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

NCT04162288 | Completed

• 1 other identifier: MP-20-2019-4571
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shared Decision Making

Keywords

Shared Decision Making; Decision aid; Nurse; Online Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Knowledge on aspects surrounding prenatal screening and SDM

  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

  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

  After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.

• Perceived usefulness

  After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.

Study Arms (2)

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

Interventions

Online Training - Shared Decision Making in Prenatal Screening OTHER

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 on SDM in prenatal screening

Online Training - Online Training on Prenatal Screening OTHER

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.

Online training on prenatal screening

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Laval University: collaborator
• Genome Quebec: collaborator
• Genome Canada: collaborator
• CERSSPL: collaborator

Study Sites (1)

Leger

Québec, Quebec, G1R 2K2, Canada

Location

Related Publications (27)

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  PMID: 33118955 DERIVED

Study Officials

• France Légaré, PhD

  VITAM - Centre de recherche en santé durable

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: When a participant is randomised to the trial, the private firm will assign a trial group following a pre-selected list of randomisation (given by the private firm). The employee of the private firm will be the one non-blinded in our study, by giving participant access to one of the formation. The ''Care Provider'' is not present in this study; in fact, all interactions are via the private firm and is directed towards an online-intervention. A randomisation list will be kept by the private firm and send to the research team after the data analysis. The Investigator are blinded also by the randomisation process. There is no officially Outcomes Assessor, because the outcomes of interest are self-reported (intention of using a DA) or pre-measured (for example; with the knowledge test, rightful answer are already known).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: November 14, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)