A Patient Decision Aid for Method of Early Abortion: a Randomized Control 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)

Conditions

• Abortion in First Trimester
• Abortion Early
• Decision Aid
• Clinical Decision-making
• Abortion, Therapeutic

Interventions

OTHER

Decision aid

Online interactive decision aid on method of early abortion

OTHER

Usual care

Patients will be directed to the abortion clinic website

Sponsors & Collaborators

• Dalhousie University

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Melissa Brooks · Dalhousie University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-05

Primary Completion

2024-03-01

Completion

2024-04-01

Countries

• Canada

Study Locations