Multi-morbidityECMNCT05829642
Estonia's Enhanced Care Management Impact Evaluation
An observational study of Multi-morbidity and Non-communicable Diseases, run by Harvard School of Public Health (HSPH) at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-morbidity, Non-communicable Diseases
- What is being tested?
- Enhanced Care Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,389 participants
- Where
- 1 siteEstonia
- Study dates
- 24 Nov 2020to 31 May 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All clinics and individuals covered by the Estonian Health Insurance Fund and determined to be eligible for Enhanced Care Management
Who may be able to join
- identified by general practitioner as having multiple chronic health conditions including type 2 diabetes, hypertension, and obesity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multi-morbidity, Non-communicable Diseases
- Being tested
- Enhanced Care Management
- Keywords
- non-communicable diseases, diabetes, hypertension, obesity, mental health
- Medical subject headings
- Noncommunicable Diseases, Diabetes Mellitus, Hypertension, Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Care ManagementBehavioural
Also called ECM coaching
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Enhanced Care Management | |
| Control | The control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with primary health care utilization
number of primary health care service interactions
Measured: through study completion, an average of 2 years
Number of Participants with inpatient care interactions
number of hospitalizations
Measured: through study completion, an average of 2 years
Number of Participants with outpatient services
number of times ambulatory services accessed
Measured: 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
Measured: through study completion, an average of 2 years
Number of Participants with emergency department visits
number of emergency department visits for any reason
Measured: through study completion, an average of 2 years
Number of Participants with hospital readmission
Inpatient readmission within 90 days after any previous inpatient admission
Measured: through study completion, an average of 2 years
Secondary outcomes (18)
Number of Participants with inpatient post-hospitalization services
number of inpatient post-hospitalization services
Measured: through study completion, an average of 2 years
Number of Participants with outpatient post-visit services
number of outpatient post-visit services
Measured: through study completion, an average of 2 years
Number of Participants with telephone follow up contacts
number of follow up contacts with patient by telephone
Measured: through study completion, an average of 2 years
Number of Participants with chronic illness-related follow up contacts
number of follow up contacts with patient due to chronic illness
Measured: through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)
monitoring of glycosylated Hb (HbA1C)
Measured: through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of creatinine
monitoring of creatinine
Measured: through study completion, an average of 2 years
Number of diabetes, hypertension and myocardial infarction patients with monitoring of cholesterol levels and fractions
monitoring of cholesterol levels/fractions
Measured: through study completion, an average of 2 years
Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients
counseling
Measured: through study completion, an average of 2 years
Number of myocardial infarction patients with appropriate statin prescription
number of appropriate prescriptions of statins
Measured: through study completion, an average of 2 years
Number of myocardial infarction patients with appropriate beta-blockers prescription
number of appropriate prescriptions of beta-blockers
Measured: through study completion, an average of 2 years
Number of diabetes patients with appropriate prescriptions
number of appropriate diabetes medication prescriptions
Measured: through study completion, an average of 2 years
Number of participants with hypertension (moderate or high-risk patients) with appropriate drug prescription
appropriate drug prescription as defined by EHIF
Measured: from enrollment to study completion
Number of participants with hyperthyroidism monitoring with TSH adequately measured
TSH (thyroid stimulating hormone) determined
Measured: through study completion, an average of 2 years
Number of participants with new diagnosis of tracer conditions
hypertension, Type 2 diabetes, or myocardial infarction diagnosis
Measured: through study completion, an average of 2 years
Number of participants with prescriptions obtained
Share of prescriptions purchased out of all the prescribed medications by provider
Measured: through study completion, an average of 2 years
Number of participants with inadequate acute care follow up
Inadequate follow up care for patients hospitalized for acute inpatient care or surgery: cardiovascular disease, acute myocardial infarction, stroke, hip fracture, cholecystectomy.
Measured: through study completion, an average of 2 years
Number of participants with incomplete discharge from acute care
Incomplete discharge from acute in-patient care (for heart failure, acute myocardial infarction, unstable angina) as defined by EHIF protocol
Measured: through study completion, an average of 2 years
Number of hypertension patients (all risk levels) with drug prescription appropriate
Percentage of active ingredients-based prescriptions
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start24 Nov 2020
- Primary completion30 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-morbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,389 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, Georgetown University, Estonia Health Insurance Fund
- Responsible party
- Principal investigator, Kevin Croke, Harvard School of Public Health (HSPH)
- Investigators
- Kevin Croke, Phd, Principal investigator, Harvard UniversityDaniel Rogger, PhD, Principal investigator, World BankBenjamin Daniels, MSc, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829642
- Sponsor's protocol ID
- P169891
- Acronym
- ECM
- Status last verified
- Aug 2023
- First submitted
- 15 Feb 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Rollout of Estonia's Enhanced Care Management Program
- ClinicalTrials.gov ID
- NCT05829642
- Acronym / sponsor ID
- ECM / P169891
- Conditions
- Multi-morbidity, Non-communicable Diseases
- Keywords
- non-communicable diseases, diabetes, hypertension, obesity, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,389 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- World Bank, Georgetown University, Estonia Health Insurance Fund
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECM intervention arm | – | Behavioral: Enhanced Care ManagementThe 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. |
| Control | – | –The control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All clinics and individuals covered by the Estonian Health Insurance Fund and determined to be eligible for Enhanced Care Management
Key inclusion criteria (1 listed)
- identified by general practitioner as having multiple chronic health conditions including type 2 diabetes, hypertension, and obesity
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Care ManagementAlso: ECM coachingECM 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 | Behavioural | ECM intervention arm |
Primary outcome
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
Number of Participants with inpatient care interactions
Time frame: through study completion, an average of 2 years
number of hospitalizations
Number of Participants with outpatient services
Time frame: through study completion, an average of 2 years
number of times ambulatory services accessed
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
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
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
18 secondary outcomes
Number of Participants with inpatient post-hospitalization services
Time frame: 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 Participants with telephone follow up contacts
Time frame: 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 diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)
Time frame: 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
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
Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients
Time frame: 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 myocardial infarction patients with appropriate beta-blockers prescription
Time frame: 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 participants with hypertension (moderate or high-risk patients) with appropriate drug prescription
Time frame: 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
Number of participants with new diagnosis of tracer conditions
Time frame: through study completion, an average of 2 years
Number of participants with prescriptions obtained
Time frame: 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
Number of participants with incomplete discharge from acute care
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Croke, Phd principal investigator
Harvard University
Daniel Rogger, PhD principal investigator
World Bank
Benjamin Daniels, MSc principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-morbidity and Non-communicable Diseases, run by Harvard School of Public Health (HSPH) at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with primary health care utilization (time frame: through study completion, an average of 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.