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Ondersteuning voor Just-In-Time toestemming voor prenatale screening: de INFORM-studie

18 september 2026 bijgewerkt door: Marsha Michie, Case Western Reserve University

Ondersteuning van Just-In-Time Toestemming voor Prenatale Screening: De INFORM-studie

This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor.

The study has one main question:

  • Do participants who use the intervention feel more confident when they make a decision about screening?

Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor.

What will participants do?

  • Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening.
  • Some participants will use the intervention before their first doctor's visit. Other participants will not use it.
  • All participants will talk with a researcher on the phone after their first doctor's visit.
  • Participants who use the intervention will answer a short survey on their phone.
  • A few participants who use the intervention will talk with a researcher a second time on the phone.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94158
    • Florida
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Currently pregnant and receiving care at a participating collaborative site - University of North Carolina, Chapel Hill; Zuckerberg Chan San Francisco General Hospital; University of Florida Health, Jacksonville.
  • 18 years of age and older
  • Able to read, speak, and understand English or Spanish
  • Has not previously been offered prenatal genetic screening for the current pregnancy
  • 24 weeks (6 months) gestational age or less

Exclusion Criteria:

  • Not pregnant, not a patient at a partner clinical site
  • Younger than 18 years of age
  • Not being able to read, speak, and understand English or Spanish
  • Has previously been offered prenatal genetic screening for the current pregnancy
  • Greater than 24 weeks gestational age (6 months)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mobile-based Educational Intervention

Participants in the intervention arm will access a mobile-based educational tool that provides concise, culturally appropriate information about prenatal genetic screening prior to their clinical visit. Immediately after viewing the intervention, participants will complete an online, 6-question acceptability survey. Participants will then complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience with the intervention and to measure decisional self-efficacy. A select subset of participants will participate in an additional qualitative telephone interview to assess the efficacy and usability of the intervention.
Gedragsmatig: Mobile-based Educational Intervention

A mobile-based informational tool that participants will access through a Quick Response (QR) code prior to the clinical encounter in which they will be offered prenatal genetic screening. This tool will provide clear and concise information about prenatal genetic screening to support pregnant participants in making an informed decision.
Geen tussenkomst: Standard of Care

Participants in the standard-of-care arm will receive routine clinical care, including the usual information and counseling provided by clinicians regarding prenatal genetic screening. Participants will complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience being offered prenatal genetic screening and measure decisional self-efficacy.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Decision Self-Efficacy
Tijdsspanne: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.

Decision self-efficacy is measured using a slightly adapted version of the "Decision Self-Efficacy Scale" developed by A. O'Connor and colleagues at the Ottawa Hospital Research Institute and is available at https://decisionaid.ohri.ca. The scale contains eleven questions about a patient's decision-making process. The scale was adapted to ask questions about the context of prenatal genetic screening and utilizes a three-point response scale. Response choices and corresponding point values are: "A lot confident (4), a little confident (2), and not confident (0)". The values from each response are summed, divided by 11 and multiplied by 100 to give a score range from 0 to 100. Zero indicates no confidence and 100 indicates extreme confidence. A researcher administers the scale over the phone, once to each participant, within 168-hours after the medical appointment where participants are offered prenatal genetic screening. It should take no more than 5-10 minutes to complete.
The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Case Western Reserve University

Medewerkers

National Human Genome Research Institute (NHGRI)

Onderzoekers

  • Hoofdonderzoeker: Marsha Michie, PhD, Case Western Reserve University
  • Hoofdonderzoeker: Megan Allyse, PhD, Case Western Reserve University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 september 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2026

Eerst geplaatst (Werkelijk)

29 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

18 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY20251580
  • R01HG013718 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Data will be shared via the Inter-university Consortium for Political and Social Research. To the extent the context of data collection can be revealed without compromising the privacy and identity of research participants, it will be included in study protocols. Data will be anonymized.

Qualitative data such as de-identified and redacted transcripts, coding summaries, and metadata will be shared. Quantitative, including de-identified individual and aggregate survey data (including raw and recoded data) will be shared.

IPD-tijdsbestek voor delen

Approximately six to twelve months after the completion of data analysis. Methods and data collection instruments will be available to the research community before the completion of the study. Published outcomes as well as data deposited in the Inter-university Consortium for Political and Social Research will be available indefinitely.

IPD-toegangscriteria voor delen

Access to all deposited materials will be available to researchers registered and verified through the Inter-university Consortium for Political and Social Research (ICPSR). The ICPSR, a digital repository, utilizes a "Reference Model for an Open Archival Information System (OAIS), an International Organization for Standardization (ISO) standard that provides the functional framework for sustaining digital objects in managed repositories." Detailed access criteria can be found here: https://www.icpsr.umich.edu/sites/icpsr/about/policies/access-policy-framework

IPD delen Ondersteunend informatietype

  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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