Chronic DiseaseMNCARESNCT04957979
Minnesota Care Coordination Effectiveness Study
An observational study of Chronic Disease and Multi-morbidity, run by HealthPartners Institute at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Multi-morbidity, Care Coordination
- What is being tested?
- Nursing/Medical Model of Care Coordination and Medical/Social Model of Care Coordination
- How many people
- 25,507 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2021to 30 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants are patients receiving care coordination in Minnesota's Health Care Homes certified adult primary care clinics, starting during the specified date ranges.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MN Community Measurement
Minneapolis, Minnesota, 55413
HealthPartners Institute
Minneapolis, Minnesota, 55425
Minnesota Department of Health (MDH)
Saint Paul, Minnesota, 55164
About this study
Official title: 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.
Read more
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:
- 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.
- Conditions
- Chronic Disease, Multi-morbidity, Care Coordination
- Being tested
- Nursing/Medical Model of Care Coordination, Medical/Social Model of Care Coordination
- Keywords
- Care Coordination, Quality of Care, Health Care Utilization
- Medical subject headings
- Chronic Disease, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing/Medical Model of Care CoordinationOther
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 CoordinationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nursing/Medical Model of Care Coordination | |
| 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. Receives: Other: Medical/Social Model of Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Measure of Care Quality
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.
Measured: 12 months pre- and post- initiation of care coordination
Change in Annual Number of Emergency Department Visits
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.
Measured: 12 months pre and post start of care coordination
Change in Annual Number of Inpatient Hospitalizations
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.
Measured: 12 months pre and post start of care coordination
General Health Status - Top Box Scoring
Percentage of patients reporting Excellent, Very Good, or Good when asked to rate general health status on 5-level Likert Scale (NHIS)
Measured: 6 to 18 months after start of care coordination
Rating of Primary Care Clinic - Top Box
Percentage of patients reporting 9 or 10 when asked to rate primary care clinic (CG-CAHPS)
Measured: 6 to 18 months after start of care coordination
Secondary outcomes (21)
Change in Percent of Patients Meeting Asthma Care at Goal
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.
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Breast Cancer Screening Criteria
Screening criteria defined as mammogram within the last 2 years.
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Colorectal Cancer Screening (Up-to-date)
Screening criteria defined as approved screening test within the last 1 to 10 years depending on type of test and current recomendations.
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Chlamydia Screening (Up-to-date)
Screening criteria defined as a screening test for chlamydia within the last year.
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Depression Screening Criteria
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.
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting A1c Control
Control criteria defined as Hemoglobin A1c < or = 7%
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Aspirin or Anti-Platelet Use Recommendations
Recommendation is documented aspirin use in patients unless contraindication or exception
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Blood Pressure Control Criteria
Control defined at BP < 140/90 mm Hg (SBP/DBP)
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Statin Use Recommendations
Recommendation is documented statin use in patients unless contraindication or exception
Measured: 12 months pre and post start of care coordination
Change in Percent of Patients Reporting Current Tobacco Use
Current tobacco use (tobacco includes any number of cigarettes, cigars, pipes, or smokeless tobacco)
Measured: 12 months pre and post start of care coordination
Access to Care
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) -
Measured: 6 to 18 months after start of care coordination
Rating of Care Coordinator
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.
Measured: 6 to 18 months after start of care coordination
Shared Decision Making
Self-reported experience of shared decision making as measured by CollaboRATE scale - Ranges 0 to 4 higher scores represented more favorable rating of SDM
Measured: 6 to 18 months after start of care coordination
Perceived Care Integration
Self-reported experience of care integration as measured by IntegRATE scale - Ranges 0 to 3 lower scores represent more favorable rating of care integration
Measured: 6 to 18 months after start of care coordination
Going Without Care Due to Cost
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)
Measured: 6 to 18 months after start of care coordination
Out-of-pocket Medical Costs
Percent of patients reporting self reporting >$500 out-of-pocket medical costs in the past 12 months (Medical expenditure panel survey)
Measured: 6 to 18 months after start of care coordination
Medication and Care Burden
Self-reported medication and care burden (modified from Treatment Burden Questionnaire) - Scores range from 0 to 100 with higher scores representing more burden/worse
Measured: 6 to 18 months after start of care coordination
Social Needs - Housing Security
Percent of patients reporting "No steady place to live" when asked to describe they current living situation (modified from CMS HRSN Screening Tool)
Measured: 6 to 18 months after start of care coordination
Social Needs - Food Security
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)
Measured: 6 to 18 months after start of care coordination
Social Needs - Access to Dependable Transportation
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)
Measured: 6 to 18 months after start of care coordination
Insurance Coverage
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)
Measured: 6 to 18 months after start of care coordination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start14 Jun 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Minnesota Department of Health, MN Community Measurement
- Responsible party
- Sponsor
- Investigators
- Leif I Solberg, MD, Principal investigator, HealthPartners InstituteSteven P Dehmer, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957979
- Sponsor's protocol ID
- 19-110
- Other IDs
- IHS-2019C1-15625
- Acronym
- MNCARES
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2021
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Approaches to Care Coordination for High-Cost/High-Need Patients in Primary Care
- ClinicalTrials.gov ID
- NCT04957979
- Acronym / sponsor ID
- MNCARES / 19-110
- Conditions
- Chronic Disease, Multi-morbidity, Care Coordination
- Keywords
- Care Coordination, Quality of Care, Health Care Utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,507 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Minnesota Department of Health, MN Community Measurement
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing/Medical Model of Care Coordination | – | Other: Nursing/Medical Model of Care CoordinationSomeone with medical/nursing training coordinates involvement of various medical resources and provides patients with education, self-management support, and referrals to community resources. |
| Medical/Social Model of Care Coordination | – | Other: Medical/Social Model of Care CoordinationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are patients receiving care coordination in Minnesota's Health Care Homes certified adult primary care clinics, starting during the specified date ranges.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing/Medical Model of Care CoordinationNo 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 | Other | Nursing/Medical Model of Care Coordination |
| Medical/Social Model of Care CoordinationSocial 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 | Other | Medical/Social Model of Care Coordination |
Primary outcome
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.
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.
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.
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)
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)
21 secondary outcomes
Change in Percent of Patients Meeting Asthma Care at Goal
Time frame: 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
Change in Percent of Patients Meeting Colorectal Cancer Screening (Up-to-date)
Time frame: 12 months pre and post start of care coordination
Change in Percent of Patients Meeting Chlamydia Screening (Up-to-date)
Time frame: 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
Change in Percent of Patients Meeting A1c Control
Time frame: 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
Change in Percent of Patients Meeting Blood Pressure Control Criteria
Time frame: 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
Change in Percent of Patients Reporting Current Tobacco Use
Time frame: 12 months pre and post start of care coordination
Access to Care
Time frame: 6 to 18 months after start of care coordination
Rating of Care Coordinator
Time frame: 6 to 18 months after start of care coordination
Shared Decision Making
Time frame: 6 to 18 months after start of care coordination
Perceived Care Integration
Time frame: 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
Out-of-pocket Medical Costs
Time frame: 6 to 18 months after start of care coordination
Medication and Care Burden
Time frame: 6 to 18 months after start of care coordination
Social Needs - Housing Security
Time frame: 6 to 18 months after start of care coordination
Social Needs - Food Security
Time frame: 6 to 18 months after start of care coordination
Social Needs - Access to Dependable Transportation
Time frame: 6 to 18 months after start of care coordination
Insurance Coverage
Time frame: 6 to 18 months after start of care coordination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif I Solberg, MD principal investigator
HealthPartners Institute
Steven P Dehmer, PhD principal investigator
HealthPartners Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Multi-morbidity, run by HealthPartners Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Measure of Care Quality (time frame: 12 months pre- and post- initiation of care coordination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.