An Evaluation of the Effectiveness and Cost-effectiveness of the Chronic Disease Co-Care (CDCC) Pilot Scheme: a Commissioned Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,772
- 试验地点
- 1
- 主要终点
- Enablement of CDCC participants by the Chinese Patient Enablement Instrument
研究概览
简要总结
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.
详细描述
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:
- Describe the characteristics of participants of the CDCC Pilot Scheme;
- Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme;
- Evaluate participant acceptability by self-reported outcomes on enablement, experience and satisfaction level about the services of CDCC;
- Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Enablement of CDCC participants by the Chinese Patient Enablement Instrument
时间窗: 12 months
Participants' enablement will be measured by the Chinese Patient Enablement Instrument (PEI) at 12 months following the enrolment into the CDCC Pilot Scheme
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)
时间窗: 12 months
Differences in the proportion of CDCC participants achieving the target outcome of disease control after 12 months as compared with non-CDCC participants. Target outcomes of disease control are defined as below: * Pre-DM: Reduction in HbA1c * HT: SBP/DBP \< 140/90 millimetres of mercury (mmHg) * DM: HbA1c \< 7%
Characteristics of the Chronic Disease Co-Care (CDCC) participants
时间窗: Characteristics of CDCC participants will be described at baseline
Characteristics including demographics, comorbidities, and medications of the CDCC participants. For continuous variables, age will be presented in years, blood pressure will be presented in millimeters of mercury, fasting glucose, low-density-lipoprotein cholesterol and triglycerides will be presented in millimole per liter, weight in kilograms and height in meter will be combined to report body mass index (BMI) in kg/m\^2, estimated glomerular filtration rate will be presented in milliliters per minute per 1.73m\^2. For categorical variables, frequency and proportion will be used. participants. For continuous variables, age will be presented in years. For categorical variables, frequency and proportion will be used.
The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio
时间窗: 12 months
The incremental cost-effectiveness ratio (ICER) per individual achieving the target outcome of disease control for the CDCC Pilot Scheme compared to the cost-effectiveness threshold of 1 annual Gross Domestic Product (GDP) after 12 months
Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire
时间窗: Questionnaires will be implemented at 6 months and 12 months after the study begins
The standards (proportion of participants) achieved by the program in each of the criterion specified under each domain of quality of care according to the CDCC Pilot Scheme protocol. The questionnaire is developed based on the evaluation framework on structure, process and outcome. The percentage of adherence out of 100% based on pre-determined key performance indicators will be reported. A higher score means a greater adherence to the standards of care.
The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire
时间窗: 12 months
The additional costs incurred on the CDCC Pilot Scheme from healthcare providers' perspective estimated from the manpower and pay scale of staff reported in the questionnaire, as well as the cost for acquiring physical space, equipment, and other IT infrastructure needed for the program. Costs will be presented as absolute values (HKD and USD).
次要结局
- Amount of direct medical costs between two groups(12 months)
- Experience and satisfaction of CDCC participants by the experience and enablement questionnaire(Experience and satisfaction of CDCC participants will be evaluated at 3 months and 12 months after recruitment)
- Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups(12 months)
- Changes in mean HbA1c/FPG in percent between two groups(12 months)
- Changes in BMI in kilogram per square metre between two groups(12 months)
- Number of attendance to doctor consultation on times in comparison groups(12 months)
- Changes in mean of HbA1c in percent between two groups(12 months)
- Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment(12 months)
- Changes in mean SBP and DBP in millimeter of mercury between two groups(12 months)
- The predicted 10-year cardiovascular disease (CVD) risk between two groups(12 months)
研究者
Dr. Eric Yuk Fai Wan
Assistant Professor
The University of Hong Kong