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Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

ABSTRACT: BACKGROUND:Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women's groups suggests that group care models may both improve access to care and the quality of care delivered through women's empowerment and the creation of social networks. We present a group antenatal care model in rural Nepal, designed and implemented by the healthcare delivery organization Nyaya Health Nepal, as well as an assessment of implementation outcomes. METHODS:The study was conducted at Bayalata Hospital in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allows for iterative improvement in design, making changes to improve the quality of the intervention. Assessments of implementation process and model fidelity were undertaken using a mobile checklist completed by nurse supervisors, and observation forms completed by program leadership. We evaluated data quarterly using descriptive statistics to identify trends. Qualitative interviews and team communications were analyzed through immersion crystallization to identify major themes that evolved during the implementation process. RESULTS:A total of 141 group antenatal sessions were run during the study period. This paper reports on implementation results, whereas we analyze and present patient-level effectiveness outcomes in a complementary paper in this journal. There was high process fidelity to the model, with 85.7% (95% CI 77.1-91.5%) of visits completing all process elements, and high content fidelity, with all village clusters meeting the minimum target frequency for 80% of topics. The annual per capita cost for group antenatal care was 0.50 USD. Qualitative analysis revealed the compromise of stable gestation-matched composition of the group members in order to make the intervention feasible. Major adaptations were made in training, documentation, feedback and logistics. CONCLUSION:Group antenatal care provided in collaboration with local government clinics has the potential to provide accessible and high quality antenatal care to women in rural Nepal. The intervention is a feasible and affordable alternative to individual antenatal care. Our experience has shown that adaptation from prior models was important for the program to be successful in the local context within the national healthcare system. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.

SUBMITTER: Harsha Bangura A

PROVIDER: S-EPMC6967133 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

Harsha Bangura Alex A Nirola Isha I Thapa Poshan P Citrin David D Belbase Bishal B Bogati Bhawana B B K Nirmala N Khadka Sonu S Kunwar Lal L Halliday Scott S Choudhury Nandini N Schwarz Ryan R Adhikari Mukesh M Kalaunee S P SP Rising Sharon S Maru Duncan D Maru Sheela S

Reproductive health 20200117 1

<h4>Background</h4>Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women ...[more]

PMID: 31952543

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Project description: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 .

Project description:BackgroundUntil now, there is no clear overview of how fidelity is assessed in school-based obesity prevention programmes. In order to move the field of obesity prevention programmes forward, the current review aimed to 1) identify which fidelity components have been measured in school-based obesity prevention programmes; 2) identify how fidelity components have been measured; and 3) score the quality of these methods.MethodsStudies published between January 2001-October 2017 were selected from searches in PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Library and ERIC. We included studies examining the fidelity of obesity prevention programmes (nutrition and/or physical activity and/or sitting) at school (children aged 4-18 year) measuring at least one component of implementation fidelity. A data extraction was performed to identify which and how fidelity components were measured. Thereafter, a quality assessment was performed to score the quality of these methods. We scored each fidelity component on 7 quality criteria. Each fidelity component was rated high (>?75% positive), moderate (50-75%) or low (<?50%).ResultsOf the 26,294 retrieved articles, 73 articles reporting on 63 different studies were included in this review. In 17 studies a process evaluation was based on a theoretical framework. In total, 120 fidelity components were measured across studies: dose was measured most often (N =?50), followed by responsiveness (N =?36), adherence (N =?26) and quality of delivery (N =?8). There was substantial variability in how fidelity components were defined as well as how they were measured. Most common methods were observations, logbooks and questionnaires targeting teachers. The quality assessment scores ranged from 0 to 86%; most fidelity components scored low quality (n =?77).ConclusionsThere is no consensus on the operationalisation of concepts and methods used for assessing fidelity in school-based obesity prevention programmes and the quality of methods used is weak. As a result, we call for more consensus on the concepts and clear reporting on the methods employed for measurements of fidelity to increase the quality of fidelity measurements. Moreover, researchers should focus on the relation between fidelity and programme outcomes and determine to what extent adaptations to programmes have been made, whilst still being effective.

Project description:Background:Noncommunicable diseases (NCDs) are the leading causes of deaths globally. Currently, there are limited high-quality data on the epidemiology and usefulness of community-based screening and treatment of NCDs in low-to-middle-income countries (LMIC), like Nepal. We describe the protocol of a community-based, longitudinal epidemiological study of screening and management of NCDs in rural Nepal. Methods:We organize monthly mobile health clinics to screen NCDs among 40- to 75-year-old residents from municipal subdivision wards 3, 4, 6, and 7 of Ghorahi submetropolitan city, Dang, Nepal (approximately 406 km west of the capital, Kathmandu). We estimate a total of 7052 eligible participants. After obtaining informed consent, trained personnel will collect sociodemographic and lifestyle data, medical, medication, and family history using validated questionnaires, plus anthropometric measures and capillary glucose levels. We will screen for hypertension, diabetes, obesity, dyslipidemia, tobacco and alcohol use, self-reported physical activity, dietary habits, cardiovascular disease, stroke, chronic lung disease, cancer, and chronic kidney disease. We will also check hemoglobin A1C, lipid panel, serum creatinine, sodium, potassium, urine dipstick, and urine albumin-to-creatinine ratio in high-risk participants. We will offer lifestyle counseling, pharmacotherapy or refer to higher level care, where appropriate; routinely follow participants with NCDs for continuity of care; and follow individuals without NCDs but with elevated glucose, prehypertension or other risk factors every year, and those without risk factors every 2?years. We will monitor participants in the community to reduce attrition and to track all-cause and disease-specific mortality. Discussion:Understanding the community burden of NCDs in resource-limited setting and testing effectiveness of community-based screening and management of NCDs will provide insights to develop national policy to address NCD burden in LMIC like Nepal.

Project description:IntroductionDespite carrying a disproportionately high burden of depression, patients in low-income countries lack access to effective care. The collaborative care model (CoCM) has robust evidence for clinical effectiveness in improving mental health outcomes. However, evidence from real-world implementation of CoCM is necessary to inform its expansion in low-resource settings.MethodsWe conducted a 2-year mixed-methods study to assess the implementation and clinical impact of CoCM using the WHO Mental Health Gap Action Programme protocols in a primary care clinic in rural Nepal. We used the Capability Opportunity Motivation-Behaviour (COM-B) implementation research framework to adapt and study the intervention. To assess implementation factors, we qualitatively studied the impact on providers' behaviour to screen, diagnose and treat mental illness. To assess clinical impact, we followed a cohort of 201 patients with moderate to severe depression and determined the proportion of patients who had a substantial clinical response (defined as ≥50% decrease from baseline scores of Patient Health Questionnaire (PHQ) to measure depression) by the end of the study period.ResultsProviders experienced improved capability (enhanced self-efficacy and knowledge), greater opportunity (via access to counsellors, psychiatrist, medications and diagnostic tests) and increased motivation (developing positive attitudes towards people with mental illness and seeing patients improve) to provide mental healthcare. We observed substantial clinical response in 99 (49%; 95% CI: 42% to 56%) of the 201 cohort patients, with a median seven point (Q1:-9, Q3:-2) decrease in PHQ-9 scores (p<0.0001).ConclusionUsing the COM-B framework, we successfully adapted and implemented CoCM in rural Nepal, and found that it enhanced providers' positive perceptions of and engagement in delivering mental healthcare. We observed clinical improvement of depression comparable to controlled trials in high-resource settings. We recommend using implementation research to adapt and evaluate CoCM in other resource-constrained settings to help expand access to high-quality mental healthcare.

Project description:BACKGROUND:Measurement of antenatal care (ANC) service coverage is often limited to the number of contacts or type of providers, reflecting a gap in the assessment of quality as well as cost estimations and health impact. The study aims to determine service subcomponents and provider and patient costs of ANC services and compares them between community (i.e. satellite clinics) and facility care (i.e. primary and secondary health centers) settings in rural Bangladesh. METHODS:Service contents and cost data were collected by one researcher and four interviewers in various community and facility health care settings in Gaibandha district between September and December 2016. We conducted structured interviews with organization managers, observational studies of ANC service provision (n?=?70) for service contents and provider costs (service and drug costs) and exit interviews with pregnant women (n?=?70) for patient costs (direct and indirect costs) in health clinics at community and facility levels. Fisher's exact tests were used to determine any different patient characteristics between community and facility settings. ANC service contents were assessed by 63 subitems categorized into 11 groups and compared within and across community and facility settings. Provider and patient costs were collected in Bangladesh taka and analyzed as 2016 US Dollars (0.013 exchange rate). RESULTS:We found generally similar provider and patient characteristics between the community and facility settings except in clients' gestational age. High compliance (>?50%) of service subcomponents were observed in blood pressure monitoring, weight measurement, iron and folate supplementation given, and tetanus vaccine, while lower compliance of service subcomponents (<?50%) were observed in some physical examinations such as edema and ultrasonogram and routine tests such as blood test and urine test. Average unit costs of ANC service provision were about double at the facility level ($2.75) compared with community-based care ($1.62). ANC patient costs at facilities ($2.66) were about three times higher than in the community ($0.78). CONCLUSION:The study reveals a delay in pregnant women's initial ANC care seeking, gaps in compliance of ANC subcomponents and difference of provider and patient costs between facility and community settings.

Dataset Information

Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

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Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

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