Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13

NCT05859139 | Completed

• 1 other identifier: MP-13-2022-2574
• Study Type: interventional
• Target: 887
• Locations: 1 country
• Sites: 1

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.

Conditions

Decision Aid

Keywords

Decision Aid; Health Professionals; Scaling strategies; Online training; Prenatal screening; Shared decision-making; Trisomy; Pregnant women; Prenatal services

Outcome Measures

Primary Outcomes (1)

• Level of SDM adoption

  The level of SDM adoption will be measured through the measurement of the level of involvement of health professionals and pregnant women (and their partners) in the decision regarding to have or not a prenatal screening test for trisomy 21, 18 and 13. The SDM adoption will be measured with the SDM-Q-9 scale, which is a validated measurement instrument. The SDM-Q-9 scale is well understood by patients and has the potential to collect valid data on the perceived involvement of patients in SDM. The SDM-Q-9 scale consists of 9 items, each corresponding to the expected behaviour of the health professional in the SDM. Each of the 9 items is rated by a six-point Likert scale (0 = Totally Disagree to 5 = Totally Agree) where higher scores reflect higher level of SDM adoption.

  At the 23rd week of pregnancy

Secondary Outcomes (13)

• The rate of the DA utilization by pregnant women, their partners and health professionals

  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)

• Perceived role in decision-making

  At the 23rd week of pregnancy

• DA appreciation

  At the 23rd week of pregnancy

• Appreciation of the online SDM training

  Immediately after the online training

• Decisional conflict

  At the 23rd week of pregnancy

Study Arms (4)

Intervention introduced to group 1

EXPERIMENTAL

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

Other: DA Scaling Strategies

Intervention introduced to group 2

EXPERIMENTAL

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

Other: DA Scaling Strategies

Intervention introduced to group 3

EXPERIMENTAL

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

Other: DA Scaling Strategies

Intervention introduced to group 4

EXPERIMENTAL

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

Other: DA Scaling Strategies

Interventions

DA Scaling Strategies OTHER

For this study the intervention will consist of different DA scaling strategies : 1) dissemination of an online DA; 2) dissemination of a paper-based DA; 3) online training for healthcare professionals.

Intervention introduced to group 1; Intervention introduced to group 2; Intervention introduced to group 3; Intervention introduced to group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

VITAM - Centre de recherche en santé durable, CIUSSS de la Capitale-Nationale

Québec, G1G 2G1, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Trisomy

Condition Hierarchy (Ancestors)

Aneuploidy; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chromosome Duplication

Study Officials

• France Légaré, Ph.D

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation of prenatal services to groups and stages will be blinded by an independent, experienced biostatistician who will not be involved in the data analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 15, 2023
• Study Start: February 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CA (1)