Clinical trial NCT04302974: Cohort Study on Patient Outcomes, Effectiveness and Cost-effectiveness of Intervention Programmes for DM/HT Patients
Official title: Cohort Study to Investigate the Outcomes of Patients With Hypertension and/or Diabetes Mellitus and the Effectiveness and Cost-effectiveness of Structured Multi-disciplinary Intervention Programmes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes Mellitus
Cardiovascular Diseases
Morbidity, Multiple
Kidney Disease, Chronic
Death
Keywords: Continuity of care
Multi-morbidity
Effectiveness
Cost-effectiveness
Multi-disciplinary intervention programme
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All Chinese patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2021.
* Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2021.

Brief 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

Detailed description: A naturalistic cohort study with a maximum follow-up period of 10 years, and retrospective extraction of relevant data from the HA clinical management system (CMS) database, designed as four sub-studies:-

1. A trajectory study on all HA primary care patients with HT and/or DM receiving care from 2006 to 2019, to explore the trajectory patterns for clinical, treatment and complication profiles and investigate the impact of multi-morbidity, continuity-of-care, different service delivery models and management strategies (including investigation frequency and specific drug regimens) on outcomes and health service utilization.
2. A 10-year effectiveness and cost-effectiveness analysis (CEA) of RAMP-DM. A cohort of RAMP-DM patients will be compared against a propensity score matched cohort of 'usual care' only DM patients to determine the effectiveness and cost-effectiveness of RAMP-DM on reducing complications and mortality and gain in quality adjusted life years (QALY). The optimal criteria and frequency of repeating RAMP-DM will be determined.
3. A 10-year effectiveness and CEA of RAMP-HT. A cohort of RAMP-HT will be compared against a propensity score matched cohort of 'usual care' only HT patients to determine the effectiveness and cost-effectiveness of RAMP-HT on reducing complications and mortality and gain in QALY. The optimal criteria and frequency of repeating RAMP-HT will be determined
4. An evaluation on the effectiveness and cost-effectiveness of PSCC. A cohort of RAMP-DM plus PSCC (RAMP-DM+PSCC) will be compared against a propensity score matched cohort of RAMP-DM only patients to evaluate the effectiveness and cost effectiveness of PSCC on the reduction of complications and mortality and gain in QALY.

Eligibility criteria: Inclusion Criteria:

(Trajectory study)

* All patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2019.
* Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2019.

  (10-year CEA study on RAMP-DM)
* Documented diagnosis of DM without any known complications on or before September 2010
* Documented management in the HA GOPC and FMC identified from the HA CMS database between 2009 and 2019,
* Patients who attended the first RAMP-DM assessment between August 2009 to September 2010 for inclusion in the RAMP-DM cohort
* Patients who have never attended any RAMP-DM assessment between August 2009 to December 2019 for inclusion in the usual care only cohort

  (10-year CEA study on RAMP-HT)
* Documented diagnosis of HT without DM and any known complications on or before March 2013
* Documented management in the HA GOPC and FMC identified from the HA CMS database between 2011 and 2021,
* Patients who attended the first RAMP-HT assessment between October 2011 to March 2013 for inclusion in the RAMP-HT cohort
* Patients who have never attended any RAMP-HT assessment between October 2011 to December 2021 for inclusion in the usual care only cohort

  (5-year CEA study on PSCC)
* Documented diagnosis of DM without any known complications on or before August 2016
* Documented management in the HA GOPC and FMC identified from the HA CMS database between 2012 and 2021,
* Patients who attended the first RAMP-DM assessment between September 2012 to August 2016
* Patients who received the first PSCC call between September 2012 to August 2016 after the first RAMP-DM assessment for inclusion in the PSCC cohort
* Patients who have never received any PSCC services between September 2012 to December 2021 for inclusion in the RAMP only cohort

Exclusion Criteria:

(applicable to all sub-studies)

* Non-Chinese
* Patients with documented DM/HT-related complications diagnosed before the date of enrolment
* Medical specialist outpatient attendance before or within the first year of inclusion to study, to exclude subjects who might have developed complications before study enrolment

Primary outcomes:
measure: Incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality)
timeFrame: 10 years
measure: Service utilization rate (out-patient clinics, Accident and Emergency and hospitalizations)
timeFrame: 10 years
measure: Incremental cost-effectiveness ratio per DM/HT-related complication or all-cause death avoided, and per QALY gained by RAMP or PSCC
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Family Medicine & Primary Care, LKS Faculty of Medicine, University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Professor and Head of Department of Family Medicine & Primary Care, HKU
name: Cindy L.K. Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wan EYF, Chin WY, Yu EYT, Chen J, Tse ETY, Wong CKH, Ha TKH, Chao DVK, Tsui WWS, Lam CLK. Retrospective cohort study to investigate the 10-year trajectories of disease patterns in patients with hypertension and/or diabetes mellitus on subsequent cardiovascular outcomes and health service utilisation: a study protocol. BMJ Open. 2021 Feb 5;11(2):e038775. doi: 10.1136/bmjopen-2020-038775.