ContraceptionNCT01994356
Physician Self Disclosure of IUC Use
A study testing Physician self-disclosure of personal IUC use and Usual contraceptive counseling in people with Contraception, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Physician self-disclosure of personal IUC use and Usual contraceptive counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2013
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- reproductive age
- currently sexually active
- scheduled for benign gynecology visit, annual exam, or family planning visit
Who cannot join
- seeking pregnancy within 1 year
- currently using IUC
- prior sterilization procedure
- currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Physician self-disclosure of personal IUC use, Usual contraceptive counseling
- Keywords
- Contraceptive counseling, Physician self disclosure, Satisfaction, Intrauterine contraceptive use
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician self-disclosure of personal IUC useBehavioural
Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling
Usual contraceptive counselingBehavioural
Also called contraceptive counseling
all subjects recieved usual contraceptive counseling
| Study group | Role | What they receive |
|---|---|---|
| Usual contraceptive counseling | Active comparator | subjects received usual contraceptive counseling Receives: Behavioral: Usual contraceptive counseling |
| Physician self-disclosure of IUC use | Experimental | subjects received usual contraceptive counseling plus intervention which was Physician self-disclosure of personal IUC use during the counseling Receives: Behavioral: Physician self-disclosure of personal IUC use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine contraceptive use
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.
Measured: immediately following clinical encounter and at 2 months
Secondary outcomes (1)
Satisfaction with clinical encounter
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.
Measured: immediately following clinical encounter and at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mya Zapata, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994356
- Sponsor's protocol ID
- IUC Disclosure
- Other IDs
- N014264
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling
- ClinicalTrials.gov ID
- NCT01994356
- Acronym / sponsor ID
- IUC Disclosure
- Conditions
- Contraception
- Keywords
- Contraceptive counseling, Physician self disclosure, Satisfaction, Intrauterine contraceptive use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Nov 2013 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual contraceptive counseling | Active comparator | Behavioral: Usual contraceptive counselingsubjects received usual contraceptive counseling |
| Physician self-disclosure of IUC use | Experimental | Behavioral: Physician self-disclosure of personal IUC usesubjects received usual contraceptive counseling plus intervention which was Physician self-disclosure of personal IUC use during the counseling |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- reproductive age
- currently sexually active
- scheduled for benign gynecology visit, annual exam, or family planning visit
Key exclusion criteria (4 listed)
- seeking pregnancy within 1 year
- currently using IUC
- prior sterilization procedure
- currently pregnant
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 |
|---|---|---|
| Physician self-disclosure of personal IUC usePhysicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling | Behavioural | Physician self-disclosure of IUC use |
| Usual contraceptive counselingAlso: contraceptive counselingall subjects recieved usual contraceptive counseling | Behavioural | Usual contraceptive counseling |
Primary outcome
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.
1 secondary outcome
Satisfaction with clinical encounter
Time frame: immediately following clinical encounter and at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician self-disclosure of personal IUC use and Usual contraceptive counseling in people with Contraception, run by University of Michigan at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intrauterine contraceptive use (time frame: immediately following clinical encounter and at 2 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 25 Nov 2013.