Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction

NCT ID: NCT02752282

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-12-31

Brief Summary

This study is a counseling intervention for new LNG-IUS users. The study explores the use of video technology to deliver anticipatory counseling on LNG-IUS side-effects, adjustment periods and bleeding changes to women newly using the LNG-IUS for contraceptive purposes. The primary aim is to understand if anticipatory counseling delivered via video can increase LNG-IUS satisfaction and continuation of the device in the first 6 months of use.

Detailed Description

Enhanced anticipatory counseling detailing side effects when initiating progestin-only injectable contraception improved its continued use among women.While continuation rates at one year among levonorgestrel intrauterine system (LNG-IUS) users are considerably higher than those for progestin-only injectable users in the United States (80% versus 56%), enhanced anticipatory counseling could have an impact on the 20% of LNG IUS users who choose to discontinue the method within one year of use. For this reason, the investigators propose a study that would develop and pilot-test an anticipatory counseling intervention detailing unscheduled bleeding and other side effects such as pelvic pain or cramping among new LNG IUS users and compare this with a "control," using video technology. The investigators have chosen video technology for the counseling intervention to ensure that all participants receive the exact same information about LNG side effects, which would be not possible using a face-to-face clinician-participant counseling model.

The investigators propose three phases for this study. In Phase 1, a systematic literature search evaluating effective components in videos used for contraceptive counseling and the development of two separate video scripts will lead to: (1) an intervention, detailing expected side effects and safety of the LNG IUS, and (2) a similar-looking "control," detailing only recommended screening guidelines for women, as well as information about LNG IUS safety. This phase of the study uses focus groups prior to the development of the video interventions, initially with family planning experts for content accuracy and cultural sensitivity, and secondarily with new LNG IUS users for acceptability. Findings from this phase will be used to fine-tune the scripts prior to the development of the videos.

In Phase 2 of the study, the investigators will pilot a trial in the clinical setting to evaluate the anticipatory counseling video intervention and its impact on LNG-IUS knowledge, continuation, health care utilization, and satisfaction. After receiving comprehensive contraceptive counseling from their clinicians, women who choose to have the LNG IUS inserted will be given a brochure that asks them to participate in an online study. After signing-on to an innovative website, participants will be randomized to either an intervention or control video and complete short questionnaires related to demographics, baseline menstruation, satisfaction, and LNG IUS knowledge before and after viewing their assigned video. Women will be followed for six months. They will be asked to complete a short online survey at three and six months regarding LNG IUS continuation, health care utilization, and satisfaction. Findings from this study will serve to design a future, appropriately powered randomized controlled trial assessing LNG IUS continuation, utilization, and satisfaction rates at 12 months.

In Phase 3, we will use the findings from Phase 2 to develop a similar protocol and recruit up to 178 women at three sites across the US to test the same primary aims of the video: LNG-IUS continuation, utilization, and satisfaction over a 12 month period. In phase 3, subjects will be randomized to watch either the control or intervention video.

Conditions

Vaginal Bleeding; Uterine Cramping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Video

Participants in this study arm will be assigned to watch a short educational video about new pap screening guidelines for women. Intervention: Cancer Screening Guidelines.

Group Type: SHAM_COMPARATOR

Cancer Screening Guidelines

Intervention Type: OTHER

Anticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines

Intervention Video

Participants in this group will be assigned to watch a short educational video providing anticipatory counseling on their LNG-IUS' side effects and expected changes in bleeding. Intervention: Anticipatory Counseling

Group Type: ACTIVE_COMPARATOR

Anticipatory Counseling

Intervention Type: OTHER

Anticipatory Counseling provides information on expected side-effects that may change or go away over time, or stay for the duration of the treatment. Anticipatory counseling can also help patients understand when their side-effects are normal and when to seek medical attention.

Interventions

Anticipatory Counseling

Anticipatory Counseling provides information on expected side-effects that may change or go away over time, or stay for the duration of the treatment. Anticipatory counseling can also help patients understand when their side-effects are normal and when to seek medical attention.

Intervention Type: OTHER

Cancer Screening Guidelines

Anticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Women aged 18 and over who are deemed appropriate candidates be their healthcare providers and choose to use LNG-IUS, either Mirena or Skyla.

2. Within five days of FIRST using either Mirena or Skyla

3. Willing to answer online questions before and after watching the assigned video (intervention or control)

4. Willing to complete short online questionnaire at three and six months

5. Has working email and/or phone number

6. Able to understand verbal and written English

7. Appropriate LNG-IUS candidates whoa re being treated for other pre-existing medical disorders while using the LNG IUS may continue to take their medications as directed by their healthcare provider.

Exclusion Criteria

1. Women aged less than 18 years old

2. Initiated LNG-IUS method more than five days from enrollment date.

3. Within six weeks postpartum

4. Breastfeeding

5. Using LNG-IUS for treatment other than contraception

6. Do not have access to the Web

7. Have neither working email or phone number

8. Does not understand written or verbal English

9. Inappropriate candidates for LNG IUS as deemed by healthcare provider

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Cook County Health

OTHER_GOV

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Emily Godfrey

Associate Professor, Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Godfrey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of California Los Angeles Medical Center

Los Angeles, California, United States

Stroger Hospital of Cook County

Chicago, Illinois, United States

University of Washington Medical Centers

Seattle, Washington, United States

Countries

United States

Other Identifiers

49648

Identifier Type: -

Identifier Source: org_study_id