- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162288
Evaluating an Online Training Program on Shared Decision-making in Prenatal Screening
February 9, 2021 updated by: France Legare, CHU de Quebec-Universite Laval
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Quebec City, Quebec, Canada, G1R 2K2
- Leger
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online training on SDM in prenatal screening
|
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.
|
Placebo Comparator: Online training on prenatal screening
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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".
|
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.
|
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".
|
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.
|
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".
|
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.
|
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".
|
After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: France Légaré, PhD, VITAM - Centre de recherche en santé durable
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gray M, Jani A. Promoting Triple Value Healthcare in Countries with Universal Healthcare. Healthc Pap. 2016;15(3):42-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Leiva Portocarrero ME, Garvelink MM, Becerra Perez MM, Giguere A, Robitaille H, Wilson BJ, Rousseau F, Legare F. Decision aids that support decisions about prenatal testing for Down syndrome: an environmental scan. BMC Med Inform Decis Mak. 2015 Sep 24;15:76. doi: 10.1186/s12911-015-0199-6.
- Delanoe A, Lepine J, Turcotte S, Leiva Portocarrero ME, Robitaille H, Giguere AM, Wilson BJ, Witteman HO, Levesque I, Guillaumie L, Legare F. Role of Psychosocial Factors and Health Literacy in Pregnant Women's Intention to Use a Decision Aid for Down Syndrome Screening: A Theory-Based Web Survey. J Med Internet Res. 2016 Oct 28;18(10):e283. doi: 10.2196/jmir.6362.
- Delanoe A, Lepine J, Leiva Portocarrero ME, Robitaille H, Turcotte S, Levesque I, Wilson BJ, Giguere AM, Legare F. Health literacy in pregnant women facing prenatal screening may explain their intention to use a patient decision aid: a short report. BMC Res Notes. 2016 Jul 11;9:339. doi: 10.1186/s13104-016-2141-0.
- Portocarrero ME, Giguere AM, Lepine J, Garvelink MM, Robitaille H, Delanoe A, Levesque I, Wilson BJ, Rousseau F, Legare F. Use of a patient decision aid for prenatal screening for Down syndrome: what do pregnant women say? BMC Pregnancy Childbirth. 2017 Mar 20;17(1):90. doi: 10.1186/s12884-017-1273-0.
- WHO. Nine steps for developing a scaling-up strategy Geneva: World Health Organization; 2010. Available from: http://www.who.int/iris/handle/10665/44432.
- Legare F, Borduas F, Freitas A, Jacques A, Godin G, Luconi F, Grimshaw J; CPD-KT team. Development of a simple 12-item theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions. PLoS One. 2014 Mar 18;9(3):e91013. doi: 10.1371/journal.pone.0091013. eCollection 2014.
- Schmidt SW. The relationship between satisfaction with workplace training and overall job satisfaction. Human Resource Development Quarterly. 2007;18(4):481-98.
- Kasper J, Liethmann K, Heesen C, Reissmann DR, Geiger F. Training doctors briefly and in situ to involve their patients in making medical decisions-Preliminary testing of a newly developed module. Health Expect. 2017 Dec;20(6):1254-1263. doi: 10.1111/hex.12565. Epub 2017 May 18.
- Giangreco A, Sebastiano A, Peccei R. Trainees' reactions to training: an analysis of the factors affecting overall satisfaction with training. The international journal of human resource management. 2009;20(1):96-111.
- Kirkpatrick D, Kirkpatrick J. Evaluating Training Programs: The four levels. San Francisco, CA, USA: Berret-Koehler Publishers, Inc.; 2009
- Abbasgholizadeh Rahimi S, Lepine J, Croteau J, Robitaille H, Giguere AM, Wilson BJ, Rousseau F, Levesque I, Legare F. Psychosocial Factors of Health Professionals' Intention to Use a Decision Aid for Down Syndrome Screening: Cross-Sectional Quantitative Study. J Med Internet Res. 2018 Apr 25;20(4):e114. doi: 10.2196/jmir.9036.
- Poulin Herron A, Agbadje TT, Cote M, Djade CD, Roch G, Rousseau F, Legare F. Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 29;9(10):e17878. doi: 10.2196/17878.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
August 22, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MP-20-2019-4571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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