Clinical trial NCT06941519: Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions
Official title: Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Chronic Conditions
Keywords: social needs, care gaps, navigation, multiple chronic conditions
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We will conduct a comparative effectiveness randomized clinical trial with two "active comparator" arms. We will evaluate the two current, usual care strategies (higher intensity "telephonic navigation" vs. lower intensity "virtual outreach") for addressing social needs among patients with multiple chronic conditions.

Detailed description: The goal of the proposed research is to compare the effectiveness of two strategies for addressing social needs in a large, high-risk population of adults with multiple chronic conditions (MCC).

Our Specific Aims are to:

Aim 1 - Comparative Effectiveness Randomized Clinical Trial: Compare two evidence-based strategies for systematically addressing patient-reported social needs in a medically complex population: Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months) vs. Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services). Our Hypotheses (H) are framed in terms of relatively greater effectiveness of the Higher Intensity strategy, although through Aims 2 \& 3 we will investigate variation within different patient groups.

H1: Overall improvement will be greater in the Higher vs Lower Intensity strategy condition on the primary (receipt of social services, social needs met, clinical care gaps closed) and secondary (patient-centered) outcomes.

Aim 2 - Qualitative Assessment: We will conduct patient focus groups and navigator interviews to examine intervention impact and mechanisms at each step in the pathway from intervention engagement to obtaining social resources to addressing social needs to improving clinical care and to explore associated barriers and facilitators. Our exploratory Qualitative Hypotheses (QH) are:

QH1: Patients will describe greater perceived impacts and positive experiences in the high intensity intervention condition than the low intensity intervention condition.

QH2: Patients and navigators will describe both direct pathways by which social risk screening and/or receipt of referrals impacts chronic disease (e.g., improved social resources) as well as indirect pathways (e.g., reduced stress, fewer competing demands, improved trust due to patient-provider/navigator relationship, increased medication affordability and use.)

Aim 3 - Heterogeneity of Treatment Effects (HTE): We will test the hypothesis that one or other of the two interventions is more impactful within prespecified sub-groups based on patient factors (age, type of social need, educational attainment) and clinical factors (comorbidity, care gaps) to inform strategies for future adaptation and dissemination.

HTE hypotheses: Younger age, higher educational attainment, fewer social needs, fewer chronic conditions, fewer care gaps will each be associated with better outcomes in the Lower Intensity vs Higher Intensity intervention arms.

Cumulatively, these three aims will provide timely and policy-relevant comparative effectiveness evidence to inform health care system approaches to addressing social needs in patients with chronic conditions (Aim 1), to understand mechanisms of action and key design elements from patient and navigator perspectives along the pathway from screening to improved health (Aim 2), and to investigate differential impacts across sub-populations (Aim 3).

Eligibility criteria: Inclusion Criteria:

* Two or more chronic medical conditions from a defined list of 24 chronic conditions
* One or more gaps in evidence-based care (related to condition-specific risk factor management, evidence-based screening and preventive care, missed appointments, and medication non-adherence),
* At least one self-reported social-related barrier to care or "social need" (e.g., transportation, food, housing, utilities, and/or financial insecurity).

Exclusion Criteria:

* major cognitive barriers (dementia, psychosis).
* multiple prior year hospitalizations ("extremely high utilizers")

Primary outcomes:
measure: Receipt of social services
timeFrame: approximately 6 months after enrollment
measure: Reduction in number of social needs
timeFrame: approximately 6 months after enrollment
measure: Clinical care gap closure
timeFrame: approximately 12 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente
name: Richard W Grant, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: