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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Chronic Conditions; Social Needs; Care Gaps; Navigation
• Intervention / Treatment: Behavioral: Telephonic Outreach; Behavioral: Virtual Outreach

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).

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen R Estacio, MHA; Phone Number: 510.891.5960; Email: karen.r.estacio@kp.org

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Recruiting
      • Division of Research
      • Contact: Karen R Estacio, MHA; Phone Number: 510.891.5960; Email: karen.r.estacio@kp.org
      • Principal Investigator: Richard W Grant, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephonic Navigation; Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)	Behavioral: Telephonic Outreach; Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)
Active Comparator: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Richard W Grant, MD MPH, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 15, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: social needs, care gaps, navigation, multiple chronic conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Multiple Chronic Conditions
• Other Study ID Numbers: IRB 2291224; BPS-2023C3-35937 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No