Decision Aid for Early Abortion
Trial Summary
What is the purpose of this trial?
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)
Research Team
Melissa Brooks
Principal Investigator
Dalhousie University
Eligibility Criteria
This trial is for English-speaking individuals of reproductive age in Canada who are within 63 days from their last menstrual period, seeking an early abortion, can give consent, and have internet access with a valid email. It excludes those who decide to continue the pregnancy or miscarry spontaneously.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Development of Knowledge Assessment Tool
Development of an abortion knowledge assessment tool with multiple choice questions to evaluate decision quality
Randomized Trial
Participants are randomized to either the decision aid or standard clinic website and complete a survey immediately after
Follow-up
Participants are contacted four weeks post-procedure to complete a survey on the type of abortion, perceived adverse effects, and satisfaction with decision
Treatment Details
Interventions
- Patient Decision Aid
Patient Decision Aid is already approved in United States, European Union, Canada for the following indications:
- Supporting decision-making in medullary thyroid cancer care
- Supporting decision-making in medullary thyroid cancer care
- Supporting decision-making in medullary thyroid cancer care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor
Melissa Brooks
Lead Sponsor
Dalhousie University
Collaborator
University of British Columbia
Collaborator
IWK Health Centre
Collaborator