Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13 (PEGASUS-II)

Laval University

Status: Completed

Conditions: Decision Aid

Treatments: Other: DA Scaling Strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT05859139

MP-13-2022-2574

Details and patient eligibility

About

This research project aims at assessing the effectiveness of a decision aid (DA) scaling intervention within the context of prenatal screening for trisomy 21, 18 and 13. The primary outcome is the level of involvement of pregnant women, their partners, and health professionals in shared decision-making (SDM) in the context of prenatal screening for trisomy 21, 18 and 13. The secondary outcome is the rate of use of online and paper versions of the DA by pregnant women, their partners and health professionals. The investigator hypothesize that the DA scaling strategies will increase the level of involvement of pregnant women, their partners (where appropriate), and health professionals in SDM.

Full description

Making a decision about prenatal screening for trisomy 21, 18 and 13 can be difficult. This is why it is important for pregnant women and their partners to be informed, accompanied and supported by health care providers. Involving them in shared decision-making (SDM) would allow them to meet their decision-making needs in this context. In addition, the use of a decision aid (DA) would facilitate SDM. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a DA has been developed. The DA was developed according to recommendations from pregnant women and their partners as well as health professionals who found it relevant. Moreover, the DA scaling up strategies were developed. This research project aim is to assess the effectiveness of the DA scaling strategies on the level of involvement of pregnant women, their partners, and health professionals in SDM on prenatal screening for trisomy 21, 18 and 13. This study, conducted in Quebec, is a randomized cluster stepped wedge trial. The study will be conducted in five periods, each corresponding to a data collection period. During the first period, all groups of clusters will be in control conditions, where health professionals will provide usual prenatal care to pregnant women without DA scaling strategies. Then, following a regular interval of 10 weeks, each group will be exposed to the intervention in 4 stages at the beginning of the periods. Once a group has received the intervention, they will access it until the end of the study. Participants are prenatal services (randomization unit), health professionals (obstetricians-gynecologists, family physicians, midwives, nurses and all other health professionals involved in prenatal care) and pregnant women as well as their partners. The intervention will consist of a DA scaling strategies, including but not limited to an online version of the DA and an online training on SDM incorporating the use of the DA. The investigators will recruit at least 28 prenatal services (study sites) and 35 pregnant women per site. The primary outcome (the level of involvement of study participants in SDM in the context of prenatal screening for trisomy 21, 18 and 13) will be measured with the validated SDM-Q-9 scale, which will be completed by pregnant women and their partners. The primary secondary outcome will be the rate of use of online and paper versions of the DA by pregnant women and their partners.

Enrollment: 887 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prenatal services (study sites) : To be eligible, prenatal services must

• be located in Quebec province

• be family medicine groups, gynecology and obstetrics departments or birth centers, other type of health facility involved in prenatal care

• agree to participate in our study including the recruitment of approximately 35 pregnant women over a total period of 50 weeks

• confirm that they will follow the research protocol.

  • Health professionals

To be eligible, health professionals must:

• be involved in prenatal care and working in a site participating in this study

• be involved in the follow-up of pregnancies

• be involved in the decision-making process in the context of prenatal screening for trisomiy 21, 18 and 13,

• be referred by their prenatal service

• understand French or English,

• consent to participate in the study

• medical residents and interns in midwifery practice, referred by participating prenatal service, are eligible too.

  • Pregnant women and their partners To be eligible, pregnant women and their partners must

• be 18 years of age or older

• have not yet decided whether or not to have prenatal testing for trisomy 21, 18 or 13 (usually before 13 weeks of pregnancy)

• be followed in one of the prenatal services participating in this study

• be able to read and understand French or English

• have the capacity to verbally consent to participate in the study or sign the consent form

Exclusion criteria

• Pregnant women and their partners The pregnant woman who have any medical complications associated or not with pregnancy (e.g. diabetes, hypertension, multiple pregnancy) is not eligible to this study
• Health professionals Health professionals working in more than one participating prenatal site as full- time or part-time employee are not eligible to this study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

887 participants in 4 patient groups

Intervention introduced to group 1

Experimental group

Description:

The intervention is introduced to the first group (G1) of clusters.

Treatment:

Other: DA Scaling Strategies

Intervention introduced to group 2

Experimental group

Description:

The intervention is introduced to the second group (G2) of clusters and G1 remains in intervention conditions.

Treatment:

Other: DA Scaling Strategies

Intervention introduced to group 3

Experimental group

Description:

The intervention is introduced to the third group (G3) of clusters and G1 and G2 remains in intervention conditions.

Treatment:

Other: DA Scaling Strategies

Intervention introduced to group 4

Experimental group

Description:

The intervention is introduced to the fourth group (G4) of clusters and G1, G2 and G3 remains in intervention conditions.

Treatment:

Other: DA Scaling Strategies