The e-SINCERE Study (e-SINCERE)

Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: The e-SINCERE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Health Services Utilization; Social Determinants of Health (SDOH); Digital Health Literacy
• Intervention / Treatment: Other: Standard Referral to 211; Behavioral: e-SINCERE (Phone Support); Behavioral: e-SINCERE (Digital Navigation)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ernest Grigorian, MS; Phone Number: 801-585-7194; Email: Ernest.Grigorian@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Community Advisory Board Members

Health system, governmental, and community service stakeholders

Able to understand English

Adult (> 18 years)

- General screening population:

Any patient who completes the SINCERE screener.

Able to understand or read English or Spanish.

- Survey study inclusion criteria:

Any patient who completes the SINCERE screener who has connected with 211 for service outreach

Able to understand or read English or Spanish.

Adult (> 18 years)

Exclusion Criteria:

• Those unable to communicate verbally in English or Spanish
• Those living in nursing facilities, or those who are not otherwise responsible for self-care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Control - Standard Referral to 211; Participants receive usual care plus a referral to United Way 211 for assistance with social needs. No additional study-provided phone or navigation support is given.	Other: Standard Referral to 211; Participants 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.
Experimental: Arm 2: Phone - Bridge Phone to 211; Participants receive a study-provided cellphone to ensure stable phone access. They are connected by phone to United Way 211 for assistance with social needs.	Behavioral: e-SINCERE (Phone Support); Participants 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.
Experimental: Arm 3: Navigation - Digital Navigator + 211; Participants receive a study-provided cellphone and direct support from a Digital Navigator. The Navigator assists participants in accessing United Way 211 and helps troubleshoot barriers to connecting with services.	Behavioral: e-SINCERE (Digital Navigation); Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks, 3 months, and 6 months after randomization
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.	6 months after randomization
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.	6 months after randomization

Collaborators and Investigators

• Sponsor: Andrea Wallace
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Andrea Wallace, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: September 12, 2025
• First Submitted That Met QC Criteria: September 12, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care
• Other Study ID Numbers: 00181891; 1R01NR021501-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No