Complex Behavioural Intervention Research Articles

Using Normalisation Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: the STAMINA lifestyle intervention

BackgroundThe National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention.MethodsTwo stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future.ResultsWorkshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner.ConclusionsApplication of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT.Trial registration(ISRCTN: 46385239). Registered on July 30, 2020.

Effectiveness of behavioural interventions with motivational interviewing on physical activity outcomes in adults: systematic review and meta-analysis

ObjectiveTo evaluate the effectiveness of behavioural interventions that include motivational interviewing on physical activity outcomes in adults.DesignSystematic review and meta-analysis.Study selectionA search of seven databases for randomised controlled trials published...

'ThinkCancer!': randomised feasibility trial of a novel practice-based early cancer diagnosis intervention.

UK cancer deaths remain high; primary care is key for earlier cancer diagnosis as half of avoidable delays occur here. Improvement is possible through lower referral thresholds, better guideline adherence, and better safety-netting systems. Few interventions target whole practice teams. We developed a novel whole-practice team intervention to address this. To test the feasibility and acceptability of a novel, complex behavioural intervention, 'ThinkCancer!', for assessment in a subsequent Phase III trial. Pragmatic, superiority pilot randomised controlled trial (RCT) with an embedded process evaluation and feasibility economic analysis in Welsh general practices. Clinical outcome data were collected from practices (the unit of randomisation). Practice characteristics and cancer safety-netting systems were assessed. Individual practice staff completed evaluation and feedback forms and qualitative interviews. The intervention was adapted and refined. Trial recruitment and workshop deliveries took place between March 2020 and May 2021. Trial progression criteria for recruitment, intervention fidelity, and routine data collection were met. Staff-level fidelity, retention, and individual level data collection processes were reviewed and amended. Interviews highlighted positive participant views on all aspects of the intervention. All practices set out to liberalise referral thresholds appropriately, implement guidelines, and address safety-netting plans in detail. 'ThinkCancer!' appears feasible and acceptable. The new iteration of the workshops was completed and the Phase III trial has been funded to assess the effectiveness and cost-effectiveness of this novel professional behaviour change intervention. Delivery at scale to multiple practices will likely improve fidelity and reach.

Mis-implementation of evidence-based behavioural health practices in primary care: lessons from randomised trials in Federally Qualified Health Centers.

Implementing evidence-based practices (EBPs) within service systems is critical to population-level health improvements - but also challenging, especially for complex behavioral health interventions in low-resource settings. "Mis-implementation" refers to poor outcomes from an EBP implementation effort; mis-implementation outcomes are an important, but largely untapped, source of information about how to improve knowledge exchange. We present mis-implementation cases from three pragmatic trials of behavioral health EBPs in U.S. Federally Qualified Health Centers (FQHCs). We adapted the Consolidated Framework for Implementation Research and its Outcomes Addendum into a framework for mis-implementation and used it to structure the case summaries with information about the EBP and trial, mis-implementation outcomes, and associated determinants (barriers and facilitators). We compared the three cases to identify shared and unique mis-implementation factors. Across cases, there was limited adoption and fidelity to the interventions, which led to eventual discontinuation. Barriers contributing to mis-implementation included intervention complexity, low buy-in from overburdened providers, lack of alignment between providers and leadership, and COVID-19-related stressors. Mis-implementation occurred earlier in cases that experienced both patient- and provider-level barriers, and that were conducted during the COVID-19 pandemic. Multi-level determinants contributed to EBP mis-implementation in FQHCs, limiting the ability of these health systems to benefit from knowledge exchange. To minimize mis-implementation, knowledge exchange strategies should be designed around common, core barriers but also flexible enough to address a variety of site-specific contextual factors and should be tailored to relevant audiences such as providers, patients, and/or leadership.

Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial

IntroductionThe COVID-19 pandemic has forced the implementation of physical distancing and self-isolation strategies worldwide. However, these measures have significant potential to increase social isolation and loneliness. Among older people, loneliness...

Pragmatic Implementation of a Music Intervention in Nursing Homes Before and During COVID-19

ObjectivesWe conducted 2 trials of a music intervention for managing behaviors in nursing home (NH) residents with dementia, before (2019) and during (2021) the pandemic. In this report, we compare adherence fidelity across the trials using the Framework for Implementation Fidelity (FIF). DesignCross-sectional, descriptive implementation comparison. Setting and ParticipantsFifty-four NHs randomized to receive the intervention (27 pre-COVID, 27 during COVID) MethodsWe compare the trials on the following FIF criteria: coverage (number of residents receiving the intervention); duration (minutes of music received per exposed day); frequency (percentage of residents with nursing staff use of music in the past week); and details of content (adherence to core components of the intervention). We report NH-level performance in each domain and compare characteristics of NHs in the bottom (low) and top (high) terciles of adherence. ResultsAcross FIF domains, adherence fidelity was lower during COVID compared with pre-COVID: coverage, residents exposed (COVID: 7.5, SD 5.6; pre-COVID: 12.7, SD 3.6); duration, music minutes per exposed day (COVID: 2.5, SD 5.1; pre-COVID: 27.1, SD 23.9); frequency, percentage of residents with nursing use of intervention in the past week (COVID: 15.0, SD 31.5; pre-COVID 40.4, SD 25.6); and details of content, compliance with core components of the intervention (COVID: 8.3, SD 1.9; pre-COVID 9.6, SD 2.0). In both trials, high–adherence fidelity NHs had better nursing staff ratios, greater percentages of Medicare residents, and lower percentages of Black residents, compared with low-fidelity NHs. Conclusions and ImplicationsAdherence fidelity was worse in the COVID vs pre-COVID trial, despite adaptations between trials intended to reduce staff burden and increase clinical targeting of the intervention. Results may point to the long-term effects of COVID on quality improvement capacity in NHs and/or a lack of available resources in most NHs to implement complex behavioral interventions without direct research support.

Installations for Civic Culture: Behavioral Policy Interventions to Promote Social Sustainability

Achieving more equitable, safer, and resilient societies—crucial dimensions of social sustainability—depends on durable transformations in people’s behavior. Traditional policy interventions attempt to influence people’s behavior in different ways, such as increased policing, fines, or awareness campaigns, but often have limited effects because they fail to systematically address local determinants of behavior. In this paper, we analyze two complex behavioral policy interventions to illustrate how installation theory can provide a framework to systematically analyze and design for large-scale behavioral change to support social sustainability. We focus on two of Antanas Mockus’ iconic “civic culture” interventions to reduce deaths in traffic accidents and domestic violence in Colombia. To study them, we collected intervention reports, citizens’ narratives, creators’ accounts and press articles to identify their main characteristics and behavioral techniques. In our results, we find that the civic culture approach used in these two interventions addresses physical, psychological and social determinants of behavior in ways that reduce reactance and promote mutual regulation and collective agency. By unraveling the essential factors of behavioral influence, installation theory and related frameworks provide a useful guide to structure, analyze and report interventions that address the behavioral components of social sustainability.

Preliminary Results of an Interdisciplinary Behavioral Program to Improve Access to Preventative Dental Care for Adults With Intellectual and Developmental Disabilities.

Adults with intellectual and developmental disabilities (AIDD) experience significant oral health disparities, partially due to perceived behavioral issues. This article describes the preliminary outcomes of a developing interdisciplinary (dental, medical, behavioral) program involving a behavioral intervention for AIDD previously receiving preventative dental care with sedation, general anesthesia, or protective stabilization (SAS). After a baseline assessment, a board-certified behavior analyst implemented increasingly complex behavioral interventions during simulated dental visits. Prior to COVID-19 pandemic-related restrictions, there were 32 active participants; 15 (46.9%) successfully completed a focused, real dental exam with simple behavioral interventions and 17 (53.1%) remain in treatment. These preliminary results suggest that many AIDD previously receiving SAS may participate in a preventative dental exam with minimal behavioral supports, if given the opportunity.

Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy

BackgroundAdjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST).MethodsIterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively.ResultsThe final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 24-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components.ConclusionsWe have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.

An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study.

BackgroundIn the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence.ObjectiveThis is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT.MethodsThis study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings.ResultsEnrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text.ConclusionsThis protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes.Trial RegistrationClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933International Registered Report Identifier (IRRID)DERR1-10.2196/39098

Unpacking the black box of voice therapy: A clinical application and revision of the Motor Learning Classification Framework (MLCF)

Purpose: Voice therapy is a complex behavioural intervention. Understanding its components is integral for continued advancement of voice therapy research, translation of evidence into the clinical setting and improved client care. The Motor Learning Classification Framework (MLCF) offers an excellent opportunity for increasing such knowledge, specifically in relation to identifying variables that affect motor learning (ML), an important mechanism hypothesised to bring about voice change during voice therapy. The MLCF has shown promising results in identifying speech-language pathologists’ (SLPs) use of ML variables during experimentally controlled voice therapy contexts. The purpose of this study was to test the feasibility of applying the framework in the clinical context of everyday voice therapy practice. Method: Data consisted of two video-recorded voice therapy sessions representing usual voice therapy care. Classification of ML variables used by SLPs during the recorded sessions was attempted based on the MLCF. Result: Several problematic features of the framework were identified. Based on deliberations between the authors of the current paper, the MLCF was revised using an iterative process. This resulted in the construction of an updated version of the framework (MLCF-V2). The MLCF-V2 organises ML strategies into two broad categories: directly observable behaviours and learning processes. The framework incorporates greater consideration of theory and empirical evidence supporting motivational, attentional focus and subjective error estimation influences on ML. Several examples of each ML variable are included as well as an attempt to provide clearer classification instruction. Conclusion: It is anticipated that the MLCF-V2 will provide a more useful and reliable classification for use in future investigations of SLPs’ use of ML variables during usual voice therapy practice.

Healthy Lifetime (HL): An Internet-Based Behavioral Health Coaching Protocol for Older Adults.

By 2060, the number of Americans 65 years and older will more than double, comprising nearly one-quarter of the population in the United States. While there are many advantages to living longer, a byproduct of aging is also a growing incidence of chronic illness and functional health limitations associated with a concurrent rise in chronic disease and disability that impair independent living in the community. We describe a personalized, behavioral health coaching protocol for early intervention that is delivered online to enhance a participant's independent functioning and to increase their self-care capacity with a goal to maintain independent living throughout aging. The electronic platform provides secure access to fillable surveys, health tracking, “just in time” communication with coaches and scheduling of two-way videos launched from the platform site. The 2-month protocol used two-way video conferencing which allowed high fidelity communication to sustain a complex behavioral intervention. Participants indicate high satisfaction with the intervention, the use of the platform, and the technology. While many health systems across the U.S. have ramped up virtual delivery of care in a proactive manner with now more than 70% of out-patient visits conducted through virtual delivery modes in some health systems, there remains much unevenness in this capability across the U.S. Our approach is to create a stable, interoperable, virtual outreach system for personalized professional health coaching that is complementary to medically oriented services that supports the health and functioning of participants as they age.

Testing a Theory of Implementation Leadership and Climate Across Autism Evidence-Based Interventions of Varying Complexity

Prominent theories within the field of implementation science contend that organizational leaders can improve providers’ fidelity to evidence-based practices (EBPs) by using focused implementation leadership behaviors that create an organizational climate for EBP implementation. However, this work has been criticized for overreliance on nonspecific, self-report fidelity measures and poor articulation of the boundary conditions that may attenuate leadership and climate’s influence. This study tests the predictions of EBP implementation leadership and climate theory on observed fidelity to three school-based EBPs for autism that vary in complexity: pivotal response training (PRT), discrete trial training (DTT), and visual schedules (VS). Educators in kindergarten to third-grade autism support classrooms in 65 schools assessed their principals’ EBP implementation leadership and school EBP implementation climate prior to the school year. Mid-school year, trained observers rated educator fidelity to all three interventions. Expert raters confirmed PRT was significantly more complex than DTT or VS using the Intervention Complexity Assessment Tool for Systematic Reviews. Linear regression analyses at the school level indicated principals’ increased frequency of EBP implementation leadership predicted a higher school EBP implementation climate, which in turn predicted higher educator fidelity to PRT—however, there was no evidence of a relationship between implementation climate and fidelity to DTT or VS. Comparing principals whose EBP implementation leadership was ±1 SD from the mean, there was a significant indirect association of EBP implementation leadership with PRT fidelity through EBP implementation climate (d = 0.49, 95% CI [0.04, 0.93]). Strategies that target EBP implementation leadership and climate may support fidelity to complex behavioral interventions.

Building sustainable communities for sustainable development: An evidence‐based behavior change intervention to reduce plastic waste and destructive fishing in Southeast Asia

AbstractEnvironmental crises often stem back to how humans make decisions and behave. Thus, the extent to which we can successfully address these challenges will depend on the extent to which we can design and deliver effective behavioral change interventions. This project examines how complex behavioral change interventions can be applied to modify human behavior of villagers living in coastal communities. Our work aimed to increase adoption of sustainable behaviors, protect marine biodiversity, improve community wellbeing, increase individual psychosocial skills and executive functions, and increase communal resiliency and adaptability. We conducted pilot and feasibility efficacy trials in two low‐resource coastal communities in Indonesia and Philippines. We used a single site case study and a quasi‐experimental design with control‐treatment matching to evaluate the intervention. Results include increased sustainable behaviors (e.g., recycling), increased prosocial behaviors (e.g., positive communication), and increased perceptions of empowerment for groups exposed to the intervention.

Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis: a multicentre, randomised controlled trial of the ProLife programme in South Africa

ObjectiveTo investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking.DesignMulticentre, individual, randomised controlled trial where participants were assigned...

CONNECT: A pragmatic clinical trial testing a remotely provided linkage to service coordination after hospitalization for TBI

ABSTRACT Objective To test whether a complex behavioral intervention delivered remotely to connect individuals to clinical resources after hospitalization for TBI improved their quality of life. Design/Methods Community-based randomized pragmatic clinical trial. Main measures TBI-QOL, Activity Measure for Post-Acute Care (AM-PAC), Clinical Satisfaction and Competency Rating Scale. Results 332 individuals ≥18 years-old hospitalized for TBI in four upper Midwest states were randomized to Remote (n = 166) and Usual Care (n = 166) groups. The groups were equivalent and representative of their state population’s racial and ethnic composition, age, and proportion living in rural communities. There were no significant differences within or between experimental groups over the study period in TBI-QOL t-scores. There was a significant improvement in AM-PAC Daily Activities within the Remote group and a significant between-group improvement in clinical satisfaction for the Remote group. Conclusion Enrolling a representative, regional community-based sample of individuals with TBI can be successful, and delivering a customized complex behavioral intervention remotely is feasible. The overall lack of intervention effectiveness was likely due to enrolling individuals without pre-identified clinical needs, initiating intervention after the immediate post-acute phase when needs are often highest, inability to provide direct clinical care remotely, and potential lack of outcome measure responsiveness in our sample.

Feasibility and Acceptability of a Dietary Intervention to Reduce Salt Intake and Increase High-Nitrate Vegetable Consumption in Malaysian Middle-Aged and Older Adults with Elevated Blood Pressure: Findings from the DePEC-Nutrition Trial.

The DePEC-Nutrition trial is a complex dietary and behavioural intervention of salt intake reduction combined with increased high-nitrate vegetable consumption among Malaysian middle-aged and older adults with elevated blood pressure. This study aimed to assess the feasibility and acceptability of the trial. Participants were recruited from the South East Asia Community Observatory (SEACO) database and randomised into one of four groups: (1) low salt; (2) high-nitrate vegetable; (3) combined high-nitrate vegetable and low salt; and (4) control. The intervention included a combination of group counselling sessions, information booklets, reinforcement videos and text messages to modify dietary behaviour. The primary outcomes evaluated were the measures of feasibility and acceptability of (1) recruitment, follow-up attendance and retention; (2) data collection procedures and clinical outcome measures; and (3) individual and combined multi-modal dietary interventions. A total of 74 participants were recruited, and the 10-month retention rate was 73%. Data collection procedures were acceptable with minimal missing data. All intervention strategies were feasible and acceptable, with group counselling being the most acceptable strategy. This study provides important insights into improving the screening process of participants, facilitating their access to the research facilities and refining the measurement protocols and dietary recommendations, which are instrumental in formulating the design of a full-scale definitive DePEC-Nutrition trial.

130. Effects of COVID-19 on a Complex Behavioral Intervention to Improve the Diagnosis and Management of UTI in Nursing Homes

BackgroundHalf of all urinary tract infections (UTI) are probably unnecessary. We conducted a cluster-randomized trial in which a toolkit to enhance the diagnosis and treatment of UTIs was introduced in study NHs via usual implementation versus an enhanced implementation approach based on external facilitation and peer comparison reporting.MethodsThirty Wisconsin NHs were randomized to each treatment arm in a 1.5:1 ratio. NHs used an online portal to report urine culture and antibiotic treatment data over a 6-month pre-intervention period (Jan-June 2019), a pre-COVID 8-month post intervention period (July 2019-Feb 2020) and an 8-month post-COVID intervention period (Mar-Oct 2020). Study outcomes included urine culture (UC), antibiotic start (AS), and antibiotic days of therapy (DOT) rates per 1,000 resident days. A generalized estimating equation model for panel data was used to assess differences in study outcomes between treatment arms before and after onset of the COVID-19 pandemic. STATA 16.1 was used for all analyses.ResultsA total of 802 UCs (457 pre-COVID, 345 post-COVID), 724 AS (401 pre-COVID, 323 post-COVID), and 6,454 DOT (3553 pre-COVID and 2901 post-COVID) were reported over the 16-month intervention period. No significant differences in the study outcomes were observed during the pre-COVID intervention period, however, UC rates in NHs assigned to the usual care arm of the study increased while those in the enhanced arm declined following onset of COVID-19 (Figure 1). AS and DOT rates followed a similar pattern although the differences between the study arms were not statistically significant.Figure 1. Post Implementation Periods ConclusionOur findings suggest that NHs assigned to usual implementation regressed in their diagnosis and treatment of UTIs during the COVID-19 pandemic while those receiving external facilitation and peer comparison reports were more resilient to the effects of COVID-19.Disclosures All Authors: No reported disclosures

A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial.

BackgroundA high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs.ObjectiveThe aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness.MethodsThis feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated.ResultsA total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors.ConclusionsThe intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

Implementation Fidelity of a Complex Behavioral Intervention to Prevent Diabetes Mellitus in Two Safety Net Patient‐Centered Medical Homes in New York City

Research ObjectiveAssessing implementation fidelity is critical for complex interventions to understand the reasons for their success or failure. However, few interventions systematically document and report implementation processes. Therefore, we sought to conduct concurrent process evaluation of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster‐randomized, controlled trial aimed at evaluating the impact of a Community Health Workers (CHW) led, health coaching intervention (in‐person and remotely) on preventing the onset of type 2 Diabetes Mellitus (DM).Study DesignThe Conceptual Framework for Implementation Fidelity (CFIF) was applied to measure implementation fidelity and factors moderating fidelity of the three core intervention components: patient goal setting, education topic coaching with CHWs, and referrals made to address social determinants of health. Descriptive statistics and regression models were computed to determine factors related to fidelity.Population StudiedThe study population included primary care patients with prediabetes range glycemia at two New York City (NYC) safety‐net hospitals (Veterans Administration NY Harbor ‐ VA and Bellevue Hospital ‐ BH). Primary care teams were randomized to receive the CHW‐driven, one‐year intervention. Of the 559 patients enrolled in the intervention arm, 79.4% completed an intake survey, constituting the analytic sample for fidelity assessment.Principal FindingsThe 2 study sites contributed 60% (BH) and 40% (VA) of the sample. Protocol adherence was as intended in the protocol for the 3 core components with more than 80% of patients setting ≥1 goal and receiving coaching on ≥1 education topic, and 45.0% receiving ≥1 referral. After adjusting for patient gender, language, race, ethnicity, and age, the study site moderated adherence to goal setting (77.4% BH vs. 87.7% VA) and having ≥1 education session (78.9% BH vs. 88.3% VA). Study site also moderated rate of encounters (median number of encounters 6 BH vs 4 VA). Scores on the Patient Activation Measure had no impact on fidelity of core intervention components.ConclusionsThe fidelity of CHORD implementation varied across its three core components and was moderated by implementation site.Implications for Policy or PracticeThe CFIF was a useful approach to collect and analyze data concerning implementation fidelity of a complex behavioral intervention. Despite being implemented in a research setting, interventions may not completely adhere to their core components, which can influence outcomes. Our study emphasizes the importance of examining implementation fidelity of complex interventions and of assessing moderating factors. Our study also empirically tested the CFIF using quantitative concurrent process evaluation of core intervention components.Primary Funding SourceNational Institutes of Health.