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.
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
- Conditions the study is for
- Multiple Chronic Conditions, Social Needs, Care Gaps
- What is being tested?
- Telephonic Outreach and Virtual Outreach
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Division of Research
Pleasanton, California, 94588
Karen R Estacio, MHA, 510.891.5960, karen.r.estacio@kp.org
Richard W Grant, MD MPH
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).
- Conditions
- Multiple Chronic Conditions, Social Needs, Care Gaps, Navigation
- 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 group | Role | What they receive |
|---|---|---|
| Telephonic Navigation | Experimental | Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months) Receives: 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) Receives: Behavioral: Virtual Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of social services
Patient survey re: receipt of resources from available programs
Measured: approximately 6 months after enrollment
Reduction in number of social needs
Reduction from baseline in number of unmet social needs
Measured: approximately 6 months after enrollment
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.
- First posted23 Apr 2025
- Study start1 Sep 2025
- Primary completion15 Sep 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard W Grant, MD MPH, Principal investigator, Kaiser Permanente
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Needs to Improve Health in Adults With Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT06941519
- Acronym / sponsor ID
- IRB 2291224
- Conditions
- Multiple Chronic Conditions, Social Needs, Care Gaps, Navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephonic Navigation | Experimental | Behavioral: Telephonic OutreachHigher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months) |
| Virtual Outreach | Active comparator | Behavioral: Virtual OutreachLower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- major cognitive barriers (dementia, psychosis).
- multiple prior year hospitalizations ("extremely high utilizers")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephonic OutreachHigher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months) | Behavioural | Telephonic Navigation |
| Virtual OutreachLower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services) | Behavioural | Virtual Outreach |
Primary outcome
Receipt of social services
Time frame: approximately 6 months after enrollment
Patient survey re: receipt of resources from available programs
Reduction in number of social needs
Time frame: approximately 6 months after enrollment
Reduction from baseline in number of unmet social needs
Clinical care gap closure
Time frame: approximately 12 months after enrollment
Reduction in number of evidence-based clinical care gaps
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 41453516Tucher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard W Grant, MD MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
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.