Navigating the Grey Zone for Antenatal Corticosteroids

Study Overview
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Brief Summary
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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.

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

Conditions
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Decision Making, Shared, Pregnancy, Preterm Birth

Intervention / Treatment
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* Behavioral: Decision support tool


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Controlled before and after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guideline + decision support tool<br>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<br>* Decision support tool for late preterm antenatal corticosteroids<br>|
| No Intervention: Guideline only<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenatal corticosteroid