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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05353699
• Other study ID #: Shiqihu
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12648
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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:?Patients 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; ?Have normal communication ability and independent behavior ability; ?Volunteer to participate in the project questionnaire survey and provide the informed consents.

• Exclusion criteria for respondents:?Patients with severe chronic diseases or in acute stage who cannot cooperate with investigators; ?Mental 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:?Health care personnel responsible for community HTN or type 2 DM management; ?Responsible for the national basic public health service project -HTN, type 2 DM health management work for at least 12 months; ?Willing to participate in the project; ?Willing to be interviewed;?Good presentation and verbal communication skills.

• Exclusion criteria for interviewees:?Health care workers who were not responsible for hypertensive or diabetic management;?Health care workers who carried out the management for less than 12 months;?Those who are not willing to participate in the project;?Unwilling to be interviewed;?Lack 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:?patients who have participated in management;?patients who are active in conversation;?patients who are willing to participate in interviews.

• Exclusion criteria for patients:?patients with hypertension or diabetes who do not participate in the management;?patients who are not willing to be interviewed.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC	World Health Organization

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Coverage change: Change from Baseline Reach at 3, 6,9 months	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.	during the intervention; immediately after the intervention
Secondary	Screening coverage of eligible for HTN change: Change from Baseline Reach at 3, 6,9 months	Screening coverage of eligible for HTN:proportion of eligible for HTN receiving screening.Data will be obtained from administrative data.	during the intervention; immediately after the intervention
Secondary	Screening coverage of eligible for type 2 DM change: Change from Baseline Reach at 3, 6,9 months	Screening coverage of eligible for type 2 DM:proportion of eligible for type 2 DM receiving screening.Data will be obtained from administrative data.	during the intervention; immediately after the intervention
Secondary	Coverage of screening for patients with HTN/type 2 DM change: Change from Baseline Reach at 3, 6,9 months	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.	during the intervention; immediately after the intervention
Secondary	Readiness change: Change from Baseline Adoption at 3, 6,9 months	Readiness for implementation:a checklist to check readiness for implementation using.Data will be obtained from administrative data.	during the intervention; immediately after the intervention
Secondary	Health centers/clinic's adoption change: Change from Baseline Adoption at 3, 6,9 months	Health centers/clinic's adoption: % proportion of health centers/clinics implemented lifestyle intervention and/or medication.Data will be obtained from administrative data.	during the intervention; immediately after the intervention
Secondary	PHC professional's adoption change: Change from Baseline Adoption at 3, 6, 9 months	PHC professional's adoption:% of PHC professionals trained in implementing the guidelines for HTN and DM.Data will be obtained from administrative data.	during the intervention; immediately after the intervention
Secondary	Timely adoption	Timely adoption:# early adopters at the local site. Observation methods will be used to assess this outcome measure.	during the intervention
Secondary	Leader adoption change: Change from Baseline Adoption at 3, 6,9 months	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.	during the intervention; immediately after the intervention
Secondary	Institution adoption change: Change from Baseline Adoption at 3, 6,9 months	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.	during the intervention; immediately after the intervention
Secondary	Follow-up fidelity change: Change from Baseline Fidelity at at 3, 6,9 months	Follow-up fidelity: % patients with "adequate" number of follow-up visits received.Data will be obtained from administrative data(records).	during the intervention; immediately after the intervention
Secondary	Health professionals implemented guidelines/protocol change: Change from Baseline Fidelity at at 3, 6,9 months	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.	during the intervention; immediately after the intervention
Secondary	Qualitative assessment-Behavior changes sustained (staff)	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.	15 months
Secondary	HTN and type 2 DM institutionalized	HTN and type 2 DM become institutionalized or part of the routine organizational practices.Data will be obtained from administrative data and survey.	immediately after the intervention
Secondary	Settings continue the intervention	proportion and representativeness of settings that continue the intervention.Data will be obtained from administrative data.	immediately after the intervention
Secondary	Total intervention cost	Total intervention cost per patient.Data will be obtained from administrative data.	immediately after the intervention
Secondary	Total treatment cost	Total treatment cost per patient.Data will be obtained from administrative data.	immediately after the intervention
Secondary	Intervention maintenance costs	% breakdown of maintenance (recurring) costs (ongoing training, personnel, materials, and other).Data will be obtained from administrative data.	immediately after the intervention
Secondary	Facility vs. community costs	% of costs of healthcare divided between facility level and community level.Data will be obtained from administrative data.	immediately after the intervention
Secondary	out-of-pocket patient costs	% out-of-pocket patient costs.Survey method will be used to assess this outcome measure.	immediately after the intervention
Secondary	Qualitative assessment-maintenance:	Interviews method will be used to assess this outcome measure.	immediately after the intervention