Minnesota Care Coordination Effectiveness Study

Chronic Disease Clinical Trial

— MNCARES  

Official title:

Comparing Two Approaches to Care Coordination for High-Cost/High-Need Patients in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04957979
• Other study ID #: 19-110
• Secondary ID: IHS-2019C1-15625
• Status: Active, not recruiting
• Start date: June 14, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75000
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Care Coordination
• Chronic Disease
• Multi-morbidity

Intervention

Other:
• Nursing/Medical Model of Care Coordination
No social worker on the clinic's care coordination team. Services provided: Coordinated medical care for patients Patient education Assistance in developing care plan Support for patient self-management Referrals for continuing care Referral to community resources Referral to mental health services if needed or requested Referral to interventional counseling for behavioral health issues
• Medical/Social Model of Care Coordination
Social worker is part of the clinic's care coordination team. Need not be licensed as a social worker Must have time dedicated to care coordination for a specific clinic or clinics Must interact with individual patients to provide them with services Must interact with individual clinicians about their individual patients in care coordination Services provided: Coordinated medical care for patients Patient education Assistance in developing care plan Support for patient self-management Assistance with referrals for continuing care Assessment and plan to address social and resource needs including housing, transportation or financial needs; Assist patient in locating and obtaining needed community resources Assistance with identifying and addressing psychological/emotional issues and referrals as needed Interventional counseling for behavioral health issues or referrals to interventional counseling, depending on licensure

Locations

Country	Name	City	State
United States	HealthPartners Institute	Minneapolis	Minnesota
United States	MN Community Measurement	Minneapolis	Minnesota
United States	Minnesota Department of Health (MDH)	Saint Paul	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
HealthPartners Institute	Minnesota Department of Health, MN Community Measurement, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of care quality	Composite measure of overall quality of care, comprised of the % of all care quality outcomes for which a patient qualifies and meets criteria (control of blood pressure, cardiovascular disease, diabetes, asthma, and depression and cancer screening)	12 months pre and post start of care coordination
Primary	Emergency department visits	# of encounters with CPT-4 E&M codes (99281-99288) at emergency department site	12 months pre and post start of care coordination
Primary	Hospitalizations	# of hospital inpatient admissions = 1 days	12 months pre and post start of care coordination
Primary	General health status	Self-reported rating of general health status (NHIS)	6 to 18 months after start of care coordination
Primary	Rating of primary care clinic	Self-reported rating of primary care clinic (CG-CAHPS)	6 to 18 months after start of care coordination
Secondary	Asthma care at goal	Asthma pts. with asthma control test (ACT) score <19	12 months pre and post start of care coordination
Secondary	Breast Cancer Screening (up-to-date)	Women 50-74 yrs old who received a mammogram in the past two years	12 months pre and post start of care coordination
Secondary	Colorectal Cancer Screening (up-to-date)	50-75 yr old pts. up-to-date for an approved screening test	12 months pre and post start of care coordination
Secondary	Chlamydia Screening (up-to-date)	Female patients 16-24 yrs old who had a screening test for chlamydia	12 months pre and post start of care coordination
Secondary	Depression improvement	PHQ9 score <5 for test nearest to end of follow-up period	12 months pre and post start of care coordination
Secondary	Diabetes care at goal (including component measures)	All-in-one measure of control A1c, blood pressure, statin use, & smoking in diabetes patients	12 months pre and post start of care coordination
Secondary	Vascular care at goal (including component measures)	All-in-one measure of control of blood pressure, statin use, & smoking + ASA use in patients with vascular disease	12 months pre and post start of care coordination
Secondary	Hospital readmissions <30 days	# of hospital inpatient admissions = 1 days following a prior hospitalization < days	12 months pre and post start of care coordination
Secondary	Primary care visits	# of encounters with CPT-4 E&M codes (99201-99215, 99381-99429) at primary care site	12 months pre and post start of care coordination
Secondary	Specialty care visits	# of encounters with CPT-4 E&M codes (99201-99215, 99381-99429, 99241-99245, 92920-93895) at primary care site	12 months pre and post start of care coordination
Secondary	Urgent care visits	# of encounters with CPT-4 E&M codes (99201-99215, 99381-99429) at urgent care site	12 months pre and post start of care coordination
Secondary	Substance use treatment	Substance use treatment indicated by HCPCS codes (H0005-H0029, H0047, H2034-H2036)	12 months pre and post start of care coordination
Secondary	# of chronic medications	# of distinct concurrent dispensed medications, combined across drug classes used for chronic conditions (e.g., hypertension, hyperlipidemia, diabetes, asthma, depression)	12 months pre and post start of care coordination
Secondary	Access to care	Self-reported rating of satisfaction with access to care (CG-CAHPS)	6 to 18 months after start of care coordination
Secondary	Rating of care coordinator	Self-reported rating of satisfaction with care coordinator (CG-CAHPS, adapted)	6 to 18 months after start of care coordination
Secondary	Shared decision making	Self-reported experience of shared decision making (CollaboRATE)	6 to 18 months after start of care coordination
Secondary	Perceived care integration	Self-reported perception of care integration (IntegRATE)	6 to 18 months after start of care coordination
Secondary	Going without care due to cost	Self report of going without care due to cost (NHIS)	6 to 18 months after start of care coordination
Secondary	Out-of-pocket medical costs	Self report out-of-pocket medical costs (Medical expenditure panel survey)	6 to 18 months after start of care coordination
Secondary	Medication and care burden	Self-reported medication and care burden (modified from Treatment Burden Questionnaire)	6 to 18 months after start of care coordination
Secondary	Social needs	Self-reported social needs (modified from CMS HRSN Screening Tool)	6 to 18 months after start of care coordination
Secondary	Insurance coverage	Self-reported insurance coverage (SHADAC survey)	6 to 18 months after start of care coordination
Secondary	A1c control	Hemoglobin A1c < or = 7% in patients with diabetes	12 months pre and post start of care coordination
Secondary	A1c level	Hemoglobin A1c in patients with diabetes	12 months pre and post start of care coordination
Secondary	Aspirin or anti-platelet use	Aspirin use in patients with vascular disease unless with contraindication or exception	12 months pre and post start of care coordination
Secondary	Blood pressure control	< 140/90 mm Hg (SBP/DBP)	12 months pre and post start of care coordination
Secondary	Blood pressure level	Systolic and diastolic blood pressure (mm Hg)	12 months pre and post start of care coordination
Secondary	Body mass index	kg/m2 (Primary Cohort only)	12 months pre and post start of care coordination
Secondary	Low-density lipoprotein level	mg/dL in patients with diabetes or vascular disease	12 months pre and post start of care coordination
Secondary	Statin use	Current statin use in patients with vascular care unless with contraindication or exception	12 months pre and post start of care coordination
Secondary	Tobacco use	Current tobacco use (tobacco includes any number of cigarettes, cigars, pipes, or smokeless tobacco) in patients with diabetes or vascular disease	12 months pre and post start of care coordination