Estonia's Enhanced Care Management Impact Evaluation

NCT ID: NCT05829642

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2389 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-24

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multi-morbidity Non-communicable Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Enhanced Care Management

Intervention Type BEHAVIORAL

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

Control

The control group will not receive any intervention.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enhanced Care Management

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ECM coaching

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

World Bank

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role collaborator

Estonia Health Insurance Fund

UNKNOWN

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kevin Croke

Assistant Professor of Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Croke, Phd

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Daniel Rogger, PhD

Role: PRINCIPAL_INVESTIGATOR

World Bank

Benjamin Daniels, MSc

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Estonia Health Insurance Fund

Tallinn, Harju, Estonia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Estonia

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P169891

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Ebeltoft Health Promotion Project
NCT00145782 COMPLETED PHASE3
Social Needs Screenings in ED
NCT04630041 COMPLETED NA
My Life, My Healthcare
NCT03017196 COMPLETED NA
Telecare in Rural Senior Centers
NCT05552638 WITHDRAWN NA