Decision AidPEGASUS-IINCT05859139
Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13
A study testing DA Scaling Strategies in people with Decision Aid, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Aid
- What is being tested?
- DA Scaling Strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 887 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
VITAM - Centre de recherche en santé durable, CIUSSS de la Capitale-Nationale
Québec, G1G 2G1
About this study
Official title: PEGASUS-2: Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13: A Stepped Wedge Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Decision Aid
- Being tested
- DA Scaling Strategies
- Keywords
- Decision Aid, Health Professionals, Scaling strategies, Online training, Prenatal screening, Shared decision-making, Trisomy, Pregnant women, Prenatal services
- Medical subject headings
- Trisomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA Scaling StrategiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention introduced to group 1 | Experimental | The intervention is introduced to the first group (G1) of clusters. Receives: 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. Receives: 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. Receives: 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. Receives: Other: DA Scaling Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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, pregnant women and their partners will answer questions about whether they used the DA to help them make their decision. For each intervention period of the study, the research team will compile the number of utilization of the online DA as well as the city of the users. The research team will also track the number of hard copies of the DA used by each prenatal service recruited.
Measured: 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
Pregnant women and their partners will be be asked to assess their perceived role in deciding whether or not to have prenatal screening for trisomies 21, 18 and 13. The investigators will use a validated 1-question scale with five options of responses (A, B, C, D and E). The investigators will combine choices A and B to identify the proportion of pregnant women (and their partners) who will have made the decision alone, choice C to identify the frequency of SDM, and thte investigators will combine D and E choices to identify the proportion of pregnant women (and their partners) who have had a passive role.
Measured: At the 23rd week of pregnancy
DA appreciation
This study will assess the participants' general appreciation of the DA. Once pregnant women and their partners have used the online or paper DA, they will respond to a questionnaire (questions with different options of responses) assessing their appreciation on the DA (on its presentation, acceptability, usefulness, neutrality, quantity and quality of information, etc.). Questions to be responded to will be adapted according to the version used (online or paper based DA).
Measured: At the 23rd week of pregnancy
Appreciation of the online SDM training
Once health care professionals have completed the online SDM training, they will respond to questions aiming at assessing their overall appreciation (on its presentation, acceptability, usefulness, quantity and quality of information, etc.). Open-ended questions will allow them to say what they liked or did not like, to offer suggestions for improvement or to add any other comments.
Measured: Immediately after the online training
Decisional conflict
To measure the level of decisional conflict among pregnant women and their partners, the investigators will use the validated scale that assess the decisional conflict. The scale has 16 items evaluated with a 5-point Likert scale (1 = Strongly agree, 5 = Strongly disagree).
Measured: At the 23rd week of pregnancy
Decisions made and chosen tests
Pregnant women and their partners will answer questions about what was their decision as to whether or not to do a screening test. If they chose to do a screening test, what was the test(s) and whether the test(s) was done in the public or private network. In addition, they will be asked if they went further for a diagnostic test.
Measured: At the 23rd week of pregnancy
Facilitators and barriers to the use of the DA
Pregnant women and their partners will be asked open-ended questions to find out what helped, or allowed, and what limited, or prevented them from using our DA in the format used (paper based or online DA).
Measured: At the 23rd week of pregnancy
Duration of the prenatal consultation
The investigators will ask pregnant women and their partners how long the targeted prenatal consultation (with the discussion on prenatal testing ) lasted.
Measured: At the 23rd week of pregnancy
Efforts and costs related to the use of the DA
Pregnant women and their partners will answer questions about whether they used our DA, and if so, will follow questions aiming at assessing the energy or effort invested in using it and the possibility that the use of the DA was associated with financial expenses or losses.
Measured: At the 23rd week of pregnancy
Efforts and costs related to the use and the distribution of the DA
The investigators will ask prenatal service leaders or champions what level of effort and energy they had to invest to use and/or distribute the DA to pregnant women and their partners. In addition, the investigators will ask them if the use and/or distribution of the DA caused them financial expenses or losses, or if this required more human resources.
Measured: Immediately after the intervention
DA use fidelity for pregnant women and their partners
After deciding whether to do or not the prenatal screening test, pregnant women and their partners will answer questions to assess the extent to which they have used the tool (e.g. number of sections read and/or completed) and when they used it. These questions are used to assess whether pregnant women (and their partners) used the tool as intended.
Measured: At the 23rd week of pregnancy
DA use fidelity for healthcare providers
A set of questions will be asked to pregnant women and their partners to assess whether a person has given them the DA (in hard copy or the internet link), and if so, by whom and when. The investigators also want to know if the healthcare providers used the DA during the prenatal consultation and how.
Measured: At the 23rd week of pregnancy
Long-term use of DA and proposed adaptations for the DA
Pregnant women and their partners will answer questions to assess whether they intend to reuse the DA for a future pregnancy or if they would like to use another DA for another medical decision.
Measured: At the 23rd week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision AidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, France Legare, CHU de Quebec-Universite Laval
- Investigators
- France Légaré, Ph.D, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859139
- Sponsor's protocol ID
- MP-13-2022-2574
- Acronym
- PEGASUS-II
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEGASUS-2: Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13: A Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05859139
- Acronym / sponsor ID
- PEGASUS-II / MP-13-2022-2574
- Conditions
- Decision Aid
- Keywords
- Decision Aid, Health Professionals, Scaling strategies, Online training, Prenatal screening, Shared decision-making, Trisomy, Pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention introduced to group 1 | Experimental | Other: DA Scaling StrategiesThe intervention is introduced to the first group (G1) of clusters. |
| Intervention introduced to group 2 | Experimental | Other: DA Scaling StrategiesThe intervention is introduced to the second group (G2) of clusters and G1 remains in intervention conditions. |
| Intervention introduced to group 3 | Experimental | Other: DA Scaling StrategiesThe intervention is introduced to the third group (G3) of clusters and G1 and G2 remains in intervention conditions. |
| Intervention introduced to group 4 | Experimental | Other: DA Scaling StrategiesThe intervention is introduced to the fourth group (G4) of clusters and G1, G2 and G3 remains in intervention conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA Scaling StrategiesFor 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. | Other | Intervention introduced to group 1, Intervention introduced to group 2, Intervention introduced to group 3, Intervention introduced to group 4 |
Primary outcome
Level of SDM adoption
Time frame: At the 23rd week of pregnancy
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.
13 secondary outcomes
The rate of the DA utilization by pregnant women, their partners and health professionals
Time frame: 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
Time frame: At the 23rd week of pregnancy
DA appreciation
Time frame: At the 23rd week of pregnancy
Appreciation of the online SDM training
Time frame: Immediately after the online training
Decisional conflict
Time frame: At the 23rd week of pregnancy
Decisions made and chosen tests
Time frame: At the 23rd week of pregnancy
Facilitators and barriers to the use of the DA
Time frame: At the 23rd week of pregnancy
Duration of the prenatal consultation
Time frame: At the 23rd week of pregnancy
Efforts and costs related to the use of the DA
Time frame: At the 23rd week of pregnancy
Efforts and costs related to the use and the distribution of the DA
Time frame: Immediately after the intervention
DA use fidelity for pregnant women and their partners
Time frame: At the 23rd week of pregnancy
DA use fidelity for healthcare providers
Time frame: At the 23rd week of pregnancy
Long-term use of DA and proposed adaptations for the DA
Time frame: At the 23rd week of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Related InfoLink provided by the sponsor.
Related trials for Decision Aid
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Recruiting
GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection
Rheumatoid Arthritis
Recruiting
A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions
Dementia Caregivers, End of Life Decision Making
Recruiting
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
Shared Decision Making
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France Légaré, Ph.D principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DA Scaling Strategies in people with Decision Aid, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of SDM adoption (time frame: At the 23rd week of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.