Contraceptive Choice at the Time of Uterine Evacuation

Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Other: Telephone message

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Day 1: Questionnaire administered prior to the information session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Day 1: Questionnaire administered prior to information session
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	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)	Day 1: Questionnaire administered prior to information session
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	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)	Day 1: Questionnaire administered prior to information session
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	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)	Day 1: Questionnaire administered prior to information session
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	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)	Day 1: Data abstraction to be performed after the subject's day 1 visit complete

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Investigators: Principal Investigator: Principal Investigator, MD, Planned Parenthood League of Massachusetts

Publications and helpful links

General Publications

• Roe AH, Fortin J, Gelfand D, Janiak E, Maurer R, Goldberg A. Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial. BMJ Sex Reprod Health. 2018 Jul;44(3):187-192. doi: 10.1136/bmjsrh-2017-200023. Epub 2018 May 18.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016P000619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Present at conferences and publish results in peer reviewed journal