Estonia's Enhanced Care Management Impact Evaluation (ECM)

August 14, 2023 updated by: Kevin Croke, Harvard School of Public Health (HSPH)

Evaluating the Rollout of Estonia's Enhanced Care Management Program

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.

Study Overview

Status

Completed

Detailed Description

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). Under ECM, patients covered by EHIF and suffering from chronic diseases such as diabetes and cardiovascular diseases will be proactively engaged and monitored by primary care providers to provide better care and to prevent health deterioration.

Risk-stratified care management for chronic conditions was first introduced in Estonia in 2017 to better support high-risk patients with an assortment of chronic conditions and an increased risk of healthcare utilization. The Enhanced Care Management (ECM) program is intended to improve the quality of care provided to complex patients with qualifying chronic conditions, 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 and higher-level medical services-for example, by supporting patients with type 2 diabetes to improve their diet and increase physical activity to limit further deterioration in their health and use of emergency or specialty health services.

In 2017, the World Bank, EHIF and the Estonian Family Physicians Association launched a pilot of risk-stratified care management with a very small number of volunteering primary health care providers. From January to February 2017, a digital environment was developed to monitor patients for family physicians. It contains important data of risk patients (health indicators, medical history, socio-economic background) which can be accessed digitally by health care providers. This allowed family physicians and nurses to monitor health indicators and treatment goals of high-risk patients and track the implementation of the treatment plan.

The family physician and nurse's responsibilities involved assessing patient needs, creating treatment plans, coordinating health-related activities, and working with a social worker to provide social support. During the pilot project, family physicians collaborated with hospitals to track patient outcomes. Results of the initial pilot convinced EHIF that it would be beneficial to test expansion of the ECM model nationally, so a full-scale study was launched during 2020 to include a representative sample of clinics and their eligible patients nationwide.

In this study, the research team will conduct a randomized controlled trial in partnership with EHIF to evaluate the impact of ECM training for physicians. The RCT will have enrolled a randomly selected 97 family physicians out of the 786 family physicians practicing in Estonia. Among those physicians' 6,739 ECM-eligible patients, 2,389 patients will have been randomly selected for enrollment into the ECM program. Using administrative records, the study will evaluate the effects of ECM enrollment on: (1) health care utilization; (2) provider management of tracer conditions; and (3) markers of quality of care such as hospital admission for primary health care-sensitive conditions.

Study Type

Observational

Enrollment (Actual)

2389

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Harju
      • Tallinn, Harju, Estonia, 10113
        • Estonia Health Insurance Fund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria (for patients):

  • 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

Exclusion Criteria (for clinics) Having participated in ECM pilot study; not being currently operational; or having five or more practicing providers in the clinic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

Other Names:
  • ECM coaching
Control
The control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with primary health care utilization
Time Frame: through study completion, an average of 2 years
number of primary health care service interactions
through study completion, an average of 2 years
Number of Participants with inpatient care interactions
Time Frame: through study completion, an average of 2 years
number of hospitalizations
through study completion, an average of 2 years
Number of Participants with outpatient services
Time Frame: through study completion, an average of 2 years
number of times ambulatory services accessed
through study completion, an average of 2 years
Number of Participants with avoidable hospital admissions
Time Frame: through study completion, an average of 2 years
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
Time Frame: through study completion, an average of 2 years
number of emergency department visits for any reason
through study completion, an average of 2 years
Number of Participants with hospital readmission
Time Frame: through study completion, an average of 2 years
Inpatient readmission within 90 days after any previous inpatient admission
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with inpatient post-hospitalization services
Time Frame: through study completion, an average of 2 years
number of inpatient post-hospitalization services
through study completion, an average of 2 years
Number of Participants with outpatient post-visit services
Time Frame: through study completion, an average of 2 years
number of outpatient post-visit services
through study completion, an average of 2 years
Number of Participants with telephone follow up contacts
Time Frame: through study completion, an average of 2 years
number of follow up contacts with patient by telephone
through study completion, an average of 2 years
Number of Participants with chronic illness-related follow up contacts
Time Frame: through study completion, an average of 2 years
number of follow up contacts with patient due to chronic illness
through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)
Time Frame: through study completion, an average of 2 years
monitoring of glycosylated Hb (HbA1C)
through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of creatinine
Time Frame: through study completion, an average of 2 years
monitoring of creatinine
through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of cholesterol levels and fractions
Time Frame: through study completion, an average of 2 years
monitoring of cholesterol levels/fractions
through study completion, an average of 2 years
Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients
Time Frame: through study completion, an average of 2 years
counseling
through study completion, an average of 2 years
Number of myocardial infarction patients with appropriate statin prescription
Time Frame: through study completion, an average of 2 years
number of appropriate prescriptions of statins
through study completion, an average of 2 years
Number of myocardial infarction patients with appropriate beta-blockers prescription
Time Frame: through study completion, an average of 2 years
number of appropriate prescriptions of beta-blockers
through study completion, an average of 2 years
Number of diabetes patients with appropriate prescriptions
Time Frame: through study completion, an average of 2 years
number of appropriate diabetes medication prescriptions
through study completion, an average of 2 years
Number of participants with hypertension (moderate or high-risk patients) with appropriate drug prescription
Time Frame: from enrollment to study completion
appropriate drug prescription as defined by EHIF
from enrollment to study completion
Number of participants with hyperthyroidism monitoring with TSH adequately measured
Time Frame: through study completion, an average of 2 years
TSH (thyroid stimulating hormone) determined
through study completion, an average of 2 years
Number of participants with new diagnosis of tracer conditions
Time Frame: through study completion, an average of 2 years
hypertension, Type 2 diabetes, or myocardial infarction diagnosis
through study completion, an average of 2 years
Number of participants with prescriptions obtained
Time Frame: through study completion, an average of 2 years
Share of prescriptions purchased out of all the prescribed medications by provider
through study completion, an average of 2 years
Number of participants with inadequate acute care follow up
Time Frame: through study completion, an average of 2 years
Inadequate follow up care for patients hospitalized for acute inpatient care or surgery: cardiovascular disease, acute myocardial infarction, stroke, hip fracture, cholecystectomy.
through study completion, an average of 2 years
Number of participants with incomplete discharge from acute care
Time Frame: through study completion, an average of 2 years
Incomplete discharge from acute in-patient care (for heart failure, acute myocardial infarction, unstable angina) as defined by EHIF protocol
through study completion, an average of 2 years
Number of hypertension patients (all risk levels) with drug prescription appropriate
Time Frame: through study completion, an average of 2 years
Percentage of active ingredients-based prescriptions
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kevin Croke, Phd, Harvard University
  • Principal Investigator: Daniel Rogger, PhD, World Bank
  • Principal Investigator: Benjamin Daniels, MSc, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Post-conclusion of analysis; indefinitely.

IPD Sharing Access Criteria

Use for research only; per agreement with EHIF.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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