Estonia's Enhanced Care Management Impact Evaluation

Non-communicable Diseases Clinical Trial

— ECM  

Official title:

Evaluating the Rollout of Estonia's Enhanced Care Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05829642
• Other study ID #: P169891
• Status: Completed
• Start date: November 24, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2389
• Est. completion date: May 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multi-morbidity
• Non-communicable Diseases
• Noncommunicable Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Estonia	Estonia Health Insurance Fund	Tallinn	Harju

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Estonia Health Insurance Fund, Georgetown University, World Bank

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with primary health care utilization	number of primary health care service interactions	through study completion, an average of 2 years
Primary	Number of Participants with inpatient care interactions	number of hospitalizations	through study completion, an average of 2 years
Primary	Number of Participants with outpatient services	number of times ambulatory services accessed	through study completion, an average of 2 years
Primary	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
Primary	Number of Participants with emergency department visits	number of emergency department visits for any reason	through study completion, an average of 2 years
Primary	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	Number of Participants with inpatient post-hospitalization services	number of inpatient post-hospitalization services	through study completion, an average of 2 years
Secondary	Number of Participants with outpatient post-visit services	number of outpatient post-visit services	through study completion, an average of 2 years
Secondary	Number of Participants with telephone follow up contacts	number of follow up contacts with patient by telephone	through study completion, an average of 2 years
Secondary	Number of Participants with chronic illness-related follow up contacts	number of follow up contacts with patient due to chronic illness	through study completion, an average of 2 years
Secondary	Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)	monitoring of glycosylated Hb (HbA1C)	through study completion, an average of 2 years
Secondary	Number of diabetes, hypertension and myocardial infarction patients with monitoring of creatinine	monitoring of creatinine	through study completion, an average of 2 years
Secondary	Number of diabetes, hypertension and myocardial infarction patients with monitoring of cholesterol levels and fractions	monitoring of cholesterol levels/fractions	through study completion, an average of 2 years
Secondary	Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients	counseling	through study completion, an average of 2 years
Secondary	Number of myocardial infarction patients with appropriate statin prescription	number of appropriate prescriptions of statins	through study completion, an average of 2 years
Secondary	Number of myocardial infarction patients with appropriate beta-blockers prescription	number of appropriate prescriptions of beta-blockers	through study completion, an average of 2 years
Secondary	Number of diabetes patients with appropriate prescriptions	number of appropriate diabetes medication prescriptions	through study completion, an average of 2 years
Secondary	Number of participants with hypertension (moderate or high-risk patients) with appropriate drug prescription	appropriate drug prescription as defined by EHIF	from enrollment to study completion
Secondary	Number of participants with hyperthyroidism monitoring with TSH adequately measured	TSH (thyroid stimulating hormone) determined	through study completion, an average of 2 years
Secondary	Number of participants with new diagnosis of tracer conditions	hypertension, Type 2 diabetes, or myocardial infarction diagnosis	through study completion, an average of 2 years
Secondary	Number of participants with prescriptions obtained	Share of prescriptions purchased out of all the prescribed medications by provider	through study completion, an average of 2 years
Secondary	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.	through study completion, an average of 2 years
Secondary	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	through study completion, an average of 2 years
Secondary	Number of hypertension patients (all risk levels) with drug prescription appropriate	Percentage of active ingredients-based prescriptions	through study completion, an average of 2 years