Clinical trial NCT05859139: Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13
Official title: PEGASUS-2: Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13: A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Aid
Keywords: Decision Aid
Health Professionals
Scaling strategies
Online training
Prenatal screening
Shared decision-making
Trisomy
Pregnant women
Prenatal services
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 887
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will consist of four groups receiving the intervention in a sequential way. Each group will include several prenatal services corresponding to the study clusters (the randomization unit). Randomization will occur at the site level. Clinics will be randomized in groups to receive the intervention. At the end, every clinic will be in intervention conditions. The study will be conducted over five periods each corresponding to a data collection period. During the first period, all groups will be in control conditions where health professionals will provide the usual prenatal care to pregnant women (no intervention). Then, after a regular interval of 10 weeks, each group will receive the intervention starting with the beginning of the remaining four periods. Once a group has received the intervention, it will remain in intervention conditions until the end of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of SDM adoption
timeFrame: At the 23rd week of pregnancy
Secondary outcomes:
measure: The rate of the DA utilization by pregnant women, their partners and health professionals
timeFrame: At the 23rd week of pregnancy (for pregnant women and their partners), and the research team will compile the information on the online and hard copies of DA utilization during weeks 10 to 50 of the study (Intervention phases)
measure: Perceived role in decision-making
timeFrame: At the 23rd week of pregnancy
measure: DA appreciation
timeFrame: At the 23rd week of pregnancy
measure: Appreciation of the online SDM training
timeFrame: Immediately after the online training
measure: Decisional conflict
timeFrame: At the 23rd week of pregnancy
measure: Decisions made and chosen tests
timeFrame: At the 23rd week of pregnancy
measure: Facilitators and barriers to the use of the DA
timeFrame: At the 23rd week of pregnancy
measure: Duration of the prenatal consultation
timeFrame: At the 23rd week of pregnancy
measure: Efforts and costs related to the use of the DA
timeFrame: At the 23rd week of pregnancy
measure: Efforts and costs related to the use and the distribution of the DA
timeFrame: Immediately after the intervention
measure: DA use fidelity for pregnant women and their partners
timeFrame: At the 23rd week of pregnancy
measure: DA use fidelity for healthcare providers
timeFrame: At the 23rd week of pregnancy
measure: Long-term use of DA and proposed adaptations for the DA
timeFrame: At the 23rd week of pregnancy
Other outcomes:
Locations:
city: Québec
country: Canada
facility: VITAM - Centre de recherche en santé durable, CIUSSS de la Capitale-Nationale
Study officials:
affiliation: Laval University
name: France Légaré, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: