Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2045 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2026-01-10

Brief Summary

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Advancements in prenatal genetic screening have significantly improved the identification of chromosomal abnormalities and heritable conditions during pregnancy, yet current standards for patient education in this domain are largely ineffective. The most effective approach to education about prenatal screening is one-on-one genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas. The investigators will address this national problem using a novel education game that can more effectively address this gap in healthcare decision-making.

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Detailed Description

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The American College of Obstetricians and Gynecologists recommends prenatal care providers offer all women prenatal genetic screening (henceforth prenatal screening) in the first trimester of pregnancy, regardless of age or risk status. This has moved the focus of prenatal screening from a subset of higher risk couples to all pregnant couples. Classically, information about prenatal screening has been provided to patients by written materials and discussions with providers during clinic visits. This approach has a number of weaknesses, including limited time, biases presented by provider perceptions of risk level, and limited clinician genetic knowledge. These factors may also contribute to disparities in screening uptake among under-represented populations during pregnancy. The most effective approach to education about prenatal screening is genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas.

New innovative education games offer promise to more effectively address healthcare decision-making by educating patients before or outside of genetic counseling or clinic interaction. Providing engaging game-based education may result in a less labor-intensive method of genetic counseling and promote a more quality professional dialogue with clinicians. It is important to note that decision-making about prenatal screening is a complex medical issue; the term "game" refers to "serious game design" driven by theory. Game technology can display complex information in a culturally and linguistically appropriate format to individuals of diverse educational backgrounds that make them ideal for prenatal screening education especially among under-representative and rural populations. In fact, games have already been successfully applied to diabetes management, medication education and obesity.

The research team completed an R21 that developed and formally evaluated a novel prenatal screening education game, titled the "Meaning of Screening", in the clinical setting. Participants (n=73) were randomized to either the gaming intervention or usual care group. Outcomes demonstrated significant improvements in knowledge (p=.004) and high user satisfaction in the intervention group. The research team is now poised to evaluate this intervention among a wide range of health literacy levels in a national sample of pregnant couples from both rural and urban areas. The central hypothesis is that a game education tool for pre-test education will be equivalent to one-on-one genetic counseling and significantly better than enhanced usual care on knowledge, decisional conflict and shared decision-making.

Aim 1: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among pregnant people with a diverse range of health literacy levels.

Methods: Working with three sites across the US, the research team will recruit 1125 pregnant people during their first trimester of pregnancy (40% from underrepresented groups and 40% from rural/frontier areas). Prior to the first or second obstetric appointment, participants will be randomized to a) game education only, b) enhanced usual care (an interactive pdf of the clinic's brochure) or c) one-on-one genetic counseling (in-person or tele-health). Immediately after their appointment and again at 20 weeks gestation they will complete surveys to measure knowledge, satisfaction, and decisional conflict. The research team will also test the impact on several exploratory measures (e.g. satisfaction, non-directiveness, clarity).

Aim 2: To assess the effectiveness of the prenatal screening education game to promote shared decision making with providers compared to enhanced usual care (an interactive pdf of the clinic's brochure) or one-on-one genetic counseling (in-person or tele-health).

Methods: Pregnant people will independently complete surveys about shared decision making with their provider. Interviews with pregnant people and clinicians will also be conducted to identify how the game impacted information needs, preferences and shared decision-making.

Aim 3: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among partners of pregnant people.

Methods: Partners will be recruited and assigned to the same study group as their pregnant partner and will engage with the game, enhanced usual care or one-on-one genetic counseling (with their pregnant partner). Partners will independently complete surveys to measure knowledge, decisional conflict, and perceptions of shared decision making with the provider.

Conditions

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Genetic Counseling Shared Decision Making Pregnancy Genetic Testing Prenatal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be recruited and randomized into three different groups, all running in parallel to each other.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

The usual care group will consist of pregnant women who receive no experimental intervention but will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format, plus any additional clinic materials or oral information provided in conversation with clinicians (n= 375 total, 125 per site). We are transferring ACOG's prenatal screening education onto the electronic platform to control for any differences in attention that may be due to technology platform and to track time interacting with the material via the web portal.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants in the Usual Care group will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format so they can read it before they complete prenatal screening.

Game Intervention

The game intervention group will consist of pregnant women who will interact with the educational intervention also delivered on an electronic platform (n= 375 total, 125 per site). Participants will also receive whatever information is routinely provided in the clinic about prenatal screening such as the brochure and oral information by clinicians.

Group Type EXPERIMENTAL

Meaning of Screening

Intervention Type BEHAVIORAL

The Meaning of Screening game is a decision making tool that is accessible through the most common web platforms. Users have the ability to explore learn about prenatal screening through multiple approaches, including presentation of facts, personal stories, and values clarification. Users will access the game from their personal phone or computer prior to completing prenatal screening.

Genetic Counseling

The one-on-one genetic counseling group will receive standard of care for genetic counseling delivered by a board-certified genetic counselor for pre-test education. The counselor will be conducting pre-test education and as with the other study groups, the decision about prenatal screening will be made at the clinical visit with the provider. This group receives also the same clinical materials and oral information by clinicians as the other two groups. Both in-person and tele-health genetic counseling options are available at all sites.

Group Type ACTIVE_COMPARATOR

Genetic Counseling

Intervention Type BEHAVIORAL

This intervention consists of a 45-minute prenatal screening genetic counseling session (in person or online) completed after confirmation of pregnancy and before actual screening.

Interventions

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Meaning of Screening

The Meaning of Screening game is a decision making tool that is accessible through the most common web platforms. Users have the ability to explore learn about prenatal screening through multiple approaches, including presentation of facts, personal stories, and values clarification. Users will access the game from their personal phone or computer prior to completing prenatal screening.

Intervention Type BEHAVIORAL

Genetic Counseling

This intervention consists of a 45-minute prenatal screening genetic counseling session (in person or online) completed after confirmation of pregnancy and before actual screening.

Intervention Type BEHAVIORAL

Usual Care

Participants in the Usual Care group will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format so they can read it before they complete prenatal screening.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adult
* English-speaking people who are attending their first or second OB clinic visit including rural referral centers
* less than 15 weeks pregnant.
* Partner of the pregnant person who speaks English and is an adult
* Able to complete study tasks on a computer or smartphone from home

Exclusion Criteria

* already had prenatal screening from this or previous pregnancies,
* have obstetric or family history of chromosomal abnormalities, or genetic high-risk pregnancy and have already met with a genetic counseling about prenatal screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes