Division of Research
Pleasanton, California, 94588, United States
Location status: Recruiting
Location contact
Karen R Estacio, MHA
CONTACT
Richard W Grant, MD MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06941519
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Pleasanton, California, 94588, United States
Location status: Recruiting
Karen R Estacio, MHA
CONTACT
Richard W Grant, MD MPH
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)
Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)
Time frame: approximately 6 months after enrollment
Patient survey re: receipt of resources from available programs
Time frame: approximately 6 months after enrollment
Reduction from baseline in number of unmet social needs
Time frame: approximately 12 months after enrollment
Reduction in number of evidence-based clinical care gaps
Contact information is provided by the study sponsor or research team.
Kaiser Permanente
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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