Clinical trial NCT05829642: Estonia's Enhanced Care Management Impact Evaluation
Official title: Evaluating the Rollout of Estonia's Enhanced Care Management Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi-morbidity
Non-communicable Diseases
Keywords: non-communicable diseases
diabetes
hypertension
obesity
mental health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: World Bank
name: Georgetown University
name: Estonia Health Insurance Fund
First posted: 2023-04-26
Enrollment: 2389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with primary health care utilization
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with inpatient care interactions
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with outpatient services
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with avoidable hospital admissions
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with emergency department visits
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with hospital readmission
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Number of Participants with inpatient post-hospitalization services
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with outpatient post-visit services
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with telephone follow up contacts
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with chronic illness-related follow up contacts
timeFrame: through study completion, an average of 2 years
measure: Number of diabetes, hypertension and myocardial infarction patients with monitoring of glycosylated Hb (HbA1C)
timeFrame: through study completion, an average of 2 years
measure: Number of diabetes, hypertension and myocardial infarction patients with monitoring of creatinine
timeFrame: through study completion, an average of 2 years
measure: Number of diabetes, hypertension and myocardial infarction patients with monitoring of cholesterol levels and fractions
timeFrame: through study completion, an average of 2 years
measure: Number of hypertension care (high risk patients), diabetes, and myocardial infarction patients
timeFrame: through study completion, an average of 2 years
measure: Number of myocardial infarction patients with appropriate statin prescription
timeFrame: through study completion, an average of 2 years
measure: Number of myocardial infarction patients with appropriate beta-blockers prescription
timeFrame: through study completion, an average of 2 years
measure: Number of diabetes patients with appropriate prescriptions
timeFrame: through study completion, an average of 2 years
measure: Number of participants with hypertension (moderate or high-risk patients) with appropriate drug prescription
timeFrame: from enrollment to study completion
measure: Number of participants with hyperthyroidism monitoring with TSH adequately measured
timeFrame: through study completion, an average of 2 years
measure: Number of participants with new diagnosis of tracer conditions
timeFrame: through study completion, an average of 2 years
measure: Number of participants with prescriptions obtained
timeFrame: through study completion, an average of 2 years
measure: Number of participants with inadequate acute care follow up
timeFrame: through study completion, an average of 2 years
measure: Number of participants with incomplete discharge from acute care
timeFrame: through study completion, an average of 2 years
measure: Number of hypertension patients (all risk levels) with drug prescription appropriate
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Estonia Health Insurance Fund
state: Harju
Study officials:
affiliation: Harvard University
name: Kevin Croke, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Daniel Rogger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Benjamin Daniels, MSc
role: PRINCIPAL_INVESTIGATOR
References: