NCT04097717

"My Decision" Tubal Sterilization Decision Support Tool

Completed NA Last updated 1 November 2024

What this trial tests

NA trial testing "My Decision" tubal sterilization decision aid in Tubal Sterilization in 549 participants. Completed in 30 April 2024.

Timeline

24 February 2020

Primary endpoint
6 January 2023

30 April 2024

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	549
Start date	24 February 2020
Primary completion	6 January 2023
Estimated completion	30 April 2024
Sites	2 locations across United States

Drugs / interventions tested

• "My Decision" tubal sterilization decision aid
• Usual Care

Conditions studied

• Tubal Sterilization — all drugs for Tubal Sterilization →
• Women's Health — all drugs for Women's Health →
• Contraception — all drugs for Contraception →
• Contraception Behavior — all drugs for Contraception Behavior →

Sponsor

University of Pittsburgh

Who can join

Adults 21 to 45, female only, with Tubal Sterilization or Women's Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study seeks to test a web-based decision support tool developed to enhance low-income women's ability to make informed decisions about tubal sterilization that align with their preferences, values and reproductive goals. Half of participants will receive usual care, while the other half will use the web-based decision aid plus usual care. The investigators hypothesize that compared to women who receive usual care alone, women randomized to the decision aid arm will have greater knowledge about sterilization and alternative options, lower decisional conflict, and will be more satisfied with their contraceptive decision at 3-month follow-up.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
2. A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women: The MyDecision/MiDecisión Randomized Clinical Trial.
   Borrero S, Mosley EA, Wu M, Dehlendorf C, et al · · 2024 · cited 7× · PMID 38502127 · DOI 10.1001/jamanetworkopen.2024.2215