Clinical trial NCT05353699: Implementation of a Comprehensive Intervention on Hypertension（HTN） and Type 2 Diabetes Mellitus（DM） at PHC Level
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Lead sponsor: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2022-04-29
Enrollment: 12648
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.
* Exclusion criteria 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.

Primary outcomes:
measure: Awareness change：Change from Baseline Awareness at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Screening rate change：Change from Baseline Screening rate at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Diagnostic rate change：Change from Baseline Diagnostic rate at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Treatment rate change：Change from Baseline Treatment rate at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Control rate change：Change from Baseline Control rate at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Implementation strategies use change: Change from Baseline Implementation at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Supervision change: Change from Baseline Implementation at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Referral completeness change: Change from Baseline Implementation at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Adaptations to protocol change: Change from Baseline Implementation at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Implementation change: Change from Baseline Implementation at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
Secondary outcomes:
measure: Coverage change: Change from Baseline Reach at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Screening coverage of eligible for HTN change: Change from Baseline Reach at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Screening coverage of eligible for type 2 DM change: Change from Baseline Reach at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Coverage of screening for patients with HTN/type 2 DM change: Change from Baseline Reach at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Readiness change: Change from Baseline Adoption at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Health centers/clinic's adoption change: Change from Baseline Adoption at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: PHC professional's adoption change: Change from Baseline Adoption at 3, 6, 9 months
timeFrame: during the intervention; immediately after the intervention
measure: Timely adoption
timeFrame: during the intervention
measure: Leader adoption change: Change from Baseline Adoption at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Institution adoption change: Change from Baseline Adoption at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Follow-up fidelity change: Change from Baseline Fidelity at at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Health professionals implemented guidelines/protocol change: Change from Baseline Fidelity at at 3, 6,9 months
timeFrame: during the intervention; immediately after the intervention
measure: Qualitative assessment-Behavior changes sustained (staff)
timeFrame: 15 months
measure: HTN and type 2 DM institutionalized
timeFrame: immediately after the intervention
measure: Settings continue the intervention
timeFrame: immediately after the intervention
measure: Total intervention cost
timeFrame: immediately after the intervention
measure: Total treatment cost
timeFrame: immediately after the intervention
measure: Intervention maintenance costs
timeFrame: immediately after the intervention
measure: Facility vs. community costs
timeFrame: immediately after the intervention
measure: out-of-pocket patient costs
timeFrame: immediately after the intervention
measure: Qualitative assessment-maintenance:
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
state: Beijing
Study officials:
References: