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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Agency for Healthcare Research and Quality (AHRQ) |
United States,
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 |
Status | Clinical Trial | Phase | |
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