Decision Making, SharedNCT04792112
Navigating the Grey Zone for Antenatal Corticosteroids
A study testing Decision support tool in people with Decision Making, Shared and Pregnancy, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Decision Making, Shared, Pregnancy, Preterm Birth
- What is being tested?
- Decision support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesCanada
- Study dates
- 20 May 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
Jason Burrows
Jason Burrows, MD
- Recruiting
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1
Jessica Liauw, MD, 604-875-2424 ext. 5779, jessica.liauw@phsa.ca
About this study
Official title: 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.
- Conditions
- Decision Making, Shared, Pregnancy, Preterm Birth
- Being tested
- Decision support tool
- Keywords
- Antenatal corticosteroid
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision support toolBehavioural
Decision support tool for late preterm antenatal corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Guideline + decision support tool | Experimental | 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. Receives: Behavioral: Decision support tool |
| Guideline only | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 months following implementation of the intervention.
Secondary outcomes (1)
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.
Measured: up to 8 months following implementation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start20 May 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision Making, SharedStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled before and after study
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jessica Liauw, University of British Columbia
- Investigators
- Jessica Liauw, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792112
- Sponsor's protocol ID
- H20-03071
- Status last verified
- May 2022
- First submitted
- 25 Feb 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits
- ClinicalTrials.gov ID
- NCT04792112
- Acronym / sponsor ID
- H20-03071
- Conditions
- Decision Making, Shared, Pregnancy, Preterm Birth
- Keywords
- Antenatal corticosteroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled before and after study
| Arm | Type | Receives |
|---|---|---|
| Guideline + decision support tool | Experimental | Behavioral: Decision support toolA 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. |
| Guideline only | No intervention | –Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision support toolDecision support tool for late preterm antenatal corticosteroids | Behavioural | Guideline + decision support tool |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Liauw, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision support tool in people with Decision Making, Shared and Pregnancy, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Liauw, MD (604-875-2424 ext. 5779, jessica.liauw@phsa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in frequency of clinical counselling about late preterm antenatal corticosteroids. (time frame: up to 8 months following implementation of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 29 Oct 2026.