Decision Aid for Early Abortion

Overseen By Melissa Brooks, MD FRCSC

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Advanced pregnancy, Medical contraindications, Miscarriage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals make informed decisions when choosing between surgical or medication abortion for early pregnancy termination in Canada. Researchers are testing an online interactive tool, called a decision aid (also known as the Patient Decision Aid), to determine if it improves decision-making compared to using a clinic's website alone. The trial includes those who are pregnant and seeking an abortion within the first 63 days, have internet access, and can read and speak English. Participants will complete surveys about their decision-making process and satisfaction. As an unphased study, this trial offers participants the chance to contribute to research that could enhance decision-making tools for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on decision-making for abortion methods rather than medication use.

What prior data suggests that this decision aid is safe for patients seeking early abortion?

Research has shown that tools like the one being tested are generally safe. These tools assist people in making informed health choices. They provide information but are not treatments, so they lack the physical risks associated with drugs or medical procedures.

For this specific tool, no evidence of harm exists. Studies indicate that such tools enhance decision-making without causing negative effects. They help people better understand their options and make choices aligned with their personal values. In summary, this tool is expected to be safe, focusing on improving decision quality without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for early abortion because it provides an innovative approach to patient decision-making. Unlike standard care options that typically involve in-person consultations at clinics, this tool offers an online interactive experience, empowering patients to make informed choices from the comfort of their homes. This method could enhance accessibility and autonomy for patients, potentially leading to more personalized and satisfactory healthcare decisions.

What evidence suggests that this decision aid is effective for improving decisional quality in early abortion?

Research has shown that tools called patient decision aids (PtDAs) can help people make better decisions when considering an abortion. These tools assist individuals in choosing what best fits their personal values and needs. In this trial, participants in the "Decision Aid" arm will use an online interactive decision aid tool. Studies have found that using a PtDA can reduce uncertainty and increase satisfaction with the decision. These tools are especially helpful in ensuring decisions are informed and align with personal values. This approach helps people feel more confident and satisfied with their choices about abortion methods. ^{1 2 3 4 6}

Who Is on the Research Team?

Melissa Brooks

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

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

I am within 9 weeks from my last period for a medication abortion.

Can provide consent

Has access to internet and a valid email address

Exclusion Criteria

If they miscarry spontaneously

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)

I have decided to continue with my pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Development of Knowledge Assessment Tool

Development of an abortion knowledge assessment tool with multiple choice questions to evaluate decision quality

Not specified

Randomized Trial

Participants are randomized to either the decision aid or standard clinic website and complete a survey immediately after

Immediately after intervention

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

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Decision Aid

Trial Overview The study tests an online decision aid designed to help patients choose between surgical or medication abortion against usual care provided by clinic websites. Participants will be randomly assigned to either option and surveyed on their knowledge and satisfaction with their decision.

How Is the Trial Designed?

Group I: Decision Aid Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

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

Patient Decision Aid is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Patient Decision Aid for:

• Supporting decision-making in medullary thyroid cancer care

Approved in European Union as Patient Decision Aid for:

• Supporting decision-making in medullary thyroid cancer care

Approved in Canada as Patient Decision Aid for:

• Supporting decision-making in medullary thyroid cancer care

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Melissa Brooks

Lead Sponsor

Trials

1

Recruited

370+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11061794/

User-Centered Development of a Patient Decision Aid for ... Among the 4 (16%) patient participants who felt information was missing, the most common suggestion was a tool for locating an abortion health care professional ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38625731/

User-Centered Development of a Patient Decision Aid for ... We systematically designed the PtDA to address an unmet need to support informed, values-aligned decision-making about the method of abortion.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772628223000833

Development of My Decision/Mi Decisión, a web-based ... My Decision/Mi Decisión is a novel, patient-facing decision tool that supports postpartum tubal sterilization decision making. To the best of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1049386718302536

Promoting or Undermining Quality Decision Making? A ... We recommend adapting an existing decision aid or designing a novel tool based on the content and language that women find most acceptable. ... effectiveness of ...

5. researchgate.net researchgate.net/figure/Decision-aid-for-early-medical-abortion-without-ultrasound-adapted-with-permission-from_fig2_349430567

Decision aid for early medical abortion without ultrasound ... Decision aid for early medical abortion without ultrasound (adapted with permission from RCOG Coronavirus (COVID‐19) infection and abortion care – information ...

6. decisionaid.ohri.ca decisionaid.ohri.ca/docs/develop/Cochrane_Review.pdf

Cochrane - Patient Decision Aids ... outcome data, and assessed risk of bias using the Cochrane risk of bias tool. Primary outcomes, based on the International Patient Decision Aid ...