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"My Decision" Tubal Sterilization Decision Support Tool

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ClinicalTrials.gov Identifier: NCT04097717
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
University of Tennessee
University of California, San Francisco
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Sonya Borrero, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 19, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 6, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Participant Knowledge about Tubal Sterilization [ Time Frame: Less than 24 weeks gestation (Time 1) ]
    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%.
  • Participant Decisional Conflict in Postpartum Contraceptive Choice [ Time Frame: Less than 24 weeks gestation (Time 1) ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Difference in sterilization knowledge scores [ Time Frame: Less than 24 weeks gestation; 32-36 weeks gestation ]
    Assessed by participant-reported responses to 10 true/false items that measure tubal sterilization and alternative contraceptive options.
  • Difference in decisional conflict scores [ Time Frame: Less than 24 weeks getation; 32-36 weeks gestation ]
    Assessed by the 10-item low literacy version of the validated Decisional Conflict Scale (DSC) to assess certainty about method choice
Change History Complete list of historical versions of study NCT04097717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Contraceptive Method Selected [ Time Frame: Less than 24 weeks gestation (Time 1) ]
    Will determine the proportion of women who select sterilization versus another method of contraception at Time 1. Assessed by participant responses to an item asking which contraceptive method they are planning to use after delivery.
  • Participant Satisfaction with Decision Making [ Time Frame: Three months postpartum (Time 3) ]
    Assessed by participant responses to the Satisfaction with Decision Scale (SWD), a validated 6-item scale measuring participants' satisfaction with healthcare decision making. The SWD uses a 5-point Likert scale where 1 is "Strongly Disagree" and 5 is "Strongly Agree." A summary score is calculated as an average of all items with a range of 1-5, with a higher score reflecting a higher level of satisfaction with the decision.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Number of participants who select tubal sterilization [ Time Frame: Three months postpartum ]
    Assessed by multiple choice and open-ended response options.
  • Number of participants who select a form of contraception other than tubal sterilization [ Time Frame: Three months postpartum ]
    Assessed by multiple choice and open-ended response options.
  • Participant Satisfaction with Decision Making [ Time Frame: Three months postpartum ]
    Assessed by the validated Satisfaction with Decision Scale.
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2019)
  • Participant Knowledge about Tubal Sterilization [ Time Frame: 32-36 weeks gestation (Time 2) ]
    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%. Participant knowledge will be measured at Time 2 to assess the sustained impact of the decision aid on knowledge.
  • Participant Decisional Conflict in Postpartum Contraceptive Choice [ Time Frame: 32-36 weeks gestation (Time 2) ]
    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). Decisional conflict will be measured at Time 2 to assess the sustained impact of the decision aid on decisional conflict.
  • Contraceptive Method Selected [ Time Frame: 32-36 weeks gestation (Time 2) ]
    Will determine the proportion of women who select sterilization versus another method of contraception at Time 2. Assessed by participant responses to an item asking which contraceptive method they are planning to use after delivery.
  • Contraceptive Method(s) Used [ Time Frame: Three months postpartum (Time 3) ]
    Assessed by participant responses to a multiple choice item asking which methods of contraception they have used or received since their pregnancy ended.
  • Ease in Contraceptive Decision Making [ Time Frame: Less than 24 weeks gestation (Time 1) ]
    Assessed by participant responses to a 10 point scale about ease of decision making with regards to contraceptive method selection. Response options range from 0 ("Strongly Disagree" that this is an easy decision to make) to 10 ("Strongly Agree" that this an easy decision to make").
  • Ease in Contraceptive Decision Making [ Time Frame: 32-36 weeks gestation (Time 2) ]
    Assessed by participant responses to a 10 point scale about ease of decision making with regards to contraceptive method selection. Response options range from 0 ("Strongly Disagree" that this is an easy decision to make) to 10 ("Strongly Agree" that this an easy decision to make").
  • Certainty about Tubal Sterilization Decision [ Time Frame: Less than 24 weeks gestation (Time 1) ]
    Assessed by participant responses to a 10 point scale indicating certainty in desire to obtain or not obtain a tubal sterilization. Response options range from 0 ("Very Certain that I Do Not Want") to 10 ("Very Certain that I Do Want").
  • Certainty about Tubal Sterilization Decision [ Time Frame: 32-36 weeks gestation (Time 2) ]
    Assessed by participant responses to a 10 point scale indicating certainty in desire to obtain or not obtain a tubal sterilization. Response options range from 0 ("Very Certain that I Do Not Want") to 10 ("Very Certain that I Do Want").
  • Participant Satisfaction with Current Contraceptive Method(s) [ Time Frame: Three months postpartum (Time 3) ]
    Assessed by participant responses to a 5-point Likert scale regarding satisfaction with current contraceptive method(s). Response options range from 1 ("Very Unsatisfied") to 5 ("Very Satisfied").
  • Number of Pregnancies Since Delivery [ Time Frame: Three months postpartum (Time 3) ]
    Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since delivery.
  • Participant Satisfaction with Sterilization Counseling [ Time Frame: Three months postpartum (Time 3) ]
    Participant responses to an 8-item patient-provider communication scale created by the PI to assess participant satisfaction with the sterilization counseling experience. Response options range from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Items will be examined individually. In addition, a summary score will be created with items 2,3,6 reverse coded such that the range will be 8-40 with a higher score reflecting greater satisfaction with sterilization counseling.
Original Other Pre-specified Outcome Measures
 (submitted: September 19, 2019)
  • Participant satisfaction with current contraceptive method [ Time Frame: Three months postpartum ]
    Assessed by multiple choice and open-ended response options.
  • Number of Pregnancies Since Delivery [ Time Frame: Three months postpartum ]
    Assessed by participant-reported survey responses.
  • Participant satisfaction with sterilization counseling [ Time Frame: Three months postpartum ]
    Assessed by participant-reported responses to an 8 item patient-provider communication scale.
 
Descriptive Information
Brief Title  ICMJE "My Decision" Tubal Sterilization Decision Support Tool
Official Title  ICMJE Developing and Testing a Decision Support Tool for Women Making Tubal Sterilization Decisions
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.
Detailed Description

Female surgical sterilization is the second most commonly used contraceptive method in the US and is disproportionately used by low-income women and women of color. Whether the higher use of sterilization in these populations reflects inappropriate overutilization is unclear. On one hand, low-income and racial minority women frequently misunderstand the permanent nature of sterilization, are often unaware of reversible contraceptive alternatives, and commonly experience regret after the procedure- suggesting suboptimal decision making. On the other hand, there is evidence of substantial unmet demand for sterilization among low-income women, due to unique access barriers posed by Medicaid sterilization regulations, putting them at high risk for unintended pregnancy and the adverse health and social consequences associated with unintended pregnancy.

Medicaid sterilization policy currently requires that all women requesting a federally-funded procedure complete a standardized consent form at least 30 days prior to sterilization. This policy was originally instituted in the 1970s to protect vulnerable women from coercive sterilization practices by attempting to ensure informed and voluntary consent. However, there is growing consensus that the policy is incapable of ensuring informed consent, and that the mandatory 30-waiting period impedes access to desired sterilization for many low-income women. The lack of a process that can ensure both informed consent and timely access for sterilization procedures hampers progress toward reproductive health equity for low-income women.

This study seeks to test a novel, web-based decision support tool to support low-income women's ability to make informed and value-concordant decisions about surgical sterilization. A decision support tool may be particularly useful in the context of sterilization decisions because this is a preference-sensitive decision with permanent implications and because there is a high level of misunderstanding about sterilization and limited awareness of alternative options among women who have undergone the surgery, indicating critical gaps in the quality of pre-sterilization counseling. Furthermore, patient-provider interactions may be complicated by a broader social and historical context in which poor and minority women's reproductive choices have not always been valued.

The study is a multi-site randomized controlled trial to test the effect of the decision aid plus usual care compared to usual care alone on decision quality among 350 racially-diverse, low-income pregnant women considering a post-partum sterilization procedure. Participant surveys will be utilized at three assessments points to evaluate outcomes.

In addition to its potential clinical utility, this research also has important policy implications, as it can inform ongoing efforts to transform the current Medicaid policy by offering a decision aid that is able to ensure informed decision making in vulnerable populations, thereby allowing the investigators to ultimately replace the current Medicaid consent form with this scalable tool. Once there is a tool to safeguard women with an evidence-based process for ensuring informed consent, further progress can be made in potentially shortening or waiving the mandatory 30-day waiting period that has restricted access to desired sterilization for many low-income women.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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)].
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Tubal Sterilization
  • Women's Health
  • Contraception
  • Contraception Behavior
  • Reproductive Behavior
Intervention  ICMJE
  • Behavioral: "My Decision" tubal sterilization decision aid
    The "My Decision" tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization.
  • Other: Usual Care
    Usual medical care will vary among participants.
Study Arms  ICMJE
  • Experimental: Decision Aid Arm
    Participants will use the web-based decision aid plus usual medical care.
    Interventions:
    • Behavioral: "My Decision" tubal sterilization decision aid
    • Other: Usual Care
  • Usual Care Arm
    Participants will receive usual medical care.
    Intervention: Other: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women
  • 21-45 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

Exclusion Criteria:

  • Unable to consent to study participation
  • Unable to interact with the content of the web-based decision aid
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Male and Trans Male participants will not be eligible for participation in this study.
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sonya Borrero, MD, MS 412-692-4841 borrsp@UPMC.edu
Contact: Kristen Rice, MPH 412-692-4317 krr78@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097717
Other Study ID Numbers  ICMJE PRO19070122
R01MD011678-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be used for publication.
Time Frame: Publication of results will occur upon completion of the study.
Access Criteria: De-identified participant data will be used for publication.
Responsible Party Sonya Borrero, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • University of Tennessee
  • University of California, San Francisco
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Sonya Borrero, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP