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

NCT05182008 | Completed

• 1 other identifier: NSHA43377
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Abortion; Decision aid

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Score

  The DCS consists of 16 statements that participants rate from "strongly agree" \[0\] to "strongly disagree" \[4\]; scores are summed, divided by 16, and multiplied by 25 (for a score out of 100). High scores indicate greater decisional conflict.

  Immediately after use of intervention (decision aid) or usual care condition (clinic website)

Secondary Outcomes (3)

• Satisfaction with decision score (SWD)

  4 weeks after enrolment (after abortion complete)

• Decision concordance

  4 weeks after enrolment (after abortion complete)

• Knowledge of abortion method score

  Immediately after use of intervention (decision aid) or usual care condition (clinic website)

Other Outcomes (1)

• Correlation between SWD scores and patient reported side effects

  4 weeks after enrolment (after abortion complete)

Study Arms (2)

Decision Aid

EXPERIMENTAL

Patients will be guided to an online interactive decision aid tool.

Other: Decision aid

Usual Care

ACTIVE COMPARATOR

Patients will be guided to visit the clinic website of the Nova Scotia Women's Choice Clinic.

Other: Usual care

Interventions

Decision aid OTHER

Online interactive decision aid on method of early abortion

Decision Aid

Usual care OTHER

Patients will be directed to the abortion clinic website

Usual Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• person of reproductive age seeking termination of pregnancy, felt to be within the eligible period for a medication abortion (\<9 weeks or 63 days from last menstrual period), can provide consent, has access to internet and a valid email address and be able to read and speak English.

You may not qualify if:

• Participants will be excluded from the four week follow up survey if they are subsequently found to be ineligible for medication abortion (pregnancy too advanced or if there are medical contraindications), if they miscarry spontaneously, or choose to continue their pregnancy.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator
• University of British Columbia: collaborator
• IWK Health Centre: collaborator

Study Sites (1)

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Melissa Brooks

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obgyn

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 10, 2022
• Study Start: May 5, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CA (1)