Mixed-methods Process Evaluation Research Articles

Monitor to innovate with feedback loops: process evaluation protocol for an anemia prevention intervention

Background: Digital process monitoring and evaluation tools designed to capture near-to-real-time intervention data paired with feedback loops have the potential to innovate intervention delivery. Objective: To describe how a multilevel social norms field trial (RANI) is using feedback loops to enhance intervention delivery. Methods: We use a mixed-methods process evaluation design to monitor the Reduction of Anemia through Normative Innovations (RANI) project; a three-year randomized control trial which aims to lower rates of anemia among women in Odisha, India. Surveys and structured observation monitor fidelity to implementation and acceptability of implementation activities among study participants. Quantitative data evaluates implementation dose, coverage, exposure, and reach of intervention activities, and qualitative data will delve more deeply into reasons for high or low functioning. Iron folic acid supplement supply and demand are also monitored for stock-outs. Data collected from 130 intervention villages is processed, visualized, and triangulated in near to real-time via Real-time Monitoring for Knowledge Generation (RPM4K), a locally developed software application. Data visualization products facilitate the examination of monitoring data to mitigate bottlenecks and identify and implement tweaks to our intervention delivery strategy on an ongoing basis. Discussion: Feedback loops facilitate timely course corrections. Feedback loops can also engender a shared understanding of ground realities for a geographically dispersed and culturally diverse team. Leveraging feedback loops, we identify opportunities to provide on-going supportive supervision for our community facilitators promoting joint problem-solving, and communication. Monthly media and hemoglobin level demonstration strategies are informed by participant engagement and acceptability. Stock-outs of iron folic acid tablets activate contingency plans to mobilize local stakeholders and advocate for timely resolutions. Unintended effects are monitored based on ongoing feedback from community facilitators. Conclusions: Documenting our processes can inform the future implementation or scale up of similar projects embracing feedback loops to iterate and innovate their intervention delivery.

“They’re gonna be there to advocate for me so I’m not by myself”: A qualitative analysis of Black women’s motivations for seeking and experiences with community doula care

ProblemIn the United States, Black women are disproportionately impacted by inequities in maternal health. BackgroundCommunity doula support may improve birth outcomes and experiences, including lower rates of preterm birth and low birthweight and increases in positive birthing experiences. Few studies have explored client experiences with doula care, specifically community doula care. AimTo explore Black doula clients’ motivations for seeking and experiences with community doula care. MethodsData are from a mixed methods process evaluation of an organization providing free community doula services in San Francisco, California. We conducted two rounds of qualitative interviews with doula clients who identified as Black or Pacific Islander between August 2019 and March 2020. Interviews explored clients’ knowledge of, experiences with, and motivations for seeking doula care and their perceptions of the services they received. We utilized a Rapid Assessment Process to synthesize findings and thematic analysis. FindingsClients’ motivations for seeking doula care included general lack of support and knowledge of mistreatment experienced by Black women in hospital settings. Doulas provided support in the form of information about the perinatal period and clients’ rights, advocacy in hospital settings, and connection to resources beyond pregnancy and birth. Some clients described doulas as helping them stay focused and make decisions during difficult labor experiences and described positive birth experiences despite experiencing complications. ConclusionCommunity doulas play an instrumental role in the birth experiences of Black women and birthing people. Efforts should be made to expand access to this needed support via policy and hospital practices.

Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial

BackgroundMenstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda.MethodsThe study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males).The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science.DiscussionThe trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a “training of trainers” model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up.Trial registrationISRCTN 45461276. Registered on 16 September 2021

Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

BackgroundReducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation.MethodsA mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach.ResultsInterviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended.ConclusionsImplementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities.Trial registrationPrimary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474.

Implementation of the Afya conditional cash transfer intervention to retain women in the continuum of care: a mixed-methods process evaluation

ObjectivesWe report the results of a mixed-methods process evaluation that aimed to provide insight on the Afya conditional cash transfer (CCT) intervention fidelity and acceptability.Intervention, setting and participantsThe Afya CCT...

Effects of an e-health intervention ‘iSupport’ for reducing distress of dementia carers: protocol for a randomised controlled trial and feasibility study

IntroductionIn the UK, National Health Service (NHS) guidelines recommend that informal carers of people living with dementia should be offered training to help them develop care skills and manage their...

Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study.

BackgroundThere is growing evidence that noncommunicable diseases (NCDs) can be attributable to unhealthy lifestyle habits. However, there has been little application of this knowledge in primary health care (PHC).ObjectiveThis study aims to evaluate the process and outcomes of a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a PHC setting. This practice is based on national guidelines targeting unhealthy lifestyle habits with a potential risk for NCDs.MethodsA pre-post implementation study design with a control group is used in a PHC setting in central Sweden. The Medical Research Council guidelines for process evaluation of complex interventions will be applied. The implementation process and outcomes will be assessed using a mix of qualitative and quantitative methods. A strategic sample of up to 6 PHC centers will be included as intervention centers, which will receive a 12-month multifaceted implementation strategy. Up to 6 matched PHC centers will serve as controls. Core components in the implementation strategy are external and internal facilitators in line with the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework and the Astrakan change leadership model. Data will be collected at baseline, during the implementation phase, and 4-6 months after the implementation strategy. Questionnaires will be sent to roughly 500 patients in every PHC center and 200 health care professionals (HCPs) before and after implementation. In addition, purposeful sampling will be used for interviews and focus group discussions with managers, HCPs, patient representatives, and internal and external facilitators. Use of data from medical records and activity logs will be an additional data source.ResultsRecruitment of PHC centers began in March 2021 and ended in Spring 2022. Based on the planned timeline with the 12-month implementation strategy and 4-6-month follow-up, we expect to collect the final data in Summer 2023.ConclusionsThis study will explain implementation process and outcomes using a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a real-world PHC context. The study is expected to provide new knowledge about the role of facilitators and their contribution to implementation outcomes. These findings can guide policy makers, managers, and PHC staff to integrate health promotion and disease prevention in PHC and provide methodological support to facilitators.Trial RegistrationClinicalTrials.gov NCT04799860; https://clinicaltrials.gov/ct2/show/NCT04799860International Registered Report Identifier (IRRID)DERR1-10.2196/37634

A mixed-method process evaluation of an East Midlands county summer 2021 holiday activities and food programme highlighting the views of programme co-ordinators, providers, and parents.

BackgroundThe Holiday Activities and Food (HAF) Programme is a UK Government initiative created to alleviate food insecurity and promote health and well-being among children and their families, who are eligible for Free School Meals (FSM), during the school holidays. This process evaluation investigated factors that facilitated and acted as a barrier to the delivery of the HAF Programme from the perspectives of key stakeholders (Co-ordinators, Providers, and Parents) involved in the HAF Programme across an East Midlands county.MethodsThis evaluation utilized a mixed-methods approach, incorporating focus groups and online surveys to gain rich, multifaceted data. The focus groups were analyzed using a hybrid inductive-deductive thematic analysis and the online surveys were analyzed using mixed-methods approach due to the variation in question type (i.e., quantitative, Likert scale and open response) to align themes to the Government Aims and Standards of the HAF Programme.FindingsThe stakeholders highlighted several factors that facilitated and acted as a barrier to the delivery of the HAF Programme. Facilitating factors included existing and maintaining relationships between Co-ordinators, Providers, and facilities/schools/communities as this improved communication and attendance. Additionally, transport provision for those attending the Programme helped overcome barriers to attendance. The primary barrier of the Programme was the late awarding of the Programme contract as this limited the time available to prepare and organize the Programme. This in turn, had several “knock on” effects that created more barriers and resulted in some of the Government Aims and Standards not being met such as, nutrition education for children and parents. Despite the challenges faced, Co-ordinators and Providers were able to deliver the Programme and positively impact upon the children and their families that attended the Programme.ConclusionFollowing the facilitators and barriers that were highlighted in this evaluation, several recommendations have been made to enhance the delivery of the HAF Programme and ensure Government Aims and Standards, to improve children and family's health and well-being, are attained.

Delivering an mHealth Adherence Support Intervention for Patients With HIV: Mixed Methods Process Evaluation of the Philippines Connect for Life Study.

BackgroundThe Philippines HIV epidemic is one of the fastest growing epidemics globally, and infections among men who have sex with men are increasing at an alarming rate. Connect for Life Philippines is a mobile health (mHealth) intervention that supports antiretroviral therapy (ART) adherence in this key population through individualized voice calls and SMS text messages.ObjectiveThe objective of this process evaluation is to assess the intervention reach, dose delivered and received, fidelity, and acceptability and to describe contextual factors affecting the implementation of an mHealth adherence support intervention for patients on ART in a clinic in Metro Manila, Philippines.MethodsA mixed methods process evaluation approach was used in an observational cohort study. Quantitative data sources for the process evaluation were call and SMS text message logs obtained from the mHealth platform and questionnaires collected at 12-, 24-, and 48-week study visits. Qualitative data were collected from process reports and through a series of focus group discussions conducted with a subset of participants during the intervention development phase, after an initial 8-week pilot phase, and at the end of the study.ResultsThe 462 study participants received 31,095 interactive voice calls and 8234 SMS text messages during the study. Owing to technical issues, intervention fidelity was low, with only 22.1% (102/462) of the participants receiving reminders via voice calls and others (360/462, 77.9%) receiving only SMS text messages during the intervention. After 48 weeks in the study, 63.5% (293/462) of the participants reported that they would be quite likely or very likely to recommend the program to a friend, and 53.8% (249/462) of the participants reported that they benefited quite a bit or very much from the intervention. Participants who were on ART for <6 months at the beginning of the study and those who received the daily or weekly pill reminders were more likely to report that they benefited from the intervention (P=.02 and P=.01, respectively).ConclusionsThe Connect for Life intervention had high participant satisfaction and acceptability, especially among those who received high dose of the intervention. However, poor reliability of local telecommunication networks had a large impact on the intervention’s usability, fidelity, and dose received.

Preventing Falls Among Older Adults in Primary Care: A Mixed Methods Process Evaluation Using the RE-AIM Framework.

Falls are a leading cause of injuries and injury deaths for older adults. The Centers for Disease Control and Prevention's Stopping Elderly Accidents Deaths and Injuries (STEADI) initiative, a multifactorial approach to fall prevention, was adapted for implementation within the primary care setting of a health system in upstate New York. The purpose of this article is to: (a) report process evaluation results for this implementation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and (b) examine the utility of RE-AIM for assessing barriers and facilitators. This evaluation used mixed methods. Qualitative evaluation involved semistructured interviews with key stakeholders and intercept interviews with health care providers and clinic staff. Quantitative methods utilized surveys with clinic staff. Process evaluation tools were developed based on the AIM dimensions of the RE-AIM framework. The study was conducted over a 2-month period, approximately 18 months postimplementation, and complements previously published results of the program's reach and effectiveness. Primary barriers by RE-AIM construct included competing organizational priorities (Adoption), competing patient care demands (Implementation), and staff turnover (Maintenance). Primary facilitators included having a physician champion (Adoption), preparing and training staff (Implementation), and communicating about STEADI and recognizing accomplishments (Maintenance). Results revealed a high degree of concordance between qualitative and quantitative analyses. The framework supported assessments of various stakeholders, multiple organizational levels, and the sequence of practice change activities. Mixed methods yielded rich data to inform future implementations of STEADI-based fall prevention.

Mixed-methods process evaluation of a residence-based SARS-CoV-2 testing participation pilot on a UK university campus during the COVID-19 pandemic

BackgroundRegular testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important strategy for controlling virus outbreaks on university campuses during the COVID-19 pandemic but testing participation rates can be low. The Residence-Based Testing Participation Pilot (RB-TPP) was a novel intervention implemented at two student residences on a large UK university campus over 4 weeks. The aim of the pilot was to increase the frequency of asymptomatic SARS-CoV-2 saliva testing onsite. This process evaluation aimed to determine whether RB-TPP was implemented as planned and identify implementation barriers and facilitators.MethodsA mixed-methods process evaluation was conducted alongside the RB-TPP. Evaluation participants were students (opting in, or out of RB-TPP) and staff with a role in service provision or student support. Monitoring data were collected from the intervention delivery team and meeting records. Data were collected from students via online survey (n = 152) and seven focus groups (n = 30), and from staff via individual interviews (n = 13). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the ‘Capability, Opportunity, Motivation–Behaviour’ (COM-B) behaviour change framework.ResultsFour hundred sixty-four students opted to participate in RB-TPP (98% of students living onsite). RB-TPP was implemented broadly as planned but relaxed social distancing was terminated early due to concerns relating to national escalation of the COVID-19 Delta variant, albeit testing continued. Most students (97.9%) perceived the period of relaxed social distancing within residences positively. The majority engaged in asymptomatic testing (88%); 46% (52% of testers) were fully compliant with pre-determined testing frequency. Implementation was facilitated by convenience and efficiency of testing, and reduction in the negative impacts of isolation through opportunities for students to socialise. Main barriers to implementation were perceived mixed-messages about the rules, ambivalent attitudes, and lack of adherence to COVID-19 protective measures in the minority.ConclusionsThis process evaluation identifies factors that help or hinder the success of university residence-based outbreak prevention and management strategies. RB-TPP led to increased rates of SARS-CoV-2 testing participation among students in university residences. Perceived normalisation of university life significantly enhanced student mental wellbeing. The complexity and challenge generated by multiple lines of communication and rapid adaptions to a changing pandemic context was evident.Trial registration numberUKAS 307727–02-01; Pre-results. ClinicalTrials.gov Identifier: NCT05045989; post-results (first posted, 16/09/21).Ethical approvalFaculty of Medicine & Health Sciences Research Ethics Committee, University of Nottingham (Ref: FMHS 96-0920)

An adapted behavioural activation intervention (DiaDeM) for people with diabetes and depression in South Asia: A feasibility study protocol

Background: The burden of depression is a rapidly growing problem worldwide. Its prevalence is particularly high among individuals with chronic physical conditions such as Type 2 Diabetes (T2DM), precipitating poorer health outcomes. There is a lack of evidence around treatments that can work among such groups, particularly in Low and Middle-Income Countries (LMICs). This study aims to test the feasibility and acceptability of a culturally adapted Behavioural Activation (BA) intervention (DiaDeM) for people with T2DM and depression in two LMICs in South Asia. Methods: A multicentre, randomised-controlled feasibility trial will be conducted from March 2022 to February 2023. We will recruit 128 adults from health facilities in Bangladesh and Pakistan with a diagnosis of T2DM and depression. Using a 1:1 allocation ratio, consenting individuals will be randomised to either optimised usual care or the DiaDeM intervention. The latter will involve six face-to-face or remotely delivered BA sessions conducted by non-mental health facilitators over six to twelve weeks. Participants will be followed up at three and six months post-randomisation. Feasibility outcomes include the feasibility and acceptability of recruitment and retention, the feasibility of intervention delivery and the feasibility of data collection at baseline and follow-up (including economic data). An embedded mixed-methods process evaluation will also be carried out to inform the main trial. Conclusions: BA is a low resource intervention for depression treatment that can be optimised for delivery in LMIC settings such as South Asia. The planned feasibility trial will directly inform a larger trial to assess the effectiveness and cost-effectiveness of such an intervention in people with T2DM and depression. It will also contribute to the wider evidence base around BA in patients with chronic physical illnesses, with particular relevance to South Asian, as well as wider LMIC regions and populations. Trial registration: ISRCTN 75501608

Prescribing and using vitiligo treatments: lessons from a nested process evaluation within the HI-Light vitiligo randomized controlled trial.

BackgroundThe HI‐Light Trial demonstrated that for active, limited vitiligo, combination treatment with potent topical corticosteroid (TCS) and handheld narrowband ultraviolet B offers a better treatment response than potent TCS alone. However, it is unclear how to implement these findings.AimWe sought to answer three questions: (i) Can combination treatment be used safely and effectively by people with vitiligo?; (ii) Should combination treatment be made available as routine clinical care?; and (iii) Can combination treatment be integrated within current healthcare provision?MethodsThis was a mixed‐methods process evaluation, including semi‐structured interviews with a purposive sample of trial participants, structured interviews with commissioners, and an online survey and focus groups with trial staff. Transcripts were coded by framework analysis, with thematic development by multiple researchers.ResultsParticipants found individual treatments easy to use, but the combination treatment was complicated and required nurse support. Both participants and site investigators felt that combination treatment should be made available, although commissioners were less certain. There was support for the development of services offering combination treatment, although this might not be prioritized above treatment for other conditions. A ‘mixed economy’ model was suggested, involving patients purchasing their own devices, although concerns regarding the safe use of treatments mean that training, monitoring and ongoing support are essential. The need for medical physics support may mean that a regional service is more practical.ConclusionCombination treatment should be made available for people seeking treatment for vitiligo, but services require partnership with medical physics and ongoing training and support for patients.

Effectiveness and cost-effectiveness of text messages with or without endowment incentives for weight management in men with obesity (Game of Stones): study protocol for a randomised controlled trial

BackgroundObesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity.MethodsA 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies.DiscussionThe trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men’s experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services.Trial registrationISRCTN 91974895. Registered on 14/04/2021.

Evaluation of an inpatient occupation-based group program using a process evaluation framework.

Occupation-based groups are used in inpatient rehabilitation to enhance delivery and intensity of intervention; however, little research is available to understand their effectiveness. The aim of this study was to examine the process of an occupation-based group to understand mechanisms and success factors. A mixed methods process evaluation using an evidence-based framework guided implementation and analysis. Participants were those involved in the 'LifeSkills' group run daily in an adult inpatient general rehabilitation ward. Quantitative administrative data, goal achievement outcome measures, group observations and qualitative semistructured interviews were conducted. Thirty participants were recruited. Factors for success included consistency in group structure and support, using meaningful practise opportunities and facilitating a real-world experience. There was no significant relationship between patient outcomes and dose of training or patient demographics. This evaluation contributes to a growing body of evidence for incorporating occupation-based approaches into rehabilitation and offers insights into practice implementation.

The structured health intervention for truckers (SHIFT) cluster randomised controlled trial: a mixed methods process evaluation

BackgroundThis paper presents the mixed methods process evaluation of the randomised controlled trial (RCT) of the Structured Health Intervention For Truckers (SHIFT), a multi-component intervention targeting physical activity and positive lifestyle behaviours in a cohort of 382 truck drivers in the UK. The SHIFT RCT found a significant difference in daily steps between intervention and control groups at 6-months in favour of the intervention participants.MethodsSHIFT was evaluated within a cluster-RCT and involved 25 transport sites (12 intervention and 13 control sites). Intervention components included an education session, Fitbit, text messages, and cab workout equipment. Participants completed questionnaires at baseline and 6-months follow-up. Semi-structured focus groups/interviews were conducted with drivers (n = 19) and managers (n = 18) from each site, after completion of the final follow-up health assessment (16-18 months post-randomisation). Questionnaires and interviews collected information on fidelity, dose, context, implementation, barriers, sustainability, and contamination.ResultsQuestionnaire and interview data from intervention participants indicated favourable attitudes towards SHIFT, specifically towards the Fitbit with a high proportion of drivers reporting regularly using it (89.1%). 79.2% of intervention participants attended the education session, which was deemed useful for facilitating improvements in knowledge and behaviour change, dietary changes were predominantly recalled. Despite not being part of the intervention, participants reported that feedback from the health assessments motivated them to change aspects of their lifestyle (intervention = 91.1%, control = 67.5%). The cab workout equipment was used less and spoken unfavourably of in the interviews. The main barriers to a healthy lifestyle at work were reported as long hours and irregular shift patterns. The most suggested improvement for the intervention was more frequent contact with drivers. Managers were positive about the objectives of SHIFT, however almost all mentioned the challenges related to implementation, specifically in smaller sites.ConclusionsOverall, SHIFT was predominantly implemented as intended, with minimal discrepancies seen between the delivery and protocol. Having said this, transport sites each have distinct characteristics, which may require adaptations to individual settings to encourage participation. Managers and drivers reported enthusiasm and necessity for SHIFT to be included in future Certificate of Professional Competence training.Trial registrationISRCTN10483894 (date registered: 01/03/2017).

Protocol for a novel sodium and blood pressure reduction intervention targeting online grocery shoppers with hypertension – the SaltSwitch Online Grocery Shopping randomized trial

High dietary sodium intake is a leading cause of hypertension. A major source of dietary sodium is salt added to processed food products available in retail food environments. The fast-growing online grocery shopping setting provides new opportunities for salt reduction interventions that support consumers in choosing healthier options. The SaltSwitch Online Grocery Shopping randomized controlled trial is investigating the feasibility, acceptability, and effectiveness of a novel intervention for lowering salt consumption and blood pressure amongst people with hypertension who shop for groceries online. The intervention is based on a bespoke web browser extension that interfaces with a major retailer's online store to highlight and interpret product sodium content and suggest similar but lower-sodium alternatives. The primary outcome of interest is change in mean systolic blood pressure between individuals randomized (1:1) to the intervention and control (usual online shopping) arms at 12 weeks. Secondary outcomes are diastolic blood pressure, spot urinary sodium and sodium:potassium ratio, sodium purchases, and dietary intake. Intervention implementation and lessons for future uptake will be assessed using a mixed methods process evaluation. Participants with hypertension who shop online for groceries and exhibit high sodium purchasing behavior are being recruited across Australia. A target sample size of 1,966 provides 80% power (2-sided alpha=0.05) to detect a 2 mm Hg difference in systolic blood pressure between groups, assuming a 15 mm Hg standard deviation, after allowing for a 10% dropout rate. This trial will provide evidence on an innovative intervention to potentially reduce salt intake and blood pressure in people with hypertension. The intervention caters to individual preferences by encouraging sustainable switches to similar but lower-salt products. If effective, the intervention will be readily scalable at low cost by interfacing with existing online retail environments.

Mixed-methods process evaluation of the Dynamic Work study: A multicomponent intervention for office workers to reduce sitting time

Previously, we observed no significant reductions in sitting time of the multicomponent Dynamic Work (DW) intervention among office workers. In this study we used mixed-method data to understand context, implementation (i.e. recruitment and delivery) and mechanism of impact (i.e. experiences) of the DW intervention and to explore whether an higher implementation index score led to larger changes in participants’ outcomes. We found considerable variation across departments regarding context (i.e. different size and work tasks) and implementation (i.e. delivery varied). Satisfaction with the DW intervention was high. An higher implementation index score was associated with lower overall sitting time, lower occupational sitting time, higher number of steps/day and steps/day at work at 4-months, which was maintained at 8-month for occupational sitting time. These findings provide an understanding that implementation was affected by a lack of availability of intervention components, department policy, work tasks, positioning and work location. Trial registrationClinicaltrials.gov, registration number:NCT03115645. Registered February 17, 2017 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03115645.

Barriers and facilitators in the delivery of a proportionate universal parenting program model (E-SEE Steps) in community family services.

BackgroundA proportionate universal (PU) approach to early years’ service provision has been advocated to improve children’s health and development and to reduce health inequality, by ensuring that services provide timely and high-quality parenting support commensurate with need. Process-oriented research is critical to examine the factors that contribute to, or hinder, the effective delivery/implementation of such a model in community-based family services. This study aimed to assess the delivery, acceptability and feasibility of a new PU parenting intervention model (called E-SEE Steps), using the Incredible Years® (IY) parent program, when delivered by trained health/family service staff in three “steps”—one universal step (the IY Babies Book), and two targeted steps (group-based IY Infant and Toddler programs).MethodsAn embedded mixed-methods process evaluation within a pragmatic parallel two-arm, assessor blinded, randomized controlled trial was conducted in community services in four local authorities in England. The process evaluation used qualitative data gathered via interviews and focus groups with intervention arm parents who were offered the targeted steps (n = 29), practitioners (n = 50), service managers (n = 7) and IY program mentors (n = 3). This was supplemented by quantitative data collected using group leader pre-training (n = 50) and post-delivery (n = 39) questionnaires, and research notes of service design decisions.ResultsThe E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare. Practitioners also highlighted the positive development opportunities provided by the IY training and supervision. However, participant views did not support the provision of the IY Babies book as a standalone universal component, and there were barriers to eligible parents—particularly those with low mood—taking up the targeted programs. Service providers struggled to align the PU model with their commissioned service contracts and with their staff capacity to engage appropriate parents, including tackling common barriers to attendance.ConclusionsDespite general enthusiasm and support for delivering high-quality parenting programs in community services in the England, several barriers exist to successfully delivering IY in a proportionate universal model within current services/systems.

Implementing specialised vestibular physiotherapy in an emergency department: a process evaluation

BackgroundDizziness and vertigo-like symptoms, often caused by common peripheral vestibular disorders such as benign paroxysmal positional vertigo (BPPV), may significantly impact function and quality of life. These symptoms often result in emergency department (ED) presentations. Evidence-based clinical practice guidelines strongly recommend using physical assessment and treatment manoeuvres for the assessment, diagnosis and treatment of these symptoms. This study aimed to evaluate the process of implementing specialised vestibular physiotherapy (SPV) in an emergency department from the clinician’s perspective.MethodsThis implementation study utilised a retrospective mixed-methods process evaluation to understand how SVP operated in an Australian emergency department. The i-PARiHS framework was embedded within the methodology and analytical approach of the study to ensure a comprehensive approach closely aligned to implementation science. Nine clinicians retrospectively completed the Organisational Readiness for Change Assessment (ORCA), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). Seven clinicians also participated in a focus group or interview.ResultsA range of barriers and facilitators to the implementation process were identified by participants, some of which spanned multiple domains of the i-PARiHS framework. Relationships with service leaders, champions and medical staff were pivotal facilitators to implementation, along with a generally held perception that SVP was acceptable and feasible. The main barrier identified was a lack of capacity to deliver and facilitate this innovation within the physiotherapy workforce and the broader multidisciplinary recipients.ConclusionsThis study demonstrates that the process of implementing an SVP service in an ED context was generally well-received by clinicians but also involved some challenges and barriers. Services looking to implement SVP in the ED should aim to build stakeholder relationships; develop a shared vision with clear goals and intended outcomes; embed the innovation in organisation processes, procedures and policies; and increase workforce capacity to deliver and facilitate SVP to guide their approach to this innovation.