The e-SINCERE Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrea Wallace
About this trial
The e-SINCERE study will evaluate whether providing stable cell phones and digital navigation assistance helps patients overcome ICT barriers and connect more successfully with community services. The study will begin with patients in the UHealth ED, with additional sites added in the future, and will involve working with community service providers and policy leaders to refine and implement the intervention. Findings from this study may guide the development of future programs and policies to improve access to services for patients facing economic and technological barriers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Community Advisory Board Members
Disqualifiers
Those unable to communicate verbally in English or Spanish
Those living in nursing facilities, or those who are not otherwise responsible for self-care
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Referral to 211
Other interventionParticipants receive a standard referral to United Way 211 for assistance with social needs. 211 specialists contact referred patients, provide available service referrals, and follow up in an ad-hoc manner as per standard 211 protocols.
e-SINCERE (Phone Support)
BehavioralParticipants receive a study-provided cellphone to ensure stable phone access. Using this device, participants are connected to United Way 211 specialists, who provide referral services for identified social needs. This intervention focuses on overcoming communication barriers that might otherwise prevent successful service connection.
e-SINCERE (Digital Navigation)
BehavioralParticipants receive a study-provided TracFone and direct support from a trained Digital Navigator. The Digital Navigator assists participants with accessing United Way 211 services, troubleshooting barriers to phone or internet use, and reinforcing follow-through on referrals. This arm is designed to provide enhanced, structured navigation support to address digital access barriers and increase successful service connections.
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Control - Standard Referral to 211Active comparator 1 intervention
Group B: Arm 2: Phone - Bridge Phone to 211Experimental treatment 1 intervention
Group C: Arm 3: Navigation - Digital Navigator + 211Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful connection to community social services (any service)
Proportion of participants who have at least one documented successful connection to a community social service (e.g., housing assistance, utilities, food support, transportation) within 6 months. Successful connection is defined as a recorded positive outcome in 211 or ServicePoint (client reached and service initiated) or participant self-report confirmed by case notes.
Time frame
6 months after randomizationSecondary outcomes
1
Health-related quality of life (PROMIS Global Health)
Change in PROMIS Global Health T-score from baseline to 6 months. Higher scores indicate better overall physical and mental health. Analysis will compare mean change between arms.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomization2
Emergency department utilization (all-cause ED visits)
Number of all-cause ED visits per participant during the 6-month follow-up period, obtained from the institution's EDW and participant self-report for non-UHealth visits. Analysis will compare mean visits and proportion with any ED revisit between arms.
Time frame
6 months after randomization3
Digital access stability (phone connectivity)
Proportion of participants in the phone/navigation arms with continuous phone connectivity (TracFone active and reachable) for at least 5 of 6 months. Connectivity assessed via phone service logs and navigator contact attempts.
Time frame
6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrea Wallace
Lead sponsor
University of Utah
Sponsor institution
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov