- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829642
Estonia's Enhanced Care Management Impact Evaluation (ECM)
Evaluating the Rollout of Estonia's Enhanced Care Management Program
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Harju
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Tallinn, Harju, Estonia, 10113
- Estonia Health Insurance Fund
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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:
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Control
The control group will not receive any intervention.
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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
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number of primary health care service interactions
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through study completion, an average of 2 years
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Number of Participants with inpatient care interactions
Time Frame: through study completion, an average of 2 years
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number of hospitalizations
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through study completion, an average of 2 years
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Number of Participants with outpatient services
Time Frame: through study completion, an average of 2 years
|
number of times ambulatory services accessed
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through study completion, an average of 2 years
|
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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
|
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Number of Participants with emergency department visits
Time Frame: through study completion, an average of 2 years
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number of emergency department visits for any reason
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through study completion, an average of 2 years
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Number of Participants with hospital readmission
Time Frame: through study completion, an average of 2 years
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Inpatient readmission within 90 days after any previous inpatient admission
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through study completion, an average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with inpatient post-hospitalization services
Time Frame: through study completion, an average of 2 years
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number of inpatient post-hospitalization services
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through study completion, an average of 2 years
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Number of Participants with outpatient post-visit services
Time Frame: through study completion, an average of 2 years
|
number of outpatient post-visit services
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through study completion, an average of 2 years
|
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Number of Participants with telephone follow up contacts
Time Frame: through study completion, an average of 2 years
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number of follow up contacts with patient by telephone
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through study completion, an average of 2 years
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Number of Participants with chronic illness-related follow up contacts
Time Frame: through study completion, an average of 2 years
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number of follow up contacts with patient due to chronic illness
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through study completion, an average of 2 years
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Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)
Time Frame: through study completion, an average of 2 years
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monitoring of glycosylated Hb (HbA1C)
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through study completion, an average of 2 years
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Number of diabetes, hypertension and myocardial infarction patients with monitoring of creatinine
Time Frame: through study completion, an average of 2 years
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monitoring of creatinine
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through study completion, an average of 2 years
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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
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monitoring of cholesterol levels/fractions
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through study completion, an average of 2 years
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Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients
Time Frame: through study completion, an average of 2 years
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counseling
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through study completion, an average of 2 years
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Number of myocardial infarction patients with appropriate statin prescription
Time Frame: through study completion, an average of 2 years
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number of appropriate prescriptions of statins
|
through study completion, an average of 2 years
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Number of myocardial infarction patients with appropriate beta-blockers prescription
Time Frame: through study completion, an average of 2 years
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number of appropriate prescriptions of beta-blockers
|
through study completion, an average of 2 years
|
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Number of diabetes patients with appropriate prescriptions
Time Frame: through study completion, an average of 2 years
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number of appropriate diabetes medication prescriptions
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through study completion, an average of 2 years
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Number of participants with hypertension (moderate or high-risk patients) with appropriate drug prescription
Time Frame: from enrollment to study completion
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appropriate drug prescription as defined by EHIF
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from enrollment to study completion
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Number of participants with hyperthyroidism monitoring with TSH adequately measured
Time Frame: through study completion, an average of 2 years
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TSH (thyroid stimulating hormone) determined
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through study completion, an average of 2 years
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Number of participants with new diagnosis of tracer conditions
Time Frame: through study completion, an average of 2 years
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hypertension, Type 2 diabetes, or myocardial infarction diagnosis
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through study completion, an average of 2 years
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Number of participants with prescriptions obtained
Time Frame: through study completion, an average of 2 years
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Share of prescriptions purchased out of all the prescribed medications by provider
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through study completion, an average of 2 years
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Number of participants with inadequate acute care follow up
Time Frame: through study completion, an average of 2 years
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Inadequate follow up care for patients hospitalized for acute inpatient care or surgery: cardiovascular disease, acute myocardial infarction, stroke, hip fracture, cholecystectomy.
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through study completion, an average of 2 years
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Number of participants with incomplete discharge from acute care
Time Frame: through study completion, an average of 2 years
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Incomplete discharge from acute in-patient care (for heart failure, acute myocardial infarction, unstable angina) as defined by EHIF protocol
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through study completion, an average of 2 years
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Number of hypertension patients (all risk levels) with drug prescription appropriate
Time Frame: through study completion, an average of 2 years
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Percentage of active ingredients-based prescriptions
|
through study completion, an average of 2 years
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Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P169891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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