Shared Decision MakingNCT04162288

Evaluating an Online Training Program on Shared Decision-making in Prenatal Screening

A study testing Online Training - Shared Decision Making in Prenatal Screening and Online Training - Online Training on Prenatal Screening in people with Shared Decision Making, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Shared Decision Making
What is being tested?: Online Training - Shared Decision Making in Prenatal Screening and Online Training - Online Training on Prenatal Screening
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteCanada
Study dates: 1 Aug 2019to 31 Jan 2020
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Be a certified nurse
Be involved in supporting prenatal screening decision-making or involved in prenatal screening processes in the province of Quebec;
Speak and write in French
Being in active practice within the last year.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Canada1 site

Leger
Québec, Quebec, G1R 2K2

Other trials in Canada

About this study

Official title: RCT Protocol for Evaluating an Online Training Program on Shared Decision-making About Screening for Down Syndrome

The investigators aim to evaluate an online training program on shared decision making within the prenatal context. The main outcome is intention on using a decision aid in prenatal screening consultation and study population is nurses. Secondary outcomes are; knowledge acquisition, acceptability of the formation and perceived usefulness. The investigators hypothesise that this web-based SDM training program developed for the prenatal screening of Down Syndrome will significantly increase nurses' intentions to use the decision aid in their clinical practice with pregnant women and their partner.

Read the detailed description

Pregnant women have difficulty choosing among the wide variety of prenatal screening options available. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a decision aid (DA) has been developped and online shared decision-making (SDM) training program for health professionals has been created to support the use of this DA and give health care professionals key elements on SDM. The decision aid was found relevant and acceptable to pregnant women and their partners; the relevance and acceptability of the online SDM training program aren't evaluated yet. This study aim to assess the intention on using a DA after taking the online training program, to evaluate knowledge acquisition and to assess the program's acceptability and perceived usefulness. This is a multi-center, two-arm, controlled trial (RCT). Thirty-six participants will be randomly allocated to either 1) an experimental group that is exposed to the investigator's complete 3 hours online training program intervention (n = 18) or 2) a control group that is exposed to an intervention which will be a 3 hours online training program focused on prenatal screening alone.

Conditions: Shared Decision Making
Being tested: Online Training - Shared Decision Making in Prenatal Screening, Online Training - Online Training on Prenatal Screening
Keywords: Shared Decision Making, Decision aid, Nurse, Online Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Online Training - Shared Decision Making in Prenatal ScreeningOther
TThe intervention consisted of an online self-study training program lasting 3 hours which aims to engage SDM in a prenatal screening context. The training was divided into four main modules: 1)SDM, 2)DS prenatal screening, 3)Decision aid and 4)Communication between healthcare professionals and patients. In each module, the targeted learning objectives and the work to be carried out (e.g. readings to be made, video to be viewed, evaluation to be carried out, etc.) are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. A simulation in the end is done to put participants in context of an actual consultation with a pregnant woman and her partner. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.
Online Training - Online Training on Prenatal ScreeningOther
The control intervention consisted of an online self-study training program lasting 3 hours which aims to provides knowledge for prenatal screening. The training has four main modules: 1)Context and history of prenatal screening(new), 2)DS prenatal screening(existing), 3)Consent in prenatal screening(new) and 4)Communication between healthcare professionals and patients(existing). In each module, the targeted learning objectives and the work to be carried out are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. For the 2 new modules, narrated capsules and reports have replaced videos of experts. There is no simulation at the end. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.

Study groups in NCT04162288
Study group	Role	What they receive
Online training on SDM in prenatal screening	Experimental	Not described Receives: Other: Online Training - Shared Decision Making in Prenatal Screening
Online training on prenatal screening	Placebo comparator	Not described Receives: Other: Online Training - Online Training on Prenatal Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening
Nurses intention of using a decision aid for prenatal screening in clinical practice is the primary outcome. To be measured, the CPD (Continuing professional development) reaction questionnaire will be used. This questionaire scores on 5 constructs; intention, social influence, beliefs about capabilities, moral norm and beliefs about consequences and has 12 questions. The constructs intention will be targeted, however the others constructs will be also evaluated for their potential on predicting behavior of health professionals. It is a self-reported questionnaire. The use of decision aid has been chosen as an outcome become it is a main component of SDM itself and of the training. The score is on a scale from 1 to 7 (Likert type), which 1 is the minimum and 7 the maximum value (except one question that has a 5 intervals of pourcentage, that will be adjusted on 7 items scale in the analysis). The higher score means better outcome.
Measured: The intention will be measured initially before accessing the formation. After the formation completed (duration is variable), the participant will have access to the questionnaire once again in a delay of 24-72 hours.

Secondary outcomes (4)

Knowledge on aspects surrounding prenatal screening and SDM
A newly designed and self-reported questionnaire consisting of 20 questions, reviewed by an SDM expert and a pedagogical advisor, explore knowledge on; Down Syndrome (2 questions), prenatal screening (7 questions), SDM (7 questions) and ethic (4 questions). There is 2 true-false questions and the other ones are multiple choices questions. Each question has the same ponderation, which is 5% on a total score of 100%. There is only one right answer to each question. There is no negative correction. The higher score means better outcome (acquisition of knowledge). The title of this questionnaire is: "Knowledge".
Measured: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Satisfaction with training: self-reported questionnaire
Satisfaction will be addressed on the content, trainers and overall satisfaction. For evaluating these kinds of satisfaction, a pre-existing self-reported questionnaire created by Schmidt (2007) will be used. The score is on a scale from 1 to 5 (Likert type), which 1 is the minimum and 5 the maximum value. The higher score means better outcome. The title of this section is :"Satisfaction" and it has two sections; "Satisfaction within the training content" and "Satisfaction with the training contributors".
Measured: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Acceptability of the training: self-reported questionnaire
Acceptability is evaluated by looking at the comprehensibility, the amount of information , the quality of information, the format chosen of the training and it is based on a pre-existing self-reported questionnaire done by Kasper and al. (2017). The score is on a scale from 1 to 5 (Likert type), which 1 is the minimum and 5 the maximum value. The higher score means better outcome. The title of this questionnaire is "Training acceptability".
Measured: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Perceived usefulness
Usefulness is declined in terms of work responsibilities, relevance of topics to career development, relevance of topics in relation to individual learning needs, consistency with declared objectives, balance between theory and practice and it is based on a self-reported questionnaire by Giangreco, Sebastiano and Peccei (2009). The score is on a scale from 1 to 5 (Likert type), which 1 is the minimum and 5 the maximum value. The higher score means better outcome. The title of this questionnaire is "Perceived usefulness of the formation".
Measured: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201931 Jan 2020

First posted14 Nov 2019
Study start1 Aug 2019
Primary completion31 Jan 2020
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Shared Decision MakingStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a multi-center, two-arm, controlled trial (RCT). Thirty-six participants will be randomly allocated to either 1) an experimental group that is exposed to our complete 3 hours online training program intervention (n = 18) or 2) a control group that is exposed to an intervention which will be a 3 hours online training program focused on prenatal screening.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04162288
Sponsor's protocol ID: MP-20-2019-4571
Status last verified: Feb 2021
First submitted: 22 Aug 2019
Last updated: 11 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Legare F, Witteman HO. Shared decision making: examining key elements and barriers to adoption into routine clinical practice. Health Aff (Millwood). 2013 Feb;32(2):276-84. doi: 10.1377/hlthaff.2012.1078.
PubMed 23381520
Moulton B, Collins PA, Burns-Cox N, Coulter A. From informed consent to informed request: do we need a new gold standard? J R Soc Med. 2013 Oct;106(10):391-4. doi: 10.1177/0141076813490686. Epub 2013 Jun 6. No abstract available.
PubMed 23759895
Gray M, Jani A. Promoting Triple Value Healthcare in Countries with Universal Healthcare. Healthc Pap. 2016;15(3):42-8.
PubMed 27009586
Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making. 2015 Jan;35(1):114-31. doi: 10.1177/0272989X14551638. Epub 2014 Oct 28.
PubMed 25351843
Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
PubMed 24470076
Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
PubMed 23381511
Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
PubMed 25222632
Legare F, Adekpedjou R, Stacey D, Turcotte S, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2018 Jul 19;7(7):CD006732. doi: 10.1002/14651858.CD006732.pub4.
PubMed 30025154
Legare F, St-Jacques S, Gagnon S, Njoya M, Brisson M, Fremont P, Rousseau F. Prenatal screening for Down syndrome: a survey of willingness in women and family physicians to engage in shared decision-making. Prenat Diagn. 2011 Apr;31(4):319-26. doi: 10.1002/pd.2624. Epub 2011 Jan 26.
PubMed 21268046
St-Jacques S, Grenier S, Charland M, Forest JC, Rousseau F, Legare F. Decisional needs assessment regarding Down syndrome prenatal testing: a systematic review of the perceptions of women, their partners and health professionals. Prenat Diagn. 2008 Dec;28(13):1183-203. doi: 10.1002/pd.2059.
PubMed 19097031
Couet N, Desroches S, Robitaille H, Vaillancourt H, Leblanc A, Turcotte S, Elwyn G, Legare F. Assessments of the extent to which health-care providers involve patients in decision making: a systematic review of studies using the OPTION instrument. Health Expect. 2015 Aug;18(4):542-61. doi: 10.1111/hex.12054. Epub 2013 Mar 4.
PubMed 23451939
Legare F, O'Connor AC, Graham I, Saucier D, Cote L, Cauchon M, Pare L. Supporting patients facing difficult health care decisions: use of the Ottawa Decision Support Framework. Can Fam Physician. 2006 Apr;52(4):476-7.
PubMed 17327891
Legare F, Ratte S, Gravel K, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals' perceptions. Patient Educ Couns. 2008 Dec;73(3):526-35. doi: 10.1016/j.pec.2008.07.018. Epub 2008 Aug 26.
PubMed 18752915
Stacey D, Hill S, McCaffery K, Boland L, Lewis KB, Horvat L. Shared Decision Making Interventions: Theoretical and Empirical Evidence with Implications for Health Literacy. Stud Health Technol Inform. 2017;240:263-283.
PubMed 28972523
Legare F, Stacey D, Briere N, Fraser K, Desroches S, Dumont S, Sales A, Puma C, Aube D. Healthcare providers' intentions to engage in an interprofessional approach to shared decision-making in home care programs: a mixed methods study. J Interprof Care. 2013 May;27(3):214-22. doi: 10.3109/13561820.2013.763777. Epub 2013 Feb 8.
PubMed 23394265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RCT Protocol for Evaluating an Online Training Program on Shared Decision-making About Screening for Down Syndrome
ClinicalTrials.gov ID: NCT04162288
Acronym / sponsor ID: MP-20-2019-4571
Conditions: Shared Decision Making
Keywords: Shared Decision Making, Decision aid, Nurse, Online Training
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: CHU de Quebec-Universite LavalUniversity, hospital or other
Collaborators: Laval University, Genome Quebec, Genome Canada, CERSSPL
Study start: 1 Aug 2019 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 14 Nov 2019 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This is a multi-center, two-arm, controlled trial (RCT). Thirty-six participants will be randomly allocated to either 1) an experimental group that is exposed to our complete 3 hours online training program intervention (n = 18) or 2) a control group that is exposed to an intervention which will be a 3 hours online training program focused on prenatal screening.

Arm	Type	Receives
Online training on SDM in prenatal screening	Experimental	Other: Online Training - Shared Decision Making in Prenatal Screening
Online training on prenatal screening	Placebo comparator	Other: Online Training - Online Training on Prenatal Screening

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Be a certified nurse
Be involved in supporting prenatal screening decision-making or involved in prenatal screening processes in the province of Quebec;
Speak and write in French
Being in active practice within the last year.

Key exclusion criteria (1 listed)

None

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
Online Training - Shared Decision Making in Prenatal ScreeningTThe intervention consisted of an online self-study training program lasting 3 hours which aims to engage SDM in a prenatal screening context. The training was divided into four main modules: 1)SDM, 2)DS prenatal screening, 3)Decision aid and 4)Communication between healthcare professionals and patients. In each module, the targeted learning objectives and the work to be carried out (e.g. readings to be made, video to be viewed, evaluation to be carried out, etc.) are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. A simulation in the end is done to put participants in context of an actual consultation with a pregnant woman and her partner. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.	Other	Online training on SDM in prenatal screening
Online Training - Online Training on Prenatal ScreeningThe control intervention consisted of an online self-study training program lasting 3 hours which aims to provides knowledge for prenatal screening. The training has four main modules: 1)Context and history of prenatal screening(new), 2)DS prenatal screening(existing), 3)Consent in prenatal screening(new) and 4)Communication between healthcare professionals and patients(existing). In each module, the targeted learning objectives and the work to be carried out are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. For the 2 new modules, narrated capsules and reports have replaced videos of experts. There is no simulation at the end. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.	Other	Online training on prenatal screening

Primary outcome

Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening
Time frame: The intention will be measured initially before accessing the formation. After the formation completed (duration is variable), the participant will have access to the questionnaire once again in a delay of 24-72 hours.
Nurses intention of using a decision aid for prenatal screening in clinical practice is the primary outcome. To be measured, the CPD (Continuing professional development) reaction questionnaire will be used. This questionaire scores on 5 constructs; intention, social influence, beliefs about capabilities, moral norm and beliefs about consequences and has 12 questions. The constructs intention will be targeted, however the others constructs will be also evaluated for their potential on predicting behavior of health professionals. It is a self-reported questionnaire. The use of decision aid has been chosen as an outcome become it is a main component of SDM itself and of the training. The score is on a scale from 1 to 7 (Likert type), which 1 is the minimum and 7 the maximum value (except one question that has a 5 intervals of pourcentage, that will be adjusted on 7 items scale in the analysis). The higher score means better outcome.

4 secondary outcomes

Knowledge on aspects surrounding prenatal screening and SDM
Time frame: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Satisfaction with training: self-reported questionnaire
Time frame: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Acceptability of the training: self-reported questionnaire
Time frame: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Perceived usefulness
Time frame: After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.

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 11 Feb 2021.
Background: PubMed 23381520Legare F, Witteman HO. Shared decision making: examining key elements and barriers to adoption into routine clinical practice. Health Aff (Millwood). 2013 Feb;32(2):276-84. doi: 10.1377/hlthaff.2012.1078.
Background: PubMed 23759895Moulton B, Collins PA, Burns-Cox N, Coulter A. From informed consent to informed request: do we need a new gold standard? J R Soc Med. 2013 Oct;106(10):391-4. doi: 10.1177/0141076813490686. Epub 2013 Jun 6. No abstract available.
Background: PubMed 27009586Gray M, Jani A. Promoting Triple Value Healthcare in Countries with Universal Healthcare. Healthc Pap. 2016;15(3):42-8.
Background: PubMed 25351843Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making. 2015 Jan;35(1):114-31. doi: 10.1177/0272989X14551638. Epub 2014 Oct 28.
Background: PubMed 24470076Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
Background: PubMed 23381511Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
Background: PubMed 25222632Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
Background: PubMed 30025154Legare F, Adekpedjou R, Stacey D, Turcotte S, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2018 Jul 19;7(7):CD006732. doi: 10.1002/14651858.CD006732.pub4.
Background: PubMed 21268046Legare F, St-Jacques S, Gagnon S, Njoya M, Brisson M, Fremont P, Rousseau F. Prenatal screening for Down syndrome: a survey of willingness in women and family physicians to engage in shared decision-making. Prenat Diagn. 2011 Apr;31(4):319-26. doi: 10.1002/pd.2624. Epub 2011 Jan 26.
Background: PubMed 19097031St-Jacques S, Grenier S, Charland M, Forest JC, Rousseau F, Legare F. Decisional needs assessment regarding Down syndrome prenatal testing: a systematic review of the perceptions of women, their partners and health professionals. Prenat Diagn. 2008 Dec;28(13):1183-203. doi: 10.1002/pd.2059.
Background: PubMed 23451939Couet N, Desroches S, Robitaille H, Vaillancourt H, Leblanc A, Turcotte S, Elwyn G, Legare F. Assessments of the extent to which health-care providers involve patients in decision making: a systematic review of studies using the OPTION instrument. Health Expect. 2015 Aug;18(4):542-61. doi: 10.1111/hex.12054. Epub 2013 Mar 4.
Background: PubMed 17327891Legare F, O'Connor AC, Graham I, Saucier D, Cote L, Cauchon M, Pare L. Supporting patients facing difficult health care decisions: use of the Ottawa Decision Support Framework. Can Fam Physician. 2006 Apr;52(4):476-7.
Individual participant dataSharing planned: No

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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, PhD principal investigator

VITAM - Centre de recherche en santé durable

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 1 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 11 Feb 2021. 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. Some participants in this study may receive a placebo. 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?

Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening (time frame: The intention will be measured initially before accessing the formation. After the formation completed (duration is variable), the participant will have access to the questionnaire once again in a delay of 24-72 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04162288, which also lists 27 linked publications.

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 11 Feb 2021.