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Multiple Chronic ConditionsNCT06941519

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

A study testing Telephonic Outreach and Virtual Outreach in people with Multiple Chronic Conditions and Social Needs, run by Kaiser Permanente at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telephonic Outreach and Virtual Outreach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteUnited States
Study dates
1 Sep 2025to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Karen R Estacio, MHA contact

510.891.5960

karen.r.estacio@kp.org

United States1 site, 1 recruiting
  • Division of Research

    Pleasanton, California, 94588

    Karen R Estacio, MHA, 510.891.5960, karen.r.estacio@kp.org

    Richard W Grant, MD MPH

    Recruiting

Other trials in United States

About this study

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).

Being tested
Telephonic Outreach, Virtual Outreach
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephonic OutreachBehavioural

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

  • Virtual OutreachBehavioural

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

Study groups in NCT06941519
Study groupRoleWhat they receive
Telephonic NavigationExperimentalHigher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)
Receives: Behavioral: Telephonic Outreach
Virtual OutreachActive comparatorLower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)
Receives: Behavioral: Virtual Outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Receipt of social services

    Patient survey re: receipt of resources from available programs

    Measured: approximately 6 months after enrollment

  2. Reduction in number of social needs

    Reduction from baseline in number of unmet social needs

    Measured: approximately 6 months after enrollment

  3. Clinical care gap closure

    Reduction in number of evidence-based clinical care gaps

    Measured: approximately 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start1 Sep 2025
  3. Primary completion15 Sep 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06941519
Sponsor's protocol ID
IRB 2291224
Other IDs
BPS-2023C3-35937
Status last verified
Jun 2026
First submitted
16 Apr 2025
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Telephonic Outreach and Virtual Outreach in people with Multiple Chronic Conditions and Social Needs, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen R Estacio, MHA (510.891.5960, karen.r.estacio@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receipt of social services (time frame: approximately 6 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06941519, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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