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

NCT06941519 | Recruiting

• 2 other identifiers: IRB 2291224BPS-2023C3-35937
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Navigation; Multiple Chronic Conditions; Social Needs; Care Gaps

Outcome Measures

Primary Outcomes (3)

• Receipt of social services

  Patient survey re: receipt of resources from available programs

  approximately 6 months after enrollment

• Reduction in number of social needs

  Reduction from baseline in number of unmet social needs

  approximately 6 months after enrollment

• Clinical care gap closure

  Reduction in number of evidence-based clinical care gaps

  approximately 12 months after enrollment

Study Arms (2)

Telephonic Navigation

EXPERIMENTAL

Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)

Behavioral: Telephonic Outreach

Virtual Outreach

ACTIVE COMPARATOR

Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)

Behavioral: Virtual Outreach

Interventions

Telephonic Outreach BEHAVIORAL

Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)

Telephonic Navigation

Virtual Outreach BEHAVIORAL

Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)

Virtual Outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Division of Research

Pleasanton, California, 94588, United States

RECRUITING

Related Publications (1)

• Tucher EL, Steele AL, Uratsu CS, Hamilton LK, Brown MC, Nugent JR, Jones DH, Gottlieb LM, Grant RW. Addressing social needs to improve health in adults with multiple chronic conditions: A comparative effectiveness trial of two real-world social needs interventions. Contemp Clin Trials. 2026 Feb;161:108210. doi: 10.1016/j.cct.2025.108210. Epub 2025 Dec 24.

  PMID: 41453516 DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard W Grant, MD MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen R Estacio, MHA

CONTACT

510.891.5960; karen.r.estacio@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 15, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)