Decision Making, Shared Clinical Trial
Official title:
Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor
This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who
are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether
a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean
delivery can improve the birth options decision-making process for patients.
Participants are screened for eligibility through electronic health records. Once an
individual is screened eligible, and email invite is sent providing information about the
study and assessing the interest in participation. An on-line consent is completed and women
are entered sequentially into the usual care group and then through further recruitment,
another sample of women are entered into the decision aid group. The primary outcome is
satisfaction with the shared decision-making process with their provider.
Once a potential participant is screened eligible, completes the on-line informed consent,
they are officially enrolled in the study and sent a link confirming their enrollment and the
study group in which they have been assigned. Participants are sequentially enrolled in the
study with enrollment first into the usual care group. Once enrollment in the usual care
group is complete, enrollment into the decision aid group will occur.
The study includes two non-randomized groups:
Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey
questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned
repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for
trial of labor (TOLAC) or repeat cesarean delivery.
Arm 2: (Decision aid group- group receiving the decision tool): Women in this group will
receive a decision aid prior to undergoing counseling by their physician. Following
completion of the decision aid and physician counseling, they will complete a series of
survey questions to assess their knowledge of the risks and benefits of TOLAC and PRCS,
certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.
The decision aid group will be compared with women who do not receive the decision aid (usual
care group).
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