- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994356
Physician Self Disclosure of IUC Use
November 19, 2013 updated by: Mya Zapata, University of Michigan
Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling
As many as one-third of female healthcare providers use intrauterine contraception (IUC), but only about 8 percent of US women overall do.
This begs the question: Might physician self-disclosure of personal IUC use increase IUC use among patients?
However, the positive or negative impact of physician self disclosure on IUC uptake or patient satisfaction is generally unknown.
The purpose of this study was to evaluate if physician self-disclosure of personal IUC use increases patient use of IUC or impacts patients' satisfaction with their clinical encounter.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We performed a prospective randomized block design pilot trail of usual contraceptive counseling versus usual counseling plus physician self-disclosure of personal intrauterine contraceptive use.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- reproductive age
- currently sexually active
- scheduled for benign gynecology visit, annual exam, or family planning visit
Exclusion Criteria:
- seeking pregnancy within 1 year
- currently using IUC
- prior sterilization procedure
- currently pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual contraceptive counseling
subjects received usual contraceptive counseling
|
all subjects recieved usual contraceptive counseling
Other Names:
|
Experimental: Physician self-disclosure of IUC use
subjects received usual contraceptive counseling plus intervention which was Physician self-disclosure of personal IUC use during the counseling
|
Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intrauterine contraceptive use
Time Frame: immediately following clinical encounter and at 2 months
|
All subjects were surveyed to determine use of intrauterine contraceptive immediately after their clinical visit where contraceptive counseling was received and at 2 months after their clinical encounter to assess intrauterine contraceptive use.
|
immediately following clinical encounter and at 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with clinical encounter
Time Frame: immediately following clinical encounter and at 2 months
|
All subjects were surveyed to determine their with satisfaction with their overall clinical encounter immediately following their clinical encounter at at 2 months.
Satisfaction was measured using a 5 point scale.
|
immediately following clinical encounter and at 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with contraceptive method
Time Frame: immediately following clinical enocunter and at 2 months
|
All subjects were surveyed to determine satisfaction with their contraceptive method of choice immediately following their clinical encounter and at 2 months.
Satisfaction was measured using a 5 point scale.
|
immediately following clinical enocunter and at 2 months
|
Satisfaction with provider
Time Frame: immediately following clinical encounter and at 2 months
|
All subjects were surveyed to determine satisfaction with their provider immediately following their clinical encounter and at 2 months.
Satisfaction was measured using a 5 point scale.
|
immediately following clinical encounter and at 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 19, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUC Disclosure
- N014264 (Other Grant/Funding Number: Sociey of Family Planning)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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