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Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level

NCT ID: NCT05353699

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention groups

Group Type EXPERIMENTAL

Implementation strategies

Intervention Type OTHER

We will adopt implementation strategies,which include Capacity-building strategies, Supervision, Integration strategies, Implementation process strategies, Dissemination strategies, Scale-up strategies.Firstly,Capacity-building strategies include:recruit, designate, and train for leadership; work with educational institutions.Secondly,Supervision includes provide clinical supervision;Thirdly,Integration strategies include: remind clinicians; use data warehousing techniques.Fourthly,Implementation process strategies include: 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.Fifthly,Dissemination strategies include: make training dynamic.Finally,Scale-up strategies include: use train-the-trainer strategies;place innovation on fee for service lists/formularies.

Control groups

as same as before

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Implementation strategies

We will adopt implementation strategies,which include Capacity-building strategies, Supervision, Integration strategies, Implementation process strategies, Dissemination strategies, Scale-up strategies.Firstly,Capacity-building strategies include:recruit, designate, and train for leadership; work with educational institutions.Secondly,Supervision includes provide clinical supervision;Thirdly,Integration strategies include: remind clinicians; use data warehousing techniques.Fourthly,Implementation process strategies include: 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.Fifthly,Dissemination strategies include: make training dynamic.Finally,Scale-up strategies include: use train-the-trainer strategies;place innovation on fee for service lists/formularies.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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Shiqihu

Identifier Type: -

Identifier Source: org_study_id