Navigating the Grey Zone for Antenatal Corticosteroids

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2024

Interventions

  • Behavioral: Decision support tool
    • Decision support tool for late preterm antenatal corticosteroids

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jessica Liauw, Clinical Assistant Professor – University of British Columbia
  • Overall Official(s)
    • Jessica Liauw, MD, Principal Investigator, University of British Columbia
  • Overall Contact(s)
    • Jessica Liauw, MD, 604-875-2424, jessica.liauw@phsa.ca

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