Navigating the Grey Zone for Antenatal Corticosteroids

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04792112

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

460

Enrollment

Locations

Arms

20.4

Anticipated Duration (Months)

230

Patients Per Site

11.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Decision Making, Shared Pregnancy Preterm Birth	Behavioral: Decision support tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

460 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Controlled before and after studyControlled before and after study

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surrey Memorial Hospital	Surrey	British Columbia	Canada	V3V 1Z2
2	BC Women's Hospital	Vancouver	British Columbia	Canada	V6H 3N1

Sponsors and Collaborators

University of British Columbia
Canadian Institutes of Health Research (CIHR)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessica Liauw, Clinical Assistant Professor, University of British Columbia

ClinicalTrials.gov Identifier:

NCT04792112

Other Study ID Numbers:

H20-03071

First Posted:

Mar 10, 2021

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jessica Liauw, Clinical Assistant Professor, University of British Columbia

Antenatal corticosteroid

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jun 2, 2022