Enhanced Care Planning for Patients With Multiple Chronic Conditions

NCT03885401 | Completed DMC

• 2 other identifiers: HM200155531R01HS026223-01A1
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Chronic Conditions; Health Behavior; Mental Health; Social Determinants of Health

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Enhanced care planning

EXPERIMENTAL

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.

Behavioral: Enhanced care planning

Usual medical care

NO 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.

Interventions

Enhanced care planning BEHAVIORAL

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.

Enhanced care planning

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two or more chronic conditions
• At least one uncontrolled condition
• Completes baseline survey

You may not qualify if:

• Participating in Richmond Accountable Health Community study
• Clinician excludes patients

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

• Krist AH, O'Loughlin K, Woolf SH, Sabo RT, Hinesley J, Kuzel AJ, Rybarczyk BD, Kashiri PL, Brooks EM, Glasgow RE, Huebschmann AG, Liaw WR. Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial. Trials. 2020 Jun 11;21(1):517. doi: 10.1186/s13063-020-04463-3.

  PMID: 32527322 DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions; Health Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Study Officials

• Alex H Krist, MD MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind clinicians, patients, or patient navigators. Outcomes assessors (e.g. chart abstractors, database managers, and the researchers) will be blinded to condition when abstracting, entering, or assessing data.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a clinician level randomized controlled trial. Sixty clinicians will be randomized to intervention (enhanced care planning for health behaviors, mental health, and social needs) or control condition (usual care). The investigators will randomly survey all patients with MCC from each clinicians' patient panel. Patients with at least one uncontrolled MCC will be randomly selected for inclusion until 10 patients are recruited from each clinician. The investigators will use hybrid implementation-effectiveness design to measure outcomes. Implementation outcomes include enhanced care plan completion; the prevalence of health behavior, mental health, and social needs; goals patients prioritize and how they want to address them; and the type, intensity, and follow-up of care team support provided to address patient goals. Effectiveness outcomes include the number of uncontrolled chronic conditions and patient reported physical, mental, and social health..

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 21, 2019
• Study Start: September 20, 2020
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)