"My Decision" Tubal Sterilization Decision Support Tool

NCT04097717 | Completed

• 2 other identifiers: STUDY20110382R01MD011678-01
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tubal Sterilization; Women's Health; Contraception; Contraception Behavior; Reproductive Behavior

Keywords

Tubal Ligation; Decision Aid

Outcome Measures

Primary Outcomes (2)

• Participant Knowledge about Tubal Sterilization

  Participant responses to 10 True/False items adapted from previously published studies of tubal sterilization knowledge and informed by in-depth interviews with women about sterilization decision making. Items assess knowledge about tubal sterilization and alternative contraception options and will be coded as correct vs. incorrect, with "Don't Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.

  Less than 24 weeks gestation (Time 1)

• Participant Decisional Conflict in Postpartum Contraceptive Choice

  Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  Less than 24 weeks gestation (Time 1)

Secondary Outcomes (2)

• Contraceptive Method Selected

  Less than 24 weeks gestation (Time 1)

• Participant Satisfaction with Decision Making

  Three months postpartum (Time 3)

Other Outcomes (12)

• Participant Knowledge about Tubal Sterilization

  32-36 weeks gestation (Time 2)

• Participant Decisional Conflict in Postpartum Contraceptive Choice

  32-36 weeks gestation (Time 2)

• Contraceptive Method Selected

  32-36 weeks gestation (Time 2)

Study Arms (2)

Decision Aid Arm

EXPERIMENTAL

Participants will use the web-based decision aid plus usual medical care.

Behavioral: "My Decision" tubal sterilization decision aid; Other: Usual Care

Usual Care Arm

OTHER

Participants will receive usual medical care.

Other: Usual Care

Interventions

"My Decision" tubal sterilization decision aid BEHAVIORAL

The "My Decision" tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization.

Decision Aid Arm

Usual Care OTHER

Usual medical care will vary among participants.

Decision Aid Arm; Usual Care Arm

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Male and Trans Male participants will not be eligible for participation in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• years of age
• Fluently speak English or Spanish
• Fluently read English or Spanish
• Considering tubal sterilization
• \< 24 weeks gestation
• Continuing current pregnancy
• Using Medicaid insurance

You may not qualify if:

• Unable to consent to study participation
• Unable to interact with the content of the web-based decision aid

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Tennessee: collaborator
• University of California, San Francisco: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Borrero S, Mosley EA, Wu M, Dehlendorf C, Wright C, Abebe KZ, Zite N. A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women: The MyDecision/MiDecision Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242215. doi: 10.1001/jamanetworkopen.2024.2215.

  PMID: 38502127 DERIVED

MeSH Terms

Conditions

Contraception Behavior; Reproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sonya Borrero, MD MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Elizabeth Mosley, PhD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This study is a randomized controlled trial in which participants will be assigned to one of two groups (intervention arm or usual care arm) in parallel for the duration of the study. All participants will be asked to complete assessments at three separate time points \[immediately after using the decision aid (for those in the intervention arm) when participants are less than 24 weeks gestation (Time 1); in the 3rd trimester between 32-36 weeks gestation (Time 2); and three months postpartum (Time 3)\].

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: February 24, 2020
• Primary Completion: January 6, 2023
• Study Completion: April 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Publication of results will occur upon completion of the study.
• Access Criteria: De-identified participant data will be used for publication.

Locations

US (2)