[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658859":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":37,"interventions":47,"overallOfficials":31,"centralContacts":52,"locations":58,"responsibleParty":72,"collaborators":31,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":31,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":31,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":106,"whyStopped":31,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of British Columbia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Post-operative day 1 or 2",[14,17,21,25,28],{"measure":15,"description":16,"timeFrame":12},"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 (\\\u003C75%) scores, compared between exposure groups.",{"measure":18,"description":19,"timeFrame":20},"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.","Day of surgery, within 15 minutes of the consent encounter",{"measure":22,"description":23,"timeFrame":24},"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.","Day of surgery, at the consent encounter",{"measure":26,"description":27,"timeFrame":12},"Decisional conflict (Decisional Conflict Scale, 16-item)","DCS score by exposure group, reported descriptively (mean, 95% CI, proportion above 37.5, and floor proportion).",{"measure":29,"description":30,"timeFrame":12},"Preference for future choice","Proportion of women who would want to be offered a choice between neuraxial and general anesthesia in a future cesarean, overall and by exposure group and technique received.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","CROSS_SECTIONAL","Background. SDM, in which the clinician contributes evidence and the patient contributes values and preferences, is the ethical and increasingly the legal standard of consent (Hopp v Lepp; Reibl v Hughes; Montgomery v Lanarkshire). Major guidelines recommend neuraxial anesthesia for cesarean delivery because of the higher maternal risk of GA, and the SOAP Center of Excellence benchmark is a GA rate below 5%. Choice of technique is nevertheless preference-sensitive (being awake or asleep at the birth, partner presence, fear of needles or of awareness, prior trauma), and GA is routinely delivered when clinically required. Neuraxial block fails in about 5% of cesarean deliveries and intraoperative pain occurs in roughly 11-22%, a leading cause of maternal dissatisfaction and medicolegal action. The institutional consent discloses these risks. What varies between providers is choice: some present GA as a genuine primary option alongside neuraxial anesthesia, while others present neuraxial as the sole primary technique with GA only as rescue. A departmental poll found that 6 of 21 anesthesiologists (29%) report offering GA as a primary option. It is unknown whether offering GA as a genuine primary option affects women's perception of SDM.\n\nDesign. Single-centre, prospective, cross-sectional study at BC Women's Hospital, Vancouver. It combines (a) structured direct observation of the pre-operative anesthesia consent encounter and (b) a patient questionnaire on the 1st or 2nd postpartum day. No change is made to clinical care or to the consent process; existing variation in practice is the exposure. Because the anesthesiologist is assigned by the duty rota, women are quasi-randomly exposed to consent with or without a genuine primary choice.\n\nRecruitment. A member of the circle of care (admitting nurse) asks the patient on the day of surgery whether they are willing to be approached. Only if they agree does a trained observer introduce the study and seek verbal assent to observation. Written informed consent is obtained 24-48 hours postpartum by a trained research assistant who is not the observer. The clinical anesthesia consent (routine care, observed) and the research consent (written, not observed) are separate processes. Providers receive an individual information sheet with an opt-out, and no per-case feedback is given. The specific exposure of interest is withheld from providers until study end; providers are not deceived about being observed.\n\nMeasures. Exposure: observer-classified offer of GA as a genuine primary option (yes\u002Fno). Observed SDM: OPTION-5, with at least 10% double-rated. Perceived SDM: SDM-Q-9 (primary outcome). Decisional conflict: Decisional Conflict Scale, descriptive. Future-choice preference. Covariates: age, parity, prior cesarean, prior anesthesia experience, education, gestational age, technique received, consultation duration.\n\nSample size and analysis. The primary analysis is a linear mixed-effects model with a random intercept for consenting provider, adjusted for covariates, reporting the adjusted mean difference with its 95% CI and the provider-level ICC. Assuming SD 12.4, alpha 0.05, a difference of 13.5 points, and ICC 0.10, 84 analyzable patients (4 per provider across 21 providers) give 97.7% power. Allowing about 20% attrition, the recruitment target is 105. A blinded biostatistician check of ICC, exposure split and SD after the first 105 patients will verify power; any increase in sample size will be submitted to the REB as an amendment. Reporting follows STROBE.\n\nData. Data are held in the institutional BCCHR\u002FPHSA-hosted REDCap instance, keyed by study ID, with the re-identification key stored separately. Records are retained for 5 years after study completion and publication.","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.",[38,43],{"label":39,"type":31,"description":40,"interventionNames":41},"GA offered as a primary option","Women whose observed pre-operative anesthesia consent presented general anesthesia as a genuine primary option the patient could choose, alongside neuraxial anesthesia. Classified per consultation by the trained observer.",[42],"Other: Observation of anesthesia consent encounter and postpartum questionnaire",{"label":44,"type":31,"description":45,"interventionNames":46},"Neuraxial only, GA as rescue","Women whose observed pre-operative anesthesia consent presented neuraxial anesthesia as the sole primary technique, with general anesthesia available only as a rescue.",[42],[48],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"Observation of anesthesia consent encounter and postpartum questionnaire","A 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.",[39,44],[53],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Ilana Sebbag, MD","CONTACT","604-875-2185","ilana.sebbag@cw.bc.ca",[59],{"facility":60,"status":31,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":31},"BC Women's Hospital","Vancouver","British Columbia","V6H 3N1","Canada","CA",{"type":67,"coordinates":68},"Point",[69,70],-123.11934,49.24966,{"lat":70,"lon":69},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Ilana Sebbag","Clinical Associate Professor","100658859","shared-decision-making-during-anesthesia-consent-for-elective-cesarean-delivery-100658859",false,"NCT07858084","Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery","Perceived and Observed Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery: A Cross-Sectional Study","SDM-Consent","Inclusion Criteria:\n\n* Age 19 years or older\n* Elective (scheduled) cesarean delivery at 37 weeks' gestation or later\n* Anesthesia consent obtained on the day of surgery\n* Anesthesia consent performed in English without an interpreter\n* Capacity to consent to research participation\n\nExclusion Criteria:\n\n* Conversion to urgent\u002Femergency cesarean delivery before consent is completed\n* Severe maternal or neonatal complication making participation inappropriate (assessed case by case with the clinical team)\n* Contraindication to neuraxial anesthesia\n* Patient declines observation pre-operatively, or declines or withdraws study consent postpartum","FEMALE","19 Years",{"count":87,"type":88},105,"ESTIMATED","OBSERVATIONAL","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.",[92,93,94,95],"Shared Decision Making","Cesarean Section","Anesthesia, Obstetrical","Informed Consent",[97,98,99,100,101,102,103,104,105],"shared decision-making","anesthesia consent","cesarean delivery","general anesthesia","neuraxial anesthesia","SDM-Q-9","OPTION-5","patient-centred communication","obstetric anesthesia","NOT_YET_RECRUITING","2026-10-05",{"date":109,"type":110},"2026-10-08","ACTUAL",{"date":112,"type":88},"2026-10",{"date":114,"type":88},"2027-12-31",{"name":5,"class":6},1]