Dataset Information

Effectiveness of a pathway-driven eHealth-based integrated care model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial.

ABSTRACT:

Background

The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging "three-manager" mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.

Methods

The trial has been designed as a 1-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months, and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence, and hypertension awareness, as well as work efficiency of care providers.

Discussion

This study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the "three-manager" mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.

Trial registration

Chinese Clinical Trial Registry ChiCTR1900027645 . Registered on November 22, 2019.

SUBMITTER: Wang Z

PROVIDER: S-EPMC7820518 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionThe control rate of hypertension is low in China, especially in rural, western and minority areas. This is related to poor medical skills among physicians in primary care institutions and low levels of trust among patients. However, primary healthcare institutions are the main battleground for the prevention and treatment of hypertension. It is worth exploring how to most effectively integrate patients, primary care physicians and cardiologists in tertiary hospitals, to build a long-term mechanism for the prevention and treatment of hypertension. In this study, we aim to evaluate the clinical effectiveness and conduct a health economic evaluation of an internet-based patient-primary care physician-cardiologist integrated management model of hypertension in areas of China with different socioeconomic levels.Methods and analysisThis is a 12-month, multicentre, randomised controlled trial involving patients with hypertension in urban communities and rural areas of Sichuan Province, China. Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS). Patients will be randomly assigned 1:1 to two groups: (1) a traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS. Patients can upload their blood pressure (BP) values and communicate with physicians using the system. The primary outcome is the change in systolic BP over a 12-month period. Secondary outcomes are changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance. All data will be recorded and stored in the RSCDMS and analysed using IBM SPSS V.26.0.Ethics and disseminationThis study has been approved by the Biomedical Research Ethics Committee of the West China Hospital of Sichuan University in Sichuan, China (No. 2020-148). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR2000030677.

Project description:IntroductionThe increasing number of older adults with multiple complex care needs has placed increased pressure on healthcare systems internationally to reorientate healthcare delivery. For many older adults, their first point of contact with the health service is with their general practitioner (GP) and GP participation with integrated care models is the foundation of a population-based approach. A knowledge gap remains in relation to the effectiveness of GP participation in community-based integrated health and social care approaches for older adults. This systematic review aims to examine the effectiveness of multidisciplinary-integrated care for community-dwelling older adults with GP participation.Methods and analysisThis systematic review will include randomised controlled trials (RCTs), quasi and cluster RCTs focusing on integrated care interventions for community-dwelling older adults by multidisciplinary teams including health and social care professionals and GPs. The databases PUBMED, EMBASE, CINAHL, Central Register of Controlled Trials in the Cochrane Library and MEDLINE will be searched. The primary outcome measure will be functional status. Secondary outcomes will include: primary healthcare utilisation, secondary healthcare utilisation, participant satisfaction with care, health-related quality of life, nursing home admission and mortality. The methodological quality of the studies will be assessed using the Cochrane Risk of Bias Tool V.2. The elements of care integration will be mapped in the individual studies using the Rainbow Model of Integrated Care taxonomy. A meta-analysis will be completed, depending on the uniformity of the data. Grading of Recommendations, Assessment, Development and Evaluation will be used to assess the certainty of evidence.Ethics and disseminationFormal ethical approval is not required as all data included are anonymous secondary data. Scientific outputs will be presented at relevant conferences and in collaboration with our public and patient involvement stakeholder panel of older adults at the Ageing Research Centre at the University of Limerick.Prospero registration numberCRD42022309744.

Project description:BackgroundAlthough China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.MethodsA cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N = 5) or a usual care group (N = 5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.DiscussionThis study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Trial registrationAustralia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:Introduction: The Chinese government has established a nationwide community-based chronic disease management program since 2009 with hypertension a vital part of it. Though drugs have been proven effective with hypertensive patients, they bring economic burden as well, especially for those who with elevated blood pressure and are potentially eligible for national programs. When the effectiveness of pharmacotherapy-only interventions remains uncertain on these patients, non-pharmacological interventions have demonstrated non-inferior effectiveness and may have economic advantages. To date, there rarely are evidences on the effectiveness and cost-effectiveness of non-pharmacological treatment in comparison with pharmacological interventions for patients with varying severity of blood pressure. This study aims to propose a study for a network meta-analysis and cost-effectiveness analysis to explore what kind of intervention is potentially effective and cost-effective to four specific patient groups, stage I-III hypertensive patients and patients with elevated blood pressure, and to provide recommendations for hypertensive management to Chinese decision makers. Methods: We will systematically search databases (MEDLINE, PubMed, Cochrane Library, etc.,) for randomized controlled trials and observational studies with qualified study design in recent decade that assess the effectiveness of non-pharmacological, pharmacological, or combined intervention aimed at adult populations who are diagnosed with the above four types of hypertension in China. The effectiveness outcomes will include changes in SBP/DBP, rate of comorbidities, mortality, and health related quality of life. We will use network meta-analysis to compare and rank effectiveness of different interventions. Subgroup analyses and meta-regression analyses will be performed to analyze and explain heterogeneity. The economic outcome will include cost-effectiveness based on simulation results from Markov models. Under study perspective of Chinese health system, life-time direct cost will be included. Discussion: This study aims to compare and rank the effectiveness and cost-effectiveness of pharmacological, non-pharmacological and combined interventions for stage I-III hypertensive patients and those who with elevated blood pressure. Compared to existing studies, this comprehensive synthesis of relevant evidences will influence future practice with better efficiency and generalizability for community-based hypertensive management programs in China. The study might also be valuable for other low- and middle-income countries to find their own solutions. PROSPERO registration number: CRD42020151518.

Project description:BACKGROUND:Over the past decade, prevalence of maternal and child morbidity and mortality in Togo, particularly in the northern regions, has remained high despite global progress. The causes of under-five child mortality in Togo are diseases with effective and low-cost prevention and/or treatment strategies, including malaria, acute lower respiratory infections, and diarrheal diseases. While Togo has a national strategy for implementing the integrated management of childhood illness (IMCI) guidelines, including a policy on integrated community case management (iCCM), challenges in implementation and low public sector health service utilization persist. There are critical gaps to access and quality of community health systems throughout the country. An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo. This study aims to evaluate the effect and implementation strategy of the ICBHSS initiative over 48 months in the catchment areas of 21 public sector health facilities. METHODS:The ICBHSS model comprises a bundle of evidence-based interventions targeting children under five, women of reproductive age, and people living with HIV through (1) community engagement and feedback; (2) elimination of point-of-care costs; (3) proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures. Using a pragmatic type II hybrid effectiveness-implementation study, we will evaluate the ICBHSS initiative with two primary aims: (1) determine effectiveness through changes in under-five mortality rates and (2) assess the implementation strategy through measures of reach, adoption, implementation, and maintenance. We will conduct a mixed-methods assessment using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. This assessment consists of four components: (1) a stepped-wedge cluster randomized control trial using a community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments for each randomized cluster. DISCUSSION:Our research is expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly. TRIAL REGISTRATION:ClinicalTrials.gov , NCT03694366 , registered 3 October 2018.

Project description:IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called 'KeepWell' that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness-implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.