ClinicalTrials.gg
RecruitingNCT06941519Updated Jun 5, 2026

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

An interventional study of Telephonic Outreach and Virtual Outreach in Multiple Chronic Conditions, Social Needs and Care Gaps, sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Multiple Chronic Conditions
  • Social Needs
  • Care Gaps
  • Navigation
03

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's planned enrollment of 800 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • major cognitive barriers (dementia, psychosis).
  • multiple prior year hospitalizations ("extremely high utilizers")
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    Telephonic Navigation

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

    Behavioral: Telephonic Outreach

  • 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

Interventions

  • BehavioralTelephonic Outreach

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

  • BehavioralVirtual 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)

06

What researchers measure

Primary outcomes

  1. Receipt of social services

    Patient survey re: receipt of resources from available programs

    Time frame: approximately 6 months after enrollment

  2. Reduction in number of social needs

    Reduction from baseline in number of unmet social needs

    Time frame: approximately 6 months after enrollment

  3. Clinical care gap closure

    Reduction in number of evidence-based clinical care gaps

    Time frame: approximately 12 months after enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 41453516 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06941519
Lead sponsor
Kaiser Permanente
Responsible party
Sponsor
First posted
Apr 23, 2025
Start date
Sep 1, 2025
Primary completion
Sep 15, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jun 5, 2026

Study contacts

Karen R Estacio, MHA
Contact
karen.r.estacio@kp.org
510.891.5960
Richard W Grant, MD MPH
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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