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The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation.

ABSTRACT: Background: There is a lack of evidence concerning the effective implementation of strategies for stroke prevention and management, particularly in resource-limited settings. A primary-care-based integrated mobile health intervention (SINEMA intervention) has been implemented and evaluated via a 1-year-long cluster-randomized controlled trial. This study reports the findings from the trial implementation and process evaluation that investigate the implementation of the intervention and inform factors that may influence the wider implementation of the intervention in the future. Methods: We developed an evaluation framework by employing both the RE-AIM framework and the MRC process evaluation framework to describe the implementation indicators, related enablers and barriers, and illustrate some potential impact pathways that may influence the effectiveness of the intervention in the trial. Quantitative data were collected from surveys and extracted from digital health monitoring systems. In addition, we conducted quarterly in-depth interviews with stakeholders in order to understand barriers and enablers of program implementation and effectiveness. Quantitative data analysis and thematic qualitative data analysis were applied, and the findings were synthesized based on the evaluation framework. Results: The SINEMA intervention was successfully implemented in 25 rural villages, reached 637 patients with stroke in rural Northern China during the 12 months of the trial. Almost 90% of the participants received all follow-up visits per protocol, and about half of the participants received daily voice messages. The majority of the intervention components were adopted by village doctors with some adaptation made. The interaction between human-delivered and technology-enabled components reinforced the program implementation and effectiveness. However, characteristics of the participants, doctor-patient relationships, and the healthcare system context attributed to the variation of program implementation and effectiveness. Conclusion: A comprehensive evaluation of program implementation demonstrates that the SINEMA program was well implemented in rural China. Findings from this research provide additional information for program adaptation, which shed light on the future program scale-up. The study also demonstrates the feasibility of combining RE-AIM and MRC process evaluation frameworks in process and implementation evaluation in trials. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03185858.

SUBMITTER: Gong E

PROVIDER: S-EPMC8635640 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:Policies and programmes in Mexico promote the integration of mental health services into primary health care (PHC), however these services remain largely unavailable in the country. Since 2014 a non-governmental organisation has delivered a mental health programme at PHC clinics in the state of Chiapas, in partnership with the local Ministry of Health (MoH). The programme provides mental health services based on the mhGAP guidelines through multiple implementation strategies, including programme financing, infrastructure strengthening, high-intensity training, and supervision. This study aimed to examine the implementation process and outcomes of this mental health programme to understand the extent to which mental health care integration has been achieved and to identify the successes and remaining challenges in order to inform the development and implementation of similar programmes. Methods:We used a mixed-methods convergent design. Quantitative data for the period between December 2016 and December 2017 were extracted from the organisation's health information system to capture process indicators, including the amount (dose) and quality (fidelity) of services delivered. We conducted two focus groups and 24 semi-structured interviews with health providers and managers to ascertain implementation outcome data: penetration, fidelity, acceptability, appropriateness and feasibility. Quantitative and qualitative data were analysed using descriptive and framework analyses, respectively. Results:During the study period, health providers delivered mental health consultations to 486 adults diagnosed with a mood or anxiety disorder. Programme fidelity was limited given that talk-based interventions, which are required in all consultations according to programme guidelines, were only provided in 24% of consultations. Only 42% of service users attended more than 50% of scheduled mental health follow-up consultations, which also hindered fidelity. Low attendance is partially attributed to limited programme appropriateness, given that interventions to address social risk factors are not available. High levels of acceptability and feasibility enabled through strong support from the organisation were key programme strengths. Conclusions:Mental health programmes at PHC can be implemented when adequate support and supervision structures are in place, and key resources are available. There is an urgent need for health systems strengthening to support efforts to provide mental health care, and to link PHC with locally-relevant social interventions.

Project description:BackgroundManaging noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China.Methods and findingsBased on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting.ConclusionsIn this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China.Trial registrationClinicalTrials.gov NCT03185858.

Project description:IntroductionObesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study.Methods and analysisMixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention.Ethics and disseminationEthics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help.

Project description:Aims and objectivesTo investigate uptake of a Chest Injury Protocol (ChIP), examine factors influencing its implementation and identify interventions for promoting its use.BackgroundFailure to treat blunt chest injuries in a timely manner with sufficient analgesia, physiotherapy and respiratory support, can lead to complications such as pneumonia and respiratory failure and/or death.DesignThis is a mixed-methods implementation evaluation study.MethodsTwo methods were used: (i) identification and review of the characteristics of all patients eligible for the ChIP protocol, and (ii) survey of hospital staff opinions mapped to the Theoretical Domains Framework (TDF) to identify barriers and facilitators to implementation. The characteristics and treatment received between the groups were compared using the chi-square test or Fischer's exact test for proportions, and the Mann-Whitney U-test for continuous data. Quantitative survey data were analysed using descriptive statistics. Qualitative data were coded in NVivo 10 using a coding guide based on the TDF and Behaviour Change Wheel (BCW). Identification of interventions to change target behaviours was sourced from the Behaviour Change Technique Taxonomy Version 1 in consultation with stakeholders.ResultsOnly 68.4% of eligible patients received ChIP. Fifteen facilitators and 10 barriers were identified to influence the implementation of ChIP in the clinical setting. These themes were mapped to 10 of the 14 TDF domains and corresponded with all nine intervention functions in the BCW. Seven of these intervention functions were selected to address the target behaviours and a multi-faceted relaunch of the revised protocol developed. Following re-launch, uptake increased to 91%.ConclusionsThis study demonstrated how the BCW may be used to revise and improve a clinical protocol in the ED context.Relevance to clinical practiceNewly implemented clinical protocols should incorporate clinician behaviour change assessment, strategy and interventions. Enhancing the self-efficacy of emergency nurses when performing assessments has the potential to improve patient outcomes and should be included in implementation strategy.

Project description:BackgroundThe introduction of the WHO's Integrated Management of Childhood Illnesses (IMCI) guidelines in the mid-1990s contributed to global reductions in under-five mortality. However, issues in quality of care have been reported. We aimed to determine resource availability and healthcare worker knowledge of IMCI guidelines in two districts in Malawi.MethodsWe conducted a mixed-methods study, including health facility audits to record availability and functionality of essential IMCI equipment and availability of IMCI drugs, healthcare provider survey and focus group discussions (FGDs) with facility staff. The study was conducted between January and April 2019 in Mchinji (central region) and Zomba (southern region) districts. Quantitative data were described using proportions and χ2 tests; linear regression was conducted to explore factors associated with IMCI knowledge. Qualitative data were analysed using a pragmatic framework approach. Qualitative and quantitative data were analysed and presented separately.ResultsForty-seven health facilities and 531 healthcare workers were included. Lumefantrine-Artemether and cotrimoxazole were the most available drugs (98% and 96%); while amoxicillin tablets and salbutamol nebuliser solution were the least available (28% and 36%). Respiratory rate timers were the least available piece of equipment, with only 8 (17%) facilities having a functional device. The mean IMCI knowledge score was 3.96 out of 10, and there was a statistically significant association between knowledge and having received refresher training (coeff: 0.42; 95% CI 0.01 to 0.82). Four themes were identified in the FGDs: IMCI implementation and practice, barriers to IMCI, benefits of IMCI and sustainability.ConclusionWe found key gaps in IMCI implementation; however, these were not homogenous across facilities, suggesting opportunities to learn from locally adapted IMCI best practices. Improving on-going mentorship, training and supervision should be explored to improve quality of care, and programming which moves away from vertical financing with short-term support, to a more holistic approach with embedded sustainability may address the balance of resources for different conditions.

Project description:BackgroundEvaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis.MethodsThis study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way.ResultsThe results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study.ConclusionsThis evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.Trial registrationClinicalTrials.gov , NCT02338869; registered 10/04/2014.

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The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation.

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