- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07716280
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS)
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS) - PATIENT
The long-term goal of this program of research is to increase the reach of Lung Cancer Screening (LCS) among low-resource healthcare settings and populations. The proposed project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in three Utah safety-net healthcare system clinics.
LUNG-IS employs a comprehensive conceptual model with theories, models, and frameworks of implementation and behavioral science, uses rigorous mixed-methods to evaluate factors that influence implementation of LCS, and uses patient navigation to facilitate clinic-community linkages.
LUNG-IS leverages existing pathways to care and Centralized Hub infrastructure that enables eligibility assessment, LCS Shared Decision Making (SDM) with clinical decision support, screening referral, and screening logistics assistance to help overcome barriers to LCS completion. The Centralized Hub model uses ubiquitous technologies (i.e., text messaging/telehealth) to enable patients to be assessed for LCS eligibility, engage in SDM if eligible, and be referred for LCS. For patients who decide to complete LCS, they will be provided patient navigation via Community Health Workers designed to address logistical barriers, hesitancy, and financial constraints around completing LCS.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Indy Li, MS
- Telefonnummer: 801-213-5697
- E-post: indy.li@hci.utah.edu
Studieorter
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- Huntsman Cancer Institute/ University of Utah
-
Kontakt:
- Indy Li, MS
- Telefonnummer: 801-213-5697
- E-post: indy.li@hci.utah.edu
-
Huvudutredare:
- Chelsey Schlechter, MPH, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Current or former, male and female, smokers.
- Age 50-80.
- Primary language English or Spanish.
- Have a phone that can send/receive text messages.
Exclusion Criteria:
- Patients who have never smoked.
- Patients who are under the age of 50 or above the age of 80.
- Primary language other than English or Spanish.
- Do not have access to a phone that can send/receive text messages.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Stage 1: TM+
Basic text messages sent directly to the patient's cell phone.
|
Basic text messages sent directly to the patient's cell phone.
|
|
Övrig: Stage 1: TM+, CA
Basic text messages sent directly to the patient's cell phone.
Also includes the option for chat bot to answer frequently asked LCS questions.
|
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
|
|
Övrig: Stage 1: TM+, Video
Basic text messages sent directly to the patient's cell phone.
Also includes the option for an educational video about LCS.
|
Basic text messages sent directly to the patient's cell phone.
Educational video about LCS.
|
|
Övrig: Stage 1: TM+, CA, Video
Basic text messages sent directly to the patient's cell phone. Also includes the option for chat bot to answer frequently asked LCS questions and option for educational video about LCS. Patients who complete SDM and are referred to LCS will also be assigned to one of the following conditions. Descriptions of these conditions are as follows: |
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
Educational video about LCS.
|
|
Övrig: Stage 2: TM+, RPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and reactive patient navigation to help get to the LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Reactive patient navigation to help get to the LCS appointment.
|
|
Övrig: Stage 2:TM+, PPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and proactive patient navigation to help get to the LCS appointment. Patients who need transportation financial assistance will receive transportation vouchers to help get them to and from their LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Proactive patient navigation to help get to the LCS appointment.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of Implementation Strategies on Lung Cancer Screening (LCS) eligibility screening
Tidsram: up to 15 weeks after study enrollment
|
Evaluate the impact of implementation strategies on Lung Cancer Screening (LCS) eligibility screening.
This outcome measure will report the proportion of participants who complete LCS eligibility screening.
|
up to 15 weeks after study enrollment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion
Tidsram: up to 7 weeks after completion of LCS eligibility screen
|
Evaluate the impact of implementation strategies on Shared Decision Making (SDM) completion.
This outcome measure will report the proportion of patients who complete SDM.
|
up to 7 weeks after completion of LCS eligibility screen
|
|
Impact of Implementation Strategies on LCS Completion
Tidsram: up to 6 months after placement of LCS referral
|
Evaluate the impact of implementation strategies on LCS completion.
This outcome measure will report the proportion of participants who complete LCS.
|
up to 6 months after placement of LCS referral
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah
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
- 187448
- 1U48DP006855-01 (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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