Qualitative Process Evaluation Research Articles

The APPLE Tree programme: Active Prevention in People at risk of dementia through Lifestyle, bEhaviour change and Technology to build REsiliEnce—randomised controlled trial

BackgroundLarge-scale trials of multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aim to determine if a lower intensity, personally tailored secondary dementia prevention programme for older people with subjective or mild objective memory decline, informed by behaviour change theory, reduces cognitive decline over 2 years.MethodsA multi-site, single-blind randomised controlled trial recruiting 704 older adults at high dementia risk due to mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Participants are randomised using 1:1 allocation ratio to the APPLE Tree intervention versus control arm (dementia prevention information), stratified by site. The intervention explores and implements strategies to promote healthy lifestyle, increase pleasurable activities and social connections and improve long-term condition self-management. Two facilitators trained and supervised by a clinical psychologist deliver ten, 1-h group video call sessions over 6 months (approximately every fortnight), video-call ‘tea breaks’ (less structured, facilitated social sessions) in intervening weeks and individual goal-setting phone calls every 2 weeks. From 6 to 12 months, participants meet monthly for ‘tea breaks’, with those not attending receiving monthly goal-setting phone calls. Participants receive a food delivery, pedometer and website access to cognitive training and information about lifestyle modification. Follow-ups for all outcome measures are at 12 and 24 months. The primary outcome is cognition (Neuropsychological Test Battery (NTB) score) at 24 months. Secondary outcomes are quality of life, cost per quality-adjusted life year (QALY) and wellbeing and lifestyle factors the intervention targets (diet, vascular risk, body weight, activity, sleep, anxiety, depression, social networks and loneliness, alcohol intake and smoking). Participants from purposively selected sites participate in qualitative process evaluation interviews, which will be analysed using thematic analytic methods.DiscussionIf effective, the intervention design, involving remote delivery and non-clinical facilitators, would facilitate intervention roll-out to older people with memory concerns.Trial registrationISRCTN17325135. Registration date 27 November 2019

Implementation of buprenorphine services in NYC syringe services programs: a qualitative process evaluation

BackgroundSyringe services programs (SSPs) hold promise for providing buprenorphine treatment access to people with opioid use disorder (OUD) who are reluctant to seek care elsewhere. In 2017, the New York City Department of Health and Mental Hygiene (DOHMH) provided funding and technical assistance to nine SSPs to develop “low-threshold” buprenorphine services as part of a multipronged initiative to lower opioid-related overdose rates. The aim of this study was to identify barriers to and facilitators of implementing SSP-based buprenorphine services.MethodsWe conducted 26 semi-structured qualitative interviews from April 2019 to November 2019 at eight SSPs in NYC that received funding and technical assistance from DOHMH. Interviews were conducted with three categories of staff: leadership (i.e., buprenorphine program management or leadership, eight interviews), staff (i.e., buprenorphine coordinators or other staff, eleven interviews), and buprenorphine providers (six interviews). We identified themes related to barriers and facilitators to program implementation using thematic analysis. We make recommendations for implementation based on our findings.ResultsPrograms differed in their stage of development, location of services provided, and provider type, availability, and practices. Barriers to providing buprenorphine services at SSPs included gaps in staff knowledge and comfort communicating with participants about buprenorphine, difficulty hiring buprenorphine providers, managing tension between harm reduction and traditional OUD treatment philosophies, and financial constraints. Challenges also arose from serving a population with unmet psychosocial needs. Implementation facilitators included technical assistance from DOHMH, designated buprenorphine coordinators, offering other supportive services to participants, and telehealth to bridge gaps in provider availability. Key recommendations include: (1) health departments should provide support for SSPs in training staff, building health service infrastructure and developing policies and procedures, (2) SSPs should designate a buprenorphine coordinator and ensure regular training on buprenorphine for frontline staff, and (3) buprenorphine providers should be selected or supported to use a harm reduction approach to buprenorphine treatment.ConclusionsDespite encountering challenges, SSPs implemented buprenorphine services outside of conventional OUD treatment settings. Our findings have implications for health departments, SSPs, and other community organizations implementing buprenorphine services. Expansion of low-threshold buprenorphine services is a promising strategy to address the opioid overdose epidemic.

Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory

BackgroundPerson-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany.This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions.MethodsFive individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes.ResultsFacilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians.Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians.ConclusionsThe findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes.Trial registrationClinicalTrials.gov identifier: NCT02295462; November 20, 2014.

Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial

Breast cancer is the most common cancer type among women worldwide with over a million new cases each year. More than 40% of these women will struggle with chronic pain and fatigue after surgery, regardless of surgical procedure. These consequences are detrimental and result in distress and disability, including work disability. Few attempts have been made to prevent chronic pain and fatigue after surgery by applying a psychological approach, despite psychological risk factors being crucial in the development of both chronic pain and fatigue. In this study, we aim to develop and test an easily implementable strategy of preventing chronic pain and fatigue after breast cancer surgery. The intervention strategy involves a pre-operative hypnosis session and a web-based post-operative Acceptance and Commitment Therapy (ACT). The hypnosis has previously been found effective in alleviating acute post-operative pain and fatigue in breast cancer patients, while ACT is well suited to cancer populations as it offers a model of healthy adaptation to difficult circumstances. Together they form an intervention strategy with both a preventive and a rehabilitative focus. This randomized controlled trial aims to estimate the effects of the pre- and post- operative interventions compared to attentional control and treatment as usual (TAU) and will also include a qualitative process evaluation. Participants will be randomized to receive either a pre-operative brief hypnosis session and a post-operative web-based psychological intervention (iACT) or a pre-operative one-session mindfulness through an audio file and post-operative TAU. Self-reported questionnaire data and biomarker data will be assessed pre-surgery, post-surgery and 3 and 12 months after surgery. In addition, we will assess registry data on sick leave and prescriptions until 2-year follow-up. In the qualitative process evaluation, data will be collected from participants from both study arms (through interviews and a diary) and two different analyses performed (socio-narrative and Grounded Theory) with the objective to describe the development of chronic post-surgical pain and fatigue and the potential influence of the interventions on these processes. The study is set-up to demonstrate a minimum difference in pain of 1 point on NRS (0-10) and 3 points on FACIT-F (0-52) between the groups at 3-months follow-up by including 200 breast cancer patients in total. This trial will be the first study to estimate the effect of a combined pre-operative hypnosis with a post-operative iACT to prevent pain and fatigue after breast cancer surgery. The results from our study might i) help the large group of women affected by chronic pain and fatigue after breast cancer surgery, ii) shed light on the mechanisms involved in chronic pain and fatigue development, and iii) serve as a model for other surgical procedures. Clinicaltrials.gov, registration number NCT04518085. Registered on January 29th, 2020. https://clinicaltrials.gov/ct2/show/NCT04518085.

Can Personalization or Creativity Reduce Banner Blindness?

<h3>Introduction</h3> Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations. <h3>Methods and analysis</h3> The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context. <h3>Ethics and dissemination</h3> This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners. <h3>Trial registration number</h3> ISRCTN19193075

ManGuard an eHealth intervention to reduce cardiovascular risk in male taxi drivers: a pilot randomised controlled trial protocol

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Department for the Economy, Northern Ireland Background Men are at higher risk then women of developing cardiovascular disease (CVD) and male taxi drivers are a particularly high risk group because of their typically unhealthy behaviours, such as poor eating habits, smoking and a sedentary lifestyle. However, only two studies of behavioural interventions targeting taxi drivers have been identified, one of which had a high attrition rate. Therefore, an eHealth intervention co-designed by taxi drivers may prove more user-friendly and effective. Purpose The aim of this study is to assess the feasibility of a randomised controlled trial (RCT) of an eHealth intervention – ManGuard – to reduce CVD risk in male taxi drivers. Methods A wait-list controlled trial of 30 male taxi drivers in Belfast, Northern Ireland, will be assigned randomly to an intervention or usual care group. The ManGuard Application comprises seven modules: i) introduction and goal setting, ii) being active iii) eating well, iv) managing stress, v) smoking, vi) alcohol and vii) keep accelerating, the latter to be used as a re-cap module. This trial will establish feasibility, including recruitment, engagement and retention rates, program usability and participant satisfaction, as well as preliminary efficacy of ManGuard in improving key outcomes. Primary outcome is to determine the feasibility of an eHealth intervention for reducing CVD risk in male taxi drivers by assessing the following outcome measures: o Acceptability, recruitment, retention and engagement rates o Usability and participant satisfaction, process evaluation and survey The secondary outcome is to evaluate the preliminary efficacy of ManGuard compared to usual care in improving the following outcomes: o Clinical indices: CVD biomarkers (cholesterol, glucose), blood pressure, anthropometry (BMI, waist circumference, body fat percentage) o Physical activity o Psychosocial status: health related quality of life, self-efficacy, social support An in-depth qualitative process evaluation to explore acceptability of the intervention will also be conducted. Trial registration: This trial has been registered prospectively on the ISRCTN registry on 5 January 2022 Conclusion eHealth interventions have been shown to promote behaviour change and reduce CVD risk in men, but there is a lack of robust evidence for this in male taxi drivers, a high-risk group. This study aims to assess the feasibility of a future RCT assessing the impact of ManGuard on CVD risk in male taxi drivers. This study will inform a fully-powered trial that will provide robust evidence for eHealth interventions for this underserved population.

Evaluation of the move to remote delivery of drug and alcohol services during the COVID-19 pandemic: A study protocol.

Background:Substance misuse is a significant global health concern. In the UK, the prevalence of substance misuse has increased over the past decade and the number of alcohol and drug related deaths are increasing. Individuals with substance dependency issues are entitled to access treatment services. However, the COVID-19 pandemic created significant challenges for public services, including drug and alcohol treatment, and resulted in significant service reconfiguration and a shift from in-person to remote delivery. This study aims to evaluate the delivery of drug and alcohol services in a large metropolitan area in Northern England during the COVID-19 pandemic. It aims to understand the impact of service reconfiguration for services, staff and service users, and to use this understanding to inform the future optimised design of services.Design and methods:The study has five workstreams within a mixed methods framework: (1) Systematic review of literature; (2) Qualitative process evaluation with service providers (digital timelines, focus groups and interviews); (3) Qualitative process evaluation with service users (interviews, focus groups, text based conversations and case studies); (4) Quantitative outcomes and health economic analysis; and (5) Data synthesis and dissemination.Expected Impact of the study for Public Health:The breadth of the study, its novel nature, and the importance of substance misuse as a public health issue, mean that this study will provide valuable findings for those who commission, deliver and use drug and alcohol treatment services nationally and internationally. There will also be important learning for the effective remote delivery of services in sectors beyond drug and alcohol treatment.

P-495 A feasibility randomised controlled trial of MyJourney: a self-guided online intervention to promote psychosocial adjustment to unmet parenthood goals

Abstract Study question Is it feasible to implement and evaluate an online self-guided psychosocial intervention for people with unmet parenthood goals (UPG), aimed to improve wellbeing, in an online randomized controlled trial (RCT)? Summary answer The evaluation of an online bilingual self-guided psychosocial intervention for people with a UPG is feasible but minor adjustments should be made to enhance practicality. What is known already Self-identifying as having a UPG, defined as being unable to have children or as many as desired, is associated with impaired wellbeing and mental health. Practice guidelines and regulatory bodies have highlighted the need to address the lack of evidence-based support for this population. It is unknown if MyJourney (www.myjourney.pt), the first online self-guided intervention for people with UPGs, can be implemented and evaluated in an RCT. Study design, size, duration We conducted a pre-registered, two-arm, parallel group, non-blinded feasibility RCT, with a 1:1 computer-generated randomised allocation and embedded qualitative process evaluation. Recruitment run from November 2020 to March 2021. Assessments were made before randomisation (T1), 10-weeks (T2) and 6-months after (T3, intervention group only). Participants allocated to the intervention group received an email to access MyJourney immediately after randomization. Participants in the control group were given access to MyJourney after filling the 10-weeks assessment (T2). Participants/materials, setting, methods Participants were recruited via social media advertising of MyJourney and its feasibility study. People who self-identified as having a UPG could click on a link to participate and of these 235 were randomised. Outcome measures related to demand, acceptability, implementation, practicality, adaptation, and limited efficacy were assessed via online surveys. The primary outcome in limited efficacy testing was hedonic wellbeing, measured with the World Health Organisation Wellbeing Index (WHO-5). Main results and the role of chance Participation and retention rates were 58.3%, 31.7% (T2) and 45.2% (T3, intervention group only). Of participants invited to register with MyJourney, 91 (76.5%) set up account, 51 (47.2%) completed the first Step of MyJourney, 12 (11.1%) completed six Steps (sufficient dose) and six (5.6%) completed all Steps within the 10-week recommended period. Acceptability ranged from 2.79 (successful at supporting) to 4.42 (easy to understand) on a 1(not at all) to 5(extremely acceptable). Average time to complete sufficient dose was 5.6 hours (SD = 18.15) and all Steps was 12.4 hours (SD = 18.15), with no differences found for participants using MyJourney in Portuguese and English. Modified intention to treat analysis showed a moderate increase in wellbeing from T1 to T2 in the intervention group (ηp2 = .156, MD = 9.300 [2.285, 16.315]) and no changes in the control group (ηp2 = .000, MD = .047 [-3.265, 3.358]). Participants in the process evaluation reported that MyJourney was needed and answered their needs for support (reflecting high demand and acceptability). Participants thought the recommended period to engage with MyJourney was short and that their engagement was influenced by multiple factors, including personal (e.g., lack of time) and MyJourney related factors (e.g., reminders). Limitations, reasons for caution Participants were mostly white, well-educated, employed, childless women. Non-blinded allocation, use of self-reported questionnaire assessments and high attrition in the intervention group could have triggered bias favourable to positive evaluations MyJourney. Wider implications of the findings MyJourney can proceed to efficacy testing, but future work should eliminate barriers for engagement (e.g., enabling users to add MyJourney icon to device and remain logged in) and explore strategies to maximise adherence (e.g., reminders with personalised content, guidance and scheduling options for routine use). Trial registration number Clinical Trials.gov NCT04850482

Counting on U training to enhance trusting relationships and mental health literacy among business advisors: protocol for a randomised controlled trial

BackgroundFinancial distress is thought to be a key reason why small-medium enterprise (SME) owners experience higher levels of mental health conditions compared with the broader population. Business advisors who form trusting, high-quality relationships with their SME clients, are therefore well placed to: (1) help prevent/reduce key sources of financial distress, (2) better understand the business and personal needs of their clients and, (3) recognise the signs and symptoms of mental health conditions and encourage help-seeking where appropriate. The aim of this study is to compare the effectiveness of relationship building training (RBT) combined with mental health first aid (MHFA) training for business advisors with MHFA alone, on the financial and mental health of their SME-owner clients.MethodsThis is a single blind, two-arm randomised controlled trial. Participants will be business advisors who provide information, guidance and/or assistance to SME owner clients and are in contact with them at least 3 times a year. The business advisors will invite their SME-owner clients to complete 3 online surveys at baseline, 6- and 12-months. Business advisors will be randomised to one of two conditions, using a 1:1 allocation ratio: (1) MHFA with RBT; or (2) MHFA alone, and complete 3 online surveys at baseline, 2- and 6-months. Primary outcomes will be measured in the business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid. Secondary outcomes will be measured in the SME owners and includes trust in their business advisors, the quality of this relationship, financial wellbeing, financial distress, psychological distress, help-seeking behaviour, and quality of life. To complement the quantitative data, we will include a qualitative process evaluation to examine what contextual factors impacted the reach, effectiveness, adoption, implementation, and maintenance of the training.DiscussionAs there is evidence for the connections between client trust, quality of relationship and financial and mental wellbeing, we hypothesise that the combined RBT and MHFA training will lead to greater improvements in these outcomes in SME owners compared with MHFA alone.Trial registrationClinicalTrials.gov: NCT04982094. Retrospectively registered 29/07/2021. The study started in February 2021 and the recruitment is ongoing.

Effectiveness and cost-effectiveness of sector-independent treatment coordination for people with substance-related disorders following an online assessment (ASSIST): study protocol for a randomized controlled trial

BackgroundThe implementation of person-centred, need-oriented and flexible care for people with substance-related problems is often insufficient, in large part due to the complexity of addiction support services among different providers. A standardized online assessment and subsequent sector-independent treatment coordination could provide individuals with more appropriate services, thereby making better use of individual services and leading to a more effective addiction support system as a whole. The aim of this study is to determine the effectiveness and cost-effectiveness of sector-independent treatment coordination following an online assessment, in comparison with the current standard of care and treatment process in Germany.MethodsThe sample size of this randomized, controlled trial has been set to a total of 400 participants with substance-related problems. Participants living in Stuttgart, Germany, will be randomly allocated to (1) the intervention group with immediate online assessment and subsequent sector-independent treatment coordination (ASSIST) or (2) the waitlist group. Participants in the waitlist group will initially remain in usual care and only be provided with the online assessment 6 months later. Short-term effects (over 2 months) and medium-term effects (over 6 months) of ASSIST will be compared between the intervention and the waitlist groups. The primary outcome is improved treatment satisfaction. Secondary outcomes include improved subjective quality of life and empowerment, reductions in patients’ substance use, unmet needs and illness-related clinical and social impairment. Health economic evaluation as well as quantitative and qualitative process evaluations will be conducted.DiscussionThe results of this study are expected to provide information on whether sector-independent treatment coordination following an online assessment contributes to improved health care service provision for people with substance-related problems. This randomized controlled trial will help identify facilitators and barriers to the sustainable implementation of a cross-sectoral care concept in substance abuse services.Trial registrationGerman Clinical Trial Register DRKS00026996. Registered on 29 October 2021

603-P: Qualitative Results from an African-American Church–Based Diabetes Self-Management Support Program

Diabetes-related health disparities, especially for African Americans (AA) , underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management support (DSMS) over time. The Praise study, a cluster randomized hybrid type II implementation trial recruited 21 AA churches, 28 peer leaders, 21 parish nurses, and 371 participants (100% AA, 73.8% female, 64±11.3 years of age) to determine the effectiveness of three DSMS approaches [Parish Nurse (PN) + Peer Leader (PL) DSMS vs. PN DSMS vs. PL DSMS], in comparison to enhanced usual care in improving and sustaining A1c and diabetes distress. Monthly DSMS groups were independently planned and facilitated by 28 trained PLs (100% African American, 18% male) and 14 trained PNs. A post-trial qualitative process evaluation was conducted to evaluate DSMS and ongoing support. Five focus groups were held (n=30) . Individual semi-structured interviews were completed with PLs and PNs (N=7) . Data were analyzed using the Rapid Analysis Process to generate themes from transcripts. Most participants were motivated to enroll in the Praise study to learn more about how to manage their diabetes. Others stated that poor health status (such as high A1C) and a need for accountability motivated them to join. PN and PL were driven to serve in these roles by a desire to educate and support other members of their community with diabetes in a structured format. Few concerns about the study were reported; however, the amount of time commitment was a common topic. Some participants encountered significant technology difficulties with attending remote sessions and a host of other issues related to the pandemic. Suggested improvements included: 1) clear study expectations from the start; 2) integrating exercise, and meal prep; and 3) using of social media for recruitment. AAs with T2D are motivated to engage in ongoing DSMS facilitated by PLs and PNs in church-settings. Improvements in training and support of PLs is needed. Disclosure J.M.Hawkins: None. A.M.Provenzano: None. R.Nwankwo: Advisory Panel; WW (Weight Watchers) . M.M.Funnell: n/a. K.A.Kloss: None. D.Hall: None. G.Piatt: None.

Music and Movement for Health: Protocol for a pragmatic cluster-randomised feasibility pilot trial of an arts-based programme for the health and wellbeing of older adults.

Background: Arts-based health programmes (ABHP) can enhance the physical and psychosocial health and wellbeing of older people. However, the feasibility and usefulness of such programmes in Ireland are currently unknown. The primary aim of this study is to examine the feasibility of the study design, its application to a music and movement for health programme and associated costs. The secondary aim is to obtain preliminary effect estimates of an ABHP on health and wellbeing in older adults. Methods: This study is a pragmatic cluster-randomised controlled feasibility trial. Community-dwelling adults, aged 65 years or older will be recruited in the mid-west region of Ireland via methods including social prescription, traditional and social media. The clusters, based on geographical region, will be block randomised to either the ABHP or control using 1:1 allocation ratio. The programme will comprise a 1.5-hour music and dance session each week for 12-weeks together with a 1-hour home-based music and movement programme for 12-weeks. A qualitative and quantitative process evaluation of the arts-based health programme will be performed. Outcomes: Primary outcomes for feasibility include recruitment rates (the number of participants recruited per cluster per month); retention rate (the number of participants who complete measures at baseline and at follow up post intervention, and minimum average attendance. Secondary outcomes will include physical function, balance, physical activity, loneliness, social isolation, cognition, mood, as well as quality of life and cost. Conclusions: If this pioneering study finds evidence to support feasibility and acceptability, a future larger-scale definitive trial will be conducted to examine the effectiveness of an arts-based health programme for older adults. This research aims to strengthen collaborative efforts to implement effective, sustainable and cost-effective programmes for older adults to support community connection, enhancing health and wellbeing, in turn reducing demands on the healthcare system. ISRCTN registration: ISRCTN35313497 (18/02/2022).

Acceptability of a brief fatigue intervention for inflammatory arthritis: a qualitative process evaluation.

ObjectivesWe developed a brief cognitive behavioural, one-to-one intervention to reduce fatigue impact for patients with inflammatory arthritis. This qualitative process evaluation explored intervention acceptability and potential refinements from the perspective of patients who attended sessions and rheumatology health professionals (RHPs) who delivered the intervention.MethodsInterviews were conducted with patients and RHPs from five National Health Service (NHS) sites. Data were analysed using inductive thematic analysis.ResultsTwenty-two patients and 11 RHPs participated.Patient themesCollaborative, non-judgemental consultations: patients valued having space to reflect, where their fatigue was validated. Relevant content, but not ground-breaking: patients appreciated the opportunity to tailor content to individual priorities. Daily diaries were useful to visualize fatigue. Self-awareness: patients reported increased acceptance, sense of control, and confidence to manage fatigue. Degrees of openness to change: sessions prompted patients to engage in behaviour change. For some, complicated lives made it difficult to plan for change.RHP themesEngagement with intervention: RHPs liked training face to face, and sessions were more enjoyable with experience of delivery. Research vs clinical practice: RHPs expressed concern about fitting sessions into NHS clinic appointments. It was difficult to offer follow-up sessions within 2 weeks. Collaborating with patients: RHPs reported that patients engaged with the tools and strategies. Some RHPs followed the manual in a linear way, whereas others used it flexibly.ConclusionThere is potential for this brief fatigue intervention to benefit patients. Future research will focus on flexibility to fit with local services and creating educational resources to use in a range of contexts.

Treatment guided by fractional exhaled nitric oxide in addition to standard care in 6- to 15-year-olds with asthma: the RAACENO RCT

BackgroundThe role of fractional exhaled nitric oxide in guiding asthma treatment in children is uncertain.ObjectiveTo compare treatment guided by both fractional exhaled nitric oxide and symptoms (intervention) with treatment guided by symptoms alone (standard care) in children with asthma who are at risk of an asthma exacerbation, in terms of the number of asthma exacerbations over 12 months.DesignThis was a pragmatic, multicentre, randomised controlled trial with embedded cost-effectiveness and qualitative process evaluations. Randomisation (1 : 1) was carried out using a remote web-based system and was minimised on recruitment centre, age, sex and British Thoracic Society treatment step. Clinical teams and participants were not blind to treatment allocation.SettingThe trial took place in 35 hospitals and seven primary care practices in the UK.ParticipantsChildren aged 6–15 years with a diagnosis of asthma who were currently prescribed inhaled corticosteroids and who had one or more parent-/patient-reported asthma exacerbation treated with oral corticosteroids in the 12 months prior to recruitment.InterventionsAsthma treatment guided by symptoms alone (standard care) and asthma treatment guided by symptoms plus fractional exhaled nitric oxide (intervention). Treatment recommendations in both groups were protocolised within a web-based algorithm, incorporating inhaled corticosteroid adherence (objectively measured using an electronic logging device) and current treatment.Main outcome measuresThe primary outcome measure was asthma exacerbations treated with oral corticosteroids in the year post randomisation. Secondary outcomes included time to first exacerbation, number of exacerbations, lung function, fractional exhaled nitric oxide, daily dose of inhaled corticosteroid, asthma control and quality of life.ResultsIn total, 509 eligible participants were recruited and the primary outcome was available for 506 participants. The primary outcome occurred in 123 out of 255 (48.2%) participants in the intervention group and 129 out of 251 (51.4%) participants in the standard-care group (adjusted odds ratio 0.88, 95% confidence interval 0.61 to 1.27). There was algorithm non-compliance on 21% of assessments. Per-protocol and complier-average causal effect analysis did not change the interpretation. This non-statistically significant estimate was consistent across predefined subgroups. There were no differences between the groups in secondary outcomes. There were no serious adverse events or deaths. No meaningful differences in health service costs, direct patient costs or indirect costs to society were identified between the groups. The economic evaluation does not provide evidence to support the cost-effectiveness of the intervention. In the qualitative process evaluation, 15 trial staff and six families were interviewed. Overall, their experiences were positive. The intervention was broadly acceptable, with caveats around clinicians using the algorithm recommendation as a guide and wariness around extreme step ups/downs in treatment in the light of contextual factors not being taken into account by the algorithm.LimitationsPotential limitations included the choice of cut-off point to define uncontrolled asthma and the change in fractional exhaled nitric oxide to trigger a change in treatment. Furthermore, the treatment decisions in the two groups may not have been sufficiently different to create a difference in outcomes.ConclusionsThe RAACENO (Reducing Asthma Attacks in Children using Exhaled Nitric Oxide) trial findings do not support the routine use of fractional exhaled nitric oxide measurements as part of asthma management in a secondary care setting. The potential for other objective markers to guide asthma management in children needs to be evaluated.Trial registrationThis trial was registered as ISRCTN67875351.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health and Care Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 9, No. 4. See the NIHR Journals Library website for further project information.

Rhode Island's Response for COVID-Positive Individuals Experiencing Homelessness and Housing Insecurity: A Qualitative Process Evaluation

From March-June 2020, Rhode Island utilized a 209-room hotel as a quarantine/isolation (Q/I) facility for COVID-positive individuals experiencing homelessness or housing insecurity. This qualitative study used semi-structured interviews to explore experiences of key stakeholders in designing and implementing the intervention. Four major themes emerged from the data analysis: 1) the isolative nature of Q/I housing tended to negatively affect residents' mental health, 2) the addition of medical oversight was a key positive development for the intervention, 3) the security presence involved in the response tended to exacerbate residents' mental health challenges, and 4) COVID-19 and this Q/I response highlighted homelessness itself as a public health crisis that must be addressed. Findings from this study may be useful for informing ongoing COVID-19 and future epidemic/pandemic responses, particularly with respect to addressing the needs of people experiencing homelessness.

Implementation of the Diabetes Community Exercise and Education Programme (DCEP) for the management of type 2 diabetes: qualitative process evaluation

ObjectivesTo examine context-specific delivery factors, facilitators and barriers to implementation of the Diabetes Community Exercise and Education Programme (DCEP) for adults with type 2 diabetes (T2D) using the Reach, Effectiveness,...

TOWARDS A MORE COMPREHENSIVE UNDERSTANDING OF FOSTERING CONNECTIONS: THE TRAUMA-INFORMED FOSTER CARE PROGRAMME: A MIXED METHODS APPROACH WITH DATA INTEGRATION

Foster carers require high-quality training to support them in caring for children with trauma-related difficulties. This paper describes a mixed methods approach that was applied to evaluate the complex intervention Fostering Connections: The Trauma-Informed Foster Care Programme, a recently developed trauma-informed psychoeducational intervention for foster carers in Ireland. A quantitative outcome evaluation and a qualitative process evaluation were integrated to capture a comprehensive understanding of the effects of this complex intervention. A convergent mixed methods model with data integration was used. Coding matrix methods were employed to integrate data. There was convergence among component studies for: programme acceptability, increased trauma-informed foster caring, improvement in child regulation and peer problems, and the need for ongoing support for foster carers. This research provides support for the intervention suggesting the importance of its implementation in Ireland. The integrative findings are discussed in relation to effects and future implementation.

Behaviour change intervention for smokeless tobacco (ST) cessation delivered through dentists within a dental setting: a feasibility study protocol

Objectives/AimTo adapt a structured behavioural support intervention for smokeless tobacco (ST) cessation and to assess the feasibility and acceptability of delivering the intervention via dentists within dental settings in Pakistan.Material and methodsThe study will have 3 phases: (1) Adapt a previously developed intervention to make it suitable for delivery in a clinical/dental setting through qualitative interviews with dental patients and dentists; (2) A multi-centre, pilot randomised control trial in two teaching dental hospitals in Pakistan. Participants (dental patients) will be randomly assigned to intervention or control group in a 1:1 allocation ratio to receive either a structured behavioural support intervention involving face to face counselling or self-help material plus usual care. Each participant will be in the study for approximately 6 months and the overall study is expected to run for 12 months; (3) An embedded qualitative process evaluation. All trial participants will be followed up at 3 and 6 months to assess self-reported ST use. Outcome measures will include: rates of eligibility, recruitment and retention, randomisation group cross-over rates, the provision of data on ST use behaviour, fidelity to the intervention and qualitative assessment of acceptability and feasibility.DiscussionDespite the high use of ST in Pakistan, users are offered negligible cessation support. The findings of this multi-centre, mixed-method feasibility study will inform the scope for a larger trial on ST cessation delivered through the existing dental health system.

Implementing a Health Care Professional-Supported Digital Intervention for Survivors of Cancer in Primary Care: Qualitative Process Evaluation of the Renewed Intervention.

BackgroundPrimary care plays an important role in supporting survivors of cancer; however, support is limited because of practitioners’ perceived lack of expertise and time. A digital intervention for survivors of cancer could provide an efficient way for primary care staff to support survivors of cancer without the need to accumulate expertise and skills to help patients make behavior changes; providing very brief support alongside this could maximize adherence to digital interventions. Renewed is a digital intervention that combines web-based behavior change advice with brief health care practitioner support from a nurse or health care assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for survivors of cancer is sparse, limiting the understanding of the acceptability and feasibility of this type of intervention.ObjectiveThis study aims to explore supporters’ experiences of providing support to survivors of cancer using Renewed, understand potential barriers to and facilitators of the implementation of Renewed in practice, and investigate the strengths and weaknesses of the intervention from the perspective of health care professionals.MethodsThis was a qualitative process evaluation nested within a large trial evaluating Renewed. A total of 28 semistructured telephone interviews were conducted with nurses and health care assistants. Data were analyzed using inductive thematic analysis.ResultsFour themes were developed during the analysis, which reflected the factors that supporters identified as hindering or enabling them to provide support alongside Renewed Online: Renewed Online as an acceptable digital tool with some improvements, confidence in enacting the supporter role, practicalities of delivering support alongside a digital intervention, and managing a patient-led approach. The analysis suggests that supporters perceived that a digital intervention such as Renewed would be beneficial in supporting survivors of cancer in primary care and fit within current practices. However, barriers to providing support alongside the intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about using a nondirective approach, in which most advice and support is provided through digital interventions, with brief additional support provided by primary care staff.ConclusionsThese findings add to the literature on how best to provide support alongside digital interventions, suggesting that although most practitioners cope well with a nondirective approach, a minority requires more training to feel confident in implementing this. This study suggests that the barriers to providing formal support to survivors of cancer in primary care could be successfully overcome with an approach such as Renewed, where a digital intervention provides most of the support and expertise, and health care practitioners provide additional brief human support to maximize engagement. Strategies to maximize the chances of successful implementation for this type of intervention are also discussed.

Evaluation of a Health Navigator Pilot Program for Youth in Foster Care

The Health Navigator Program (HNP) was a pilot health mentor intervention program for youth in British Columbia, Canada, with connections to the provincial child welfare system. In this article, youth participants are referred to as “independent youth” as they are independent of traditional familial care. Children and youth in the foster care system face increased prevalence and risk of physical and mental health challenges with lasting implications throughout adulthood. The cumulative effect of childhood trauma, lack of connections to supportive adults, and structural obstacles such as poverty, racism, and sexism all contribute to creating significant barriers for independent youth navigating the health care system. The HNP was created to address these obstacles and facilitate improved health outcomes for independent youth. Youth from 2 program sites were paired with medical student volunteers who provided advocacy and mentorship. A qualitative process evaluation was undertaken to assess the effectiveness of the HNP in achieving the intended program outcomes. Findings revealed that the independent youth participants increased awareness of their own health needs, gained confidence in navigating the health care system, and had improved short-term health outcomes. Relationship building with a caring adult, outside of a paid professional role, was shown to be the most significant factor in achieving these positive outcomes.