Shared Decision MakingSDM-ConsentNCT07858084
Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery
An observational study of Shared Decision Making and Cesarean Section, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Shared Decision Making, Cesarean Section, Anesthesia, Obstetrical
- What is being tested?
- Observation of anesthesia consent encounter and postpartum questionnaire
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to 31 Dec 2027
- Phase
- Observational
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
- Capacity to consent to research participation
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perceived and Observed Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery: A Cross-Sectional Study
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.
Read the detailed description
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.
Design. 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.
Recruitment. 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.
Measures. Exposure: observer-classified offer of GA as a genuine primary option (yes/no). 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.
Sample 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.
Data. Data are held in the institutional BCCHR/PHSA-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.
- Being tested
- Observation of anesthesia consent encounter and postpartum questionnaire
- Keywords
- shared decision-making, anesthesia consent, cesarean delivery, general anesthesia, neuraxial anesthesia, SDM-Q-9, OPTION-5, patient-centred communication, obstetric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of anesthesia consent encounter and postpartum questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation of anesthesia consent encounter and postpartum questionnaire | |
| 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. Receives: Other: Observation of anesthesia consent encounter and postpartum questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 1 or 2
Secondary outcomes (5)
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.
Measured: Post-operative day 1 or 2
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.
Measured: Day of surgery, within 15 minutes of the consent encounter
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.
Measured: Day of surgery, at the consent encounter
Decisional conflict (Decisional Conflict Scale, 16-item)
DCS score by exposure group, reported descriptively (mean, 95% CI, proportion above 37.5, and floor proportion).
Measured: Post-operative day 1 or 2
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.
Measured: Post-operative day 1 or 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Shared Decision MakingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilana Sebbag, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858084
- Sponsor's protocol ID
- H26-02365
- Acronym
- SDM-Consent
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD). De-identified data may be made available if required by a journal as a condition of publication, subject to institutional, ethical, and privacy requirements.
Publications
Charles EA, Carter H, Stanford S, Blake L, Eley V, Carvalho B, Sultan P, Kua J, O'Carroll JE. Intraoperative Pain during Cesarean Delivery under Neuraxial Anesthesia: A Systematic Review and Meta-analysis. Anesthesiology. 2025 Jul 1;143(1):156-167. doi: 10.1097/ALN.0000000000005486. Epub 2025 Apr 4.
PubMed 40184602Guglielminotti J, Landau R, Li G. Adverse Events and Factors Associated with Potentially Avoidable Use of General Anesthesia in Cesarean Deliveries. Anesthesiology. 2019 Jun;130(6):912-922. doi: 10.1097/ALN.0000000000002629.
PubMed 30789362Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.
PubMed 38284415SOAP 2026 Centers of Excellence: Defining Excellence in Obstetric Anesthesia Care [Internet]. Milwaukee: Society for Obstetric Anesthesia and Perinatology; 2026 Jun 12 [cited 2026 Jun 26]. Available from: https://soap.memberclicks.net/assets/COE/2026Materials/RL4%20DG%20JM%20June%2012%20SOAP%20Centers%20of%20Excellence_%20Defining%20Excellence%20in%20Obstetric%20Anesthesia%20Care%20JM_GA_6.12.26.pdf
Heywood R. R.I.P. SIDAWAY: PATIENT-ORIENTED DISCLOSURE-A STANDARD WORTH WAITING FOR? Montgomery v Lanarkshire Health Board[2015] UKSC 11. Med Law Rev. 2015 Summer;23(3):455-66. doi: 10.1093/medlaw/fwv024. Epub 2015 May 28. No abstract available.
PubMed 26023076Reibl v Hughes [1980] 2 SCR 880 (SCC).
Hopp v Lepp [1980] 2 SCR 192 (SCC).
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.
PubMed 24275499Linder SK, Swank PR, Vernon SW, Mullen PD, Morgan RO, Volk RJ. Validity of a low literacy version of the Decisional Conflict Scale. Patient Educ Couns. 2011 Dec;85(3):521-4. doi: 10.1016/j.pec.2010.12.012. Epub 2011 Feb 5.
PubMed 21300518O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Stubenrouch FE, Mus EMK, Lut JW, Hesselink EM, Ubbink DT. The current level of shared decision-making in anesthesiology: an exploratory study. BMC Anesthesiol. 2017 Jul 12;17(1):95. doi: 10.1186/s12871-017-0386-3.
PubMed 28701156Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
PubMed 19879711Barr PJ, O'Malley AJ, Tsulukidze M, Gionfriddo MR, Montori V, Elwyn G. The psychometric properties of Observer OPTION(5), an observer measure of shared decision making. Patient Educ Couns. 2015 Aug;98(8):970-6. doi: 10.1016/j.pec.2015.04.010. Epub 2015 Apr 29.
PubMed 25956069Elwyn G, Tsulukidze M, Edwards A, Legare F, Newcombe R. Using a 'talk' model of shared decision making to propose an observation-based measure: Observer OPTION 5 Item. Patient Educ Couns. 2013 Nov;93(2):265-71. doi: 10.1016/j.pec.2013.08.005. Epub 2013 Aug 27.
PubMed 24029581