Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level
- Conditions
- HypertensionDiabetes Mellitus, Type 2
- Interventions
- Other: Implementation strategies
- Registration Number
- NCT05353699
- Lead Sponsor
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12648
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Intervention groups Implementation strategies -
- Primary Outcome Measures
Name Time Method Awareness change：Change from Baseline Awareness at 3, 6,9 months during the intervention; immediately after the intervention Awareness of HTN/ type 2 DM in population:% awareness towards HTN/ type 2 DM in population.Survey method will be used to assess this outcome measure.
Diagnostic rate change：Change from Baseline Diagnostic rate at 3, 6,9 months during the intervention; immediately after the intervention Diagnostic rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM diagnosed among those who have been screened blood pressure/blood sugar.Data will be obtained from administrative record.
Treatment rate change：Change from Baseline Treatment rate at 3, 6,9 months during the intervention; immediately after the intervention Treatment rate of patients with HTN:% patients with HTN who took antihypertensive drugs in the last two weeks was determined among those who have been diagnosed blood pressure; Treatment rate of patients with type 2 DM:% patients with type 2 DM who have taken treatment measures (including lifestyle intervention and/or medication) among those who have been diagnosed blood sugar.Data will be obtained from administrative record.
Screening rate change：Change from Baseline Screening rate at 3, 6,9 months during the intervention; immediately after the intervention Screening rate of patients with HTN/ type 2 DM:% patients with HTN/ type 2 DM screened among those who have ever screened blood pressure/blood sugar.Data will be obtained from administrative record.
Control rate change：Change from Baseline Control rate at 3, 6,9 months during the intervention; immediately after the intervention Control rate of patients with HTN/type 2 DM:% patients whose blood pressure/ blood sugar are controlled among those who have been treated.Data will be obtained from administrative record.
Implementation strategies use change: Change from Baseline Implementation at 3, 6,9 months during the intervention; immediately after the intervention Implementation strategies use:qualitative interviews with managers of health centers.Interviews method will be used to assess this outcome measure.
Supervision change: Change from Baseline Implementation at 3, 6,9 months during the intervention; immediately after the intervention Supervision model: % scheduled supervision field visits completed.Data will be obtained from administrative data.
Implementation change: Change from Baseline Implementation at 3, 6,9 months during the intervention; immediately after the intervention Qualitative assessment: qualitative interviews with managers of health.Interviews method will be used to assess this outcome measure.
Referral completeness change: Change from Baseline Implementation at 3, 6,9 months during the intervention; immediately after the intervention Referral completeness: % referrals completed as prescribed by the clinical algorithm.Data will be obtained from administrative data.
Adaptations to protocol change: Change from Baseline Implementation at 3, 6,9 months during the intervention; immediately after the intervention Adaptations to protocol during intervention period: qualitative interviews with managers of local health department and health centers.Interviews method will be used to assess this outcome measure.
- Secondary Outcome Measures
Name Time Method Readiness change: Change from Baseline Adoption at 3, 6,9 months during the intervention; immediately after the intervention Readiness for implementation:a checklist to check readiness for implementation using.Data will be obtained from administrative data.
Health centers/clinic's adoption change: Change from Baseline Adoption at 3, 6,9 months during the intervention; immediately after the intervention Health centers/clinic's adoption: % proportion of health centers/clinics implemented lifestyle intervention and/or medication.Data will be obtained from administrative data.
Timely adoption during the intervention Timely adoption：# early adopters at the local site. Observation methods will be used to assess this outcome measure.
Follow-up fidelity change: Change from Baseline Fidelity at at 3, 6,9 months during the intervention; immediately after the intervention Follow-up fidelity: % patients with "adequate" number of follow-up visits received.Data will be obtained from administrative data(records).
Qualitative assessment-Behavior changes sustained (staff) 15 months Long-term maintenance of changes in management behavior related to hypertension/type 2 DM. Interview and observation methods will be used to assess this outcome measure.
Total treatment cost immediately after the intervention Total treatment cost per patient.Data will be obtained from administrative data.
Screening coverage of eligible for HTN change: Change from Baseline Reach at 3, 6,9 months during the intervention; immediately after the intervention Screening coverage of eligible for HTN:proportion of eligible for HTN receiving screening.Data will be obtained from administrative data.
Screening coverage of eligible for type 2 DM change: Change from Baseline Reach at 3, 6,9 months during the intervention; immediately after the intervention Screening coverage of eligible for type 2 DM:proportion of eligible for type 2 DM receiving screening.Data will be obtained from administrative data.
Leader adoption change: Change from Baseline Adoption at 3, 6,9 months during the intervention; immediately after the intervention Leader adoption: # leaders recruited/designated/trained for the change effort in intervention implementation.Interview and observation methods will be used to assess this outcome measure.
HTN and type 2 DM institutionalized immediately after the intervention HTN and type 2 DM become institutionalized or part of the routine organizational practices.Data will be obtained from administrative data and survey.
Settings continue the intervention immediately after the intervention proportion and representativeness of settings that continue the intervention.Data will be obtained from administrative data.
Total intervention cost immediately after the intervention Total intervention cost per patient.Data will be obtained from administrative data.
Intervention maintenance costs immediately after the intervention % breakdown of maintenance (recurring) costs (ongoing training, personnel, materials, and other).Data will be obtained from administrative data.
Qualitative assessment-maintenance: immediately after the intervention Interviews method will be used to assess this outcome measure.
Coverage change: Change from Baseline Reach at 3, 6,9 months during the intervention; immediately after the intervention Coverage of population receiving health service for HTN and type 2 DM:proportion of target population receiving HTN and DM service.Data will be obtained from administrative data.
Coverage of screening for patients with HTN/type 2 DM change: Change from Baseline Reach at 3, 6,9 months during the intervention; immediately after the intervention Coverage of screening for patients with HTN/type 2 DM:% patients with HTN/type 2 DM who have been screened for hypertension/ diabetes.Data will be obtained from administrative data.
PHC professional's adoption change: Change from Baseline Adoption at 3, 6, 9 months during the intervention; immediately after the intervention PHC professional's adoption:% of PHC professionals trained in implementing the guidelines for HTN and DM.Data will be obtained from administrative data.
Institution adoption change: Change from Baseline Adoption at 3, 6,9 months during the intervention; immediately after the intervention Institution adoption:% intended Institution incorporated Administrative of HTN and DM in their routine service systems.Interview and observation methods will be used to assess this outcome measure.
Health professionals implemented guidelines/protocol change: Change from Baseline Fidelity at at 3, 6,9 months during the intervention; immediately after the intervention Health professionals implemented guidelines /protocol: % of PHC professionals implemented according to the guidelines/protocol in actual work. Interview and observation methods will be used to assess this outcome measure.
Facility vs. community costs immediately after the intervention % of costs of healthcare divided between facility level and community level.Data will be obtained from administrative data.
out-of-pocket patient costs immediately after the intervention % out-of-pocket patient costs.Survey method will be used to assess this outcome measure.
Trial Locations
- Locations (1)
National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
🇨🇳Beijing, Beijing, China