Enhanced Care Planning for Multiple Chronic Conditions

Overseen By Paulette Lail-Kashiri, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Richmond study, clinician excludes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for individuals with multiple long-term health conditions through an enhanced care planning approach. It will test a new method that addresses not only medical needs but also behavioral, mental health, and social needs. Participants will collaborate with care teams to create personalized care plans using a tool called MOHR and will receive community support. The trial seeks individuals with at least two ongoing health issues, with one not well-managed. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance overall well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced care planning approach is safe for patients with multiple chronic conditions?

Research shows that patients generally favor enhanced care planning. This method helps manage multiple long-term health issues by improving communication between doctors and local support services. Studies have found that these care plans effectively address needs related to lifestyle choices, mental health, and social factors, often overlooked in regular care.

No specific reports have linked negative effects directly to enhanced care planning in the available sources, suggesting it is well-tolerated. Enhanced care planning tailors care to each patient, potentially leading to better overall health. This approach supports, rather than replaces, regular medical care and emphasizes teamwork between patients and healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about enhanced care planning for managing multiple chronic conditions because it offers a personalized approach that goes beyond standard care. This method uses the My Own Health Report (MOHR) to screen for unhealthy behaviors, mental health, and social needs, allowing patients to create and update a customized care plan. What sets this treatment apart is its integration of clinical-community linkages, where a clinical navigator and community health worker assist patients by connecting them to local resources. The program emphasizes ongoing communication through messaging and video visits, making it a more holistic and supportive option compared to traditional care, which often lacks systematic assessments and community support.

What evidence suggests that enhanced care planning is effective for multiple chronic conditions?

Research has shown that better care planning can significantly help manage multiple long-term health issues. In this trial, participants in the enhanced care planning arm will receive a personalized care plan using tools like MOHR, which assesses various health needs. This approach addresses not only medical needs but also mental, emotional, and social needs, which are often overlooked. Clinical navigators and community health workers will assist these participants in adhering to their care plans and connecting with local resources. People using this type of care planning have reported feeling better both physically and mentally. Overall, this method aims to improve quality of life by focusing on the whole person and their surroundings. ^{6 7 8 9 10}

Who Is on the Research Team?

Alex Krist, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with at least one uncontrolled condition and two or more chronic conditions who have completed a baseline survey. It's not open to those already in the Richmond Accountable Health Community study or excluded by their clinician.

Inclusion Criteria

I have a health condition that is not currently under control.

Completes baseline survey

You have two or more long-term health problems.

Exclusion Criteria

The doctor has determined that you are not eligible for the study.

You are currently involved in the Richmond Accountable Health Community study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

A baseline assessment is mailed to 50 randomly selected patients to identify those with uncontrolled MCC

Within 6 months of enrollment

Intervention

Enhanced care planning and clinical-community linkages are implemented, including quarterly updates to care plans

2 years

Quarterly updates

Follow-up

Participants are monitored for improvements in MCC outcomes and quality of life measures

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced care planning

Trial Overview The trial tests an enhanced care planning approach that includes behavioral, mental health, and social support, comparing it to usual care in patients with multiple chronic conditions within a randomized controlled setting.

How Is the Trial Designed?

Group I: Enhanced care planning Experimental Treatment 1 Intervention

The intervention consists of two components - enhanced care planning and clinical-community linkages. The enhanced care plan is created using MOHR (https://myownhealthreport.org). MOHR screens patients for unhealthy behaviors, mental health needs, and social needs. Patients identify the needs they would like to address and create a care plan, which they update quarterly. A clinical navigator and community health worker (CHW) help patients address their care plans using clinical-community linkages, which has four components. First, clinicians and clinical navigators have a resource registry identifying community programs and support - No Wrong Door (NWD) and https://navigator.aafp.org/. Second, MOHR shares information (care plans, patient narrative, and patient progress) across clinical and community team members. Third, MOHR supports messaging and video visits for team members and patients. Finally, MOHR sends care team members quarterly patient progress updates.

Group II: Usual medical care Active Control 1 Intervention

Clinicians randomized to the control condition will continue to provide "usual care." This includes current non-systematic assessment of health behaviors, mental health needs, and social needs. Neither clinicians nor patients will be eligible to receive CHW support or have access to NWD. Clinicians may refer some control patients to community programs as part of their current usual care. Control clinicians will be blinded as to which patients are included in the study. At the end of the study, the investigators will share with control clinicians our lessons learned, access to MOHR, and lists of useful community resources.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03885401?term=AREA%5BConditionSearch%5D(Social%20determinants%20of%20mental%20health)&rank=4

Enhanced Care Planning for Patients With Multiple Chronic ... Effectiveness outcomes include the number of uncontrolled chronic conditions and patient reported physical, mental, and social health.. Masking : Single ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8515222/

Transforming care for people with multiple chronic conditions Transforming care for people living with MCC entails organizing health care to take care of people living with illnesses in the context of their lives, ...

3. annfammed.org annfammed.org/content/22/Supplement_1/6795

Development and Testing of an Interoperable e-care Plan ... Background: Multiple chronic conditions (MCC) the most common condition seen in practice are present in 33% of adults and 80% of individuals ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK604785/?report=reader

Executive Summary - Implementation of an Electronic Care Plan ... Individuals with multiple chronic conditions (MCC) constitute more than 25 percent of the U.S. population. Not only do MCC cause decreased quality of life and ...

5. clinicaltrial.be clinicaltrial.be/en/details/64611?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Enhanced Care Planning for Patients With Multiple Chronic... The investigators will compare patient-level intervention and control outcomes to assess improvements in MCC outcomes (primary outcome) and self ...

6. aspe.hhs.gov aspe.hhs.gov/data-capacity-patient-centered-outcomes-research-through-creation-electronic-care-plan-people-0

Data Capacity for Patient-Centered Outcomes Research ... Data aggregation is particularly important and challenging for people with multiple chronic conditions (MCC), who undergo frequent care transitions (e.g., ...

7. reporter.nih.gov reporter.nih.gov/project-details/10726452

MultiPle dAta SouRcEs (MC COMPARE) - NIH RePORTER We will focus on unrecognized chronic conditions, partner study variables, partner study outcomes, health behaviors, social determinants of health, and adverse ...

8. ahrq.gov ahrq.gov/ecareplan/about/index.html

About the eCare Plan for Multiple Chronic Conditions The eCare Plan project aims to build care planning tools that will improve how we do research and provide healthcare for people with multiple chronic ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824977

Person-Centered Care Planning for People Living With or ... Person-centered care planning (PCCP) is an approach to provide comprehensive care that is responsive to the individual to improve health outcomes and increase ...

10. cdc.gov cdc.gov/pcd/issues/2025/24_0539.htm

Trends in Multiple Chronic Conditions Among US Adults ... Among midlife adults, trends increased for diabetes (10.9% to 12.5%), CKD (2.5% to 3.1%), and stroke (2.6% to 3.1%), while trends meaningfully ...