Vaginal BleedingACCCUSSNCT02752282
Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
A study testing Anticipatory Counseling and Cancer Screening Guidelines in people with Vaginal Bleeding and Uterine Cramping, run by University of Washington at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Bleeding, Uterine Cramping
- What is being tested?
- Anticipatory Counseling and Cancer Screening Guidelines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 and over who are deemed appropriate candidates be their healthcare providers and choose to use LNG-IUS, either Mirena or Skyla.
- Within five days of FIRST using either Mirena or Skyla
- Willing to answer online questions before and after watching the assigned video (intervention or control)
- Willing to complete short online questionnaire at three and six months
- Has working email and/or phone number
- Able to understand verbal and written English
- 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.
Who cannot join
- Women aged less than 18 years old
- Initiated LNG-IUS method more than five days from enrollment date.
- Within six weeks postpartum
- Breastfeeding
- Using LNG-IUS for treatment other than contraception
- Do not have access to the Web
Show all 9Show fewer
- Have neither working email or phone number
- Does not understand written or verbal English
- Inappropriate candidates for LNG IUS as deemed by healthcare provider
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
University of California Los Angeles Medical Center
Los Angeles, California, 90095
University of Washington Medical Centers
Seattle, Washington, 98112
About this study
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.
Read the 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
- Being tested
- Anticipatory Counseling, Cancer Screening Guidelines
- Keywords
- Family Planning, LNG-IUS, Health Education
- Medical subject headings
- Uterine Hemorrhage, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory CounselingOther
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.
Cancer Screening GuidelinesOther
Anticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines
| Study group | Role | What they receive |
|---|---|---|
| Control Video | Sham comparator | 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. Receives: Other: Cancer Screening Guidelines |
| Intervention Video | Active comparator | 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 Receives: Other: Anticipatory Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LNG-IUS knowledge, satisfaction and continuation from baseline
Using standardize questionnaires we will assess any significant differences in LNG-IUS knowledge, satisfaction or continuation after 6 months between control arm and intervention arm subjects.
Measured: 6 months
Secondary outcomes (4)
Percent of subjects in Phase II who complete all 3 surveys on-time over 6 months compared by recruitment method and site
Assess what percent of study participants were successfully recruited via a brochure or email contact at Seattle and Chicago.
Measured: 6 months
Number of subjects reporting LNG-IUS discontinuation during the study time frame (6 months) by reason for LNG-IUS removal
Track number of subjects who have their LNG-IUS removed during the study period by reason, including: bleeding, cramping, acne, weight gain, depression or other reasons.
Measured: 6 months
LNG-IUS user self-reported satisfaction with video counseling
A survey using modified likert scales and free text boxes, will ask participants how helpful the video was, how many times they watched the video, and any feedback they had about video elements to improve.
Measured: 6 months
LNG-IUS user self-reported LNG-IUS healthcare utilization during study period
Compare LNG-IUS user self-reported healthcare utilization at baseline (before the LNg-IUS was placed) with 3 and 6 months after LNG-IUS use. This include number of phone calls and office visits and the user reported helpfulness of these interactions with their healthcare providers.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal BleedingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Cook County Health, University of California, Los Angeles
- Responsible party
- Principal investigator, Emily Godfrey, University of Washington
- Investigators
- Emily Godfrey, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752282
- Sponsor's protocol ID
- 49648
- Acronym
- ACCCUSS
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
- ClinicalTrials.gov ID
- NCT02752282
- Acronym / sponsor ID
- ACCCUSS / 49648
- Conditions
- Vaginal Bleeding, Uterine Cramping
- Keywords
- Family Planning, LNG-IUS, Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bayer, Cook County Health, University of California, Los Angeles
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Video | Sham comparator | Other: Cancer Screening GuidelinesParticipants in this study arm will be assigned to watch a short educational video about new pap screening guidelines for women. Intervention: Cancer Screening Guidelines. |
| Intervention Video | Active comparator | Other: Anticipatory CounselingParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 18 and over who are deemed appropriate candidates be their healthcare providers and choose to use LNG-IUS, either Mirena or Skyla.
- Within five days of FIRST using either Mirena or Skyla
- Willing to answer online questions before and after watching the assigned video (intervention or control)
- Willing to complete short online questionnaire at three and six months
- Has working email and/or phone number
Key exclusion criteria (9 listed)
- Women aged less than 18 years old
- Initiated LNG-IUS method more than five days from enrollment date.
- Within six weeks postpartum
- Breastfeeding
- Using LNG-IUS for treatment other than contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory CounselingAnticipatory 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. | Other | Intervention Video |
| Cancer Screening GuidelinesAnticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines | Other | Control Video |
Primary outcome
Change in LNG-IUS knowledge, satisfaction and continuation from baseline
Time frame: 6 months
Using standardize questionnaires we will assess any significant differences in LNG-IUS knowledge, satisfaction or continuation after 6 months between control arm and intervention arm subjects.
4 secondary outcomes
Percent of subjects in Phase II who complete all 3 surveys on-time over 6 months compared by recruitment method and site
Time frame: 6 months
Number of subjects reporting LNG-IUS discontinuation during the study time frame (6 months) by reason for LNG-IUS removal
Time frame: 6 months
LNG-IUS user self-reported satisfaction with video counseling
Time frame: 6 months
LNG-IUS user self-reported LNG-IUS healthcare utilization during study period
Time frame: baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Godfrey, MD, MPH principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory Counseling and Cancer Screening Guidelines in people with Vaginal Bleeding and Uterine Cramping, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LNG-IUS knowledge, satisfaction and continuation from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.