- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957979
Minnesota Care Coordination Effectiveness Study (MNCARES)
Comparing Two Approaches to Care Coordination for High-Cost/High-Need Patients in Primary Care
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:
- Control of chronic conditions like diabetes, heart disease, asthma, and depression
- Hospitalizations
- Emergency department visits
- Use of medications and diagnostic tests
- Use of specialty care
- General health status
- Patient satisfaction and access to care
- Use of shared decision-making (where the doctor and the patient make treatment decisions together)
- Patient burden (how much time and effort the patient spends trying to get healthy)
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55413
- MN Community Measurement
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Minneapolis, Minnesota, United States, 55425
- HealthPartners Institute
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Saint Paul, Minnesota, United States, 55164
- Minnesota Department of Health (MDH)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nursing/Medical Model of Care Coordination
Someone with medical/nursing training coordinates involvement of various medical resources and provides patients with education, self-management support, and referrals to community resources.
|
No social worker on the clinic's care coordination team. Services provided:
|
|
Medical/Social Model of Care Coordination
In addition to the services provided in the Medical/Nursing Model, a social worker by education has dedicated FTE as a member of the care team at the clinic, providing some direct services for care coordination patients and either spending some time on-site or in regular communication with its clinicians in addition to providing social work services.
|
Social worker is part of the clinic's care coordination team.
Services provided:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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12 months pre- and post- initiation of care coordination
|
|
Change in Annual Number of Emergency Department Visits
Time Frame: 12 months pre and post start of care coordination
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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.
|
12 months pre and post start of care coordination
|
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Change in Annual Number of Inpatient Hospitalizations
Time Frame: 12 months pre and post start of care coordination
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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.
|
12 months pre and post start of care coordination
|
|
General Health Status - Top Box Scoring
Time Frame: 6 to 18 months after start of care coordination
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Percentage of patients reporting Excellent, Very Good, or Good when asked to rate general health status on 5-level Likert Scale (NHIS)
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6 to 18 months after start of care coordination
|
|
Rating of Primary Care Clinic - Top Box
Time Frame: 6 to 18 months after start of care coordination
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Percentage of patients reporting 9 or 10 when asked to rate primary care clinic (CG-CAHPS)
|
6 to 18 months after start of care coordination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months pre and post start of care coordination
|
|
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.
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12 months pre and post start of care coordination
|
|
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.
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12 months pre and post start of care coordination
|
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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.
|
12 months pre and post start of care coordination
|
|
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.
|
12 months pre and post start of care coordination
|
|
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%
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12 months pre and post start of care coordination
|
|
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
|
12 months pre and post start of care coordination
|
|
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)
|
12 months pre and post start of care coordination
|
|
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
|
12 months pre and post start of care coordination
|
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Change in Percent of Patients Reporting Current Tobacco Use
Time Frame: 12 months pre and post start of care coordination
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Current tobacco use (tobacco includes any number of cigarettes, cigars, pipes, or smokeless tobacco)
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12 months pre and post start of care coordination
|
|
Access to Care
Time Frame: 6 to 18 months after start of care coordination
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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) -
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6 to 18 months after start of care coordination
|
|
Rating of Care Coordinator
Time Frame: 6 to 18 months after start of care coordination
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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.
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6 to 18 months after start of care coordination
|
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Shared Decision Making
Time Frame: 6 to 18 months after start of care coordination
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Self-reported experience of shared decision making as measured by CollaboRATE scale - Ranges 0 to 4 higher scores represented more favorable rating of SDM
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6 to 18 months after start of care coordination
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Perceived Care Integration
Time Frame: 6 to 18 months after start of care coordination
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Self-reported experience of care integration as measured by IntegRATE scale - Ranges 0 to 3 lower scores represent more favorable rating of care integration
|
6 to 18 months after start of care coordination
|
|
Going Without Care Due to Cost
Time Frame: 6 to 18 months after start of care coordination
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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)
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6 to 18 months after start of care coordination
|
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Out-of-pocket Medical Costs
Time Frame: 6 to 18 months after start of care coordination
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Percent of patients reporting self reporting >$500 out-of-pocket medical costs in the past 12 months (Medical expenditure panel survey)
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6 to 18 months after start of care coordination
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Medication and Care Burden
Time Frame: 6 to 18 months after start of care coordination
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Self-reported medication and care burden (modified from Treatment Burden Questionnaire) - Scores range from 0 to 100 with higher scores representing more burden/worse
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6 to 18 months after start of care coordination
|
|
Social Needs - Housing Security
Time Frame: 6 to 18 months after start of care coordination
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Percent of patients reporting "No steady place to live" when asked to describe they current living situation (modified from CMS HRSN Screening Tool)
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6 to 18 months after start of care coordination
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Social Needs - Food Security
Time Frame: 6 to 18 months after start of care coordination
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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)
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6 to 18 months after start of care coordination
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Social Needs - Access to Dependable Transportation
Time Frame: 6 to 18 months after start of care coordination
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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)
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6 to 18 months after start of care coordination
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Insurance Coverage
Time Frame: 6 to 18 months after start of care coordination
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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)
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6 to 18 months after start of care coordination
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leif I Solberg, MD, HealthPartners Institute
- Principal Investigator: Steven P Dehmer, PhD, HealthPartners Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-110
- IHS-2019C1-15625 (Other Identifier: Patient Centered Outcomes Research Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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