Qualitative Process Evaluation Research Articles

Empowering parents to optimize feeding practices with preschool children (EPO-Feeding): A study protocol for a feasibility randomized controlled trial.

Parental feeding practices (PFPs) play a key role in fostering preschoolers' dietary habits and in mitigating the risk of childhood obesity. Nevertheless, parents often employ inappropriate feeding practices, leading to children's potential nutrition-related issues. Thus, research is needed to inform interventions that focus on optimizing feeding practices. This protocol describes the evaluation of a novel intervention-Empowering Parents to Optimize Feeding Practices (EPO-Feeding Program). The program will be evaluated with a two-arm feasibility randomized controlled trial (RCT) in Yangzhou, China. The program includes four weekly group-based training sessions led by healthcare professionals for parents of preschool children. The intervention incorporates sessions, group discussions, motivational interviewing, and supplementary materials (e.g., key messages and educational videos) aimed at enhancing parents' knowledge, skills, and behaviours related to feeding practices. The primary outcomes include i) implementation feasibility, primarily assessed through retention rates; and ii) program acceptability through a survey and qualitative process evaluation. Secondary outcomes encompass the potential impacts on i) PFPs, ii) parental perception of child weight (PPCW), iii) parenting sense of competence, iv) children's eating behaviours, and v) child weight status. Quantitative analyses include descriptive estimates for evaluating the feasibility and linear mixed regression analysis for testing the potential effects. Qualitative valuation will use thematic framework analysis. If this study shows this program to be feasible to implement and acceptable to parents, it will be used to inform a fully powered trial to determine its effectiveness. The research will also help inform policy and practices in the context of child nutrition promotion, particularly regarding implementing group-based training sessions by healthcare providers in similar settings. Clinicaltrials.gov, Protocol #NCT06181773, 20/11/2023.

Implementation and Evaluation of a Large Community-Based Colorectal Cancer Screening Program.

Colorectal cancer (CRC) screening can significantly reduce incidence and mortality; however, screening rates are suboptimal. The lowest rates are among those with no usual source of care and the uninsured. We describe the implementation and evaluation of a community-based CRC screening program from 2012 to 2015 designed to increase screening within a predominantly Hispanic US-Mexico border population. The multicomponent, evidence-based program provided in-person, bilingual, culturally tailored health education facilitated by community health workers, no-cost primarily stool-based testing and diagnostic colonoscopy, and navigation. We recruited uninsured individuals due for CRC screening from clinics and community sites. An extensive qualitative and quantitative program process and outcome evaluation was conducted. In total, 20 118 individuals were approached, 8361 were eligible for screening; 74.8% completed screening and 74.6% completed diagnostic testing; 14 cancers were diagnosed. The mean age of participants was 56.8 years, and the majority were Hispanic, female, and of low socioeconomic status. The process evaluation gathered information that enabled effective program implementation and demonstrated effective staff training, compliance with processes, and high patient satisfaction. This program used a population-based approach focusing on uninsured individuals and proved successful at achieving high fecal immunochemical test kit return rates and colonoscopy completion rates. Key factors related to its success included tailoring the intervention to our priority population, strong partnerships with community-based sites and clinics, expertise in clinical CRC screening, and an active community advisory board. This program can serve as a model for similar populations along the border to increase CRC screening rates among the underserved.

Can communities be mobilised to build capacity to respond to the COVID-19 pandemic? A qualitative process evaluation

ObjectivesGovernment guidance to manage COVID-19 was challenged by low levels of health and digital literacy and lack of information in different languages. ‘Covid Confidence’ sessions (CC-sessions) were evaluated to assess...

A smoking cessation smartphone app that delivers real-time 'context aware' behavioural support: the Quit Sense feasibility RCT.

During a quit attempt, cues from a smoker's environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides 'in the moment' support to help them manage these during a quit attempt. To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense. A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a 'Study Within A Trial' evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation. Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website. Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram. Participants were allocated to 'usual care' arm (n = 105; text message referral to the National Health Service SmokeFree website) or 'usual care' plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app. Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative). Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met. The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions. Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support. The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense. Progression to a definitive trial is warranted providing improved biochemical validation rates. This trial is registered as ISRCTN12326962. This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/92/31) and is published in full in Public Health Research; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.

Lessons learned from qualitative fieldwork in a multilingual setting.

Qualitative research conducted in a multilingual setting is an arduous, yet essential, endeavour. As part of my PhD research program, I set out to conduct qualitative process evaluation of a stroke trial in 11 languages in the Indian subcontinent. In this article, I reflect upon the challenges, oversights, and successes that I experienced in the hope of offering insight of use to fellow researchers conducting healthcare fieldwork in multicultural contexts where many languages are spoken. My account starts with a description of the setting's context and the necessity of conducting research in multiple languages. I elaborate on the planning of the study which included selection of the sample and preparation of relevant documents, including informed consent in patients' languages. Subsequent steps entailed submission and approval of requisite documents, setup and training of a research team, and conducting interviews using interpreters. During this process, I developed a hybrid technique for conducting interviews that reduced fatigue for both patient interviewees and interpreters while still yielding in-depth insights. Additionally, I discuss the benefits of engaging professional translators for performing translations. Finally, I introduce a stepwise approach to facilitate the thematic analysis of qualitative data. I believe this account will encourage and empower researchers to pave their own way while anticipating and preparing for potential obstacles when conducting research in similar settings.

Evaluation of a complex couplet care intervention in a neonatal intensive care unit: A mixed methods study protocol.

Families with an infant in need of intensive care most often experience a harmful separation after birth. This is due to a division of medical specialties into neonatal care and maternal care. Therefore, a couplet care intervention is implemented for mother-infant dyads in a neonatal intensive care unit. This study protocol provides a comprehensive evaluation of the intervention. The aim is to evaluate the effect and implementation of a complex couplet care intervention to promote zero separation between mother and infant. The couplet care intervention is a family-centered model of care, where treatment-requiring mother-infant dyads will be admitted together and receive couplet care by neonatal nurses. The study adheres to the framework of the Medical Research Council and will use a mixed methods embedded design comprising a quasi-experimental trial and a qualitative process evaluation. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex couplet care intervention. Separation of mother-infant dyads after birth has an adverse impact on family health and well-being. This study protocol evaluates a complex couplet care intervention. With this study, a first step is taken to help bridge the gap between current practices and a new care model to prevent the separation of mothers and their infants.

Fluidity of Equipoise in a Multi-Centred Pilot RCT: Influences on Clinician Decision-Making in Offering Trial Entry

ObjectivesThe embedded Qualitative Process Evaluation (QPE) within the CSTICH- Pilot RCT explored facilitators and barriers to recruitment within the Pilot. This study reports a secondary analysis of the overarching theme of Fluidity of Equipoise and the influences on individual and community clinical equipoise around the use of Emergency Cervical Cerclage (ECC). Study designRCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention. The ability of trial recruiters to convey this equipoise is also key to participant recruitment and fully informed consent. This exploratory qualitative process evaluation used semi-structured interviews with healthcare professionals (HCPs) involved in trial recruitment. Interviews were audio-recorded, transcribed, and analysed using codebook thematic analysis. Results23 HCPs were interviewed. Clinical equipoise around the use of ECC was variable and influenced by a multitude of factors including: (1) obstetric history; (2) gestation; (3) standard site practice, and (4) HCPs previous experiences of ECC. We have interpreted this variability as ‘fluidity of equipoise’. ConclusionsClinical equipoise around complex pregnancy related conditions was fluid and influenced by the complexities of obstetric histories and gestation at presentation. Equipoise of HCPs involved in trial recruitment should be considered carefully as it can impact the nuances of recruitment, particularly in more challenging trials such as CSTICH-2. Study-specific documents and training can be used to increase staff and patient awareness of uncertainty in the evidence base for interventions under investigation. Further research is needed around the potential consequences of equipoise fluidity.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

IntroductionSub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living...

ARRIVE Together: A Qualitative Process Evaluation of the New Jersey State Police Co-responding Pilot Program

Law enforcement personnel are often first to respond to calls involving behavioral health emergencies. However, encounters with law enforcement are more dangerous and lethal for people with behavioral health conditions. Co-responding models, wherein law enforcement and behavioral health professionals respond to calls together, are among the top programs developed to improve responding to behavioral health crises. The current study describes a qualitative process evaluation of a co-responding pilot program in New Jersey: “Alternative Responses to Reduce Instances of Violence & Escalation” (ARRIVE Together). The evaluation centered on the experience of the co-responding team as to their perceptions of specific deployments and of the program implementation overall. Semi-structured interviews were conducted following 10 consecutive encounters (three interviews per encounter; February-March 2022). Transcripts were transcribed and thematically analyzed by two trained researchers independently. Once thematically analyzed, researchers determined a consensus and developed a SWOT analysis report. Thematic analysis produced six major themes: communication, staffing, training, resources, community outreach, and deployments with minors. Overall, participants were enthusiastic about the program, but they shared numerous observations about ways in which the program could be improved. Sample size, the brief follow-up window, and lack of generalizability to other contexts were among the most limiting factors. Further research should include an effectiveness evaluation and extend to urban and suburban communities and communities of color. Future research should also explore after-response affects including accessibility to follow-up care. The current study gives insight into piloting a co-responding model for approaching behavioral health crisis calls.

Identification of Anterior Large Vessel Occlusion Stroke During the Emergency Call: Protocol for a Controlled, Nonrandomized Trial.

Endovascular thrombectomy (ET), combined with intravenous thrombolysis if possible, is an effective treatment option for patients with stroke who have confirmed anterior large vessel occlusion (aLVO). However, ET is mainly limited to comprehensive stroke centers (CSCs), resulting in a lack of ET capacity in remote, sparsely populated areas. Most stroke networks use the "Drip and Ship" or "Mothership" strategy, resulting in either delayed ET or intravenous thrombolysis, respectively. This study protocol introduces the Leitstellen-Basierte Erkennung von Schlaganfall-Patienten für eine Thrombektomie und daraufhin abgestimmte Optimierung der Rettungskette (LESTOR) strategy, developed to optimize the preclinical part of the stroke chain of survival to improve the clinical outcome of patients with suspected aLVO stroke. This involves refining the dispatch strategy for identifying patients with acute aLVO stroke using a phone-based aLVO query. This includes dispatching emergency physicians and emergency medical services (EMS) to urban emergency sites, as well as dispatching helicopter EMS to remote areas. If a highly suspected aLVO is identified after a standardized aLVO score evaluation during a structured examination at the emergency scene, prompt transport to a CSC should be prioritized. The LESTOR study is a controlled, nonrandomized study implementing the LESTOR strategy, with a stepped-wedge, cluster trial design in 6 districts in southwest Germany. In an interprofessional, iterative approach, an aLVO query or dispatch protocol intended for use by dispatchers, followed by a coordinated aLVO examination score for use by EMS, is being developed, evaluated, and pretested in a simulation study. After the training of all participating health care professionals with the corresponding final aLVO query, the LESTOR strategy is being implemented stepwise. Patients otherwise receive usual stroke care in both the control and intervention groups. The primary outcome is the modified Rankin Scale at 90 days in patients with stroke receiving endovascular treatment. We will use a generalized linear mixed model for data analysis. This study is accompanied by a cost-effectiveness analysis and a qualitative process evaluation. This paper describes and discusses the protocol for this controlled, nonrandomized LESTOR study. Enrollment was completed in June 2023. Data analysis is ongoing and the first results are expected to be submitted for publication in 2024. The project started in April 2020 and will end in February 2024. We expect that the intervention will improve the clinical outcome of patients with aLVO stroke, especially outside the catchment areas of CSCs. The results of the accompanying process evaluation and the cost-effectiveness analysis will provide further insights into the implementation process and allow for a better interpretation of the results. German Clinical Trials Register DRKS00022152; https://drks.de/search/de/trial/DRKS00022152. DERR1-10.2196/51683.

Examining the implementation of a community paediatric clinic in a socially disadvantaged Irish community: A retrospective process evaluation.

Understanding interventions and their implementation is essential for improving community initiatives. Kidscope is a community paediatric development clinic providing free health and developmental assessment and onward referral for children aged zero to six years in an urban area of southern Ireland where many children experience complex needs. Established in 2010, Kidscope developed an inter-disciplinary, multi-agency community team by drawing on the strengths of local services and practitioners to deliver holistic approaches to child health and development. Recent studies examining stakeholder engagement and Kidscope outcomes highlighted the need to examine implementation to better understand the processes and mechanisms of the clinic and how events have affected outcomes. Guided by the UK Medical Research Council Framework for Developing and Evaluating Complex Interventions, this study used a post-hoc qualitative process evaluation study design with multiple data sources; stakeholder perspectives (interviews, focus group, questionnaires) and document analysis (annual reports, meeting minutes, work plans). A diverse set of research questions were developed in conjunction with a Patient and Public Involvement Group. Guiding frameworks supported thematic analysis of primary data, document analysis of secondary data, and triangulation of findings across datasets. Data analysis yielded 17 themes and 18 sub-themes. Successful implementation hinged on developing a coalition of linked practitioners and services whose skills were utilised and enhanced within Kidscope to deliver a high-quality healthcare model to vulnerable children and families. Relational and multi-disciplinary working, innovative approaches to implementation and sustainability, training and education provision, and the accessible community location were among the mechanisms of change resulting in improved child, family, practitioner, and system-level outcomes. External factors such as COVID-19 and deficits in Ireland's disability services posed significant barriers to fidelity. This study provides evidence of the processes, mechanisms, and model of care employed by a community-based paediatric clinic to successfully engage society's most vulnerable families and promote health equity. This study makes an important contribution to the field of implementation research by offering an example of a robust approach to conceptualising and measuring implementation outcomes of community healthcare initiative in a changing, real-world context.

The Quality in Acute Stroke Care (QASC) global scale-up using a cascading facilitation framework: a qualitative process evaluation

BackgroundVariation in hospital stroke care is problematic. The Quality in Acute Stroke (QASC) Australia trial demonstrated reductions in death and disability through supported implementation of nurse-led, evidence-based protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS Protocols) following stroke. Subsequently, a pre-test/post-test study was conducted in acute stroke wards in 64 hospitals in 17 European countries to evaluate upscale of the FeSS Protocols. Implementation across countries was underpinned by a cascading facilitation framework of multi-stakeholder support involving academic partners and a not-for-profit health organisation, the Angels Initiative (the industry partner), that operates to promote evidence-based treatments in stroke centres. .We report here an a priori qualitative process evaluation undertaken to identify factors that influenced international implementation of the FeSS Protocols using a cascading facilitation framework.MethodsThe sampling frame for interviews was: (1) Executives/Steering Committee members, consisting of academics, the Angels Initiative and senior project team, (2) Angel Team leaders (managers of Angel Consultants), (3) Angel Consultants (responsible for assisting facilitation of FeSS Protocols into multiple hospitals) and (4) Country Co-ordinators (senior stroke nurses with country and hospital-level responsibilities for facilitating the introduction of the FeSS Protocols). A semi-structured interview elicited participant views on the factorsthat influenced engagement of stakeholders with the project and preparation for and implementation of the FeSS Protocol upscale. Interviews were recorded, transcribed verbatim and analysed inductively within NVivo.ResultsIndividual (n = 13) and three group interviews (3 participants in each group) were undertaken. Three main themes with sub-themes were identified that represented key factors influencing upscale: (1) readiness for change (sub-themes: negotiating expectations; intervention feasible and acceptable; shared goal of evidence-based stroke management); (2) roles and relationships (sub-themes: defining and establishing roles; harnessing nurse champions) and (3) managing multiple changes (sub-themes: accommodating and responding to variation; more than clinical change; multi-layered communication framework).ConclusionA cascading facilitation model involving a partnership between evidence producers (academic partners), knowledge brokers (industry partner, Angels Initiative) and evidence adopters (stroke clinicians) overcame multiple challenges involved in international evidence translation. Capacity to manage, negotiate and adapt to multi-level changes and strategic engagement of different stakeholders supported adoption of nurse-initiated stroke protocols within Europe. This model has promise for other large-scale evidence translation programs.

Pragmatic, feasibility randomized controlled trial of a recorded mental health recovery narrative intervention: narrative experiences online intervention for informal carers (NEON-C).

Informal carers of people with mental health problems often have unmet support needs. Mental health recovery narratives are increasingly accessible, but their relevance to and effect on informal carers have been minimally investigated. The Narrative Experiences Online (NEON) Intervention is a first-in-field intervention that provides informal carers with access to a diverse collection of recorded mental health recovery narratives. This trial aimed to examine the feasibility and acceptability of the NEON Intervention for informal carers. This study involved a two-arm feasibility randomized controlled trial. Carers were randomly assigned to receiving versus not receiving the NEON Intervention. The feasibility aspects investigated included the acceptability of the intervention and of randomization, trial processes, engagement rates, recruitment procedures, attrition, sample size estimation, identification of candidate primary and secondary outcomes, and the feasibility of conducting a definitive trial. A qualitative process evaluation was conducted. A total of 121 carers were eligible, of whom 54 were randomized (intervention: 27, control: 27). Twelve-month follow-up data were available for 36 carers. Carers accessed a mean of 25 narratives over a 12-month period, and the intervention group, compared with the control group, reported a small effect on hope and a moderate effect on the presence of meaning in life. Five modifications were recommended to improve the user experience, applicability, and trial processes. The NEON Intervention is feasible and acceptable. Significant refinement of the NEON Intervention and trial processes is required to personalize and ensure applicability to carers. Further feasibility testing is recommended prior to a definitive trial.

Doing research in non-specialist mental health services for children and young people: lessons learnt from a process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) feasibility randomised controlled trial

BackgroundThe rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings poses great challenges for effectiveness evaluations. This paper reports learning from an embedded process evaluation of the ICALM RCT which tested the feasibility of delivering Interpersonal Counselling for Adolescents (IPC-A) plus Treatment as Usual (TAU) versus TAU only for adolescent (age 12–18) mild depression by non-qualified mental health professionals in non-specialist sectors.MethodsA qualitative mixed methods process evaluation, drawing on Bronfenbrenner’s socioecological model to investigate key influences on trial delivery across macro-(e.g. policy), meso-(e.g. service characteristics) and micro-(e.g. on-site trial processes) contextual levels. Data collection methods included 9 site questionnaires, 4 observations of team meetings, policy documents, and 18 interviews with stakeholders including therapists, heads of service and managers. Thematic analysis focused on understanding how contextual features shaped trial implementation.ResultsThe ICALM trial concluded in 2022 having only randomised 14 out of the target 60 young people. At a macro-level, trial delivery was impacted by the COVID-19 pandemic, with services reporting a sharp increase in cases of (social) anxiety over low mood, and backlogs at central referral points which prolonged waiting times for mild cases (e.g. low mood). An interaction between high demand and lack of capacity at a meso-service level led to low prioritisation of trial activities at a micro-level. Unfamiliarity with research processes (e.g. randomisation) and variation in TAU support also accentuated the complexities of conducting an RCT in this setting.ConclusionsConducting a RCT of IPC-A in non-specialist services is not feasible in the current context. Failure to conduct effectiveness trials in this setting has clinical implications, potentially resulting in escalation of mild mental health problems. Research done in this setting should adopt pragmatic and innovative recruitment and engagement approaches (e.g. creating new referral pathways) and consider alternative trial designs, e.g. cluster, stepped-wedge or non-controlled studies using complex systems approaches to embrace contextual complexity.Trial registrationISRCTN registry, ISRCTN82180413. Registered on 31 December 2019.

Safe inhalation pipe provision (SIPP): protocol for a mixed-method evaluation of an intervention to improve health outcomes and service engagement among people who use crack cocaine in England

BackgroundOver 180,000 people use crack cocaine in England, yet provision of smoking equipment to support safer crack use is prohibited under UK law. Pipes used for crack cocaine smoking are often homemade and/or in short supply, leading to pipe sharing and injuries from use of unsafe materials. This increases risk of viral infection and respiratory harm among a marginalised underserved population. International evaluations suggest crack pipe supply leads to sustained reductions in pipe sharing and use of homemade equipment; increased health risk awareness; improved service access; reduction in injecting and crack-related health problems. In this paper, we introduce the protocol for the NIHR-funded SIPP (Safe inhalation pipe provision) project and discuss implications for impact.MethodsThe SIPP study will develop, implement and evaluate a crack smoking equipment and training intervention to be distributed through peer networks and specialist drug services in England. Study components comprise: (1) peer-network capacity building and co-production; (2) a pre- and post-intervention survey at intervention and non-equivalent control sites; (3) a mixed-method process evaluation; and (4) an economic evaluation. Participant eligibility criteria are use of crack within the past 28 days, with a survey sample of ~ 740 for each impact evaluation survey point and ~ 40 for qualitative process evaluation interviews. Our primary outcome measure is pipe sharing within the past 28 days, with secondary outcomes pertaining to use of homemade pipes, service engagement, injecting practice and acute health harms.Anticipated impactSIPP aims to reduce crack use risk practices and associated health harms; including through increasing crack harm reduction awareness among service providers and peers. Implementation has only been possible with local police approvals. Our goal is to generate an evidence base to inform review of the legislation prohibiting crack pipe supply in the UK. This holds potential to transform harm reduction service provision and engagement nationally.ConclusionPeople who smoke crack cocaine in England currently have little reason to engage with harm reduction and drug services. Little is known about this growing population. This study will provide insight into population characteristics, unmet need and the case for legislative reform.Trial registration: ISRCTN12541454 https://doi.org/10.1186/ISRCTN12541454

Process evaluation of the Yéego! Program to increase healthy eating and gardening among American Indian elementary school children

BackgroundAmerican Indian children are at increased risk for obesity and diabetes. School-based health promotion interventions are one approach to promoting healthy behaviors to reduce this risk, yet few studies have described their implementation and fidelity. We conducted a qualitative process evaluation of the Yéego! Healthy Eating and Gardening Program, a school-based intervention to promote healthy eating among Navajo elementary school children. The intervention included a yearlong integrated curriculum, as well as the construction and maintenance of a school-based garden.MethodsOur process evaluation included fidelity checklists completed by program staff and qualitative interviews with program staff and classroom teachers after the intervention was implemented. We used content analysis to identify themes.ResultsWe identified several themes related to evidence of delivery adherence, program satisfaction, and lessons learned about delivery. Intervention staff followed similar procedures to prepare for and deliver lessons, but timing, teaching styles, and school-level factors also impacted overall implementation fidelity. Teachers and students had positive perceptions of the program, especially lessons that were highly visual, experiential, and connected to Navajo culture and the surrounding community. Teachers and program staff identified ways to enhance the usability of the curriculum by narrowing the scope, relating content to student experiences, and aligning content with school curriculum standards.ConclusionsThe program was implemented with moderately high fidelity across contexts. We identified areas where modifications could improve engagement, acceptability, efficacy, and sustainability of the program. Our results have implications for the evaluation and dissemination of school-based health interventions to promote healthy eating among children, especially in American Indian communities.

Nurses' and physicians' perspectives on implementation barriers and facilitators in a transfer program for parents of adolescents with chronic illness.

To identify barriers and facilitators impacting the implementation of a comprehensive transfer program aimed at parents of adolescents with chronic illness in clinical practice. A real-time, qualitative process evaluation. Individual interviews were conducted with 10 nurses and seven physicians from paediatric and adult outpatient clinics: Nephrology, hepatology, neurology, and rheumatology. Data were analysed through the lens of normalization process theory. Themes were framed within the theory's four components. (1) Coherence: Healthcare professionals' views on their core tasks and on the parents' role influenced their perception of the program. (2) Cognitive participation: A named key worker, autonomy, and collaboration impacted healthcare professionals' involvement in the program. (3) Collective action: Department prioritization and understanding of the program's aim were key factors in its successful delivery. (4) Reflective monitoring: Participants experienced that the program helped parents during transfer but questioned if the program was needed by all families. We identified three barriers: Healthcare professionals' lack of understanding of the parental role during transfer, top-down decisions among nurses, and physicians' uncertainty about their role in joint consultations. Facilitators: Healthcare professionals' understanding of the program's purpose and expected effect, the nurses' significant role as named keyworkers, and good collaboration across paediatric and adult departments. Implementation strategies should be developed before implementing a transfer program in clinical practice. Implementing a parental transfer program in clinical practice can be challenging. Therefore, for successful implementation, it is crucial to identify barriers and facilitators. Barriers and facilitators exist at the personal, professional, and organizational levels, and it is important to understand them. The results of this qualitative study could support the implementation of transfer programs in other settings. Consolidated criteria for reporting qualitative studies (COREQ). No patient or public contribution. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Nurses' and physicians' experiences of ownership of the transfer program is essential for successful implementation. Clinics should appoint a named keyworker, preferably a nurse, as the driving force during the implementation of a transfer program. Nurses and physicians should receive training about the purpose, justification, and expected effect of a transfer program before implementation.

Maximizing Professional-Led Sexual Well-being Support in Cancer Care: Findings From a Qualitative Process Evaluation Following Healthcare Professionals' Engagement With an eLearning Resource.

Provision of healthcare professional (HP)-led sexual support in cancer care is lacking, perpetuated by barriers including a lack of HP awareness of sexual concerns and strategies to help patients and partners cope. In response, the Maximizing Sexual Wellbeing|Cancer Care eLearning resource (MSW|CC) was developed and demonstrated efficacy in reducing HPs' attitudinal barriers to the provision of sexual support. However, the mechanisms for such change are not yet known. A qualitative process evaluation was used to explore mechanisms that influence HP engagement with MSW|CC and its adoption into practice. Semistructured interviews were conducted with HPs providing cancer care in Northern Ireland upon MSW|CC completion. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed. Seventeen participants were interviewed, and 4 key themes were identified: (1) MSW|CC raises HPs' awareness of the need for holistic sexual support as part of routine clinical care; (2) MSW|CC prepares and equips HPs to provide sexual support in cancer care; (3) MSW|CC is coherent, engaging, and acceptable; and (4) MSW|CC: moving forward. Participants derived benefits from MSW|CC, deeming it an acceptable resource. Insights into MSW|CC mechanisms of success were identified, including language to address sexual concerns, alongside patient referral resources. Perceived MSW|CC shortcomings from an earlier study were confirmed as a software issue.Implications for Practice:Healthcare professionals require training and resources to enhance sexual support provision in cancer care. Proactive implementation strategies used to maximize HP engagement with MSW|CC could equip HPs with tools to improve patient sexual outcomes after cancer.

Strategies to improve the implementation and effectiveness of community-based psychosocial support interventions for displaced, migrant and host community women in Latin America.

As evidence supporting the effectiveness of mental health and psychosocial interventions grows, more research is needed to understand optimal strategies for improving their implementation in diverse contexts. We conducted a qualitative process evaluation of a multicomponent psychosocial intervention intended to promote well-being among refugee, migrant and host community women in three diverse contexts in Ecuador and Panamá. The objective of this study is to describe the relationships among implementation determinants, strategies and outcomes of this community-based psychosocial intervention. The five implementation strategies used in this study included stakeholder engagement, promoting intervention adaptability, group and community-based delivery format, task sharing and providing incentives. We identified 10 adaptations to the intervention and its implementation, most of which were made during pre-implementation. Participants (n=77) and facilitators (n=30) who completed qualitative interviews reported that these strategies largely improved the implementation of the intervention across key outcomes and aligned with the study's intervention and implementation theory of change models. Participants and facilitators also proposed additional strategies for improving reach, implementation and maintenance of this community-based psychosocial intervention.

Adults living with type 2 diabetes experiences of a randomised adapted diabetes nutrition education programme: a qualitative process evaluation

Aim: The purpose of this study was to investigate how a randomised controlled trial (RCT) of an adapted diabetes nutrition education programme (NEP) was received by adults with sub-optimally controlled (HbA1c of ≥ 8%) type 2 diabetes in a tertiary setting. This could aid in understanding the small effect of NEP on HbA1c and other outcomes and the high attrition rate. Methods: This qualitative study was done alongside the year-long RCT. In the RCT, intervention participants received four NEP components, and both intervention and control group participants received education materials (fridge/wall poster). Five focus-group discussions were held with the intervention group participants at two time periods: after they completed the NEP curriculum (7th month) (n = 26; 67% of randomised participants [RP]( and at the end of the study (12 months) [n = 24; 61.5% RP). Nineteen (50% RP) control group participants were individually interviewed at the end of the study. Data were analysed using a thematic framework. Results: All participants (control and intervention) reported high satisfaction with the NEP. Participants emphasised the value of the fridge/wall poster for themselves and their families. Participants (control and intervention) reported various benefits of the NEP: improved diabetes knowledge, skills in dietary self-care, family support for self-care, better health and motivation for appropriate self-care. Some participants also reported positive changes to their diet and physical activity behaviours. The perceived benefits were the main reason for completing the study. Conclusions: Irrespective of the arm of participation, the NEP was well received, and perceived benefits inspired participation. The limited NEP impact and the sub-optimal programme participation do not appear to be related to participants’ perceptions of the adapted NEP.