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

NCT ID: NCT06941519

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Telephonic Navigation

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

Group Type: EXPERIMENTAL

Telephonic Outreach

Intervention Type: BEHAVIORAL

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

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)

Group Type: ACTIVE_COMPARATOR

Virtual Outreach

Intervention Type: 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)

Interventions

Telephonic Outreach

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

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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")

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard W Grant, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Division of Research

Pleasanton, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen R Estacio, MHA

Role: CONTACT

karen.r.estacio@kp.org

510.891.5960

Facility Contacts

Karen R Estacio, MHA

Role: primary

karen.r.estacio@kp.org

510-891-5960

Other Identifiers

BPS-2023C3-35937

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 2291224

Identifier Type: -

Identifier Source: org_study_id