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Contraceptive Choice at the Time of Uterine Evacuation

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ClinicalTrials.gov Identifier: NCT02836561
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts

Study Description
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Brief Summary:
The goal of this project is to investigate whether a pre-visit telephone intervention could increase awareness of long-acting reversible contraception (LARC) availability at the time of uterine evacuation.

Condition or disease Intervention/treatment Phase
Contraception Other: Telephone message Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention
Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Message
Participants who are randomized to the intervention message will receive contraception information in advance of their appointment that may be helpful in their decision-making.
 Other: Telephone message
A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation
No Intervention: Control Message
Participants who are randomized to the control message will receive appointment logistic information that may be a helpful reminder.


Outcome Measures
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Primary Outcome Measures :
  1. Knowledge that LARC can start at uterine evacuation: Percentage of women who report that LARC methods are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study [ Time Frame: Day 1: Questionnaire administered prior to the information session ]
    Percentage of women who know that the implant and IUD are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study. Compared between those who receive the pre-visit information (intervention group) and those who do not receive this information (control group)


Secondary Outcome Measures :
  1. Intervention utility: Percentage of women who report that receiving information about contraception before their appointment was either very useful or somewhat useful, as assessed on a 4-point scale on a questionnaire created for this study [ Time Frame: Day 1: Questionnaire administered prior to information session ]
    Percentage of women who who report that receiving information about contraception before their appointment was either very useful or somewhat useful, as assessed on a 4-point scale on a questionnaire created for this study. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)

  2. General LARC knowledge: Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study [ Time Frame: Day 1: Questionnaire administered prior to information session ]
    Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)

  3. Intent to use LARC: Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study [ Time Frame: Day 1: Questionnaire administered prior to information session ]
    Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)

  4. LARC stage of change: Percentage of women who report being somewhat or very interested in starting a LARC method, as assessed on a 4-point scale on a questionnaire created for this study [ Time Frame: Day 1: Questionnaire administered prior to information session ]
    Percentage of women who report being somewhat or very interested in starting an implant or IUD, as assessed on a 4-point scale on a questionnaire created for this study. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)

  5. Uptake of LARC at time of uterine evacuation: Percentage of women who receive a LARC method at the time of uterine evacuation, as documented within the electronic medical record [ Time Frame: Day 1: Data abstraction to be performed after the subject's day 1 visit complete ]
    Percentage of women who receive an implant or an IUD at the time of uterine evacuation, compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Scheduled for uterine evacuation
  • Speaks English proficiently in order to understand the telephone conversation and the survey questions.

Exclusion Criteria:

  • Previous participation in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836561


Locations
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United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Investigators
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Principal Investigator: Principal Investigator, MD Planned Parenthood League of Massachusetts
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT02836561    
Other Study ID Numbers: 2016P000619
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Present at conferences and publish results in peer reviewed journal