Clinical trial NCT06310148: Evaluation of the Chronic Disease Co-Care Pilot Scheme
Official title: An Evaluation of the Effectiveness and Cost-effectiveness of the Chronic Disease Co-Care (CDCC) Pilot Scheme: a Commissioned Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Chronic Disease
Disease Management
Primary Healthcare
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
name: Primary Healthcare Office, Hong Kong
First posted: 2024-03-15
Enrollment: 3772
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.

This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.

Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation.

Detailed description: This study aims to evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the CDCC Pilot Scheme in Hong Kong. The objectives of this study are the following:

1. Describe the characteristics of participants of the CDCC Pilot Scheme;
2. Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme;
3. Evaluate participant acceptability by self-reported outcomes on enablement, experience and satisfaction level about the services of CDCC;
4. Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months;
5. Determine the provider costs and cost-effectiveness for delivering the CDCC Pilot Scheme relative to its effectiveness on participants health outcomes

The detailed study design of each objective are:

Objective (a): All participants in CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included in the evaluation. The characteristics including demographics, comorbidities, and medications of the participants will be summarized using descriptive statistics.

Objective (b): For the evaluation of the structure of care, quantitative data will be collected through structured questionnaires on the quality of care with DHC/DHC Express managers at 6 months and repeated at 12 months. Each DHC/DHC Express will also nominate two family doctors and one of each network allied health professionals (optometrists, podiatrists, dietitians, and physiotherapists subject to the availability in each center) within their service network to complete the questionnaire at 12 months. For the evaluation of the standards on process and outcome of care, all participants in the CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included.

Objective (c): Participants will be conveniently sampled after completion of the Health Risk Factor Assessment (HRFA) at DHC/DHC Express between 1 Jan 2024 and 31 Mar 2024 to complete surveys on self-reported outcomes. For the first survey at 3 months, a questionnaire will be used to assess participants' enablement level and experience during the screening phase. The second follow-up survey will be administered at 12 months to assess participants' experience in clinical encounters.

Objective (d): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the effectiveness of the CDCC Pilot Scheme. A total of 264 CDCC participants, and 264 non-CDCC participants screened positive for HT, pre-DM, or DM will be included as intervention and comparison group, respectively. All participants will be followed up 12 months. Records for CDCC participants who meet the inclusion criteria between 1 Jan 2024 and 30 Apr 2024, will be extracted from the Electronic Health Record Sharing System database. Meanwhile, a convenient sample of 1,886 non-CDCC participants (comparison group) will be recruited from the community between 1 Jan 2024 and 30 Apr 2024.

Objective (e): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the costs and cost-effectiveness of the CDCC Pilot Scheme. The total costs incurred on the CDCC Pilot Scheme from 1st January 2024 to 31st December 2024, including set-up costs, ongoing operational costs and ongoing administrative and maintenance costs will be collected via questionnaires. Direct medical costs for CDCC participants and non-CDCC participants will be collected after 12 months.

Eligibility criteria: Inclusion Criteria of interventional group:

* Hong Kong residents
* Aged ≥45 years
* Registered as a member of DHC/DHC Express
* Provided informed consent on sharing their data in the electronic Health Record Sharing System
* Provided consent to join the CDCC Pilot Scheme Terms and Conditions.

Exclusion Criteria of interventional group:

* With known history of DM or HT

Inclusion Criteria of comparison group:

* Hong Kong residents
* Aged ≥45 years
* Provided informed consent for the study.

Exclusion Criteria of comparison group:

* Without known history of DM or HT

Primary outcomes:
measure: Characteristics of the Chronic Disease Co-Care (CDCC) participants
timeFrame: Characteristics of CDCC participants will be described at baseline
measure: Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire
timeFrame: Questionnaires will be implemented at 6 months and 12 months after the study begins
measure: Enablement of CDCC participants by the Chinese Patient Enablement Instrument
timeFrame: 12 months
measure: Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP)
timeFrame: 12 months
measure: The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire
timeFrame: 12 months
measure: The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio
timeFrame: 12 months
Secondary outcomes:
measure: Experience and satisfaction of CDCC participants by the experience and enablement questionnaire
timeFrame: Experience and satisfaction of CDCC participants will be evaluated at 3 months and 12 months after recruitment
measure: Number of attendance to doctor consultation on times in comparison groups
timeFrame: 12 months
measure: Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups
timeFrame: 12 months
measure: Changes in mean HbA1c/FPG in percent between two groups
timeFrame: 12 months
measure: Changes in mean SBP and DBP in millimeter of mercury between two groups
timeFrame: 12 months
measure: Changes in mean of HbA1c in percent between two groups
timeFrame: 12 months
measure: Changes in BMI in kilogram per square metre between two groups
timeFrame: 12 months
measure: Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment
timeFrame: 12 months
measure: The predicted 10-year cardiovascular disease (CVD) risk between two groups
timeFrame: 12 months
measure: Amount of direct medical costs between two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG
Study officials:
References: