Dignity therapy intervention fidelity: a cross-sectional descriptive study with older adult outpatients with cancer

Objectives Intervention fidelity is imperative to ensure confidence in study results and intervention replication in research and clinical settings. Like many brief protocol psychotherapies, Dignity Therapy lacks sufficient evidence of intervention fidelity. To overcome this gap, our study purpose was to examine intervention fidelity among therapists trained with a systematized training protocol. Methods For preliminary fidelity evaluation in a large multi-site stepped wedge randomized controlled trial, we analyzed 46 early transcripts of interviews from 10 therapists (7 female; 7 White, 3 Black). Each transcript was evaluated with the Revised Dignity Therapy Adherence Checklist for consistency with the Dignity Therapy protocol in terms of its Process (15 dichotomous items) and Core Principles (6 Likert-type items). A second rater independently coded 26% of the transcripts to assess interrater reliability. Results Each therapist conducted 2 to 10 interviews. For the 46 scored transcripts, the mean Process score was 12.4/15 (SD = 1.2), and the mean Core Principles score was 9.9/12 (SD = 1.8) with 70% of the transcripts at or above the 80% fidelity criterion. Interrater reliability (Cohen’s kappa and weighted kappa) for all Adherence Checklist items ranged between .75 and 1.0. For the Core Principles items, Cronbach’s alpha was .92. Conclusions Preliminary findings indicate that fidelity to Dignity Therapy delivery was acceptable for most transcripts and provide insights for improving consistency of intervention delivery. The systematized training protocol and ongoing monitoring with the fidelity audit tool will facilitate consistent intervention delivery and add to the literature about fidelity monitoring for brief protocol psychotherapeutic interventions.

A study to investigate the implementation process and fidelity of a hospital to community pharmacy transfer of care intervention

Background Hospital to community pharmacy transfer of care medicines-related interventions for inpatients discharged home aim to improve continuity of care and patient outcomes. One such intervention has been provided for seven years within a region in England. This study reports upon the implementation process and fidelity of this intervention. Methods The process evaluation guidance issued by the Medical Research Council has informed this study. A logic model to describe the intervention and causal assumptions was developed from preliminary semi-structured interviews with project team members. Further semi-structured interviews were undertaken with intervention providers from hospital and community pharmacy, and with patient and public representatives. These aimed to investigate intervention implementation process and fidelity. The Consolidated Framework for Implementation Research and the Consolidated Framework for Intervention Fidelity informed interview topic guides and underpinned the thematic framework analysis using a combined inductive and deductive approach. Results Themes provided information about intervention fidelity and implementation that were mapped across the sub processes of implementation: planning, execution, reflection and evaluation, and engagement. Interviewees described factors such as lack of training, awareness, clarity on the service specification, governance and monitoring and information and feedback which caused significant issues with the process of intervention implementation and suboptimal intervention fidelity. Conclusions This provides in-depth insight into the implementation process and fidelity of a ToC intervention, and the extant barriers and facilitators. The findings offer learning to inform the design and implementation of similar interventions, contribute to the evidence base about barriers and facilitators to such interventions and provides in-depth description of the implementation and mechanisms of impact which have the potential to influence clinical and economic outcome evaluation.

Psychological Impacts of COVID–19 on Healthcare Trainees and Perceptions towards a Digital Wellbeing Support Package

We explore the impact of COVID–19 on the psychological wellbeing of healthcare trainees, and the perceived value of a digital support package to mitigate the psychological impacts of the pandemic (PoWerS Study). This mixed–methods study includes (i) exposure to a digital support package; (ii) participant survey to assess wellbeing, perceptions of work and intervention fidelity; (iii) semi–structured qualitative interviews. Interviews were digitally recorded and transcribed, data were handled and analysed using principles of thematic framework analysis. Participants are 42 health and medical trainees (9M, 33F) from 13 higher education institutions in the UK, studying during the COVID–19 pandemic. Survey findings showed high satisfaction with healthcare training (92.8%), but low wellbeing (61.9%), moderate to high perceived stressfulness of training (83.3%), and high presenteeism (50%). Qualitative interviews generated 3 over–arching themes, and 11 sub–themes. The pandemic has impacted negatively on emotional wellbeing of trainees, yet mental health is not well promoted in some disciplines, and provision of pastoral support is variable. Disruption to academic studies and placements has reduced perceived preparedness for future clinical practice. Regular check–ins, and wellbeing interventions will be essential to support the next generation health and care workforce, both in higher education and clinical settings. The digital support package was perceived to be accessible, comprehensive, and relevant to healthcare trainees, with high intervention fidelity. It is a useful tool to augment longer–term provision of psychological support for healthcare trainees, during and after the COVID–19 pandemic.

Assessing the fidelity of a peer-led chronic pain management program (PAP)

Background Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP’s intervention fidelity. Methods To optimize fidelity to the intervention, we used various strategies and measured them in a continuous process using several different approaches: (a) peer volunteer (PV) training workshop, (b) biweekly meetings with the research team, (c) a detailed teaching manual, (d) a fidelity checklist, (e) on-site visits and direct observations, and (f) semi-structured interview. Results The PVs’ attendance was high, and most of them achieved a high level of implementation in following the fidelity checklist. As part of a large clustered RCT, the fidelity assessment was carried out to help determine the effectiveness of the intervention. Conclusions Overall, the PVs successfully delivered the intervention, and the results of the study indicate the effectiveness of the PAP. Trial registration ClinicalTrials.govNCT03823495. Registered on 30 January 2019.

Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial

Background Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. Objective The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. Methods We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. Results Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. Conclusions Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. Trial Registration ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. International Registered Report Identifier (IRRID) PRR1-10.2196/31695

IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) – study protocol for a cluster-randomized trial

Background IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effectiveness of bundled implementation strategies on intervention fidelity of the Healthy School Start (HSS) program, while simultaneously monitoring effects on health outcomes of children and parents. The HSS is a 4-component family support program for children starting school (5–7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents’ risk of developing type 2 diabetes. Methods IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months (primary outcomes). Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1 + 2 (Enhanced). Bundle 2 consists of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include change in acceptability, appropriateness, feasibility, and organisational readiness as perceived by school staff. In addition, child weight status and diet, and parents’ feeding practices and risk of type 2 diabetes will be monitored. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering and covariates into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and perceptions on sustainability. Discussion This systematic approach to investigating the effectiveness of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and external support needed for the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools. Trial registration Registered prospectively at ClinicalTrials.gov ID: NCT04984421, registered July 30, 2021

Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. OBJECTIVE The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. METHODS We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. RESULTS Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. CONCLUSIONS Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. CLINICALTRIAL ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/31695