Chronic Disease Clinical Trial
— MNCARESOfficial title:
Comparing Two Approaches to Care Coordination for High-Cost/High-Need Patients in Primary Care
Verified date | May 2024 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25507 |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute | Minnesota Department of Health, MN Community Measurement, Patient-Centered Outcomes Research Institute |
United States,
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 |
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