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

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.

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

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.

Clinical Trials on Shared Decision Making

Clinical Trials on Online Training - Shared Decision Making in Prenatal Screening

Subscribe