Enhanced Care Planning for Patients With Multiple Chronic Conditions

Health Behavior Clinical Trial

Official title:

Enhanced Care Planning and Clinical-Community Linkages to Comprehensively Address the Basic Needs of Patients With Multiple Chronic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885401
• Other study ID #: HM20015553
• Secondary ID: 1R01HS026223-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: September 2023
• Source: Virginia Commonwealth University
• Contact: Alex H Krist, MD MPH
• Phone: 703-389-2404
• Email: ahkrist[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with multiple chronic conditions (MCC) have a range of needs that extend beyond traditional medical care, including behavioral, mental health, and social needs. While primary care does its best to address these needs, few practices can undertake a systematic approach without broader health system and coordinated community support. Fortunately, communities and health systems are investing in new models of care to address these needs. New tools are emerging that allow for enhanced care planning to identify and prioritize patients' needs based on their values, preferences, social, and clinical context. Additionally, support systems to promote partnerships between patients and clinical and community care teams are emerging. Building on work occurring as part of the Richmond Accountable Health Community, the investigators propose to (a) evaluate the implementation of an enhanced care planning approach, paired with community-clinical linkages support to address health behavior, mental health, and social needs; (b) determine within a randomized controlled trial the benefit of this approach compared to usual care; and (c) assess which person, family, community, and system contextual factors that influence MCC.

Description:

The number of patients in the United States with multiple chronic conditions (MCC) is growing. Many patients with poorly controlled MCC also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address these basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems. Responding to the Special Emphasis Notice NOT-HS-16-013, Optimizing Care for People Living with MCC through the Development of Enhanced Care Planning, the investigators propose a clinician-level randomized controlled trial to study how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. This study will build on the Centers for Medicare and Medicaid Services (CMS)-funded Accountable Health Community (AHC) in Richmond, Virginia. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record (EHR), clinicians will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to 50 randomly selected patients; 10 respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected, with over-sampling of minorities. The intervention includes two components. First, an enhanced care planning tool called My Own Health Report (MOHR) will screen patients for health behavior, mental health, and social needs. Clinical navigator support will help patients prioritize needs, create care plans based on preferences, and write a personal narrative to guide the care team. Patients will update care plans quarterly. Second, community-clinical linkage support will include community resource registries, personnel to span settings (clinical navigators, community health workers), and care team coordination tools (sharing MOHR content, secure messaging, and virtual visits). The investigators will compare patient-level intervention and control outcomes to assess improvements in MCC outcomes (primary outcome) and self-reported PROMIS-29 measures (physical health, mental health, social wellbeing) six months and two years post-enrollment. the investigators will also conduct a mixed-methods, multilevel assessment of person-, family-, community-, and system-level contextual influences on implementation and effectiveness. Data sources will include EHR and MOHR data, chart reviews, patient surveys, field notes, and semi-structured interviews of patients, clinicians, and community stakeholders. If effective, this study will help inform efforts by primary care clinicians to participate in the growing number of AHC-like systems as a strategy to better control MCC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Two or more chronic conditions

• At least one uncontrolled condition

• Completes baseline survey

Exclusion Criteria:

• Participating in Richmond Accountable Health Community study

• Clinician excludes patients

Related Conditions & MeSH terms

• Chronic Disease
• Disease
• Health Behavior
• Mental Health
• Multiple Chronic Conditions
• Social Determinants of Health

Intervention

Behavioral:
• Enhanced care planning
The intervention includes (1) screening for unhealthy behaviors, mental health needs, and social needs, (2) creation of a care plan, (3) quarterly updates to the plan, (4) a clinical navigator and community health worker to support accomplishing the care plan, (5) registry of community resources and programs, and (6) messaging and video-visit system for team members.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhanced care plan creation (implementation outcome)	This outcome reports the percent of intervention patients who complete the creation of an enhanced care plan (numerator = intervention patients who create an enhanced care plan / denominator = all enrolled intervention patients).	Within 6 months of enrollment
Primary	Health behavior, mental health, and social needs	This outcome will measure the number of health behavior, mental health, and social needs that patients have who complete an enhanced care plan. This is a frequency count of each specific need based on the health risk assessment output.	Within 6 months of enrollment
Primary	Referral to and connection to community resources (implementation outcome)	This outcome will measure which community resources intervention patients are referred to for assistance with addressing health behaviors, mental health, and social needs. This is a frequency count of the number of intervention patients referred to each potential community resource.	Over 2 years after enrollment
Primary	Effectiveness - chronic condition control	Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care	6 months after creating a care plan
Primary	Maintenance - chronic condition control	Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care	2 years after creating a care plan
Primary	Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29)	Pre-post change in eight Patient Reported Outcomes Measurement Information System (PROMIS-29) domains for intervention patients versus usual care. Norm-based scores will be calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population. Higher scores means that the patient is reporting greater symptoms. Scores will be calculated using the Healthmeasures Scoring Service (http://www.healthmeasures.net/score-and-interpret/calculate-scores).	6 months after creating a care plan
Primary	Maintenance - quality of life: eight PROMIS-29 domains	Pre-post change in eight PROMIS-29 domains for intervention patients versus usual care	2 years after creating a care plan