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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online training on SDM in prenatal screening
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.
Placebo Comparator: Online training on prenatal screening
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Quebec-Universite Laval

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laval University
Genome Canada
Genome Quebec
CERSSPL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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