Conceptual Framework For Implementation Fidelity Research Articles

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.

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.

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.

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.

Implementing a Natural Family Planning Program: The Case of The Metropolitan Archdiocese of Cagayan De Oro

Implementing a Natural Family Planning Program: The Case of The Metropolitan Archdiocese of Cagayan De Oro

Implementation Fidelity of a Complex Behavioral Intervention to Prevent Diabetes Mellitus in Two Safety Net Patient‐Centered Medical Homes in New York City

Research ObjectiveAssessing implementation fidelity is critical for complex interventions to understand the reasons for their success or failure. However, few interventions systematically document and report implementation processes. Therefore, we sought to conduct concurrent process evaluation of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster‐randomized, controlled trial aimed at evaluating the impact of a Community Health Workers (CHW) led, health coaching intervention (in‐person and remotely) on preventing the onset of type 2 Diabetes Mellitus (DM).Study DesignThe Conceptual Framework for Implementation Fidelity (CFIF) was applied to measure implementation fidelity and factors moderating fidelity of the three core intervention components: patient goal setting, education topic coaching with CHWs, and referrals made to address social determinants of health. Descriptive statistics and regression models were computed to determine factors related to fidelity.Population StudiedThe study population included primary care patients with prediabetes range glycemia at two New York City (NYC) safety‐net hospitals (Veterans Administration NY Harbor ‐ VA and Bellevue Hospital ‐ BH). Primary care teams were randomized to receive the CHW‐driven, one‐year intervention. Of the 559 patients enrolled in the intervention arm, 79.4% completed an intake survey, constituting the analytic sample for fidelity assessment.Principal FindingsThe 2 study sites contributed 60% (BH) and 40% (VA) of the sample. Protocol adherence was as intended in the protocol for the 3 core components with more than 80% of patients setting ≥1 goal and receiving coaching on ≥1 education topic, and 45.0% receiving ≥1 referral. After adjusting for patient gender, language, race, ethnicity, and age, the study site moderated adherence to goal setting (77.4% BH vs. 87.7% VA) and having ≥1 education session (78.9% BH vs. 88.3% VA). Study site also moderated rate of encounters (median number of encounters 6 BH vs 4 VA). Scores on the Patient Activation Measure had no impact on fidelity of core intervention components.ConclusionsThe fidelity of CHORD implementation varied across its three core components and was moderated by implementation site.Implications for Policy or PracticeThe CFIF was a useful approach to collect and analyze data concerning implementation fidelity of a complex behavioral intervention. Despite being implemented in a research setting, interventions may not completely adhere to their core components, which can influence outcomes. Our study emphasizes the importance of examining implementation fidelity of complex interventions and of assessing moderating factors. Our study also empirically tested the CFIF using quantitative concurrent process evaluation of core intervention components.Primary Funding SourceNational Institutes of Health.

Implementation fidelity of the Falls Management Exercise Programme: a mixed methods analysis using a conceptual framework for implementation fidelity

ObjectivesFalls in older adults cause significant morbidity and mortality and incur cost to health and care services. The Falls Management Exercise (FaME) programme is a 24-week intervention for older adults that, in clinical trials, improves balance and functional strength and leads to fewer falls. Similar but more modest outcomes have been found when FaME is delivered in routine practice. Understanding the degree to which the programme is delivered with fidelity is important if ‘real-world’ delivery of FaME is to achieve the same magnitude of outcome as in clinical trials. The objective of this study was to examine the implementation fidelity of FaME when delivered in the community to inform quality improvement strategies that maximise programme effectiveness. Study designA mixed methods implementation study of FaME programme delivery. MethodsData from programme registers, expert observations of FaME classes, and semistructured interviews with FaME instructors were triangulated using a conceptual framework for implementation fidelity. Quantitative data were analysed using descriptive statistics. Interviews were transcribed verbatim and analysed using thematic analysis. ResultsIn total, 356 participants enrolled on 29 FaME programmes, and 143 (40%) participants completed at least 75% of the classes within a programme. Observations showed that 72%–78% of programme content was delivered, and 80%–84% quality criteria were met. Important content that was most often left out included home exercises, Tai Chi moves, and floor work, whereas quality items most frequently missed out included asking about falls in the previous week, following up attendance absence and explaining the purpose of exercises. Only 24% of class participants made the expected strength training progression. Interviews with FaME instructors helped explain why elements of programme content and quality were not delivered. Strategies for improving FaME delivery were established and helped to maintain quality and fidelity. ConclusionsFaME programmes delivered in the ‘real world’ can be implemented with a high degree of fidelity, although important deviations were found. Facilitation strategies could be used to further improve programme fidelity and maximise participant outcomes.

Factors affecting the delivery of complex rehabilitation interventions in research with neurologically impaired adults: a systematic review

BackgroundRehabilitation research does not always improve patient outcomes because of difficulties implementing complex health interventions. Identifying barriers and facilitators to implementation fidelity is critical. Not reporting implementation issues wastes research resources and risks erroneously attributing effectiveness when interventions are not implemented as planned, particularly progressing from single to multicentre trials. The Consolidated Framework for Implementation Research (CFIR) and Conceptual Framework for Implementation Fidelity (CFIF) facilitate identification of barriers and facilitators. This review sought to identify barriers and facilitators (determinants) affecting implementation in trials of complex rehabilitation interventions for adults with long-term neurological conditions (LTNC) and describe implementation issues.MethodsImplementation, complex health interventions and LTNC search terms were developed. Studies of all designs were eligible. Searches involved 11 databases, trial registries and citations. After screening titles and abstracts, two reviewers independently shortlisted studies. A third resolved discrepancies. One reviewer extracted data in two stages; 1) descriptive study data, 2) units of text describing determinants. Data were synthesised by (1) mapping determinants to CFIF and CFIR and (2) thematic analysis.ResultsForty-three studies, from 7434 records, reported implementation determinants; 41 reported both barriers and facilitators. Most implied determinants but five used implementation theory to inform recording. More barriers than facilitators were mapped onto CFIF and CFIR constructs. “Patient needs and resources”, “readiness for implementation”, “knowledge and beliefs about the intervention”, “facilitation strategies”, “participant responsiveness” were the most frequently mapped constructs. Constructs relating to the quality of intervention delivery, organisational/contextual aspects and trial-related issues were rarely tapped. Thematic analysis revealed the most frequently reported determinants related to adherence, intervention perceptions and attrition.ConclusionsThis review has described the barriers and facilitators identified in studies implementing complex interventions for people with LTNCs. Early adoption of implementation frameworks by trialists can simplify identification and reporting of factors affecting delivery of new complex rehabilitation interventions. It is vital to learn from previous experiences to prevent unnecessary repetitions of implementation failure at both trial and service provision levels. Reported facilitators can provide strategies for overcoming implementation issues. Reporting gaps may be due to the lack of standardised reporting methods, researcher ignorance and historical reporting requirements.Systemic review registrationPROSPERO CRD42015020423

Implementation fidelity and acceptability of an intervention to improve vaccination uptake and child health in rural India: a mixed methods evaluation of a pilot cluster randomized controlled trial

BackgroundThe Tika Vaani intervention, an initiative to improve basic health knowledge and empower beneficiaries to improve vaccination uptake and child health for underserved rural populations in India, was assessed in a pilot cluster randomized trial. The intervention was delivered through two strategies: mHealth (using mobile phones to send vaccination reminders and audio-based messages) and community mobilization (face-to-face meetings) in rural Indian villages from January to September 2018. We assessed acceptability and implementation fidelity to determine whether the intervention delivered in the pilot trial can be implemented at a larger scale.MethodsWe adapted the Conceptual Framework for implementation fidelity to assess acceptability and fidelity of the pilot interventions using a mixed methods design. Quantitative data sources include a structured checklist, household surveys, and mobile phone call patterns. Qualitative data came from field observations, intervention records, semi-structured interviews and focus groups with project recipients and implementers. Quantitative analyses assessed whether activities were implemented as planned, using descriptive statistics to describe participant characteristics and the percentage distribution of activities. Qualitative data were analyzed using content analysis and in the light of the implementation fidelity model to explore moderating factors and to determine how well the intervention was received.ResultsFindings demonstrated high (86.7%) implementation fidelity. A total of 94% of the target population benefited from the intervention by participating in a face-to-face group meeting or via mobile phone. The participants felt that the strategies were useful means for obtaining information. The clarity of the intervention theory, the motivation, and commitment of the implementers as well as the periodic meetings of the supervisors largely explain the high level of fidelity obtained. Geographic distance, access to a mobile phone, level of education, and gender norms are contextual factors that contributed to heterogeneity in participation.ConclusionsAlthough the intervention was evaluated in the context of a randomized trial that could explain the high level of fidelity obtained, this evaluation provides confirmatory evidence that the results of the study reflect the underlying theory. The mobile platform coupled with community mobilization was well-received by the participants and could be a useful way to improve health knowledge and change behavior.Trial registrationISRCTN 44840759 (22 April 2018)

Implementing a context-driven awareness programme addressing household air pollution and tobacco: a FRESH AIR study

Most patients with chronic respiratory disease live in low-resource settings, where evidence is scarcest. In Kyrgyzstan and Vietnam, we studied the implementation of a Ugandan programme empowering communities to take action against biomass and tobacco smoke. Together with local stakeholders, we co-created a train-the-trainer implementation design and integrated the programme into existing local health infrastructures. Feasibility and acceptability, evaluated by the modified Conceptual Framework for Implementation Fidelity, were high: we reached ~15,000 Kyrgyz and ~10,000 Vietnamese citizens within budget (~€11,000/country). The right engaged stakeholders, high compatibility with local contexts and flexibility facilitated programme success. Scores on lung health awareness questionnaires increased significantly to an excellent level among all target groups. Behaviour change was moderately successful in Vietnam and highly successful in Kyrgyzstan. We conclude that contextualising the awareness programme to diverse low-resource settings can be feasible, acceptable and effective, and increase its sustainability. This paper provides guidance to translate lung health interventions to new contexts globally.

Measuring Implementation Strategy Fidelity in HealthyHearts NYC: A Complex Intervention Using Practice Facilitation in Primary Care.

Few studies have assessed the fidelity of practice facilitation (PF) as an implementation strategy, and none have used an a priori definition or conceptual framework of fidelity to guide fidelity assessment. The authors adapted the Conceptual Framework for Implementation Fidelity to guide fidelity assessment in HealthyHearts NYC, an intervention that used PF to improve adoption of cardiovascular disease evidence-based guidelines in primary care practices. Data from a web-based tracking system of 257 practices measured fidelity using 4 categories: frequency, duration, content, and coverage. Almost all (94.2%) practices received at least the required 13 PF visits. Facilitators spent on average 26.3 hours at each site. Most practices (95.7%) completed all Task List items, and 71.2% were educated on all Chronic Care Model strategies. The majority (65.8%) received full coverage. This study provides a model that practice managers and implementers can use to evaluate fidelity of PF, and potentially other implementation strategies.

Shifting care from hospital to community, a strategy to integrate care in Singapore: process evaluation of implementation fidelity

BackgroundAccessibility to efficient and person-centered healthcare delivery drives healthcare transformation in many countries. In Singapore, specialist outpatient clinics (SOCs) are commonly congested due to increasing demands for chronic care. To improve this situation, the National University Health System (NUHS) Regional Health System (RHS) started an integrated care initiative,the Right-Site Care (RSC) program in 2014. Through collaborations between SOCs at the National University Hospital and primary and community care (PCC) clinics in the western region of the county, the program was designed to facilitate timely discharge and appropriate transition of patients, who no longer required specialist care, to the community. The aim of this study was to evaluate the implementation fidelity of the NUHS RHS RSC program using the modified Conceptual Framework for Implementation Fidelity (CFIF), at three distinct levels; providers, organizational, and system levels to explain outcomes of the program and to inform further development of (similar) programs.MethodsA convergent parallel mixed methods study using the realist evaluation approach was used. Data were collected between 2016 and 2018 through non-participatory observations, reviews of medical records and program database, together with semi-structured interviews with healthcare providers. Triangulation of data streams was applied guided by the modified CFIF.ResultsOur findings showed four out of six program components were implemented with low level of fidelity, and 9112 suitable patients were referred to the program while 3032 (33.3%) declined to be enrolled. Moderating factors found to influence fidelity included: (i) complexity of program, (ii) evolving providers’ responsiveness, (iii) facilitation through synergistic partnership, training of PCC providers by specialists and supportive structures: care coordinators, guiding protocols, shared electronic medical record and shared pharmacy, (iv) lack of organization reinforcement, and (v) mismatch between program goals, healthcare financing and providers’ reimbursement.ConclusionFunctional integration alone is insufficient for a successful right-site care program implementation. Improvement in relationships between providers, organizations, and patients are also warranted for further development of the program.