Framework For Implementation Fidelity Research Articles

Effects of implementation of a care bundle on rates of necrotising enterocolitis and own mother’s milk feeding in the East Midlands: protocol for a mixed methods impact and process evaluation study

IntroductionPrevention of necrotising enterocolitis (NEC) is vital for improving neonatal outcomes. Feeding own mother’s milk helps prevent NEC. Rates of own mother’s milk feeding in the East Midlands are lower...

Evaluating the Implementation Fidelity of a Pilot Pragmatic Randomized Clinical Trial Comparing Daily-Delivered Meals to Mailed Frozen Meals.

In pragmatic clinical trials (PCTs), the intervention is carried out by participating sites instead of research staff. In this paper, we evaluate study sites' implementation adherence during a pilot PCT of home-delivered meals for older adults with dementia. Participants at three home-delivered meal programs were randomized to receive either (1) meals delivered daily or (2) frozen meals mailed every two weeks; participants' outcomes were tracked for six months. Using the adherence domains from the Framework for Implementation Fidelity, we identified six metrics to assess adherence, with a total possible adherence score ranging from 6 (low adherence) to 18 (high adherence); all three sites scored within the top quartile of adherence. Despite challenges to meal delivery during the COVID-19 pandemic, sites successfully implemented the intervention, justifying a follow-on PCT to test the comparative effectiveness of models of meal delivery on the time to nursing home placement for people living with dementia.

Fidelity of implementation of national guidelines on malaria diagnosis for children under-five years in Rivers State, Nigeria

BackgroundMalaria is still a disease of global public health importance and children under-five years of age are the most vulnerable to the disease. Nigeria adopted the “test and treat” strategy in the national malaria guidelines as one of the ways to control malaria transmission. The level of adherence to the guidelines is an important indicator for the success or failure of the country’s roadmap to malaria elimination by 2030. This study aimed to assess the fidelity of implementation of the national guidelines on malaria diagnosis for children under-five years and examine its associated moderating factors in health care facilities in Rivers State, Nigeria.MethodsThis was a descriptive, cross-sectional study conducted in Port Harcourt metropolis. Data were collected from 147 public, formal private and informal private health care facilities. The study used a questionnaire developed based on Carroll’s Conceptual Framework for Implementation Fidelity. Frequency, mean and median scores for implementation fidelity and its associated factors were calculated. Associations between fidelity and the measured predictors were examined using Mann Whitney U test, Kruskal Wallis test, and multiple linear regression modelling using robust estimation of errors. Regression results are presented in adjusted coefficient (β) and 95% confidence intervals.ResultsThe median (IQR) score fidelity score for all participants was 65% (43.3, 85). Informal private facilities (proprietary patent medicine vendors) had the lowest fidelity scores (47%) compared to formal private (69%) and public health facilities (79%). Intervention complexity had a statistically significant inverse relationship to implementation fidelity (β = − 1.89 [− 3.42, − 0.34]). Increase in participant responsiveness (β = 8.57 [4.83, 12.32]) and the type of malaria test offered at the facility (e.g., RDT vs. no test, β = 16.90 [6.78, 27.03]; microscopy vs. no test, β = 21.88 [13.60, 30.16]) were positively associated with fidelity score.ConclusionsThis study showed that core elements of the “test and treat” strategy, such as testing all suspected cases with approved diagnostic methods before treatment, are still not fully implemented by health facilities. There is a need for strategies to increase fidelity, especially in the informal private health sector, for malaria elimination programme outcomes to be achieved.

PRAGMATIC IMPLEMENTATION OF A BEHAVIORAL INTERVENTION PRE- AND POSTPANDEMIC: A TALE OF TWO TRIALS

Abstract We describe two embedded pragmatic trials (ePCTs) of a personalized music intervention for nursing home (NH) residents with ADRD conducted pre-COVID (2019) and 2021 (COVID). Between trials, the implementation strategy was modified to incorporate learnings from the first trial and to address COVID-related restrictions. 54 intervention NHs (27 from Trial 1, 27 from Trial 2) comprised the sample. We compare the trials using the Framework for Implementation Fidelity (FIF) criteria: coverage (number of residents who received the intervention); duration (dose of music received); and frequency (how often nursing staff used the music with the residents). Adherence was worse in Trial 2 (post-COVID) versus Trial 1 (pre-COVID). On average, 12.7 (SD: 3.6) residents were exposed per NH in Trial 1 and 7.5 (SD: 5.5) in Trial 2. Median minutes of music per day was 27.1 (SD: 23.9) minutes in Trial 1 and 2.5 (SD: 5.2) minutes in Trial 2. A greater proportion of exposed residents had nursing staff administer music in Trial 1 (frequency; 0.4 (SD:0.3)) than Trial 2 (0.2 (0.3)). Despite changes to increase nursing engagement and clinical targeting, adherence to intervention was dramatically lower in Trial 2 than in Trial 1. While it is impossible to completely disentangle changes to the implementation strategy from the lingering effects of COVID, it is clear that the NH environment fundamentally changed during the pandemic. With that change comes the need to re-evaluate strategies for implementation and incentivizing participation

CORPORATE PERSPECTIVES OF A NATIONAL NURSING HOME PRAGMATIC TRIAL AND FACTORS AFFECTING IMPLEMENTATION FIDELITY

Abstract Implementation fidelity is concerning for embedded pragmatic clinical trials (ePCTs), where effectiveness is evaluated in real-world settings instead of a structured clinical environment. Healthcare facilities paused ePCT research activities during the COVID-19 pandemic to address related staffing issues and infections. We examined a 54-nursing-home ePCT implementing Music & Memory, a nonpharmacological intervention using music to improve quality of life for residents living with dementia. Our qualitative study describes factors influencing implementation fidelity across four nursing home corporations. The interview guide assesses corporate perceptions of implementation barriers, facilitators, and participation incentives. Themes were organized within the Conceptual Framework for Implementation Fidelity’s potential modifying factors: 1) context, 2) participant responsiveness, 3) intervention complexity, 4) facilitation strategies, 5) quality of delivery, and 6) recruitment. Interviewees (n=4) lead corporate-wide dementia initiatives. 1) Context: COVID-19-related capacity issues and local “champion” turnover impacted success. 2) Participant responsiveness: Developing playlists strengthened staff-resident relationships, although time-consuming and requiring staff competency. Residents experienced decreased agitation while staff satisfaction increased. 3) Intervention complexity: Brown’s research team adapted processes to save staff time. 4) Facilitation strategies: The relationship with Brown promoted problem-solving. 5) Quality of delivery: The ePCT was an effective, non-pharmacological approach addressing dementia symptoms. 6) Recruitment: Corporate leadership makes decisions regarding individual nursing homes’ recruitment in research. Financial incentives did not drive participation, although some voiced appreciation for offsetting time and resources invested. Recommendations for future efforts included in-person champion training and site-specific quality improvement efforts. Researchers maintaining relationships with corporate and local leadership promotes sustainable engagement.

Pragmatic Implementation of a Music Intervention in Nursing Homes Before and During COVID-19

ObjectivesWe conducted 2 trials of a music intervention for managing behaviors in nursing home (NH) residents with dementia, before (2019) and during (2021) the pandemic. In this report, we compare adherence fidelity across the trials using the Framework for Implementation Fidelity (FIF). DesignCross-sectional, descriptive implementation comparison. Setting and ParticipantsFifty-four NHs randomized to receive the intervention (27 pre-COVID, 27 during COVID) MethodsWe compare the trials on the following FIF criteria: coverage (number of residents receiving the intervention); duration (minutes of music received per exposed day); frequency (percentage of residents with nursing staff use of music in the past week); and details of content (adherence to core components of the intervention). We report NH-level performance in each domain and compare characteristics of NHs in the bottom (low) and top (high) terciles of adherence. ResultsAcross FIF domains, adherence fidelity was lower during COVID compared with pre-COVID: coverage, residents exposed (COVID: 7.5, SD 5.6; pre-COVID: 12.7, SD 3.6); duration, music minutes per exposed day (COVID: 2.5, SD 5.1; pre-COVID: 27.1, SD 23.9); frequency, percentage of residents with nursing use of intervention in the past week (COVID: 15.0, SD 31.5; pre-COVID 40.4, SD 25.6); and details of content, compliance with core components of the intervention (COVID: 8.3, SD 1.9; pre-COVID 9.6, SD 2.0). In both trials, high–adherence fidelity NHs had better nursing staff ratios, greater percentages of Medicare residents, and lower percentages of Black residents, compared with low-fidelity NHs. Conclusions and ImplicationsAdherence fidelity was worse in the COVID vs pre-COVID trial, despite adaptations between trials intended to reduce staff burden and increase clinical targeting of the intervention. Results may point to the long-term effects of COVID on quality improvement capacity in NHs and/or a lack of available resources in most NHs to implement complex behavioral interventions without direct research support.

Assessing implementation fidelity of an on-site pharmacist intervention within Australian residential aged care facilities: A mixed methods study

BackgroundAn on-site pharmacist (OSP) intervention was implemented which sought to improve medication management within residential aged care facilities (RACFs) in the Australian Capital Territory, Australia. The objectives of this mixed methods study were to evaluate the implementation fidelity of the OSP intervention and to determine the moderating factors which influenced delivery of this intervention.MethodsThis convergent parallel mixed methods study was underpinned by Hasson’s conceptual framework for implementation fidelity. Implementation fidelity for seven intervention RACFs was quantitatively assessed using three quantitative data sets: (1) range of OSP intervention activities delivered; (2) random sample of 10% of medication reviews assessed for quality; (3) proportion of residents who received at least one medication review. Semi-structured interviews (n = 14) with managers and OSPs across the intervention RACFs were conducted to identify moderating factors which may have influenced OSP intervention delivery.ResultsThe OSP intervention was generally delivered as intended with overall medium levels of implementation fidelity. This delivery was supported by a range of facilitation strategies with most participants perceiving that the intervention was delivered to a high standard. RACF managers and OSPs were mostly well engaged and responsive. A number of potential barriers (including the part-time OSP role, COVID-19 pandemic, RACFs spread out over a large area with significant distance between resident dwellings) and facilitators (including the pharmacist support meetings, OSPs who took time to establish relationships, RACF managers who actively supported OSPs and worked with them) for OSP intervention delivery were identified which have potential implications for the roll out of OSPs within Australian RACFs.ConclusionIn this study, the implementation fidelity of OSP intervention delivery was assessed with overall medium levels of fidelity found across the intervention RACFs. This suggested that the OSP intervention can generally be delivered as intended in real world RACFs. OSP intervention delivery was influenced by a range of moderating factors, some of which posed barriers and others which facilitated the OSP intervention being delivered as intended.

Implementation fidelity to HIV assisted partner services (aPS) during scale-up in western Kenya: a convergent mixed methods study

BackgroundHIV assisted partner services (aPS) is an intervention to improve HIV status awareness among sex and drug-injecting partners of people newly diagnosed with HIV (index clients). Implementation fidelity—the degree to which an intervention is conducted as intended – is critical to effectiveness, but there are limited data about aPS fidelity when delivered by HIV testing service (HTS) providers. We explored factors affecting implementation fidelity to aPS in two high-HIV prevalence counties in western Kenya.MethodsWe used convergent mixed methods adapting the conceptual framework for implementation fidelity within the aPS scale-up project. This was an implementation study examining scale-up of APS within HTS programs in Kisumu and Homa Bay counties that recruited male sex partners (MSPs) of female index clients. We defined implementation fidelity as the extent to which HTS providers followed the protocol for phone and in-person participant tracing at six expected tracing attempts. Quantitative data were collected from tracing reports in 31 facilities between November 2018 and December 2020, and in-depth interviews (IDIs) were conducted with HTS providers. Descriptive statistics were used to describe tracing attempts. IDIs were analyzed using thematic content analysis.ResultsOverall, 3017 MSPs were mentioned of whom 98% (2969/3017) were traced, with most tracing attempts being successful (2831/2969, 95%). Fourteen HTS providers participated in the IDIs—mostly females (10/14, 71%) with a median age of 35 years (range 25–52), who all had post-secondary education (14/14, 100%). The proportion of tracing attempts occurring by phone ranged from 47 to 66%, with the highest proportion occurring on the first attempt and lowest on the sixth attempt. Contextual factors either enhanced or impeded implementation fidelity to aPS. Positive provider attitudes towards aPS and conducive work environment factors promoted implementation fidelity, while negative MSP responses and challenging tracing conditions impeded it.ConclusionInteractions at the individual (provider), interpersonal (client—provider), and health systems (facility) levels affected implementation fidelity to aPS. As policymakers prioritize strategies to reduce new HIV infections, our findings highlight the importance of conducting fidelity assessments to better anticipate and mitigate the impact of contextual factors during the scale-up of interventions.

Implementation fidelity of the ‘Stay One Step Ahead’ home safety intervention: a mixed-methods analysis

ObjectiveTo assess implementation fidelity of the Stay One Step Ahead (SOSA), a complex intervention which was delivered by health visiting teams, children’s centres, and family mentors and was aimed at...

Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices

BackgroundIt is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY).MethodsWe applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure.ResultsContent adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA).ConclusionsThe fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions.Trial registrationThe trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666.

Assessing the implementation fidelity of HPV self-collection offered by community health workers during home visits (the EMA strategy): a case study in a low-middle-resource setting in Argentina

BackgroundIn Argentina, HPV self-collection offered by community health workers was demonstrated to be effective to improve cervical cancer screening uptake. Based on these findings, the EMA strategy was scaled up in nine Argentinian provinces. However, there is no evidence about the degree of fidelity—in relation to the core components proposed by the National Program on Cervical Cancer Prevention—with which this strategy was implemented in the new jurisdictions. We carried out a fidelity evaluation of the EMA strategy scaling-up aimed at evaluating the level of adherence to the core components of the EMA strategy, and how different moderating factors affected the implementation fidelity.MethodsThis descriptive study used a multi-method approach involving quantitative and qualitative evaluations of the implementation fidelity using the Conceptual Framework for Implementation Fidelity. Evaluation of the degree of adherence to the core components of the EMA strategy was carried out through the analysis of a self-administered survey of health promoters, observations, and secondary data from the National Screening Information System. The analysis of moderating factors was carried out through analysis of field notes, and semi-structured interviews with key stakeholders.ResultsOur results showed that the core components with highest fidelity were training, sample handling, and transportation. Regarding the offer of HPV self-collection, we found some adaptations such as locations in which health promoters offered HPV self-collection, and fewer pieces of information provided to women during the offer. In the follow-up and treatment core component, we found a reduced adherence to triage and colposcopy. Some contextual factors had a negative impact on implementation fidelity, such as urban insecurity and the reduction in the number of health promoters that offered HPV self-collection. Moderating factors that contributed to achieve high level of fidelity included a well-defined strategy with clear steps to follow, permanent feedback and high level of engagement among implementers.ConclusionsOur study shows how the analysis of fidelity and adaptations of HPV self-collection in real-world contexts are key to measure and maximize its effectiveness in low-middle-income settings.

EVALUATING IMPLEMENTATION FIDELITY TO A NURSE-LED CARE MODEL IN NURSING HOMES: A MIXED-METHODS STUDY

Abstract Implementation fidelity assesses the degree to which an intervention is delivered as intended. Little is known about how it acts as a moderator between an intervention and its intended outcome(s) and which factors affect the fidelity trajectory over time. We exemplify implementation fidelity in INTERCARE, a nurse-led care model implemented in eleven Swiss nursing homes (NH) successfully decreasing unplanned hospital transfers. A mixed-methods design was used, guided by the Conceptual Framework for Implementation Fidelity. Fidelity to INTERCARE’s core components was measured with 44 self-developed items at 4-time points (baseline, 6, 12 months after intervention start, 9 months post-intervention; fidelity scores were calculated for each component and overall. Structured notes from NH meetings were used to identify moderators affecting the fidelity trajectory over time. Generalized linear mixed models were computed to analyze the quantitative data. Deductive thematic analysis was used for the qualitative analysis. The quantitative and qualitative findings were integrated using triangulation. A higher overall fidelity score showed a decreasing rate of unplanned hospital transfers (OR: 0.65 (CI=0.43-0.99), p=0.047). Higher fidelity score to advance care planning was associated with lower unplanned transfers (OR= 0.24 (CI 0.13-0.44), p= < 0.001) and a lower fidelity score for communication tools (e.g., ISBAR) to higher rates in unplanned transfers (OR= 1.69 (CI 1.30-2.19), p= < 0.003). High implementation fidelity to INTERCARE was necessary to achieve a reduction in unplanned transfers. In-house physicians with a collaborative approach and staff’s perceived need for nurses working in extended roles were important factors for high fidelity.

Protocol for a Mixed-Methods Process Evaluation of BetterBrains: A Person-Centered Online Intervention to Delay Cognitive Decline in Adults at Risk of Dementia.

The BetterBrains Randomized Controlled Trial (RCT) will evaluate the effectiveness of an online, person-centered, risk factor management, coaching intervention in community-dwelling, healthy adults at risk of cognitive decline. Multi-component interventions are challenging to evaluate due to program complexity and personalization to individual needs and contexts. This paper describes a multi-level process evaluation conducted alongside the BetterBrains RCT. To understand how and why the BetterBrains intervention was effective or ineffective at reducing cognitive decline in healthy adults whilst considering the context in which it was implemented. 1,510 non cognitively-deteriorated community-dwelling adults aged 40-70 years old at risk of cognitive decline will be recruited and randomly assigned to the intervention or control group. All BetterBrains intervention participants, coaches, and the research team will be included in the evaluation. A mixed-methods design will be used, guided by The Framework for Implementation Fidelity and the program logic model. Data will be sourced from interviews, focus groups, surveys, BetterBrains coach notes, participant weekly check-in surveys, and audio recordings of intervention coaching sessions. Quantitative data will be analyzed via descriptive and inferential statistics and qualitative data will be analyzed using content and thematic analysis. The process evaluation will provide information about contextual and influencing factors related to the implementation of BetterBrains and the RCT outcomes. Understanding how BetterBrains was implemented and its associated impacts will inform the translation of the program into community and clinical settings, providing easy access to online, personalized dementia prevention services.

The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis

BackgroundThe Workwell trial is a multi-centre randomised controlled trial with the aims of evaluating the effectiveness and cost-effectiveness of job retention vocational rehabilitation for employed people with inflammatory arthritis, who are experiencing work difficulties due to their arthritis. Vocational rehabilitation is delivered by health service occupational therapists, who have received additional training in providing this Workwell intervention. A process evaluation will be undertaken alongside the main trial to investigate implementation fidelity; understand key stakeholders’ perspectives of the intervention and the social and structural context in which the intervention is provided; and explore issues related to future implementation in clinical practice. This protocol describes the aims, objectives, and methodology of the Workwell trial process evaluation.MethodsThis mixed methods process evaluation will follow the Medical Research Council’s Guidance on process evaluations for complex interventions. It will be underpinned by the conceptual framework for implementation fidelity (CFIF) and normalisation process theory (NPT). We will analyse treatment records, work assessments, and treatment notes to ascertain implementation fidelity. Semi-structured interviews with trial participants, their employer/line managers, treating therapists, and their therapy service managers will be undertaken to explore perceptions of the intervention, contextual factors, and potential for future implementation in practice. Interview topic guides will be informed by NPT. Therapists’ views about Workwell training will be explored via questionnaires following training, and interviews and focus groups following treatment delivery to inform future implementation. Quantitative data will be analysed descriptively. Qualitative data will be analysed using thematic analysis. NPT will guide data analysis and interpretation. Findings from the different elements of this embedded design process evaluation will be reported separately and then the elements integrated. The process evaluation data will be analysed independently of the Workwell trial outcome evaluation. The process evaluation data will then be reviewed in the light of the trial findings.DiscussionFew trials of job retention vocational rehabilitation in arthritis have included process evaluations. This process evaluation will assist in understanding factors influencing trial outcomes and identifying potential contextual barriers and facilitators for the potential implementation of Workwell vocational rehabilitation into clinical services.Trial registrationClinicalTrials.gov NCT03942783. Registered on 08 May 2019. ISRCTN Registry ISRCTN61762297. Registered on 13 May 2019. Retrospectively registered.

Implementation of a pharmacist-led transitional pharmaceutical care programme: Process evaluation of Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH).

What is known and objectiveThe recently conducted Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH) transitional care programme, which aimed to test the effectiveness of a transitional care programme on the occurrence of ADEs post‐discharge, did not show a significant effect. To clarify whether this non‐significant effect was due to poor implementation or due to ineffectiveness of the intervention as such, a process evaluation was conducted. The aim of the study was to gain more insight into the implementation fidelity of MARCH.MethodsA mixed methods design and the modified Conceptual Framework for Implementation Fidelity was used. For evaluation, the implementation fidelity and moderating factors of four key MARCH intervention components (teach‐back, the pharmaceutical discharge letter, the post‐discharge home‐visit and the transitional medication review) were assessed. Quantitative data were collected during and after the intervention. Qualitative data were collected using semi‐structured interviews with MARCH healthcare professionals (community pharmacists, clinical pharmacists, pharmacy assistants and pharmaceutical consultants) and analysed using thematic analysis.Results and DiscussionNot all key intervention components were implemented as intended. Teach‐back was not always performed. Moreover, 63% of the pharmaceutical discharge letters, 35% of the post‐discharge home‐visits and 44% of the transitional medication reviews were not conducted within their planned time frames. Training sessions, structured manuals and protocols with detailed descriptions facilitated implementation. Intervention complexity, time constraints and the multidisciplinary coordination were identified as barriers for the implementation.What is new and ConclusionOverall, the implementation fidelity was considered to be moderate. Not all key intervention components were carried out as planned. Therefore, the non‐significant results of the MARCH programme on ADEs may at least partly be explained by poor implementation of the programme. To successfully implement transitional care programmes, healthcare professionals require full integration of these programmes in the standard work‐flow including IT improvements as well as compensation for the time investment.

Are shared decision making studies well enough described to be replicated? Secondary analysis of a Cochrane systematic review.

BackgroundInterventions to change health professionals’ behaviour are often difficult to replicate. Incomplete reporting is a key reason and a source of waste in health research. We aimed to assess the reporting of shared decision making (SDM) interventions.MethodsWe extracted data from a 2017 Cochrane systematic review whose aim was to determine the effectiveness of interventions to increase the use of SDM by healthcare professionals. In a secondary analysis, we used the 12 items of the Template for Intervention Description and Replication (TIDieR) checklist to analyze quantitative data. We used a conceptual framework for implementation fidelity to analyze qualitative data, which added details to various TIDieR items (e.g. under “what materials?” we also reported on ease of access to materials). We used SAS 9.4 for all analyses.ResultsOf the 87 studies included in the 2017 Cochrane review, 83 were randomized trials, three were non-randomized trials, and one was a controlled before-and-after study. Items most completely reported were: “brief name” (87/87, 100%), “why” (rationale) (86/87, 99%), and “what” (procedures) (81/87, 93%). The least completely reported items (under 50%) were “materials” (29/87, 33%), “who” (23/87, 26%), and “when and how much” (18/87, 21%), as well as the conditional items: “tailoring” (8/87, 9%), “modifications” (3/87, 4%), and “how well (actual)” (i.e. delivered as planned?) (3/87, 3%). Interventions targeting patients were better reported than those targeting health professionals or both patients and health professionals, e.g. 84% of patient-targeted intervention studies reported “How”, (delivery modes), vs. 67% for those targeting health professionals and 32% for those targeting both. We also reported qualitative analyses for most items. Overall reporting of items for all interventions was 41.5%.ConclusionsReporting on all groups or components of SDM interventions was incomplete in most SDM studies published up to 2017. Our results provide guidance for authors on what elements need better reporting to improve the replicability of their SDM interventions.

Implementation fidelity of tuberculosis preventive therapy for under five children exposed to sputum smear positive pulmonary tuberculosis in Kaski district, Nepal: An implementation research.

In line with the WHO recommendation, Nepal has started implementing Tuberculosis prevention therapy (TBPT) for under five children exposed to Sputum Smear Positive Pulmonary Tuberculosis, as one of the strategies for prevention, care and control of TB. Implementation fidelity study is important to assess on what extent preventive program is being implemented. The objective of the study measured the implementation fidelity of TBPT program Kaski district, Nepal. We used a mixed-method explanatory sequential design study. Quantitative data were collected through retrospective review of records from April 2018 to May 2019 and level of adherence was established. Moderating factors influencing the implementation of TBPT were TBPT were assessed qualitatively. Sixteen in-depth interviews and a focus group discussion was conducted purposively with responsible stakeholders. The study was guided by the Conceptual Framework for Implementation Fidelity (CFIR) developed by Carroll. The majority of the components of the TBPT program were found to be implemented with a moderate level of fidelity. The proportion of under five years children initiate and complete the full course of TBPT was 72.5% and 75.86% respectively. The proportion of index cases traced for household contact, contact tracing within two months and timely initiation of therapy within two months were 54.19%, 82.73% and 86.20%. Moderating factors identified in the implementation of the program were contact tracing and enrollment, partnership and ownership, training resources, medication, awareness and information dissemination. The TBPT program is being moderately implemented in Kaski districts. Addressing the key challenges identified in contact tracing, partnership/ownership, incentives, training and knowledge of health workers results in more identification of children eligible for TBPT.

Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project

BackgroundAlthough transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity?MethodsA mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework.ResultsSix out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent’s and healthcare professional’s engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program.ConclusionBarriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit.

Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson\u2019s disease (CHAPS) in meeting challenges in care management

BackgroundParkinson’s disease (PD) complexity poses challenges for individuals with Parkinson’s, providers, and researchers. A recent multisite randomized trial of a proactive, telephone-based, nurse-led care management intervention - Care Coordination for Health Promotion and Activities in Parkinson’s Disease (CHAPS) - demonstrated improved PD care quality. Implementation details and supportive stakeholder feedback were subsequently published. To inform decisions on dissemination, CHAPS Model components require evaluations of their fidelity to the Chronic Care Model and to their implementation. Additionally, assessment is needed on whether CHAPS addresses care challenges cited in recent literature.MethodsThese analyses are based on data from a subset of 140 intervention arm participants and other CHAPS data. To examine CHAPS Model fidelity, we identified CHAPS components corresponding to the Chronic Care Model’s six essential elements. To assess implementation fidelity of these components, we examined data corresponding to Hasson’s modified implementation fidelity framework. Finally, we identified challenges cited in current Parkinson’s care management literature, grouped these into themes using open card sorting techniques, and examined CHAPS data for evidence that CHAPS met these challenges.ResultsAll Chronic Care Model essential elements were addressed by 17 CHAPS components, thus achieving CHAPS Model fidelity. CHAPS implementation fidelity was demonstrated by adherence to content, frequency, and duration with partial fidelity to telephone encounter frequency. We identified potential fidelity moderators for all six of Hasson’s moderator types. Through card sorting, four Parkinson’s care management challenge themes emerged: unmet needs and suggestions for providers (by patient and/or care partner), patient characteristics needing consideration, and standardizing models for Parkinson’s care management. CHAPS activities and stakeholder perceptions addressed all these themes.ConclusionsCHAPS, a supportive nurse-led proactive Parkinson’s care management program, improved care quality and is designed to be reproducible and supportive to clinicians. Findings indicated CHAPS Model fidelity occurred to the Chronic Care Model and fidelity to implementation of the CHAPS components was demonstrated. Current Parkinson’s care management challenges were met through CHAPS activities. Thus, dissemination of CHAPS merits consideration by those responsible for implementing changes in clinical practice and reaching people in need.Trial registrationClinicalTrials.gov as NCT01532986, registered on January 13, 2012.

Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach

BackgroundIn pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the Framework for Implementation Fidelity (FIF), we develop an approach for measuring variability in site-level implementation fidelity. This approach is then applied to measure site-level fidelity in a cluster-randomized pragmatic trial of Music & MemorySM (M&M), a personalized music intervention targeting agitated behaviors in residents living with dementia, in US nursing homes (NHs).MethodsIntervention NHs (N = 27) implemented M&M using a standardized manual, utilizing provided staff trainings and iPods for participating residents. Quantitative implementation data, including iPod metadata (i.e., song title, duration, number of plays), were collected during baseline, 4-month, and 8-month site visits. Three researchers developed four FIF adherence dimension scores. For Details of Content, we independently reviewed the implementation manual and reached consensus on six core M&M components. Coverage was the total number of residents exposed to the music at each NH. Frequency was the percent of participating residents in each NH exposed to M&M at least weekly. Duration was the median minutes of music received per resident day exposed. Data elements were scaled and summed to generate dimension-level NH scores, which were then summed to create a Composite adherence score. NHs were grouped by tercile (low-, medium-, high-fidelity).ResultsThe 27 NHs differed in size, resident composition, and publicly reported quality rating. The Composite score demonstrated significant variation across NHs, ranging from 4.0 to 12.0 [8.0, standard deviation (SD) 2.1]. Scaled dimension scores were significantly correlated with the Composite score. However, dimension scores were not highly correlated with each other; for example, the correlation of the Details of Content score with Coverage was τb = 0.11 (p = 0.59) and with Duration was τb = − 0.05 (p = 0.78). The Composite score correlated with CMS quality star rating and presence of an Alzheimer’s unit, suggesting face validity.ConclusionsGuided by the FIF, we developed and used an approach to quantitatively measure overall site-level fidelity in a multi-site pragmatic trial. Future pragmatic trials, particularly in the long-term care environment, may benefit from this approach.Trial registrationClinicaltrials.gov NCT03821844. Registered on 30 January 2019, https://clinicaltrials.gov/ct2/show/NCT03821844.