NCT06941519

Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a comparative effectiveness randomized clinical trial with two "active comparator" arms. The investigators 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). 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). Hypotheses (H) are framed in terms of relatively greater effectiveness of the Higher Intensity strategy, although through Aims 2 \& 3 the investigators 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: The investigators 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. 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): The investigators 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).

Conditions

• Multiple Chronic Conditions
• Social Needs
• Care Gaps
• Navigation

Interventions

Type	Name	Description
BEHAVIORAL	Telephonic Outreach	Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)
BEHAVIORAL	Virtual Outreach	Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-09-15
• Completion: 2029-12-01
• First posted: 2025-04-23
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States