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Navigating the Grey Zone for Antenatal Corticosteroids

Primary Purpose

Decision Making, Shared, Pregnancy, Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Decision support tool
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Decision Making, Shared focused on measuring Antenatal corticosteroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Surrey Memorial HospitalRecruiting
  • BC Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Guideline + decision support tool

Guideline only

Arm Description

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.

Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool).

Outcomes

Primary Outcome Measures

The change in frequency of clinical counselling about late preterm antenatal corticosteroids.
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 Outcome Measures

The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.
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.

Full Information

First Posted
February 25, 2021
Last Updated
May 30, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04792112
Brief Title
Navigating the Grey Zone for Antenatal Corticosteroids
Official Title
Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decision Making, Shared, Pregnancy, Preterm Birth
Keywords
Antenatal corticosteroid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Controlled before and after study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guideline + decision support tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Guideline only
Arm Type
No Intervention
Arm Description
Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool).
Intervention Type
Behavioral
Intervention Name(s)
Decision support tool
Intervention Description
Decision support tool for late preterm antenatal corticosteroids
Primary Outcome Measure Information:
Title
The change in frequency of clinical counselling about late preterm antenatal corticosteroids.
Description
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.
Time Frame
up to 8 months following implementation of the intervention.
Secondary Outcome Measure Information:
Title
The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.
Description
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.
Time Frame
up to 8 months following implementation of the intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Liauw, MD
Phone
604-875-2424
Ext
5779
Email
jessica.liauw@phsa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Liauw, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Burrows
First Name & Middle Initial & Last Name & Degree
Jason Burrows, MD
Facility Name
BC Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Liauw, MD
Phone
604-875-2424
Ext
5779
Email
jessica.liauw@phsa.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Navigating the Grey Zone for Antenatal Corticosteroids

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