Cohort Study on Patient Outcomes, Effectiveness and Cost-effectiveness of Intervention Programmes for DM/HT Patients
NCT04302974 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100000
Last updated 2024-12-10
Summary
Objectives: To determine the outcome trajectories of patients with hypertension (HT) and/or diabetes mellitus (DM), and evaluate the long-term effectiveness and cost-effectiveness of the Risk Assessment and Management Programmes (RAMP) and other primary care services such as Patient Support Call Centre (PSCC) on reducing complications and mortality
Design: Population-based cohort study
Setting: Hospital Authority (HA) primary care clinics Participants: All patients aged ≥18 years with DM or HT managed in HA primary care clinics between 2006 and 2021
Main outcome measures: (1) incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality); (2) service utilization (out-patient clinics, Accident and Emergency and overnight hospitalizations); (3) Incremental cost-effectiveness ratio per complications or all-cause death avoided, and per QALY gained by RAMP or PSCC.
Methods: A naturalistic cohort study (maximum 10-year follow-up) and retrospective data extraction from the HA clinical management system (CMS) database will be conducted to identify and correlate outcome trajectories of HT and/or DM patients with personal, service delivery and process of care factors. Outcomes of propensity score matched cohorts who have and have not participated in the programmes will be compared. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression will be conducted to evaluate the effect of RAMP, PSCC and other primary care services on the risk of complications, mortality and service utilization. Empirical costs and effectiveness data will be used to calculate cost-effectiveness from the provider's perspective.
Significance: Findings will inform how to optimize service delivery for HT/DM patients in Hong Kong
Conditions
- Hypertension
- Diabetes Mellitus
- Cardiovascular Diseases
- Morbidity, Multiple
- Kidney Disease, Chronic
- Death
Interventions
- PROCEDURE
-
Different structures and processes of primary care management strategies
Different structures and processes of primary care management strategies includes: Multi-morbidity, continuity-of-care, different service delivery models and management strategies (i.e. investigation frequency and specific drug regimens)
- PROCEDURE
-
Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM)
Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for diabetes (RAMP-DM), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All DM patients are eligible to enrol into the DM RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
- PROCEDURE
-
Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)
Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for hypertension (RAMP-HT), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All HT patients are eligible to enrol into the HT RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
- PROCEDURE
-
Patient Support Call Centre (PSCC)
RAMP Patients can also be referred to the Patient Empowerment Programme(PEP) - a structured self-care education programme delivered by non-governmental organisations(NGOs). If the DM control is suboptimal but the patient is unable to attend the PEP, they may be referred to the Patient Support Call Centre(PSCC) service. PSCC provides individualized telephone counselling by trained nurses. PSCC empowers high-risk DM patients to engage in self-care behaviours by providing regular protocol-led telephone support to advise and reinforce healthy behaviours. Targeted self-care behaviours include self-monitoring, medication management, balanced diet, exercise, risk factor reduction, problem solving and healthy coping. Enrolled patients receive weekly to bi-weekly calls in the first 3 months and additional calls as required for a maximum of 9 months. Subsequent follow-up calls are undertaken to assess self-care behaviours related to the selected goals and to develop a care plan with the patient.
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Cindy L.K. Lam, MD · Professor and Head of Department of Family Medicine & Primary Care, HKU
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-01
- Primary Completion
- 2024-06-30
- Completion
- 2024-09-30
Countries
- China
Study Locations
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