Physician Self Disclosure of IUC Use

Contraception Clinical Trial

Official title:

Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994356
• Other study ID #: IUC Disclosure
• Secondary ID: N014264
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 19, 2013
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Physician self-disclosure of personal IUC use
Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling
• Usual contraceptive counseling
all subjects recieved usual contraceptive counseling

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with contraceptive method	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	No
Other	Satisfaction with provider	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	No
Primary	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.	immediately following clinical encounter and at 2 months	No
Secondary	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.	immediately following clinical encounter and at 2 months	No