跳至主要内容
临床试验/NCT05360095
NCT05360095已完成不适用

Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education

Erin Rothwell3 个研究点 分布在 1 个国家目标入组 2,045 人开始时间: 2023年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,045
试验地点
3
主要终点
Change in Prenatal Screening Knowledge

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Usual Care

Active Comparator

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.

干预措施: Usual Care (Behavioral)

Game Intervention

Experimental

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.

干预措施: Meaning of Screening (Behavioral)

Genetic Counseling

Active Comparator

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.

干预措施: Genetic Counseling (Behavioral)

结局指标

主要结局

Change in Prenatal Screening Knowledge

时间窗: Baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation

Knowledge of Prenatal Screening survey determines how well a patient understands important aspects of prenatal genetic screening. It will be adapted from the multidimensional measure of informed choice (MMIC). The knowledge score will range from 0 to 12 with higher scores indicating greater knowledge.

次要结局

  • Shared Decision Making(After clinic visit (between 10 and 14 weeks gestation))
  • Change in Decisional Conflict(After clinic visit (between 10 and 14 weeks gestation) and again at 20 weeks gestation)

研究者

发起方
Erin Rothwell
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erin Rothwell

Professor, Interim Vice President for Research

University of Utah

研究点 (3)

Loading locations...

相似试验