NCT05353699Unknown不适用

Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level: a Hybrid Type II Cluster-controlled Multisite Effectiveness-implementation Trial

National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC1 个研究点分布在 1 个国家目标入组 12,648 人开始时间: 2022年5月1日最近更新: 2022年4月29日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 12,648
试验地点: 1
主要终点: Awareness change：Change from Baseline Awareness at 3, 6,9 months

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Background: The disease burden of hypertension(HTN) and type 2 diabetes mellitus(DM) is rising rapidly in China.Comprehensive interventions(Implementation strategies for providers and interventions for patients) are critical to strengthen primary health care systems and address the burden of multiple comorbidities. In order to promote equal access to health services and narrow the gap in population health, China has launched the national Essential Public Health Services Equity Programme (EPHSEP) nationwide. EPHSEP contains guidelines for health management services for HTN and type 2 DM. The program has been in operation for 10 years. However, the management of HTN and type 2 DM in China is far from satisfactory. The purpose of this study is to understand current control and management situation of HTN and type 2 DM, investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards, propose feasible implementation strategies,implement in certain areas,and to evaluate the effectiveness of interventions and the performance and impact of implementation strategies.

Methods: Based on previous work,four community health service centres and four township health centres will be selected in West Coast District of Qingdao city of Shandong province,Suzhou City of Jiangsu province, Changsha city of Hunan province and Luohe city of Henan Province.In each of the four provinces,one community health service center and one township health center will be selected.Two community health service centres and two township health centres will be selected as the intervention groups, and the other community health service centres and township health centres will be selected as the control groups.

The study will be divided into three phases: Phase 1, 2 and 3. Phase 1 and phase 2 cross-sectional studies are the basis for phase 3 intervention studies.

Phase 1 will be conducted from March 2022 to April 2022.In phase 1, a quantitative questionnaire survey will be conducted among 5464 HTN and 7040 type 2 DM patients in 8 community health service centers to obtain the data of awareness rate, screening rate, diagnosis rate, treatment rate, control rate and management service of hypertension and type 2 diabetes patients,so as to understand current control and management situation of HTN and type 2 DM.

Phase 2 will be conducted in April 2022. In phase 2, about 64 medical staff and related managers providing HTN and type 2 DM health management services and 80 patients with HTN and type 2 DM in 8 community health service centers will be investigated through qualitative interviews,so as to investigate the barriers and facilitators in the implementation of HTN and type 2 DM service delivery standards and to propose feasible implementation strategies.

Phase 3 will be conducted a mixed-methods type 2 hybrid effectiveness-implementation study from May 2022 to January 2023. Interventions are divided into four levels through a cascading model of screening, diagnosis, treatment, and control. Implementation strategies are divided into 6 categories according to Implementation Mapping: Capacity-building strategies（Recruit, designate, and train for leadership; Work with educational institutions), Supervision(Provide clinical supervision), Integration strategies(Remind clinicians; Use data warehousing techniques), Implementation process Strategies(Identify and prepare champions; Identify early adopters; Inform local opinion leaders; Involve patients/consumers and family members; Obtain and use patients/consumers and family feedback), Dissemination strategies(Make training dynamic), Scale-up strategies(Use train-the-trainer strategies;Place innovation on fee for service lists/formularies). We will adopt between site design to select 4（2*2 ）community health service centers and 4（2*2）township health centers, among which 2 community health service centers and 2 township health centers will implement the strategy, while the other selected sites will not implement the strategy. The 2*2 community health service centers and 2*2 township health centers will be divided into group matching control and self pre- and post-control. In phase 3, 2280 patients with HTN and 2656 patients with type 2 DM will be surveyed by quantitative questionnaire, and about 64 medical staff and related managers providing HTN and type 2 DM health management services will be surveyed by qualitative interview. This is to implement improved implementation strategies and to assess the effectiveness of interventions and the performance and impact of implementation strategies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Health Services Research
盲法: Single (Participant)

入排标准

年龄范围: 35 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•For the quantitative questionnaire survey, the demander's population in phase 1 will include a total of 5464 patients with HTN and 7040 patients with type 2 DM in the 8 selected primary medical institutions.The demander's population in phase 2 is the same as that in phase 1.In phase 3, the demander's population will include a total of 2280 patients with HTN and 2656 patients with type 2 DM in the 8 selected primary medical institutions.
•Inclusion criteria for respondents:①Patients with HTN and type 2 DM who have received basic public health service management for more than one year, and have no plan to move within the next year; ②Have normal communication ability and independent behavior ability; ③Volunteer to participate in the project questionnaire survey and provide the informed consents.

排除标准

•for respondents:①Patients with severe chronic diseases or in acute stage who cannot cooperate with investigators; ②Mental disorders or cognitive disorders (including dementia, cognitive impairment, deafness, etc.).
•For the qualitative interview component, the provider's population will include policy-decision makers, managers, health professionals, healthcare workers who provide health management services for HTN and type 2 DM, and stakeholders who contain governmental officials/staff from civil society/non-governmental organization.Focus group discussions (FGDs) will be conducted. At each level, a group of people gets together for focus groups.During the interview, the specific number of interviewees shall be determined according to the principle of information saturation.
•Inclusion criteria for interviewees:①Health care personnel responsible for community HTN or type 2 DM management; ②Responsible for the national basic public health service project -HTN, type 2 DM health management work for at least 12 months; ③Willing to participate in the project; ④Willing to be interviewed;⑤Good presentation and verbal communication skills.
•Exclusion criteria for interviewees:①Health care workers who were not responsible for hypertensive or diabetic management;②Health care workers who carried out the management for less than 12 months;③Those who are not willing to participate in the project;④Unwilling to be interviewed;⑤Lack of expressive ability or difficulty in communicating in Mandarin; The demander's population will include a total of 80 patients with HTN and type 2 DM in the selected 8 primary medical institutions. The qualitative interview mainly adopts the personal in-depth interview method to understand the main problems in the implementation of the intervention measures, explore the causes of the problems, and possible improvement measures and suggestions.
•Inclusion criteria include:①patients who have participated in management;②patients who are active in conversation;③patients who are willing to participate in interviews.
•Exclusion criteria for patients:①patients with hypertension or diabetes who do not participate in the management;②patients who are not willing to be interviewed.