Feasibility of Automating Fidelity Monitoring in a Dementia Care Intervention
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SUBMITTER: Hodgson N
PROVIDER: S-EPMC7743747 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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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.
| S-EPMC5583039 | biostudies-literature
Project description:ObjectivesPeople with dementia are susceptible to adverse effects of medicines. However, they are not always closely monitored. We explored (1) feasibility and (2) clinical impact of nurse-led medication monitoring.DesignFeasibility "before-and-after" intervention study.SettingThree care homes in Wales.ParticipantsEleven service users diagnosed with dementia, taking at least one antipsychotic, antidepressant, or antiepileptic medicine.InterventionWest Wales Adverse Drug Reaction (ADR) Profile for Mental Health Medicines.Outcome measures(1) Feasibility: recruitment, retention, and implementation. (2) Clinical impact: previously undocumented problems identified and ameliorated, as recorded in participants' records before and after introduction of the profile, and one month later.ResultsNurses recruited and retained 11 of 29 eligible service users. The profile took 20-25 minutes to implement, caused no harm, and supplemented usual care. Initially, the profile identified previously undocumented problems for all participants (mean 12.7 (SD 4.7)). One month later, some problems had been ameliorated (mean 4.9 (3.6)). Clinical gains included new prescriptions to manage pain (2 participants), psoriasis (1), Parkinsonian symptoms (1), rash (1), dose reduction of benzodiazepines (1), new care plans for oral hygiene, skin problems, and constipation.ConclusionsParticipants benefited from structured nurse-led medication monitoring. Clinical trials of our ADR Profile are feasible and necessary.
| S-EPMC3951004 | biostudies-literature
Project description:Background/aimsEnsuring fidelity to a behavioral intervention implemented in nursing homes requires awareness of the unique considerations of this setting for research. The purpose of this article is to describe the goals of care cluster-randomized trial and the methods used to monitor and promote fidelity to a goals of care decision aid intervention delivered in nursing homes.MethodsThe cluster randomized trial tested whether a decision aid for goals of care in advanced dementia could improve (1) the quality of communication and decision-making, (2) the quality of palliative care, and (3) the quality of dying for nursing home residents with advanced dementia. In 11 intervention nursing homes, family decision-makers for residents with advanced dementia received a two-component intervention: viewing a video decision aid about goals of care choices and then participating in a structured decision-making discussion with the nursing home care plan team, ideally within 3 months after the decision aid was viewed. Following guidelines from the National Institutes of Health Behavior Change Consortium, fidelity was assessed in study design, in nursing home staff training for intervention implementation, and in monitoring and receipt of the intervention. We also monitored the content and timing of goals of care discussions.ResultsInvestigators enrolled 151 family decision-maker/resident dyads in intervention sites; of those, 136 (90%) received both components of the intervention, and 92%-99% of discussions addressed each of four recommended content areas-health status, goals of care, choice of a goal, and treatment planning. A total of 94 (69%) of the discussions between family decision-makers and the nursing home care team were completed within 3 months.ConclusionThe methods we used for intervention fidelity allowed nursing home staff to implement a goals of care decision aid intervention for advanced dementia. Key supports for implementation included design features that aligned with nursing home practice, efficient staff training, and a structured guide for goals of care discussions between family decision-makers and staff. These approaches may be used to promote fidelity to behavioral interventions in future clinical trials.
| S-EPMC5133163 | biostudies-literature
Project description:Context:Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed. Objectives:(1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content. Methods:Post-training evaluations, visit checklists, and visit audio-recordings. Results:Data were collected from June, 2016 through April, 2017. We include procedures for (1) identification, training and certification of oncology nurses as CONNECT interventionists; (2) monitoring intervention delivery; and (3) maintaining intervention quality. All nurses (N?=?14) felt prepared to deliver key competencies after a 3-day in-person training. As assessed via visit checklists, interventionists delivered an average of 94% (SD 13%) of key content for first intervention visits and 85% (SD 14%) for subsequent visits. As assessed via audio-recordings, interventionists delivered an average of 85% (SD 8%) of key content for initial visits and 85% (SD 12%) for subsequent visits. Conclusion:We present a 3-part strategy for training interventionists and monitoring and maintaining intervention delivery in a primary palliative care trial. Training was effective in having nurses feel prepared to deliver primary palliative care skills. As assessed via nursing checklists and visit audio-recordings, intervention fidelity was high.
| S-EPMC5898502 | biostudies-literature
Project description:BackgroundInterpreting data about intervention effectiveness requires an understanding of which intervention components were delivered and whether they were delivered as planned (fidelity of delivery). These studies aimed to develop a reliable measure for assessing fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention (COTiD-UK) (Study 1) and measure fidelity of delivery of COTiD-UK across sessions, sites and occupational therapists (Study 2).MethodsThe studies used a longitudinal observational design nested within a multi-site randomised controlled trial. Where practicable, all intervention sessions were audio-recorded. Fidelity checklists and coding guidelines were developed, piloted and refined until good agreement was achieved between two coders. Ten percent of sessions were purposively sampled from 12 sites and 31 occupational therapists. Transcripts were coded using checklists developed in Study 1; 10% of sets of intervention session transcripts were double coded to ensure that agreement was maintained. Percentages of components that were delivered were calculated for each session, site and occupational therapist.ResultsA reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments. COTiD-UK was delivered with moderate fidelity across all six sessions (range: 52.4-75.5%). The mean range of fidelity varied across sites (26.7-91.2%) and occupational therapists (26.7-94.1%).ConclusionsA reliable, systematic method for measuring fidelity of delivery of COTiD-UK was developed and applied, and can be adapted for use in similar interventions. As COTiD-UK was delivered with moderate fidelity, there is a reasonable degree of confidence that intervention effects were attributable to COTiD-UK.
| S-EPMC6929510 | biostudies-literature
Project description:BackgroundResearchers 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.MethodsThe 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.ResultsNo 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).ConclusionOur 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 registrationNCT03075085 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.
| S-EPMC6114253 | biostudies-literature
Project description:ContextEmergency department (ED) visits provide opportunities to empower patients to discuss advance care planning with their outpatient clinicians, but systematically developed, feasible interventions do not currently exist. Brief negotiated interview (BNI) interventions, which allow ED clinicians to efficiently motivate patients, have potential to meet this need.ObjectivesWe developed a BNI ED intervention to empower older adults with life-limiting illness to formulate and communicate medical care goals to their primary outpatient clinicians. This study assessed the fidelity and feasibility of this intervention in a high-volume ED.MethodsWe enrolled adult patients with serious illnesses (advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease on dialysis, predicted survival <12 months) in an urban, tertiary care academic medical center ED. All participants received the BNI intervention. We video-recorded the encounters. Two reviewers assessed the recordings for intervention fidelity based on adherence to the BNI steps (Part I) and communication skills (Part II).ResultsWe reviewed 46 video recordings. The mean total adherence score was 21.07/27 (SD 3.68) or 78.04%. The Part I mean adherence score was 12.07/15 (SD 2.07) or 80.47%. The Part II mean adherence score was 9.0/12 (SD 2.51) or 75%. The majority (75.6%) of recordings met the prespecified threshold for high intervention fidelity.ConclusionED clinicians can deliver a BNI intervention to increase advance care planning conversations with high fidelity. Future research is needed to study the intervention's efficacy in a wider patient population.
| S-EPMC6289886 | biostudies-literature
Project description:Fidelity (consistency of intervention implementation) is essential to rigorous research. Intervention fidelity maintains study internal validity, intervention reproducibility, and transparency in the research conduct. The purpose of this manuscript is to describe intervention fidelity strategies/procedures developed for a pilot study testing a new palliative care nursing intervention (FamPALcare) for families managing advanced lung disease. The procedures described herein are based on the fidelity best practices recommendations from the NIH Consortium. An evidence-based checklist guided observational ratings of the fidelity procedures used and the intervention content implemented in each intervention session. Descriptive data on how participants understood (received), enacted, or used the intervention information were summarized. The fidelity checklist observational scores found ≥93% of the planned intervention content was implemented, and the fidelity strategies were adhered to consistently during each intervention session. The small variation (7%) in implementation was expected and related to participants' varying experiences, input, and/or questions. The helpfulness scale items include participants' ability to use home care resources, to anticipate and manage end-of-life symptoms, and to use Advance Directive forms. The high ratings (M = 4.4) on the 1-5 (very helpful) Likert Helpfulness Scale verified participants utilized the information from the intervention. Furthermore, there was an improvement in patients' breathlessness scores and completion of Advance Directive forms at 3 months after baseline. It is essential to plan intervention fidelity strategies to use throughout a study and to report fidelity results.
| S-EPMC8440457 | biostudies-literature
Project description:ObjectivesPsychosocial support for people with dementia with Lewy bodies (DLB) and family care partners is frequently lacking, despite the need expressed by those with lived experience. Our objective was to examine the feasibility and acceptability of an intervention designed to build coping capability.DesignThe design was non-randomised with all participants receiving the intervention.SettingThe setting was a Memory Assessment and Management Service in the Northeast of England.ParticipantsParticipants comprised 19 dyads consisting of a person with DLB and a family care partner.InterventionThe intervention was group-based, with weekly sessions attended for up to four successive weeks. It was informed by Social Cognitive Theory.MeasurementsData were collected on recruitment, attendance and attrition, self-efficacy, mood, stress and participant experience.ResultsRecruitment was achieved with minimal attrition and three successive groups were delivered. Care partners felt more in control and able to cope in at least 3 of 13 areas with 73% feeling this way in eight or more areas. Three themes were identified from post-intervention interviews: people like us, outcomes from being a group member and intervention design.ConclusionsA DLB-specific group intervention is acceptable to people with DLB and family care partners, and recruitment is feasible within a specialist service. Participation may enhance understanding of this condition and reduce social isolation. It may improve care partners' coping capability particularly if targeted towards those with low prior understanding of DLB and more stress. Means of evaluating outcomes for people with DLB need further development.
| S-EPMC8721619 | biostudies-literature
Project description:BackgroundAdvance care planning (ACP) is highly relevant for people with early-stage dementia to communicate their care preferences for serious illness conditions with their family caregivers before they become mentally incapacitated.MethodsA multi-centre, quasi-experimental study was conducted to test the feasibility and acceptability of a theory-guided, dyadic ACP intervention ('Have a Say' programme) among participants with early-stage dementia-family caregiver dyads. The feasibility of the trial design, intervention procedures, subject recruitment and retention, and study instruments were assessed. Study outcomes were measured at baseline (T0), immediately after the intervention (T1), and at 1 month (T2) and 3 months post-intervention (T3). Acceptability of the intervention was determined by the satisfaction score, completion rate and qualitative interviews as process evaluation with a purposive sample of participants and ACP facilitators. Generalised estimating equations were performed to examine differential changes between groups over time, with covariates adjusted.ResultsSubject recruitment from five elderly community centres yielded a recruitment rate of 60% and resulted in 36 client-caregiver dyads. The intervention was acceptable to the dyads, with a mean satisfaction score of 4.4 out of 5 and completion rate of 94.4%. The attrition rates at T1, T2, and T3 were 8.3%, 13.9%, and 19.4%, respectively. The intervention group reported a significantly greater improvement in the readiness for ACP at T1, self-efficacy for ACP at T3, and dyadic concordance on end-of-life care preferences at all time points than the control group, but not on depressive symptoms. Family caregivers in the intervention group reported a significantly higher caregiving burden at T2 than the control group. The qualitative findings revealed that triadic involvement of and trusting relationships among the dyads and ACP facilitators, and documentation of clients' views are the programme strengths, while the structured format and discussion about medical issues posed implementation challenges.ConclusionsThis ACP intervention and trial design were feasible and acceptable to the dyads. Several refinements were identified, including adding a nurse-led group-based session for information giving, allowing flexibility in arrangement, and adding measure of ACP engagement of family caregivers. A rigorous trial to test the effects of the ACP intervention is warranted.Trial registrationRetrospectively registered on 14/08/2020 at clinicaltrials.gov (Identifier: NCT04513106).
| S-EPMC9979490 | biostudies-literature