Delivery of Health CareNCT07557303
Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
A study testing Mobile-based Educational Intervention in people with Delivery of Health Care and Genetic Testing, run by Case Western Reserve University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery of Health Care, Genetic Testing, Humans
- What is being tested?
- Mobile-based Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Neeta Vora, MD, (984) 974-2131, Neeta_vora@med.unc.edu
Amber Ivins, MSCR, amber_ivins@med.unc.edu
- Recruiting
University of Florida Health
Jacksonville, Florida, 32209
Niamh Condon, DO, FACOOG, 904-383-1037, Niamh.Condon@jax.ufl.edu
Julie Nowak, julie.nowak@jax.ufl.edu
- Recruiting
Zuckerberg Chan San Francisco General Hospital
San Francisco, California, 94158
Miriam Kuppermann, MPH, PhD, 415-502-4089, miriam.kuppermann@ucsf.edu
Kimberly Coleman-Phox, MPH, 415-476-6406, kimberly.coleman-phox@ucsf.edu
About this study
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:
Read more
- 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.
- Conditions
- Delivery of Health Care, Genetic Testing, Humans, Pregnancy, Noninvasive Prenatal Testing, Informed Consent
- Being tested
- Mobile-based Educational Intervention
- Keywords
- Non-invasive prenatal screening (NIPS), Non-Invasive Prenatal Testing (NIPT), Cell-free DNA (cfDNA), Prenatal genetic screening, Informed consent, Decision making, Surveys and Questionnaires, Informed choice, Educational intervention, Decision Regret, Decision Satisfaction
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based Educational Intervention | Experimental | 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. Receives: Behavioral: Mobile-based Educational Intervention |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Self-Efficacy
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.
Measured: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start10 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delivery of Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal stepped-wedge trial design
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Marsha Michie, Case Western Reserve University
- Investigators
- Marsha Michie, PhD, Principal investigator, Case Western Reserve UniversityMegan Allyse, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557303
- Sponsor's protocol ID
- STUDY20251580
- Other IDs
- R01HG013718
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Allyse MA, Sengupta S, Michie M. The Challenges of Reproductive Autonomy in an Unjust System. Am J Bioeth. 2025 Dec;25(12):67-69. doi: 10.1080/15265161.2025.2570681. Epub 2025 Nov 18. No abstract available.
PubMed 41252505Allyse M, Riggan K, Bonhomme N, Michie M. Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening. Hastings Cent Rep. 2025 Mar;55(2):29-38. doi: 10.1002/hast.4976.
PubMed 40245273
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study
- ClinicalTrials.gov ID
- NCT07557303
- Acronym / sponsor ID
- STUDY20251580
- Conditions
- Delivery of Health Care, Genetic Testing, Humans, Pregnancy, Noninvasive Prenatal Testing, Informed Consent
- Keywords
- Non-invasive prenatal screening (NIPS), Non-Invasive Prenatal Testing (NIPT), Cell-free DNA (cfDNA), Prenatal genetic screening, Informed consent, Decision making, Surveys and Questionnaires, Informed choice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal stepped-wedge trial design
| Arm | Type | Receives |
|---|---|---|
| Mobile-based Educational Intervention | Experimental | Behavioral: Mobile-based Educational InterventionParticipants 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based Educational InterventionA 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. | Behavioural | Mobile-based Educational Intervention |
Primary outcome
Decision Self-Efficacy
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 41252505Allyse MA, Sengupta S, Michie M. The Challenges of Reproductive Autonomy in an Unjust System. Am J Bioeth. 2025 Dec;25(12):67-69. doi: 10.1080/15265161.2025.2570681. Epub 2025 Nov 18. No abstract available.
- Background: PubMed 40245273Allyse M, Riggan K, Bonhomme N, Michie M. Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening. Hastings Cent Rep. 2025 Mar;55(2):29-38. doi: 10.1002/hast.4976.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marsha Michie, PhD principal investigator
Case Western Reserve University
Megan Allyse, PhD principal investigator
Case Western Reserve University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based Educational Intervention in people with Delivery of Health Care and Genetic Testing, run by Case Western Reserve University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabina Rubeck, MPH (216-368-2547, sabina.rubeck@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Self-Efficacy (time frame: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.