- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07174466
- Ursprunglig rättegång
E-SINCERE-studien (e-SINCERE)
Förbättrad digital tillgång för att bridge sociala behov och minska skillnaderna i hälso- och sjukhälsan: E-SINCERE-studien
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ernest Grigorian, MS
- Telefonnummer: 801-585-7194
- E-post: Ernest.Grigorian@utah.edu
Studieorter
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- University of Utah
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
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. |
|
Experimentell: 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. |
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. |
|
Experimentell: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Successful connection to community social services (any service)
Tidsram: 6 months after randomization
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health-related quality of life (PROMIS Global Health)
Tidsram: Baseline, 2 weeks, 3 months, and 6 months after randomization
|
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)
Tidsram: 6 months after randomization
|
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)
Tidsram: 6 months after randomization
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Andrea Wallace, PhD, University of Utah
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 00181891
- 1R01NR021501-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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