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

NCT05353699 | Unknown

• 1 other identifier: Shiqihu
• Study Type: interventional
• Target: 12,648
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (10)

• Awareness change：Change from Baseline Awareness at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Screening rate change：Change from Baseline Screening rate at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Diagnostic rate change：Change from Baseline Diagnostic rate at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Treatment rate change：Change from Baseline Treatment rate at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Control rate change：Change from Baseline Control rate at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Implementation strategies use change: Change from Baseline Implementation at 3, 6,9 months

  Implementation strategies use:qualitative interviews with managers of health centers.Interviews method will be used to assess this outcome measure.

  during the intervention; immediately after the intervention

• Supervision change: Change from Baseline Implementation at 3, 6,9 months

  Supervision model: % scheduled supervision field visits completed.Data will be obtained from administrative data.

  during the intervention; immediately after the intervention

• Referral completeness change: Change from Baseline Implementation at 3, 6,9 months

  Referral completeness: % referrals completed as prescribed by the clinical algorithm.Data will be obtained from administrative data.

  during the intervention; immediately after the intervention

• Adaptations to protocol change: Change from Baseline Implementation at 3, 6,9 months

  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.

  during the intervention; immediately after the intervention

• Implementation change: Change from Baseline Implementation at 3, 6,9 months

  Qualitative assessment: qualitative interviews with managers of health.Interviews method will be used to assess this outcome measure.

  during the intervention; immediately after the intervention

Secondary Outcomes (21)

• Coverage change: Change from Baseline Reach at 3, 6,9 months

  during the intervention; immediately after the intervention

• 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 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 change: Change from Baseline Reach at 3, 6,9 months

  during the intervention; immediately after the intervention

• Readiness change: Change from Baseline Adoption at 3, 6,9 months

  during the intervention; immediately after the intervention

Study Arms (2)

Intervention groups

EXPERIMENTAL

Other: Implementation strategies

Control groups

NO INTERVENTION

as same as before

Interventions

Implementation strategies 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.

Intervention groups

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC: lead
• World Health Organization: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)