Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia
About this trial
Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery. Neuraxial anesthesia is recommended for most cesarean deliveries, and many anesthesiologists therefore present it as the only primary option, with general anesthesia (GA) available only as a rescue. Others present GA as a genuine alternative the patient can choose. This study will observe the existing variation in practice and will not change care. A trained observer will attend the pre-operative anesthesia consent encounter for women having an elective cesarean delivery at BC Women's Hospital and record which options were presented, using the observer-rated OPTION-5 instrument. Written research consent and a questionnaire follow 24-48 hours after delivery, and include the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The primary aim is to compare patient-perceived SDM (SDM-Q-9) between consultations in which GA was offered as a genuine primary option and those in which it was not. This study hypothesizes that the SDM-Q-9 score will be higher when GA was offered as a primary option. Secondary aims are to describe observed SDM, decisional conflict, provider-level variation, and women's preference to be offered a choice in a future cesarean. The findings will inform a planned interventional trial of a standardized consent model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 19 years or older
Elective (scheduled) cesarean delivery at 37 weeks' gestation or later
Anesthesia consent obtained on the day of surgery
Anesthesia consent performed in English without an interpreter
Disqualifiers
Conversion to urgent/emergency cesarean delivery before consent is completed
Severe maternal or neonatal complication making participation inappropriate (assessed case by case with the clinical team)
Contraindication to neuraxial anesthesia
Patient declines observation pre-operatively, or declines or withdraws study consent postpartum
Trial population
Women aged 19 or older having an elective cesarean delivery at 37 weeks or later at BC Women's Hospital, with anesthesia consent obtained on the day of surgery.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Observation of anesthesia consent encounter and postpartum questionnaire
Other interventionA trained non-treating observer attends and rates the routine pre-operative anesthesia consent encounter (OPTION-5). The patient completes a questionnaire 24-48 hours postpartum (SDM-Q-9, Decisional Conflict Scale). No change to clinical care.
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: GA offered as a primary option1 intervention
Group B: Neuraxial only, GA as rescue1 intervention
Trial outcomes
Primary outcomes
1
Patient-perceived shared decision-making (SDM-Q-9 score)
Between-group difference in SDM-Q-9 total score (0-45), (higher = greater perceived involvement), between women whose consent included GA as a genuine primary option and those whose consent did not. Analysed with a linear mixed-effects model with a random intercept for consenting provider.
Time frame
Post-operative day 1 or 2Secondary outcomes
1
Proportion with adequate SDM-Q-9 score
Proportion of patients with an adequate 9-item Shared-Decision Making Score (SDM-Q-9,) score 0-45, transformed to a 0-100% scale, and using the top-box method to determine adequate (\>75%) vs inadequate (\<75%) scores, compared between exposure groups.
Time frame
Post-operative day 1 or 22
Observed shared decision-making (OPTION-5)
Observer-rated OPTION-5 score (0-20), with higher scores meaning higher observed levels of shared-decision making between provider and patient, overall and by exposure group, with concordance with the SDM-Q-9.
Time frame
Day of surgery, within 15 minutes of the consent encounter3
Provider variability in offering choice
Proportion of consultations in which a genuine primary choice was offered; between-provider variation (ICC); whether offers were provider-initiated or prompted by patient questions; disclosure elements delivered.
Time frame
Day of surgery, at the consent encounter4
Decisional conflict (Decisional Conflict Scale, 16-item)
DCS score by exposure group, reported descriptively (mean, 95% CI, proportion above 37.5, and floor proportion).
Time frame
Post-operative day 1 or 2Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: