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To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education.

ABSTRACT: Self-management education (SME) is a key determinant of diabetes treatment outcomes. While SME programs are often adapted for implementation, the impact of adaptations on diabetes SME effectiveness is not well documented. This study evaluated the impact of the implementation fidelity of diabetes SME programs on program effectiveness, exploring which factors influence implementation fidelity. Data from 33 type 2 diabetes SME program providers and 166 patients were collected in 8 countries (Austria, Belgium, Germany, Ireland, UK, Israel, Taiwan and USA). Program providers completed a questionnaire assessing their adherence to the program protocol and factors that influenced the implementation. Patients answered a pre-post questionnaire assessing their diabetes-related health literacy, self-care behavior, general health and well-being. Associations between implementation fidelity and outcomes were estimated through logistic regressions and repeated measures MANOVA, controlling for potential confounders. Adaptations of the program protocol regarding content, duration, frequency and/or coverage were reported by 39% of the providers and were associated with better, not worse, outcomes than strict adherence. None of the factors related to the participants, facilitating strategies, provider or context systematically influenced the implementation fidelity. Future research should focus on individual and contextual factors that may influence decisions to adapt SME programs for diabetes.

SUBMITTER: Schinckus L

PROVIDER: S-EPMC8069177 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education.

Schinckus Louise L Van den Broucke Stephan S van der Zanden Gerard G Levin-Zamir Diane D Mueller Gabriele G Riemenschneider Henna H Hayter Victoria V Yardley Lucy L Schillinger Dean D Doyle Gerardine G Ganahl Kristin K Pelikan Jürgen J Chang Peter P

International journal of environmental research and public health 20210413 8

Self-management education (SME) is a key determinant of diabetes treatment outcomes. While SME programs are often adapted for implementation, the impact of adaptations on diabetes SME effectiveness is not well documented. This study evaluated the impact of the implementation fidelity of diabetes SME programs on program effectiveness, exploring which factors influence implementation fidelity. Data from 33 type 2 diabetes SME program providers and 166 patients were collected in 8 countries (Austri ...[more]

PMID: 33924494

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Project description:BackgroundPatients with type 2 diabetes require recommendations for self-management education and support.ObjectiveIn this study, we aim to design the Diabetes Engagement and Activation Platform (DEAP)-an automated patient education tool integrated into primary care workflow-and examine its implementation and effectiveness.MethodsWe invited patients aged 18-85 years with a hemoglobin A1c (HbA1c) level ≥8 to participate in a randomized controlled trial comparing DEAP with usual care. DEAP modules addressing type 2 diabetes self-management education and support domains were programmed into patient portals, each with self-guided educational readings, videos, and questions. Care teams received patient summaries and were alerted to patients with low confidence or requesting additional help. HbA1c, BMI, and systolic and diastolic blood pressure (DBP) were measured.ResultsOut of the 680 patients invited to participate, 337 (49.5%) agreed and were randomized. All of the 189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules. Postmodule knowledge and confidence scores were high. Only 18 patients requested additional help from the care team. BMI was lower for intervention patients than controls at 3 months (31.7 kg/m2 vs 32.1 kg/m2; P=.04) and 6 months (32.5 kg/m2 vs 33.0 kg/m2; P=.003); improvements were even greater for intervention patients completing at least one module. There were no differences in 3- or 6-month HbA1c or blood pressure levels in the intent-to-treat analysis. However, intervention patients completing at least one module compared with controls had a better HbA1c level (7.6% vs 8.2%; P=.03) and DBP (72.3 mm Hg vs 75.9 mm Hg; P=.01) at 3 months.ConclusionsThe findings of this study concluded that a significant proportion of patients will participate in an automated virtual diabetes self-management program embedded into patient portals and health systems show promise in helping patients manage their diabetes, weight, and blood pressure.Trial registrationClinicalTrials.gov NCT02957721; https://clinicaltrials.gov/ct2/show/NCT02957721.

Project description:BackgroundHealthcare professionals' person-centered communication skills are pivotal for delivering successful diabetes education. Many healthcare professionals favor person-centeredness as a concept, but implementation in practice remains challenging. Today, programs have often a fixed curriculum dominated by biomedical issues. Most person-centered methods are developed targeting individual consultations, although group-based programs are a widespread and efficient method of support. Person-centeredness in group-based programs requires a change in practice towards addressing biopsychosocial issues and facilitating group processes. The objective of this study was to explore how healthcare professionals implement new approaches to facilitate group-based, person-centered diabetes education targeting people with type 2 diabetes.MethodsThe study was guided by action research and divided into three studies: investigation, development, and pilot using a variety of qualitative methods. In the first study; observations across five settings were conducted. Forty-nine group participants and 13 professionals took part; the focus was to investigate approaches that supported or hindered person-centeredness in groups. Observations were supplemented by interviews (n = 12) and two focus groups (n = 16) with group participants, as well as interviews (n = 5) with professionals. In the second study; 14 professionals collaborated in two workshops to develop new approaches. In the third study, new approaches were pilot-tested using observations in three settings. Twenty-five group participants and five professionals took part. The analysis of the pilot test led to the final workshop where six professionals took part.ResultsImplementation was characterized by three categories. Some professionals chose not to implement the methods because they conflicted with their practice relying on the biomedical model. Other incorporated some approaches but was unable to structure the process, leaving participants uncertain about the aim. Finally, one setting succeeded with implementation, tailoring content and processes to group participants' needs.ConclusionThe use of action research created context-sensitive approaches and increased professionals' readiness to implement. More attention should be paid to systematic training of professionals. Training should be structured stepwise incorporating techniques directed towards existing skills including ample time to train and reiterate skills.

Project description:BackgroundComplex interventions such as self-management courses are difficult to evaluate due to the many interacting components. The way complex interventions are delivered can influence the effect they have for patients, and can impact the interpretation of outcomes of clinical trials. Implementation fidelity evaluates whether complex interventions are delivered according to protocol. Such assessments have been used for one-to-one psychological interventions; however, the science is still developing for group interventions.MethodsWe developed and tested an instrument to measure implementation fidelity of a two-day self-management course for people with epilepsy, SMILE(UK). Using audio recordings, we looked at adherence and competence of course facilitators. Adherence was assessed by checklists. Competence was measured by scoring group interaction, an overall impression score and facilitator "didacticism". To measure "didacticism", we developed a novel way to calculate facilitator speech using computer software. Using this new instrument, implementation fidelity of SMILE(UK) was assessed on three modules of the course, for 28% of all courses delivered.ResultsUsing the instrument for adherence, scores from two independent raters showed substantial agreement with weighted Kappa of 0.67 and high percent agreement of 81.2%. For didacticism, the results from both raters were highly correlated with an intraclass coefficient of 0.97 (p < 0.0001). We found that the courses were delivered with a good level of adherence (> 50% of scored items received the maximum of 2 points) and high competence. Groups were interactive (mean score: 1.9-2.0 out of 2) and the overall impression was on average assessed as "good". Didacticism varied from 42% to 93% of total module time and was not associated with the other competence scores.ConclusionThe instrument devised to measure implementation fidelity was reproducible and easy to use. The courses for the SMILE(UK) study were delivered with a good level of adherence to protocol while not compromising facilitator competence.Trial registrationISRCTN57937389 .

Project description:BackgroundNative Hawaiians and Pacific Islanders (NHPIs) experience a disproportionate burden of type 2 diabetes and related complications. Although diabetes self-management education and support (DSMES) interventions have generally yielded positive results, few NHPIs have been included in these studies, and even fewer studies have been evaluated using a randomized controlled trial design and/or implementation research methods. The purpose of this pilot study was to evaluate implementation outcomes of a culturally adapted diabetes self-management education intervention delivered by peer educators to Native Hawaiians and Pacific Islanders residing in Honolulu, Hawai'i.MethodsIn three study sites, the peer educators and 48 participants randomized to the intervention were invited to participate in the mixed methods implementation research. We used a convergent parallel design to collect implementation data including fidelity, feasibility, acceptability, appropriateness, adoption, and sustainability. Data were collected from class observations, participants' class feedback, and post-intervention focus groups with participants and peer educators.ResultsIn 314 end-of-class feedback surveys, 97% of respondents expressed that they were satisfied or highly satisfied with the class content and activities, 98% reported that the classes and materials were very useful, 94% reported very applicable, and 93% reported materials were culturally appropriate. Respondents identified several aspects of the program as especially enjoyable: interactions with peer educators, meeting in groups, learning about other participants' experiences with diabetes, and the information presented in each class. Major themes that emerged from the end-of-intervention focus groups were the relevance of the educational materials, strategies to manage blood glucose, hands-on activities, cultural aspects of the program, including the stories and analogies used to convey information, and appreciation of the group format and peer educators.ConclusionsResults from this research support a culturally tailored, peer educator approach to DSMES among NHPIs. Delivery of the Partners in Care program is feasible in health care and community settings and is a reimbursable DSMES program.Trial registrationClinicaltrials.gov Identifier: NCT01093924 prospectively registered 01.20.09.

Project description:BackgroundDelivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health.ObjectiveThis study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months.MethodsThis randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models.ResultsA total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).ConclusionsThe MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement.Trial registrationAustralia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.

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To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education.

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To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education.

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