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Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial.

ABSTRACT: BACKGROUND:Gestational Diabetes Mellitus (GDM) testing and management in Morocco is associated with delays resulting in late commencement of treatment. To reduce delays and to increase access of women to GDM care, a country-adapted intervention targeting primary health care providers was designed to test the hypothesis that detection and initial management of GDM at the primary level of care improves newborn outcomes in terms of lower birthweights and less cases of macrosomia and impacts on maternal weight gain, glucose balance and pregnancy outcomes. MATERIALS AND METHODS:We conducted a cluster randomized controlled trial in two districts of Morocco. In each district, 10 health centers were randomly selected to serve either as intervention or control sites. Pregnant women attending antenatal care in the study facilities were eligible to participate. At the intervention sites, women were offered GDM screening by capillary glucose testing following International Association of Diabetes in Pregnancy Study Groups/WHO criteria. Women diagnosed with GDM received counselling on nutrition and exercise and were followed up through their health center whereas at control facilities routine practice was applied. Primary outcome was birthweight and secondary outcomes maternal weight gain, glucose control and pregnancy complications. We further assessed GDM prevalence in the intervention arm. Statistical analysis was performed on 210 recruited women. Continuous variables were reported using means while categorical variables using frequencies with tests of independence applying chi-squared tests. Differences of outcome variables between the two groups were estimated by mixed-effects regression models and effect sizes adjusted for confounders. The trial is registered under NCT02979756 at ClinicalTrials.gov. RESULTS:GDM prevalence reached 23.7% in Marrakech. Birthweight in the intervention group was 147grams lower than in the control group (p = 0.08) as was the proportion of macrosomes (3.5% versus 18.4%; p< 0.001). In the intervention arm, women did two times more follow-ups than at control sites (p = 0.001) and mean follow-up intervals were shorter (11.3 days versus 18.7 days; p < 0.001). Overall, 30% more fasting blood sugar values were balanced (p = 0.005) and mean weekly maternal weight gain 49 grams lower (p = 0.032) in the intervention group. More women from control facilities had a delivery complication whereas more newborn complications were observed in women from intervention facilities. No difference between the two groups existed regarding mode of delivery and mean gestational age at delivery. One of the main limitations of the study was the Hawthorn-effect at control sites that might have led to an underestimation of the effect size. CONCLUSION:A high GDM prevalence in Morocco calls for a context-adapted screening and management approach to enable early interventions. GDM detection and care through antenatal care at primary health facilities may have positively impacted on newborn birthweight but findings are inconclusive. Results of this study will contribute to the decision on a potential upscaling of the intervention in Morocco. Future research could examine long term metabolic changes including diabetes type 2 in the cohort of women and their children.

SUBMITTER: Utz B

PROVIDER: S-EPMC6310282 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial.

Utz Bettina B Assarag Bouchra B Smekens Tom T Ennassiri Hassan H Lekhal Touria T El Ansari Nawal N Fakhir Bouchra B Barkat Amina A Essolbi Amina A De Brouwere Vincent V

PloS one 20181228 12

<h4>Background</h4>Gestational Diabetes Mellitus (GDM) testing and management in Morocco is associated with delays resulting in late commencement of treatment. To reduce delays and to increase access of women to GDM care, a country-adapted intervention targeting primary health care providers was designed to test the hypothesis that detection and initial management of GDM at the primary level of care improves newborn outcomes in terms of lower birthweights and less cases of macrosomia and impacts ...[more]

PMID: 30592751

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Project description:Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up.We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers.In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes.The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.

Project description:BackgroundGestational diabetes mellitus (GDM) is associated with an increased risk for a future type 2 diabetes mellitus in women and their children. As linkage between maternal health and non-communicable diseases, antenatal care plays a key role in the primary and secondary prevention of GDM associated adverse outcomes. While implementing a locally adapted GDM screening and management approach through antenatal care services at the primary level of care, we assessed its acceptability by the implementing health care providers.MethodsAs part of a larger implementation effectiveness study assessing a decentralized gestational diabetes screening and management approach in the prefecture of Marrakech and the rural district of Al Haouz in Morocco, we conducted four focus group discussions with 29 primary health care providers and seven in-depth interviews with national and regional key informants. After transcription of data, we thematically analyzed the data using a combined deductive and inductive approach.ResultsThe intervention of screening and managing women with gestational diabetes added value to existing antenatal care services but presented an additional workload for first line health care providers. An existing lack of knowledge about gestational diabetes in the community and among private health care physicians required of public providers to spend more time on counselling women. Nurses had to adapt recommendations on diet to the socio-economic context of patients. Despite the additional task, especially nurses and midwives felt motivated by their gained capacity to detect and manage gestational diabetes, and to take decisions on treatment and follow-up.ConclusionsDetection and initial management of gestational diabetes is an acceptable strategy to extend the antenatal care service offer in Morocco and to facilitate service access for affected pregnant women. Despite its additional workload, gestational diabetes management can contribute to the professional motivation of primary level health care providers.Trial registrationclinicaltrials.gov; NCT02979756.

Project description:IntroductionIn Canada, as in most Organisation for Economic Co-operation and Development countries, healthcare systems face significant challenges in ensuring better access to primary care. A regional healthcare organisation in Quebec (Canada) serving a population of approximately 755 459 citizens has implemented a standardised access approach to primary care services for this population. The objective of this new clinical and organisational practice is to ensure that users benefit from the same referral process, regardless of the entry point, in order to be directed to the right services. This new practice integrates a shared decision-making process between the user and the professional, and a collaborative process between different health professionals within and between services. The objective of our research is to identify and characterise the conditions of implementation of this practice.MethodsThis effectiveness-implementation hybrid investigation will use an embedded single-case study, defined in this case as the process of implementing a clinical and organisational practice within a healthcare organisation. Further to an evaluation conducted during a preliminary phase of the project, this study consists of evaluating the implementation of this new practice in four medical clinics (family medicine groups). A qualitative analysis of the data and a quantitative preimplementation and postimplementation analysis based on performance indicators will be conducted. This study is ultimately situated within a participatory organisational approach that involves various stakeholders and users at each step of the implementation and evaluation process.Ethics and disseminationThis study was approved by the Ethics Committee of the Sectoral Research in Population Health and Primary Care of the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (#2020-1800). The results of the investigation will be presented to the stakeholders involved in the advisory committees and at several scientific conferences. Manuscripts will be submitted to peer-reviewed journals.

Project description:IMPORTANCE:Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings. OBJECTIVE:To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic. DESIGN:Patients were randomized to be offered LR-OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods. SETTING:Safety-net primary care clinic. PARTICIPANTS:Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18-75 yr with diabetes and a current hemoglobin A1c (HbA1c) ? 9.0%. INTERVENTION:Eight 1-hr individual sessions of LR-OT focused on diabetes management. OUTCOMES AND MEASURES:Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR-OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations. RESULTS:Seventy-three patients were offered LR-OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation. CONCLUSIONS AND RELEVANCE:LR-OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care. WHAT THIS ARTICLE ADDS:This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy's effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

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

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

Project description:BackgroundGestational diabetes mellitus (GDM) is associated with risks for both the mother and child. The escalated prevalence of GDM because of obesity and changes in screening criteria demands for greater health care needs than before.ObjectiveThis study aimed to understand the perception of patients and health care providers of the barriers to GDM management and preferred interventions to manage GDM in an Asian setting.MethodsThis mixed methods study used a convergent parallel design. Survey data were collected from 216 women with GDM, and semistructured interviews were conducted with 15 women and with 8 health care providers treating patients with GDM. Participants were recruited from 2 specialized GDM clinics at the National University Hospital, Singapore.ResultsThe patients were predominantly Chinese (102/214, 47.6%), employed (201/272, 73.9%), with higher education (150/216, 69.4%) and prenatal attendance at a private clinic (138/214, 64.2%), already on diet control (210/214, 98.1%), and receiving support and information from the GDM clinic (194/215, 90.2%) and web-based sources (131/215, 60.9%). In particular, working women reported barriers to GDM management, including the lack of reminders for blood glucose monitoring, diet control, and insufficient time for exercise. Most women preferred getting such support directly from health care providers, whether at the GDM clinic (174/215, 80.9%) or elsewhere (116/215, 53.9%). Smartphone apps were the preferred means of additional intervention. Desirable intervention features identified by patients included more information on GDM, diet and exercise options, reminders for blood glucose testing, a platform to record blood glucose readings and illustrate or understand trends, and a means to communicate with care providers.ConclusionsA GDM-focused smartphone app that is able to integrate testing, education, and communication may be a feasible and acceptable intervention to provide support to women with GDM, particularly for working women.

Project description:IntroductionIntegrating early detection and management of non-communicable diseases in primary healthcare has an unprecedented role in making healthcare more accessible particularly in low- and middle-income countries such as Ethiopia. This study aims to design, implement and evaluate an evidence-based intervention guided by the HEARTS technical package and implementation guide to address barriers and facilitators of integrating early detection and management of hypertension, diabetes mellitus and cardiovascular diseases in primary healthcare settings of Addis Ababa.MethodologyWe will employ a type-3 hybrid implementation-effectiveness study from November 2020 to May 2022. This study will target patients ≥40 years of age. Ten health centres will be randomly selected from each subcity of Addis Ababa. The study will have four phases: (1) Baseline situational analysis (PEN facility-capacity assessment, 150 observations of patient healthcare provider interactions and 697 patient medical record reviews), (2) Consolidated Framework for Implementation Research (CFIR) inspired qualitative assessment of barriers and facilitators (20 in-depth interviews of key stakeholders), (3) Design of intervention protocol. The intervention will have capacity enhancement components including training of non-communicabledisease (NCDservice providers, provision of essential equipment/supporting materials and monthly monitoring and feedback and (4) Implementation monitoring and evaluation phase using the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework. Outcomes on early detection and management of NCDs will be assessed to examine the effectiveness of the study.Ethics and dissemination planEthical clearance was obtained from the Addis Ababa University, College of Health Sciences Institutional Review Board and Addis Ababa Health Bureau. We plan to present the findings from this research in conferences and publish them in peer-reviewed journals.

Dataset Information

Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial.

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Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial.

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