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Fidelity monitoring in complex interventions: a case study of the WISE intervention.

ABSTRACT: Background:Researchers face many decisions in developing a measurement tool and protocol for monitoring fidelity to complex interventions. The current study uses data evaluating a nutrition education intervention, Together, We Inspire Smart Eating (WISE), in a preschool setting to explore issues of source, timing, and frequency of fidelity monitoring. Methods:The overall study from which these data are drawn was a pre/post design with an implementation-focused process evaluation. Between 2013 and 2016, researchers monitored fidelity to evidence-based components of the WISE intervention in 49 classrooms in two Southern states. Data collectors obtained direct assessment of fidelity on a monthly basis in study classrooms. Research staff requested that educators provide indirect assessment on a weekly basis. We used mean comparisons (t-tests), correlations (Pearson's r), and scatterplots to compare the direct and indirect assessments. Results:No mean comparisons were statistically different. Correlations of direct and indirect assessments of the same component for the same month ranged between -?0.51 (p?=?0.01) and 0.54 (p?=?0.001). Scatterplots illustrate that negative correlations can be driven by individuals who are over reporting (i.e., self-report bias) and that near zero correlations approximate the ideal situation (i.e., both raters identify high fidelity). Conclusion:Our findings illustrate that, on average, observed and self-reports may seem consistent despite weak correlations and individual cases of extreme over reporting by those implementing the intervention. The nature of the component to which fidelity is being monitored as well as the timing within the context of the intervention are important factors to consider when selecting the type of assessment and frequency of fidelity monitoring. Trial registration:NCT03075085 Registered 20 February 2017. Trial registration corresponds to the funding that supported the writing of this manuscript, not the data collection. The original study was not a trial and was collected without registration. However, the data reported here provided foundational preliminary data for the trial.

SUBMITTER: Swindle T

PROVIDER: S-EPMC6114253 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Fidelity monitoring in complex interventions: a case study of the WISE intervention.

Swindle Taren T Selig James P JP Rutledge Julie M JM Whiteside-Mansell Leanne L Curran Geoff G

Archives of public health = Archives belges de sante publique 20180829

<h4>Background</h4>Researchers face many decisions in developing a measurement tool and protocol for monitoring fidelity to complex interventions. The current study uses data evaluating a nutrition education intervention, Together, We Inspire Smart Eating (WISE), in a preschool setting to explore issues of source, timing, and frequency of fidelity monitoring.<h4>Methods</h4>The overall study from which these data are drawn was a pre/post design with an implementation-focused process evaluation. ...[more]

PMID: 30181874

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Project description:Objectives: The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences.Design: Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention.Setting: The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations.Participants: 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded.Interventions: The course was run over three and a half days; facilitators delivered a semistructured manualised course.Outcomes: We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression.Results: We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67-2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25-2.00). Overall impression was three (maximum 4, IQR 2.00-3.00).Conclusions: Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions.Trial registration isrctn no: ISRCTN24426731.

Project description:BackgroundIntervention fidelity is the degree to which interventions have been implemented as intended by their developers. Assessing fidelity is crucial for accurate interpretation of intervention effectiveness, but fidelity is often poorly addressed within trials of complex healthcare interventions. The reasons for this are unclear, and information on the use of methods to enhance and assess fidelity in trials of complex interventions remains insufficient. This study aimed to explore the knowledge, practice and attitudes towards intervention fidelity amongst researchers, triallists and healthcare professionals involved with the design and conduct of trials of complex healthcare interventions.MethodsAn online survey consisting of closed and open-ended questions exploring four sections (Demographics, Fidelity knowledge, Practice and Attitudes) was conducted. This was an opportunistic sample of individuals with experience of direct involvement in trials of complex healthcare interventions (e.g. design/development, conduct, evaluation).ResultsData from 264 participants representing 15 countries were analysed. The majority (65.9%, n?=?174) of participants identified themselves as 'Researchers'. The majority of participants were familiar with the term "intervention fidelity" (69.7%, n?=?184) and indicated that fidelity is important (89.7%, n?=?236). Mean self-reported understanding of fidelity was moderate. Although 68% (n?=?182) had previously used strategies to assess (e.g. audio/video-recording sessions) and enhance (e.g. training manual) fidelity in trials of complex interventions, only a limited proportion of participants indicated always reporting these strategies in subsequent publications (30.9%, n?=?56). Poor knowledge or understanding was the most commonly cited barrier to addressing intervention fidelity in trials (77.4%, n?=?202). Over half of respondents (52.1%, n?=?137) had never completed specific fidelity training or research, and the vast majority (89.7%, n?=?236) would welcome specific training in this area.ConclusionDespite good awareness of intervention fidelity and its importance, poor knowledge and understanding appears to be a key factor limiting how intervention fidelity is addressed in trials of complex interventions. Participants identified a need for further training and education in this area. Additionally, clarification of the terminology, definition and components of intervention fidelity would facilitate better understanding of the concept. A discrepancy between participants' use of fidelity strategies and subsequent reporting raises concerns around inadequate fidelity reporting in the trials literature.

Project description:BACKGROUND:Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS:The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS:A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS:The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.

Project description:OBJECTIVES:To understand whether interventions are effective, we need to know whether the interventions are delivered as planned (with fidelity) and engaged with. To measure fidelity and engagement effectively, high-quality measures are needed. We outline a five-step method which can be used to develop quality measures of fidelity and engagement for complex health interventions. We provide examples from a fidelity study conducted within an evaluation of an intervention aimed to increase independence in dementia. METHODS:We propose five steps that can be systematically used to develop fidelity checklists for researchers, providers, and participants to measure fidelity and engagement. These steps include the following: (1) reviewing previous measures, (2) analysing intervention components and developing a framework outlining the content of the intervention, (3) developing fidelity checklists and coding guidelines, (4) obtaining feedback about the content and wording of checklists and guidelines, and (5) piloting and refining checklists and coding guidelines to assess and improve reliability. RESULTS:Three fidelity checklists that can be used reliably were developed to measure fidelity of and engagement with, the Promoting Independence in Dementia (PRIDE) intervention. As these measures were designed to be used by researchers, providers, and participants, we developed two versions of the checklists: one for participants and one for researchers and providers. CONCLUSIONS:The five steps that we propose can be used to develop psychometrically robust and implementable measures of fidelity and engagement for complex health interventions that can be used by different target audiences. By considering quality when developing measures, we can be more confident in the interpretation of intervention outcomes drawn from fidelity and engagement studies. Statement of contribution What is already known on the subject? Fidelity and engagement can be measured using a range of methods, such as observation and self-report. Studies seldom report psychometric and implementation qualities of fidelity measures. What does this study add? A method for developing fidelity and engagement measures for complex health interventions. Guidance on how to consider quality when developing fidelity and engagement measures.

Project description:IntroductionIntervention fidelity concerns the degree to which interventions are implemented as intended. Fidelity frameworks propose fidelity is a multidimensional concept relevant at intervention designer, provider, and recipient levels; yet the extent to which it is assessed multidimensionally is unclear. Smoking cessation interventions are complex, including multiple components, often delivered over multiple sessions and/or at scale in clinical practice; this increases susceptibility variation in the fidelity with which they are delivered. This review examined the extent to which five dimensions from the Behaviour Change Consortium fidelity framework (design, training, delivery, receipt, and enactment) were assessed in fidelity assessments of smoking cessation interventions (randomised control trials (RCTs)).MethodsFive electronic databases were searched using terms "smoking cessation," "interventions," "fidelity," and "randomised control trials." Eligible studies included RCTs of smoking cessation behavioural interventions, published post 2006 after publication of the framework, reporting assessment of fidelity. The data extraction form was structured around the framework, which specifies a number of items regarding assessment and reporting of each dimension. Data extraction included study characteristics, dimensions assessed, data collection, and analysis strategies. A score per dimension was calculated, indicating its presence.Results55 studies were reviewed. There was a wide variability in data collection approaches used to assess fidelity. Fidelity of delivery was the most commonly assessed and linked to the intervention outcomes (73% of the studies). Fidelity of enactment scored the highest according to the framework (average of 92.7%), and fidelity of training scored the lowest (average of 37.1%). Only a quarter of studies linked fidelity data to outcomes (27%).ConclusionThere is wide variability in methodological and analytical approaches that precludes comparison and synthesis. In order to realise the potential of fidelity investigations to increase scientific confidence in the interpretation of observed trial outcomes, studies should include analyses of the association between fidelity data and outcomes. Findings have highlighted recommendations for improving fidelity evaluations and reporting practices.

Project description:Objectives Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. Design We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. Intervention The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. Results The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. Conclusions The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. Trial registration number ISRCTN67209155.

Dataset Information

Fidelity monitoring in complex interventions: a case study of the WISE intervention.

Publications

Fidelity monitoring in complex interventions: a case study of the WISE intervention.

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