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Completed

NCT Number: NCT04957979

Minnesota Care Coordination Effectiveness Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Institute, Minneapolis, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nursing/Medical Model of Care Coordination

Other

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

Other

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

Primary outcomes

  1. Change in Composite Measure of Care Quality

    Time frame: 12 months pre- and post- initiation of care coordination

    The analytic outcome is defined as the absolute change in the percentage of eligible care quality measures met by a patient in the year before and after care coordination initiation. The composite measure of care quality is calculated as the percentage of all applicable care quality measures a patient meets based on clinical guidelines, including control of blood pressure, cardiovascular disease, diabetes, asthma, depression, and cancer screening. Criteria for each of the components was assessed using health outcomes from EHR and insurance claims to capture occurrence and timing of recommended screenings. A positive change (post % - pre % > 0) reflects an improvement in the percentage of care quality measures met, while a negative change indicates a decline.

  2. Change in Annual Number of Emergency Department Visits

    Time frame: 12 months pre and post start of care coordination

    Change in # of encounters with CPT-4 E&M codes (99281-99288) at emergency departments across the year before and year after care coordination initiation per 100 people. Negative values of change represent improvement, positive values represent a increase in number of admissions.

  3. Change in Annual Number of Inpatient Hospitalizations

    Time frame: 12 months pre and post start of care coordination

    Change in # of hospital inpatient admissions ≥ 1 days across the year before and year after care coordination initiation per 100 people. Negative values of change represent improvement, positive values represent a increase in number of admissions.

  4. General Health Status - Top Box Scoring

    Time frame: 6 to 18 months after start of care coordination

    Percentage of patients reporting Excellent, Very Good, or Good when asked to rate general health status on 5-level Likert Scale (NHIS)

  5. Rating of Primary Care Clinic - Top Box

    Time frame: 6 to 18 months after start of care coordination

    Percentage of patients reporting 9 or 10 when asked to rate primary care clinic (CG-CAHPS)

Secondary outcomes

  1. Change in Percent of Patients Meeting Asthma Care at Goal

    Time frame: 12 months pre and post start of care coordination

    The analytic outcome is defined as the absolute change in the percentage of eligible patients (those with a current asthma diagnosis) demonstrating asthma control (Asthma Control Test (ACT) score <19) within each arm in the year before and after care coordination initiation. A positive change reflects an improvement in the percentage of eligible patients with asthma control while a negative change indicates a decline.

  2. Change in Percent of Patients Meeting Breast Cancer Screening Criteria

    Time frame: 12 months pre and post start of care coordination

    Screening criteria defined as mammogram within the last 2 years.

  3. Change in Percent of Patients Meeting Colorectal Cancer Screening (Up-to-date)

    Time frame: 12 months pre and post start of care coordination

    Screening criteria defined as approved screening test within the last 1 to 10 years depending on type of test and current recomendations.

  4. Change in Percent of Patients Meeting Chlamydia Screening (Up-to-date)

    Time frame: 12 months pre and post start of care coordination

    Screening criteria defined as a screening test for chlamydia within the last year.

  5. Change in Percent of Patients Meeting Depression Screening Criteria

    Time frame: 12 months pre and post start of care coordination

    Screening for depression, based on Patient Health Questionnaire (PHQ-9) screen score used to quantify presence and severity of depression. Total scores range from 0 to 27, with higher score indicating more severe depression. Meeting depression screening criteria defined as the most recent PHQ-9 score < 5, indicating no or minimal depression at the time of assessment.

  6. Change in Percent of Patients Meeting A1c Control

    Time frame: 12 months pre and post start of care coordination

    Control criteria defined as Hemoglobin A1c < or = 7%

  7. Change in Percent of Patients Meeting Aspirin or Anti-Platelet Use Recommendations

    Time frame: 12 months pre and post start of care coordination

    Recommendation is documented aspirin use in patients unless contraindication or exception

  8. Change in Percent of Patients Meeting Blood Pressure Control Criteria

    Time frame: 12 months pre and post start of care coordination

    Control defined at BP < 140/90 mm Hg (SBP/DBP)

  9. Change in Percent of Patients Meeting Statin Use Recommendations

    Time frame: 12 months pre and post start of care coordination

    Recommendation is documented statin use in patients unless contraindication or exception

  10. Change in Percent of Patients Reporting Current Tobacco Use

    Time frame: 12 months pre and post start of care coordination

    Current tobacco use (tobacco includes any number of cigarettes, cigars, pipes, or smokeless tobacco)

  11. Access to Care

    Time frame: 6 to 18 months after start of care coordination

    Percent of responders reporting 'Always' or 'Usually' able to get an appointment for care they need right away on survey items assessing rating of satisfaction with access to care (CG-CAHPS) -

  12. Rating of Care Coordinator

    Time frame: 6 to 18 months after start of care coordination

    The analytic outcome is defined as the percentage of patients who rated their care coordinator as a 9 or 10 on a 0-10 scale adapted from the Clinician & Group Survey (CG-CAHPS) assessment. The rating reflects patients' overall satisfaction with their care coordinator. Higher scores (9 or 10) indicate a more positive assessment of care coordination, while lower scores suggest less favorable experiences. This measure is limited to patients who recalled a recent interaction with their care coordinator.

  13. Shared Decision Making

    Time frame: 6 to 18 months after start of care coordination

    Self-reported experience of shared decision making as measured by CollaboRATE scale - Ranges 0 to 4 higher scores represented more favorable rating of SDM

  14. Perceived Care Integration

    Time frame: 6 to 18 months after start of care coordination

    Self-reported experience of care integration as measured by IntegRATE scale - Ranges 0 to 3 lower scores represent more favorable rating of care integration

  15. Going Without Care Due to Cost

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting "Yes" when asked if there was any time when you needed medical care, but did not get it because you couldn't afford it in the last 12-months to cost (NHIS)

  16. Out-of-pocket Medical Costs

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting self reporting >$500 out-of-pocket medical costs in the past 12 months (Medical expenditure panel survey)

  17. Medication and Care Burden

    Time frame: 6 to 18 months after start of care coordination

    Self-reported medication and care burden (modified from Treatment Burden Questionnaire) - Scores range from 0 to 100 with higher scores representing more burden/worse

  18. Social Needs - Housing Security

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting "No steady place to live" when asked to describe they current living situation (modified from CMS HRSN Screening Tool)

  19. Social Needs - Food Security

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting "Often", "Sometimes", or "Rarely" when asked to describe how often they or other adults in their household eat less/skip a meal because there wasn't enough money or food - (modified from CMS HRSN Screening Tool)

  20. Social Needs - Access to Dependable Transportation

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting "Yes" when asked if lack of reliable transportation has kept them from participating in ADLs (modified from CMS HRSN Screening Tool)

  21. Insurance Coverage

    Time frame: 6 to 18 months after start of care coordination

    Percent of patients reporting "No" when asked if they have any type of health care coverage (modified from CMS HRSN Screening Tool)Self-reported insurance coverage (SHADAC survey)

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • MN Community Measurement
  • Minnesota Department of Health
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: MNCARES

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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