Enhanced Care Planning for Patients With Multiple Chronic Conditions

• ClinicalTrials.gov Identifier: NCT03885401
• Recruitment Status: Recruiting
• First Posted: March 21, 2019
• Last Update Posted: October 9, 2020
• Sponsor: Virginia Commonwealth University
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Virginia Commonwealth University

Tracking Information

• First Submitted Date: March 9, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: October 9, 2020
• Actual Study Start Date: September 20, 2020
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2019)

• Enhanced care plan creation (implementation outcome) [ Time Frame: Within 6 months of enrollment ]
  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).
• Health behavior, mental health, and social needs [ Time Frame: Within 6 months of enrollment ]
  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.
• Referral to and connection to community resources (implementation outcome) [ Time Frame: Over 2 years after enrollment ]
  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.
• Effectiveness - chronic condition control [ Time Frame: 6 months after creating a care plan ]
  Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
• Maintenance - chronic condition control [ Time Frame: 2 years after creating a care plan ]
  Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
• Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 6 months after creating a care plan ]
  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).
• Maintenance - quality of life: eight PROMIS-29 domains [ Time Frame: 2 years after creating a care plan ]
  Pre-post change in eight PROMIS-29 domains for intervention patients versus usual care

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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..

Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Screening

Condition

• Multiple Chronic Conditions
• Health Behavior
• Mental Health
• 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.

Study Arms

• Experimental: Enhanced care planning
  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.
  Intervention: Behavioral: Enhanced care planning
• No Intervention: Usual medical care
  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.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 19, 2019): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Alex H Krist, MD MPH; 703-389-2404; ahkrist@vcu.edu

Contact: Paulette Lail-Kashiri, MPH; 804-828-9626; plkashiri@vcu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03885401
• Other Study ID Numbers: HM20015553; 1R01HS026223-01A1 ( U.S. AHRQ Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Virginia Commonwealth University
• Study Sponsor: Virginia Commonwealth University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Alex H Krist, MD MPH; Virginia Commonwealth University

• PRS Account: Virginia Commonwealth University
• Verification Date: October 2020