Clinical trial NCT04957979: Minnesota Care Coordination Effectiveness Study
Official title: Comparing Two Approaches to Care Coordination for High-Cost/High-Need Patients in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Multi-morbidity
Care Coordination
Keywords: Care Coordination
Quality of Care
Health Care Utilization
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Minnesota Department of Health
name: MN Community Measurement
First posted: 2021-07-12
Enrollment: 25507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are patients receiving care coordination in Minnesota's Health Care Homes certified adult primary care clinics, starting during the specified date ranges.

Brief summary: Medical care has improved greatly over the past 50 years. Treatments for most medical conditions can help us lead longer and healthier lives, but there are still problems. Many patients with two or more conditions see many different doctors and sometimes take more medications than needed. These patients can feel lost and confused. In addition, non-medical issues involving housing, food, transportation, employment, income, support from others, and language barriers can have a large impact on our health.

In Minnesota, many primary care clinics are using a method called care coordination to improve the health of patients who have a number of chronic diseases (some examples of chronic diseases include diabetes, heart disease, asthma and depression). With care coordination, a nurse in the clinic helps the various doctors, clinics, and specialists to work together, in the interest of the patient. In some clinics, a social worker also helps with care coordination. These social workers help with issues like housing, transportation, or employment. Care coordination can help reduce patient confusion. It also can improve health and lower patient burdens and costs of getting medical care.

To help find out what types of care coordination are most successful, we are proposing a study. Our plan is to track the health of patients receiving care coordination and compare two types:

A. Care coordination done by a nurse or other clinic staff B. Care coordination where a licensed social worker also assists the patient

In this study, we will measure many things, including:

1. Control of chronic conditions like diabetes, heart disease, asthma, and depression
2. Hospitalizations
3. Emergency department visits
4. Use of medications and diagnostic tests
5. Use of specialty care
6. General health status
7. Patient satisfaction and access to care
8. Use of shared decision-making (where the doctor and the patient make treatment decisions together)
9. Patient burden (how much time and effort the patient spends trying to get healthy)
10. Patients' out-of-pocket medical costs

This project will be important to patients because it could reduce confusion and fragmented care while improving all the items above. Those improvements will be more likely because this project takes advantage of engagement with patients and others. We have four patient partners who will help conduct the study and interpret and broadly share the results. The project was developed with the input from patients, clinic leaders, people from state government, and experts on health and quality care.

By measuring a wide variety of outcomes for the adults receiving coordination services in these clinics, we hope to identify the specific actionable information that will allow these and other clinics to improve their services for these patients with complex needs.

Throughout the project, we will communicate our findings to clinics and health systems. As a result, many people may receive better care.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Historical Cohort: Receiving care coordination services in a participating clinic with a care coordination start date between January 2018 and February 2019
* Primary Cohort: Receiving care coordination services in a participating clinic with a care coordination start date between January 2021 and December 2021
* Currently insured by the MN Department of Human Services (DHS), Blue Cross Blue Shield MN (BCBS), UCare, or HealthPartners (HP) (for utilization outcomes only)
* Consents to participate in interview or responds to a survey (for those data collection events only)

Exclusion Criteria:

* Cannot complete an interview in English (interviews only)
* Cannot complete a survey in English, Spanish, Somali, or Hmong (for interviews only, reflecting most prevalent languages in MN)
* On a known research exclusion list

Primary outcomes:
measure: Change in Composite Measure of Care Quality
timeFrame: 12 months pre- and post- initiation of care coordination
measure: Change in Annual Number of Emergency Department Visits
timeFrame: 12 months pre and post start of care coordination
measure: Change in Annual Number of Inpatient Hospitalizations
timeFrame: 12 months pre and post start of care coordination
measure: General Health Status - Top Box Scoring
timeFrame: 6 to 18 months after start of care coordination
measure: Rating of Primary Care Clinic - Top Box
timeFrame: 6 to 18 months after start of care coordination
Secondary outcomes:
measure: Change in Percent of Patients Meeting Asthma Care at Goal
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Breast Cancer Screening Criteria
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Colorectal Cancer Screening (Up-to-date)
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Chlamydia Screening (Up-to-date)
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Depression Screening Criteria
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting A1c Control
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Aspirin or Anti-Platelet Use Recommendations
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Blood Pressure Control Criteria
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Meeting Statin Use Recommendations
timeFrame: 12 months pre and post start of care coordination
measure: Change in Percent of Patients Reporting Current Tobacco Use
timeFrame: 12 months pre and post start of care coordination
measure: Access to Care
timeFrame: 6 to 18 months after start of care coordination
measure: Rating of Care Coordinator
timeFrame: 6 to 18 months after start of care coordination
measure: Shared Decision Making
timeFrame: 6 to 18 months after start of care coordination
measure: Perceived Care Integration
timeFrame: 6 to 18 months after start of care coordination
measure: Going Without Care Due to Cost
timeFrame: 6 to 18 months after start of care coordination
measure: Out-of-pocket Medical Costs
timeFrame: 6 to 18 months after start of care coordination
measure: Medication and Care Burden
timeFrame: 6 to 18 months after start of care coordination
measure: Social Needs - Housing Security
timeFrame: 6 to 18 months after start of care coordination
measure: Social Needs - Food Security
timeFrame: 6 to 18 months after start of care coordination
measure: Social Needs - Access to Dependable Transportation
timeFrame: 6 to 18 months after start of care coordination
measure: Insurance Coverage
timeFrame: 6 to 18 months after start of care coordination
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: MN Community Measurement
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners Institute
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Department of Health (MDH)
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Leif I Solberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Institute
name: Steven P Dehmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: