with trained interviewers collecting data on tablets. In the U.S. data were collected online through self-administered surveys. Results: The final five scales measured: (1) parental observation of stigma their child experiences (seven items), (2) parental perceptions of stigma toward their child (eight items), (3) parental secondary experienced stigma (eight items), (4) perceived parental secondary stigma (five items), and (5) parental internalized stigma (seven items). All scales performed strongly and similarly across both country samples. The scales had ordinal αs ranging from 0.864 to 0.960, indicating strong reliability. Conclusions: This study provides a set of preliminarily validated stigma measures to capture the experience of parents of children who are d/DHH. Measuring stigma among parents is critical to understanding parental mental health, as parental well-being affects the health and development of their child. Furthermore, measuring observed stigma by parents can allow the researcher to gain an understanding of the stigma experienced by children who are d/DHH that they may not be able to communicate. Further studies testing these measures across other countries and with more diverse samples are needed.

'Walk Buds': A walking intervention to increase physical activity, physical fitness, and emotional wellbeing, in 9-13 year old children with intellectual disabilities. Results of a clustered randomised feasibility trial.

Children with intellectual disability are less physically active and more sedentary than typically developing peers. To date no studies have tested the feasibility of a school-based walking intervention for children with Intellectual Disability. A clustered randomised controlled trial (cRCT), with an embedded process evaluation, was used to test the feasibility of a school-based walking intervention. Eight schools (n = 161 pupils aged 9-13 years) were randomised into either an intervention arm or an 'exercise as usual' arm. Measures included physical activity, physical fitness and emotional wellbeing. Baseline and 3-month follow-up data were collected. The 'Walk Buds' intervention was found to be acceptable to teaching staff and pupils, with an uptake rate of the walking sessions offered of 84%. A number of challenges were experienced, relating to the COVID-19 pandemic, and difficulties collecting accelerometer data. Barriers, facilitators and required changes identified through the mixed methods process evaluation are discussed.

MulTI-domain self-management in older People wiTh OstEoarthritis and multi-morbidities: protocol for the TIPTOE randomised controlled trial

BackgroundFour out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone.MethodsTIPTOE is a multi-centre, two-arm, individually randomised controlled trial where 824 individuals over 65 years old with knee and/or hip joint pain from their OA affected joint and at least one other long-term health condition will be randomised to receive either the Living Well Self-Management support intervention or usual care. Eligible participants can self-refer onto the trial via a website or be referred via NHS services across Wales and England. Those randomised to receive the Living Well support intervention will be offered up to six one-to-one coaching sessions with a TIPTOE-trained healthcare practitioner and a co-designed book. Participants will be encouraged to nominate a support person to assist them throughout the study. All participants will complete a series of self-reported outcome measures at baseline and 6- and 12-month follow-up. The primary outcome is symptoms and quality of life as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ). Routine data will be used to evaluate health resource use. A mixed methods process evaluation will be conducted alongside the trial to inform future implementation should the TIPTOE intervention be found both clinically and cost-effective. An embedded ‘Study Within A Project’ (SWAP) will explore and address barriers to the inclusion of under-served patient groups (e.g. oldest old, low socioeconomic groups, ethnic groups).DiscussionTIPTOE will evaluate the clinical and cost-effectiveness of a co-designed, living well personalised self-management support intervention for older individuals with knee and/or hip OA and MLTCs. The trial has been designed to maximise inclusivity and access.Trial registrationISRCTN 16024745. Registered on October 16, 2023.

Process evaluation of an mHealth-based school education program to reduce salt intake scaling up in China (EduSaltS): a mixed methods study using the RE-AIM framework

BackgroundAn mHealth-based school health education platform (EduSaltS) was promoted in real-world China to reduce salt intake among children and their families. This progress evaluation explores its implementation process and influencing factors using mixed methods.MethodsThe mixed-methods process evaluation employed the RE-AIM framework. Quantitative data were collected from a management website monitoring 54,435 third-grade students across two cities. Questionnaire surveys (n = 27,542) assessed pre- and post-education effectiveness. Mixed-effects models were used to control cluster effects. Qualitative interviews (23 individuals and 8 focus groups) identified program performance, facilitators, and barriers. Findings were triangulated using the RE-AIM framework.ResultsThe program achieved 100% participation among all the third-grade classes of the 208 invited primary schools, with a 97.7% registration rate among all the 54,435 families, indicating high "Reach." Qualitative interviews revealed positive engagement from children and parents through the "small hands leading big hands" strategy. The high completion rate of 84.9% for each health cloud lesson and the significant improvement in salt reduction knowledge and behaviors scores from 75.0 (95%CI: 74.7–75.3) to 80.9 (95%CI: 80.6–81.2) out of 100 demonstrated the "Effect" of EduSaltS. The program's "Adoption" and "Implementation" were supported by attractive materials, reduced workload via auto-delivered lessons/activities and performance evaluation, and high fidelity to recommended activities, with medians 3.0 (IQR: 2.0–8.0)/class and 9.0 (IQR: 5.0–14.0)/school. Stable course completion rates (79.4%-93.4%) over one year indicated promising "Maintenance." Apart from the facilitating features praised by the interviewees, government support was the basis for the scaling up of EduSaltS. Barriers included the lack of smartphone skills among some parents and competing priorities for schools. Unhealthy off-campus environments, such as excessive use of salt in pre-packaged and restaurant foods, also hindered salt reduction efforts. The program's scalability was evident through its integration into existing health education, engagement of local governments and adaptation across various mobile devices.ConclusionsThe mHealth-based school health education program is scalable and effective for public salt reduction in China. Identified barriers and facilitators can inform future health program scale-ups. The program's successful implementation demonstrates its potential for broader application in public health initiatives aimed at reducing dietary salt intake.

Group-based pelvic floor muscle training for pregnant women: A randomized controlled feasibility study.

This study aims to test the feasibility and acceptability of a group-based pelvic floor muscle training for pregnant women in China and facilitate women's adherence to the pelvic floor muscle training programme. Urinary incontinence is a prevalent health problem in women worldwide, especially in pregnant women. Supervised pelvic floor muscle training is recommended as the first-line conservative treatment for urinary incontinence. However, the implementation and effectiveness of pelvic floor muscle training are limited by insufficient human resources and low adherence. Group-based interventions may improve people's adherence to interventions by facilitating peer support. However, it has been investigated in a limited number of maternity studies. Feasibility testing randomized controlled trial, accompanied by a mixed methods process evaluation. This study was guided by the Medical Research Council framework for complex interventions and the Behaviour Change Wheel guide to developing interventions. A three-phase, mixed-methods design was used in this study. This study reported the feasibility of the group-based pelvic floor muscle training programme. Semi-structured reviews were conducted following the intervention to explore the acceptability of the programme. The study included 48 pregnant women with a recruitment rate of 52.17%. The adherence rate to the training programme was 66.67%. The intervention was positively valued, in particular the support promoting participants' adherence, but additional changes need to be made to the programme for a future trial. Group-based pelvic floor muscle training programme provides a possible way of delivering pelvic floor muscle training with limited health professionals in China. The study showed promising results concerning the acceptability and feasibility of the intervention, which were well perceived by both pregnant women and the midwife. Group-based pelvic floor muscle training may have the potential of reducing the prevalence of urinary incontinence in pregnant women with insufficient healthcare professionals. This study assessed the feasibility of delivering group-based pelvic floor muscle training in pregnant women in China. The group-based pelvic floor muscle training is acceptable to both pregnant women and the midwife, but integrating online and face-to-face sessions need to be considered. The findings of this study provided evidence for delivering group-based pelvic floor muscle training to pregnant women in China. The study has adhered to CONSORT guidelines (Table S1) and TIDier checklist (Table S2). The patient and public have been invited as stakeholders during the development of the intervention. They worked with healthcare professionals to co-design the group-based pelvic floor muscle training programme. The trial was registered on ClinicalTrials.gov (NCT05242809) under the title 'Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China'.

An innovative model of access and triage to reduce waiting in an outpatient epilepsy clinic: a process evaluation

PurposeInterventions that improve timely access to outpatient health services are essential in managing demand. This process evaluation aimed to describe the implementation, mechanism of impact and context of an intervention to reduce waiting for first appointments in an outpatient epilepsy clinic.Design/methodology/approachThe UK Medical Research Council framework was used as the theoretical basis for a process evaluation alongside an intervention trial. The intervention, Specific Timely Appointments for Triage (STAT), is a data-driven approach that combines a one-off backlog reduction strategy with methods to balance supply and demand. A mixed methods process evaluation synthesised routinely collected quantitative and qualitative data, which were mapped to the domains of implementation, mechanisms of impact and contextual elements.FindingsThe principles of the STAT model were implemented as intended without adaptation. The STAT model reached all patients referred, including long waiters and was likely generalisable to other medical outpatient clinics. Mechanisms of impact were increased clinic capacity and elimination of unwanted variation. Contextual elements included the complexity of healthcare systems and the two-tier triage practice that contributes to prolonged waiting for patients classified as non-urgent.Originality/valueThis process evaluation shows how a data-driven strategy was applied in a medical outpatient setting to manage demand. Improving patient flow by reducing waiting in non-urgent, outpatient care is a complex problem. Understanding how and why interventions work is important for improved timeliness of care, and sustainability of public health services.

Implementation of a digital exercise programme in health services to prevent falls in older people.

StandingTall uses eHealth to deliver evidence-based balance and functional strength exercises. Clinical trials have demonstrated improved balance, reduced falls and fall-related injuries and high adherence. This study aimed to evaluate the implementation of StandingTall into health services in Australia and the UK. Two hundred and forty-six participants (Australia, n =184; UK, n =62) were recruited and encouraged to use StandingTall for 2h/week for 6-months. A mixed-methods process evaluation assessed uptake and acceptability of StandingTall. Adherence, measured as % of prescribed dose completed, was the primary outcome. The study, conducted October 2019 to September 2021 in Australia and November 2020 to April 2022 in the UK, was affected by COVID-19. Participants' mean age was 73 ± 7years, and 196 (81%) were female. Of 129 implementation partners (e.g. private practice clinicians, community exercise providers, community service agencies) approached, 34% (n =44) agreed to be implementation partners. Of 41 implementation partners who referred participants, 15 (37%) referred ≥5. Participant uptake was 42% (198/469) with mean adherence over 6 months being 41 ± 39% of the prescribed dose (i.e. 39 ± 41 min/week) of exercise. At 6 months, 120 (76%) participants indicated they liked using StandingTall, 89 (56%) reported their balance improved (moderately to a great deal better) and 125 (80%) rated StandingTall as good to excellent. For ongoing sustainability, health service managers highlighted the need for additional resources. StandingTall faced challenges in uptake, adoption and sustainability due to COVID-19 and a lack of ongoing funding. Adherence levels were lower than the effectiveness trial, but were higher than other exercise studies. Acceptance was high, indicating promise for future implementation, provided sufficient resources and support are made available. Australian and New Zealand Clinical Trials Registry ACTRN12619001329156.

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

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

Implementing a real-time patient experience feedback in inpatient rehabilitation: Process evaluation informed by the normalisation process theory.

Near real-time patient experience feedback (NRTPEF) can enable a patient-centric, immediate service recovery but has not been widely used in inpatient rehabilitation. We 1) assess the utility, feasibility, and acceptability of implementing a new NRTPEF, perceived by patients and providers; and 2) understand how the NRTPEF became embedded into routine provider practices. Mixed methods process evaluation of the 8-month implementation of an innovative NRTPEF in an inpatient rehabilitation unit, using interviews and focus groups with all the service-unit leaders and interviews with a randomised sample of patients. Beyond descriptive statistics and content analysis, the Normalisation Process Theory (NPT) informed a framework analysis. Patients and service-unit leaders perceived high utility in the NRTPEF (median: 9 for both; 0-10 scale) and qualitative comments emphasised the value of providing/obtaining timely feedback. The system was found feasible and acceptable for patients (median: 9.5), but with an improvement margin for providers (median: 7.3). Suggestions include strengthening the data-relay format. Even in the pilot form, providers found the NRTPEF became embedded into practice (median 10; average: 8.6). The analysis based on the NPT shows how providers saw differential value, engaged with, and used the patient feedback into reconfigured practices. An innovative NRTPEF was found useful, feasible and acceptable, but with refinement opportunities before scale-up.

Evaluating the impact of a ward environment with 20 single occupancy rooms and two four-bedded bays on patient and staff experiences and outcomes in an acute NHS Trust: a mixed-methods study protocol

IntroductionTraditionally, wards in acute care hospitals consist predominately of multioccupancy bays with some single rooms. There is an increasing global trend towards a higher proportion of single rooms in hospitals,...

Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24–1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4 months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14–15/20, range = 11–20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants “liked” or “strongly liked” all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) “agreed” or “strongly agreed,” it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants “agreeing” or “strongly agreeing” that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations.

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

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

Enhancing Men's Awareness of Testicular Diseases (E-MAT) using virtual reality: A randomised pilot feasibility study and mixed method process evaluation.

Testicular cancer is among the most common malignancies in men under the age of 50 years. Most testicular symptoms are linked to benign diseases. Men's awareness of testicular diseases and testicular self-examination behaviours are suboptimal. In this pilot feasibility study and process evaluation we examine the feasibility of conducting a future definitive randomised controlled trial (RCT) to test the effect of the Enhancing Men's Awareness of Testicular Diseases using Virtual Reality intervention (E-MATVR) compared to the Enhancing Men's Awareness of Testicular Diseases using Electric information control (E-MATE). The study protocol is registered on ClinicalTrials.gov (NCT05146466). Male athletes, engaged in Gaelic games, and aged 18 to 50 years were included. Recruitment was via FacebookTM, XTM (formerly TwitterTM), and posters. Participants were individually randomised to either E-MATVR or E-MATE. Data were collected at baseline (T0), immediately post-test (T1), and three months post-test (T2) using surveys. Qualitative interviews were conducted with participants and researchers. Data were collected from 74 participants. Of those, 66 were retained. All E-MATVR participants and most E-MATE participants (n = 33, 89.2%) agreed/strongly agreed that the device was easy to use and that they were engaged to learn by the device. Most E-MATVR participants (n = 34, 91.9%) and all E-MATE participants agreed/strongly agreed that the time it took them to complete the intervention was reasonable. All 74 participants were extremely satisfied/somewhat satisfied with their overall participation in the study. E-MATVR was described as interactive, easy, fun, and close to real life. Initial difficulty using VR equipment, nausea, and technical issues were identified as challenges to engaging with E-MATVR. Recommendations were made to make VR more accessible, shorten the survey, and incorporate more interactivity. Across all participants, mean testicular knowledge scores (range 0-1) increased from 0.4 (SD 0.2) at T0 to 0.8 (SD 0.2) at T1. At T2, overall mean scores for participants were 0.7 (SD 0.2). Mean knowledge scores did not differ by trial arm at any timepoint. At T2, all E-MATVR participants and 29/32 E-MATE participants (90.6%) reported purposefully examining their testes within the past three months. Findings are promising, highlighting the feasibility of using VR to promote young athletes' awareness of testicular diseases. Considering the strengths, limitations, and lessons learned from this study, some modifications are required prior to conducing an RCT. These include but are not limited to shortening survey questions, incorporating more interactivity and visual content, and targeting more heterogenous male-dominated environments.

Improving prevention and early detection of sepsis among patient groups at risk: Introducing a model for a multimodal information campaign-The SepWiss study protocol.

Sepsis is a life-threatening organ dysfunction due to a dysregulated host response to infection. Annually, sepsis leads to approx. 90.000 deaths in Germany. Risk factors include amongst others older age (>60), innate or acquired dysfunction of the immune system, and underlying chronic diseases of the lung, heart, liver, or kidneys. The manifestation of sepsis is a medical emergency, and patient outcomes depend on timely diagnosis and immediate treatment. In addition, vaccinations e.g., against pneumococci or influenza virus, are a highly effective public health tool to prevent the most common underlying infections that may lead to sepsis. However, a lack of public awareness for the relevance of vaccination and detecting sepsis as an emergency underlines the need for public health interventions that address these issues. SepWiss aims to evaluate the effects of a multimodal information campaign designed to address this lack of awareness among the risk population in Germany. SepWiss is an intervention at state level, consisting of a multimodal information campaign targeting risk groups in the German federal states of Berlin and Brandenburg (intervention region). Based on available evidence, various information formats were developed and implemented by outdoor advertising, social media, educational formats and through stakeholders' platforms, starting in August 2021. The control region comprises of the remaining 14 German federal states. We will analyze vaccination coverage (primary outcome), and sepsis knowledge, the ability to detect sepsis as an emergency, and attitude towards vaccination (secondary outcomes) amongst the risk population in a controlled before-after comparison. The implementation is accompanied by a mixed-method process evaluation. SepWiss is the first project of its kind to evaluate a complex multi-faceted evidence-based information campaign with regards to the topics of vaccination coverage, and the importance of sepsis detection and prevention for the most vulnerable populations in Germany. Results will be valuable for informing further nationwide campaigns. German Registry for Clinical Trials: DRKS00024475. Registered February 24th, 2021.

Promoting healthy sleep in 0-2-year-old infants: a study protocol for the development and mixed method evaluation of a sleep health program tailored to Dutch youth healthcare regions

BackgroundSleep problems are common among infants and can have a serious impact on the health and wellbeing of both child and parents. To sustainably promote infant sleep on a population level, it is necessary to develop evidence-based programs that can be implemented on a large scale. The Youth Health Care setting, with its focus on prevention, child health promotion and services widely available for parents, can be a suitable setting to do so. Currently however, sleep health promotion in this setting seems to be suboptimal. To promote healthy infant sleep on a population level, programs need to be accessible and comprehensible for all parents, including parents with limited (health) literacy. Therefore, this study aims to develop, implement and evaluate a program called ‘Sleep on number 1’, that is tailored to Dutch Youth Health Care, to sustainably promote healthy sleep in 0-2-year-old infants.MethodsThe program was developed based on co-creation with parents and Youth Health Care professionals, evidence-based behaviour change theories and sleep health promotion methods. Program effectiveness is investigated with a quasi-experimental study design comparing the program group with the care as usual control group. Participants consist of parents of 0-2-year-old children. Primary outcome is infant sleep quality at the age of 10 weeks and 6, 9, 14 and 24 months, measured with a sleep diary. The primary data analysis focuses on night awakenings at 9 months. Secondary outcomes focus on parental behaviour regarding infant sleep, related behavioural determinants and parental satisfaction with Youth Health Care sleep advice. Program effectiveness is analysed using a linear mixed-model in case of data clustering, and an independent samples T-test or linear regression in case no substantial clustering effects are found. A mixed methods process evaluation is performed with parents and Youth Health Care professionals, assessing program reach, adoption, implementation, maintenance and working mechanisms.DiscussionThe ‘Sleep on number 1’ program is an evidence-based sleep health program for 0-2-year-old children, tailored to Dutch Youth Health Care. If effective, this program has the potential to improve infant sleep on a population level.Trial registrationISRCTN, ISRCTN27246394, registered on 10/03/2023. https://www.isrctn.com/ISRCTN27246394.

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

ObjectivesTo evaluate the feasibility and acceptability of a primary care-based intervention for improving post-diagnostic dementia care and support (PriDem), and implementation study procedures.DesignA non-randomised, mixed methods, feasibility study.SettingSeven general practices...

Experiences with implementing advance care planning (ACP-GP) in Belgian general practice in the context of a cluster RCT: a process evaluation using the RE-AIM framework

BackgroundGeneral practice is often recommended as an ideal setting to initiate advance care planning (ACP), but uptake of ACP in this setting is low. ACP-GP is a complex intervention to facilitate ACP for patients with chronic, life-limiting illness in Belgian general practice. It aims to increase patient ACP engagement and general practitioner (GP) ACP self-efficacy. In a cluster-randomized controlled trial, the intervention was not superior to control in increasing these outcomes. A parallel process evaluation aimed to enhance understanding of how the intervention was implemented, and which factors might have influenced trial results.MethodsWe conducted a mixed-methods process evaluation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources include recruitment and implementation monitoring, questionnaires for patients and GPs, and semi-structured (focus group) interviews with patients and GPs. Questionnaire data were analyzed descriptively. Qualitative data were first analyzed inductively; themes were then assigned deductively to RE-AIM dimensions.ResultsThirty-five GPs and 95 patients were recruited to the trial; GP reach was low. Sixteen GPs and 46 patients provided questionnaire data at 3 months post-baseline; qualitative data were transcribed for 14 GPs and 11 patients. Adoption of intervention components was moderate to good, with the exception of the documentation template for GPs. Interviews revealed varying patient attitudes towards ACP, but patients nonetheless emphasized that conversations made them feel reassured. GPs especially valued a positive framing of ACP. When adopted, the intervention was well-implemented and participant satisfaction was high. However, intention for maintenance was moderate, with GPs raising questions of how to sustainably implement ACP conversations in the future.ConclusionsImplementing the complex ACP-GP intervention in general practice is feasible, and can be successful. However, the implementation process is challenging and the sustainability is suboptimal. Our findings will guide future research and recommendations for facilitating and implementing ACP in general practice.Trial registrationISRCTN12995230; prospectively registered on 19/06/2020.

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

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

Yorkshire Lung Screening Trial (YLST) pathway navigation study: a protocol for a nested randomised controlled trial to evaluate the effect of a pathway navigation intervention on lung cancer screening uptake

IntroductionLung cancer is the most common cause of cancer death globally. In 2022 the UK National Screening Committee recommended the implementation of a national targeted lung cancer screening programme, aiming...