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

Abstract

Background: Many patients with poorly controlled multiple chronic conditions (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 their 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.

Methods: We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network 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 we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR), to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients' needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR.

Discussion: This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC.

Trial registration: ClinicalTrials.gov: NCT03885401. Registered on 19 September 2019.

Keywords: Goal setting; Health behaviors; Health promotion; Health risk assessment; Mental health; Primary care; Social determinants of health.

Fig. 1

Hierarchy of social, mental health, health behavior, and healthcare needs. Patients struggling to address more basic needs like social risks, mental health needs, or unhealthy behaviors will have more difficulties engaging in their health care

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule of assessments and interventions. Sixty clinicians will be randomized to the intervention or control condition in a 1:1 ratio. Fifty patients with chronic conditions will be randomly selected to receive the baseline screening survey. Among respondents, 300 patients (10 per clinician) will be randomly selected for study participation. The intervention will include a 3-month intensive care planning and support period and a 3-month maintenance support period. Control patients will continue with usual medical care. Clinicians and patients will be recruited quarterly between December 2019 and December 2021, allowing for approximately 40 patients each quarter to receive intensive care planning support

Fig. 3

Overview of enhanced care planning intervention. The intervention includes creation of an enhanced care plan (MOHR), redefined (patient navigator) and new (community health worker) care roles, a resource registry, and linkage support to community programs (e.g., sharing care plans, communication tools)

Fig. 4

Proposed project timeline. The project began March 2019 and will continue through February 2024