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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04957979
Other study ID # 19-110
Secondary ID IHS-2019C1-15625
Status Completed
Phase
First received
Last updated
Start date June 14, 2021
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
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 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

Study Design


Related Conditions & MeSH terms


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
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