NCT05829642

Brief Summary

Estonia's aging population faces an increasing burden of non-communicable diseases (NCDs) and a growing population suffers with multiple chronic conditions. These changes have reduced well-being and quality of life for many older Estonians, while increasing the use of high cost specialist and emergency care. In response, the Estonia Health Insurance Fund (EHIF) is working to support primary care physicians to improve care for complex patients with multiple chronic conditions. A new EHIF-led program, Enhanced Care Management (ECM), entails training family physicians to identify complex patients, co-develop proactive care plans with them, and to undertake more active outreach to and management of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

February 15, 2023

Last Update Submit

August 14, 2023

Conditions

Keywords

non-communicable diseasesdiabeteshypertensionobesitymental health

Outcome Measures

Primary Outcomes (6)

  • Number of Participants with primary health care utilization

    number of primary health care service interactions

    through study completion, an average of 2 years

  • Number of Participants with inpatient care interactions

    number of hospitalizations

    through study completion, an average of 2 years

  • Number of Participants with outpatient services

    number of times ambulatory services accessed

    through study completion, an average of 2 years

  • Number of Participants with avoidable hospital admissions

    number of hospital admissions with asthma, COPD, diabetes, congestive heart failure, or hypertension as primary diagnosis

    through study completion, an average of 2 years

  • Number of Participants with emergency department visits

    number of emergency department visits for any reason

    through study completion, an average of 2 years

  • Number of Participants with hospital readmission

    Inpatient readmission within 90 days after any previous inpatient admission

    through study completion, an average of 2 years

Secondary Outcomes (18)

  • Number of Participants with inpatient post-hospitalization services

    through study completion, an average of 2 years

  • Number of Participants with outpatient post-visit services

    through study completion, an average of 2 years

  • Number of Participants with telephone follow up contacts

    through study completion, an average of 2 years

  • Number of Participants with chronic illness-related follow up contacts

    through study completion, an average of 2 years

  • Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)

    through study completion, an average of 2 years

  • +13 more secondary outcomes

Study Arms (2)

ECM intervention arm

The Enhanced Care Management (ECM) intervention consists of training and coaching family physicians and their teams to develop holistic care and pro-active outreach plans for chronically ill patients or those vulnerable to developing chronically illnesses, as identified and agreed between the enrolled providers and the Estonian Health Insurance Fund (EHIF). The core goal of ECM is to improve the quality of care provided to complex patients, including by increasing the use of preventive care, improving coordination of care across health system levels, and increasing patient involvement in care. These elements can improve patient health and quality of life, and may reduce the need for curative medical services.

Behavioral: Enhanced Care Management

Control

The control group will not receive any intervention.

Interventions

ECM aims to enable primary health care providers to coordinate care for patients with complex medical needs. It involves the close coordination of services across all treatment modalities and clinical team members, including primary care physicians, specialists, pharmacists, and other healthcare professionals. Providers undertake: Comprehensive care planning: A comprehensive care plan is developed and updated by all members of the patient's healthcare team, including their primary care physician, specialist, and other providers, to ensure that all aspects of treatment are addressed. Proactive outreach: Outreach activities, such as phone calls, home visits, and other forms of contact with the patient and their family are also used to promote patient engagement in health management Monitoring: Close monitoring of patients and their health conditions is essential to ensure that treatments are effective and that any adverse effects are quickly identified and addressed

Also known as: ECM coaching
ECM intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All clinics and individuals covered by the Estonian Health Insurance Fund and determined to be eligible for Enhanced Care Management

You may qualify if:

  • identified by general practitioner as having multiple chronic health conditions including type 2 diabetes, hypertension, and obesity

You may not qualify if:

  • terminal illness; acute cancer (cancer in treatment), schizophrenia, dialysis due to renal failure, congenital malformations requiring specialized care, and rare diseases; patients with more than 7 chronic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Estonia Health Insurance Fund

Tallinn, Harju, 10113, Estonia

Location

MeSH Terms

Conditions

Noncommunicable DiseasesDiabetes MellitusHypertensionObesityPsychological Well-Being

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Kevin Croke, Phd

    Harvard University

    PRINCIPAL INVESTIGATOR
  • Daniel Rogger, PhD

    World Bank

    PRINCIPAL INVESTIGATOR
  • Benjamin Daniels, MSc

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Global Health

Study Record Dates

First Submitted

February 15, 2023

First Posted

April 26, 2023

Study Start

November 24, 2020

Primary Completion

June 30, 2022

Study Completion

May 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

IPD will be anonymized and catalogued on the World Bank Microdata Catalog in consultation with EHIF, including indicators identifying the design variables relevant to each individual.

Shared Documents
ANALYTIC CODE
Time Frame
Post-conclusion of analysis; indefinitely.
Access Criteria
Use for research only; per agreement with EHIF.

Locations