Physician Self Disclosure of IUC Use

• ClinicalTrials.gov Identifier: NCT01994356
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Last Update Posted: November 25, 2013
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Mya Zapata, University of Michigan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Contraception	Behavioral: Physician self-disclosure of personal IUC use; Behavioral: Usual contraceptive counseling	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling
• Study Start Date: January 2011
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual contraceptive counseling; subjects received usual contraceptive counseling	Behavioral: Usual contraceptive counseling; all subjects recieved usual contraceptive counseling; Other Name: contraceptive counseling
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	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan Medical Center

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

More Information

• Responsible Party: Mya Zapata, Clinical Lecturer, University of Michigan
• ClinicalTrials.gov Identifier: NCT01994356
• Other Study ID Numbers: IUC Disclosure; N014264 ( Other Grant/Funding Number: Sociey of Family Planning )
• First Posted: November 25, 2013
• Last Update Posted: November 25, 2013
• Last Verified: November 2013

Keywords provided by Mya Zapata, University of Michigan:

Contraceptive counseling; Physician self disclosure; Satisfaction; Intrauterine contraceptive use

Additional relevant MeSH terms:

Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs