Clinical trial NCT03885401: Enhanced Care Planning for Patients With Multiple Chronic Conditions
Official title: Enhanced Care Planning and Clinical-Community Linkages to Comprehensively Address the Basic Needs of Patients With Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Health Behavior
Mental Health
Social Determinants of Health
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-03-21
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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..
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Enhanced care plan creation (implementation outcome)
timeFrame: Within 6 months of enrollment
measure: Health behavior, mental health, and social needs
timeFrame: Within 6 months of enrollment
measure: Referral to and connection to community resources (implementation outcome)
timeFrame: Over 2 years after enrollment
measure: Effectiveness - chronic condition control
timeFrame: 6 months after creating a care plan
measure: Maintenance - chronic condition control
timeFrame: 2 years after creating a care plan
measure: Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 6 months after creating a care plan
measure: Maintenance - quality of life: eight PROMIS-29 domains
timeFrame: 2 years after creating a care plan
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alex H Krist, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.