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

Shared Decision Making Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162288
• Other study ID #: MP-20-2019-4571
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2021
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Shared Decision Making

Intervention

Other:
• Online Training - Shared Decision Making 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.
• Online Training - 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.

Locations

Country	Name	City	State
Canada	Leger	Quebec City	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	CERSSPL, Genome Canada, Genome Quebec, Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (26)

Abbasgholizadeh Rahimi S, Lépine J, Croteau J, Robitaille H, Giguere AM, Wilson BJ, Rousseau F, Lévesque I, Légaré 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. — View Citation

Couët N, Desroches S, Robitaille H, Vaillancourt H, Leblanc A, Turcotte S, Elwyn G, Légaré 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. Review. — View Citation

Delanoë A, Lépine J, Leiva Portocarrero ME, Robitaille H, Turcotte S, Lévesque I, Wilson BJ, Giguère AM, Légaré 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. — View Citation

Delanoë A, Lépine J, Turcotte S, Leiva Portocarrero ME, Robitaille H, Giguère AM, Wilson BJ, Witteman HO, Lévesque I, Guillaumie L, Légaré 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. — View Citation

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.

Gray M, Jani A. Promoting Triple Value Healthcare in Countries with Universal Healthcare. Healthc Pap. 2016;15(3):42-8. — View Citation

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. Review. — View Citation

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. — View Citation

Kirkpatrick D, Kirkpatrick J. Evaluating Training Programs: The four levels. San Francisco, CA, USA: Berret-Koehler Publishers, Inc.; 2009

Légaré 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:CD006732. doi: 10.1002/14651858.CD006732.pub4. Review. — View Citation

Légaré 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. — View Citation

Légaré F, O'Connor AC, Graham I, Saucier D, Côté L, Cauchon M, Paré L. Supporting patients facing difficult health care decisions: use of the Ottawa Decision Support Framework. Can Fam Physician. 2006 Apr;52:476-7. — View Citation

Légaré F, Ratté 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. Review. — View Citation

Légaré F, St-Jacques S, Gagnon S, Njoya M, Brisson M, Frémont 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. — View Citation

Légaré F, Stacey D, Brière N, Fraser K, Desroches S, Dumont S, Sales A, Puma C, Aubé 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. — View Citation

Légaré 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. Review. Update in: Cochrane Database Syst Rev. 2018 Jul 19;7:CD006732. — View Citation

Légaré 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. Review. — View Citation

Leiva Portocarrero ME, Garvelink MM, Becerra Perez MM, Giguère A, Robitaille H, Wilson BJ, Rousseau F, Légaré 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. — View Citation

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. — View Citation

Portocarrero ME, Giguère AM, Lépine J, Garvelink MM, Robitaille H, Delanoë A, Lévesque I, Wilson BJ, Rousseau F, Légaré 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. — View Citation

Schmidt SW. The relationship between satisfaction with workplace training and overall job satisfaction. Human Resource Development Quarterly. 2007;18(4):481-98.

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. Review. — View Citation

St-Jacques S, Grenier S, Charland M, Forest JC, Rousseau F, Légaré 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. Review. — View Citation

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. — View Citation

Stacey D, Légaré 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. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431. — View Citation

WHO. Nine steps for developing a scaling-up strategy Geneva: World Health Organization; 2010. Available from: http://www.who.int/iris/handle/10665/44432.

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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".	After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Secondary	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".	After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Secondary	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".	After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.
Secondary	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".	After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.

External Links

•   Website about PEGASUS (PErsonalized Genomics for prenatal Abnormalities Screening USing maternal blood : Towards First Tier Screening and Beyond)