Navigating the Grey Zone for Antenatal Corticosteroids

May 30, 2022 updated by: Jessica Liauw, University of British Columbia

Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits

The purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

460

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 Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Recruiting
        • Surrey Memorial Hospital
        • Contact:
          • Jason Burrows
        • Principal Investigator:
          • Jason Burrows, MD
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • BC Women's Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 year or older.
  • Delivered a live neonate at 34+0 to 36+6 weeks of gestation.
  • Speaks English.
  • Agrees to participate in the questionnaire during their first week post-partum.
  • Delivered at one of the six participating obstetrical hospitals.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guideline + decision support tool
A decision support tool summarizing harms and benefits of late preterm antenatal corticosteroids will be integrated into the clinical practice guideline available to clinicians in the hospitals in the experimental arm.
Behavioral: Decision support tool
Decision support tool for late preterm antenatal corticosteroids
No Intervention: Guideline only
Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in frequency of clinical counselling about late preterm antenatal corticosteroids.
Time Frame: up to 8 months following implementation of the intervention.
The difference in the proportion of patients who delivered a neonate at 34+0 to 36+6 weeks' gestation who report having had a discussion about antenatal corticosteroids with their care provider pre-intervention versus post-intervention.
up to 8 months following implementation of the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.
Time Frame: up to 8 months following implementation of the intervention.
The difference in the average median score on the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) scale, among those that report having had a discussion about late preterm antenatal corticosteroids with their health care provider. We will use an adapted scale including 19 items, each of which are scored on a 5-point Likert scale. A higher score indicates better risk communication and treatment decision making effectiveness.
up to 8 months following implementation of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Jessica Liauw, MD, University of British Columbia

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)

May 20, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-03071

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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