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Monitoring intervention fidelity of a lifestyle behavioral intervention delivered through telehealth.

ABSTRACT: 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.

SUBMITTER: Sineath A

PROVIDER: S-EPMC5583039 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Monitoring intervention fidelity of a lifestyle behavioral intervention delivered through telehealth.

Sineath Ashley A Lambert Lauren L Verga Catherine C Wagstaff Miranda M Wingo Brooks C BC

mHealth 20170825

<h4>Background</h4>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 interven ...[more]

PMID: 28894745

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Project description:BackgroundTelehealth-delivered dietary interventions are effective for chronic disease management and are an emerging area of clinical practice. However, to apply interventions from the research setting in clinical practice, health professionals need details of each intervention component.ObjectiveThe aim of this study was to evaluate the completeness of intervention reporting in published dietary chronic disease management trials that used telehealth delivery methods.MethodsEligible randomized controlled trial publications were identified through a systematic review. The completeness of reporting of experimental and comparison interventions was assessed by two independent assessors using the Template for Intervention Description and Replication (TIDieR) checklist that consists of 12 items including intervention rationale, materials used, procedures, providers, delivery mode, location, when and how much intervention delivered, intervention tailoring, intervention modifications, and fidelity. Where reporting was incomplete, further information was sought from additional published material and through email correspondence with trial authors.ResultsWithin the 37 eligible trials, there were 49 experimental interventions and 37 comparison interventions. One trial reported every TIDieR item for their experimental intervention. No publications reported every item for the comparison intervention. For the experimental interventions, the most commonly reported items were location (96%), mode of delivery (98%), and rationale for the essential intervention elements (96%). Least reported items for experimental interventions were modifications (2%) and intervention material descriptions (39%) and where to access them (20%). Of the 37 authors, 14 responded with further information, and 8 could not be contacted.ConclusionsMany details of the experimental and comparison interventions in telehealth-delivered dietary chronic disease management trials are incompletely reported. This prevents accurate interpretation of trial results and implementation of effective interventions in clinical practice.

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.

Project description:BackgroundIndividuals with physical disabilities experience higher rates of chronic health conditions than individuals without physical disabilities. Self-management programs that use health coaching are effective at eliciting health behavior change in health outcomes such as goal setting, adherence, and health care use. Additionally, web-based resources such as telehealth-based technologies, including SMSS text messaging, web-based applications, and educational multimedia content, can complement health coaching to improve health-related behaviors and the use of health services. The complexity of studies using these resources requires a fidelity protocol to ensure that health behavior studies are administered properly.ObjectiveThe My Health, My Life, My Way fidelity protocol provides methods, strategies, and procedures of a multifaceted telehealth program for individuals with permanent physical disabilities and chronic health conditions. This health behavior study is a randomized controlled trial with four study arms: (1) scheduled coaching calls with gamified rewards, (2) no scheduled coaching calls with gamified rewards, (3) scheduled coaching calls with fixed rewards, and (4) no scheduled coaching calls with fixed rewards. To guide the fidelity protocol developed, we used the National Institutes of Health Behavior Change Consortium framework (NIH BCC).MethodsThe fidelity intervention protocol was developed by using the 5 primary domains provided by the NIH BCC: study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Following the NIH BCC guidelines and implementing social cognitive theory, this study is designed to ensure that all study arms receive equal treatment across conditions and groups. Health coaches and providers will be trained to deliver consistent health coaching, and thus participants will receive appropriate attention. Educational content will be developed to account for health literacy and comprehension of the material. Multiple fidelity intervention steps such as coaching call logs, regular content review, and participant progress monitoring will translate to participants using the skills learned in their daily lives. Different monitoring steps will be implemented to minimize differences among the 4 treatment groups.ResultsMy Health, My Life, My Way has been approved by the institutional review board and will begin enrollment in January 2024 and end in December 2024, with results reported in early 2025.ConclusionsIntervention fidelity protocols are necessary to ensure that health behavior change studies can be implemented in larger real-world settings. The My Health, My Life, My Way fidelity protocol has used the guidelines by the NIH BCC to administer a telehealth intervention combined with health coaching for individuals with physical disabilities and chronic health conditions. This fidelity protocol can be used as a complementary resource for other researchers who conduct similar research using telehealth technologies and health coaching in real-world settings.Trial registrationClinicalTrials NCT05481593; https://clinicaltrials.gov/study/NCT05481593.International registered report identifier (irrid)PRR1-10.2196/53410.

Project description: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.

Project description:BackgroundLifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care (PHC) has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors.Methods/designThe trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison) group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2) nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3) semi-structured interviews/focus with nurses, managers and clients in 'early intervention' sites to explore the feasibility, acceptability and sustainability of the intervention.DiscussionThe study will provide evidence about the effectiveness and feasibility of brief lifestyle interventions delivered by generalist community nurses as part of routine practice. This will inform future community nursing practice and PHC policy.Trial registrationACTRN12609001081202.

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Monitoring intervention fidelity of a lifestyle behavioral intervention delivered through telehealth.

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Monitoring intervention fidelity of a lifestyle behavioral intervention delivered through telehealth.

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