Clinical trial NCT05809817: Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data
Official title: Economic Evaluation of the Current Proposal and Different Decision-making Scenarios of Coverage Increases of an Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Periodontitis
Diabetic Complication
Dental Care
Keywords: Periodontics
Periodontal Medicine
Type 2 Diabetes Mellitus
Non-surgical Periodontal Therapy
Diabetic complication
Cost-Effectiveness Analysis
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2DM under follow-up in the PSCV

Brief summary: The goal of this study is to evaluate the cost-effectiveness of the current proposal and different decision-making scenarios of periodontal care coverage increases for patients with T2DM in Chile. The main objective of the clinical section of this study (effectiveness) aims to determine the effectiveness of periodontal care in patients with T2DM under follow-up in the Cardiovascular Health Program (Programa de Salud Cardiovascular, PSCV) of the in the CEMO Villa Sur of Pedro Aguirre Cerda and the CESFAM Antonio Varas of Puerto Montt.

A highly matched control group is proposed using Propensity Score Matching of PSCV patients with T2DM who have not received periodontal care. This would allow a better comparison of the individuals who will actually be treated against a counterfactual against of those with similar characteristics who did not receive periodontal intervention during the follow-up period of this first stage.

Detailed description: Introduction: Oral diseases and type 2 Diabetes Mellitus (T2DM) constitute an important public health problem in Chile, due to their high prevalence and economic and social impact. T2DM increases the risk of oral diseases such as periodontitis, and the latter worsens the metabolic control of T2DM, increasing the risk of macrovascular and microvascular complications. More than 10% of total health spending in Chile is allocated to the treatment of T2DM, especially for the management of its complications. The main T2DM control program in Chile is the Cardiovascular Health Program (PSCV) that treats more than 900,000 people with T2DM, however, its results are still insufficient. Although periodontal treatment improves the metabolic control of T2DM, the proposed goal of periodontal care coverage for patients with T2DM in the context of the PSCV is only 2%. Therefore, the decision to expand periodontal care coverage to efficiently improve the health status of these patients is crucial.

Objective: To evaluate the cost-effectiveness of the current proposal and different decision-making scenarios for increasing periodontal care coverage for patients with T2DM from the perspective of the public health system in Chile.

Methods: In the first stage, a prospective observational cohort study will be conducted at the CEMO Villa Sur in Pedro Aguirre Cerda and at the CESFAM Puerto Varas in the commune of Puerto Montt to estimate treatment costs and the effectiveness of periodontal care on glycated hemoglobin (HbA1c) levels in the context of PSCV (real-world data). The intervention cohort will consist of those patients with T2DM receiving periodontal care during 2023, while the comparison cohort will consist of those on the waiting list during the same period, matched 1:1 through Propensity Score Matching. In a second stage the costs and effects of each coverage alternative (2%, 20%, 40%, 60%, 80% and 100%) will be modeled using microsimulation techniques to estimate the projected impact over a lifetime horizon of HbA1c changes on the risk of complications, death and decreased quality of life. Costs for each clinical stage will be obtained from national GES (Explicit Health Guarantees) cost estimates, supplemented by other sources, and quality-adjusted life years will be used as a summary measure of effects. Costs and effects will be combined to estimate the incremental cost-effectiveness ratio (ICER). From the probabilistic sensitivity analysis, acceptability curves and frontiers and expected loss curves for the proposed courses of action will be estimated.

Eligibility criteria: * Inclusion criteria:

  1. Intervention: Patients with T2DM under follow-up in the PSCV who present records of HbA1c levels for the last three months prior to care and who receive complete periodontal treatment at the CEMO Villa Sur in the commune of Pedro Aguirre Cerda and at the CESFAM Puerto Varas in Puerto Montt under the PSCV will be selected.
  2. Control: A control cohort of patients with T2DM under follow-up in the PSCV will be determined, matching 1:1 through Propensity Score Matching according to baseline HbA1c levels and demographic baseline data (age and sex).
* Exclusion criteria:

  1. Patients with a history of periodontal treatment.
  2. Pregnant or breastfeeding.
  3. Time spent in PSCV\<1year.

Primary outcomes:
measure: Metabolic control
timeFrame: Baseline and 3 months after periodontal treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Puerto Varas
country: Chile
facility: CESFAM Puerto VARAS
state: De Los Rios
city: Santiago
country: Chile
facility: CEMO Villa Sur
Study officials:
affiliation: Department of Conservative Dentistry, Faculty of Dentistry, University of Chile
name: Mauricio Baeza, DDS,MSc,PhD
role: STUDY_CHAIR
References: