Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05182008 |
| Other study ID # |
NSHA43377 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2022 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
Melissa Brooks, MD FRCSC |
| Phone |
902-470-6726 |
| Email |
melissa.brooks[@]iwk.nshealth.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: There are two options for women seeking early pregnancy termination in Canada;
either surgical or medication abortion. When making a decision about which option is best for
them, patient must consider their values as well as social resources and circumstances
Patient decision aids (PtDAs) are tools to help patients make health-related decisions,
particularly when no 'best' choice exist.
Our research team has developed an online interactive patient decision aid on method of
abortion based on international standards for decision aid development. We would like to
investigate whether it leads to improved decisional quality in patients seeking early
abortion.
Methods: Phase 1 will be development of an abortion knowledge assessment tool. We will start
by developing ten multiple choice questions based on information that is classically included
in abortion education material. The goal is to ultimately include 5-7 well-performing
questions in the trial. The ten questions will be sent to content experts to answer and rate.
They will rate the questions on representativeness and importance. The questions will also be
administered to community members without specific abortion knowledge. Results will be used
to assess content validity and discriminator validity and revise the questionnaire.
Phase 2 will be a randomized trial of people seeking abortion at less than 63 days gestation.
Those who wish to participate will be randomized either the decision aid (study group) or the
standard abortion clinic website (control). They will then be asked to participate in a
survey immediately after they are finished reviewing the decision aid or website to. This
survey will include questions about their decision, demographics, medical history, and their
level of knowledge about abortion methods (by administering the knowledge assessment tool
described above). The evaluation of the decision making will be measured using the Decisional
Conflict Score. Four weeks post procedure, participants will be contacted by e-mail again and
asked to complete a second survey identifying which type of abortion they underwent along
with an inventory of perceived adverse treatment effects, as well as completing a
Satisfaction with Decision Scale (SWD)
Description:
There are two options for women seeking early pregnancy termination in Canada; either
surgical or medication abortion. Each offers unique benefits and drawback. When making a
decision about which option is best for them, patient must consider their values as well as
social resources and circumstances. These decisions must be made quickly because of the time
sensitive nature of abortion. Research has shown that people seeking abortion value making an
informed decision on method.
Patient decision aids (PtDAs) are tools to help patients make health-related decisions,
particularly when no 'best' choice exist. Research shows that in comparison to usual care,
decision aids have been shown to improve patient knowledge and risk perception, reduce
decisional conflict, and promote shared decision making and value-congruent decisions (i.e.
decisions that are in alignment with the patients stated values and priorities) Our research
team has developed an online interactive patient decision aid on method of abortion based on
international standards for decision aid development. We would like to investigate whether it
leads to improved decisional quality in patients seeking early abortion.
Phase 1 will be development of an abortion knowledge assessment tool. This tool will be used
in Phase 2 of the study to evaluate decision quality. We will start by developing ten
multiple choice questions based on information that is classically included in abortion
education material. The goal is to ultimately include 5-7 well-performing questions in the
trial. The ten questions will be sent to content experts to answer and rate. They will rate
the questions on representativeness (Overall how well does this question represent key facts
that a patient should know before deciding about abortion method?) and importance (How
important is this question for patients to understand to be considered informed?). The
questions will also be administered to community members without specific abortion knowledge.
Based on data from these surveys the questions will be revised. To ensure content validity,
only questions the experts rate as sufficiently representative and important will be
included. Discriminant validity will be evaluated by comparing the scores of content experts
to those of community members. Only questions with adequate discriminant validity will be
included. Content experts will be persons known to the primary investigator and will be
recruited directly. Community members will be recruited online though social media (eg.
Facebook). Both content experts and community members will complete an online consent form
and online survey.
Phase 2 of the study will be integrated into the standard workflow of the Nova Scotia Women's
Clinic. Patients are able to self refer to the clinic and during the initial intake phone
call, they will be asked if they can be contacted by the research coordinator to discuss
study participation. Those who agree will be contacted by the research coordinator to review
the study and patients will be ask if they would like to participate in the they study. Those
who wish to participate will be randomized and e-mailed a weblink to an online consent form
and either the decision aid (study group) or the standard NSWCC website (control).
Participants will be randomized in a 1:1 ratio within blocks of size 2, 4, and 6 (in random
order). To further ensure the randomization is concealed, a statistician who is not on the
study team will generate the sequence using the R package, blockrand. They will then be asked
to participate in a survey immediately after they are finished reviewing the decision aid or
website to. This survey will include questions about their decision, demographic information,
medical history,and their level of knowledge about abortion methods (by administering the
knowledge assessment tool described above). The evaluation of the decision making will be
measured using the Decisional Conflict Score, which measures the quality of the decision
making process and consist of question for which patients rate their experiences on a scale
of strongly agree or disagree. Four weeks post procedure, participants will be contacted by
e-mail again and asked to complete a second survey identifying which type of abortion they
underwent along with an inventory of perceived adverse treatment effects, as well as
completing a Satisfaction with Decision Scale (SWD)
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