NCT01994356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

November 19, 2013

Last Update Submit

November 19, 2013

Conditions

Keywords

Contraceptive counselingPhysician self disclosureSatisfactionIntrauterine contraceptive use

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Satisfaction with clinical encounter

    immediately following clinical encounter and at 2 months

Other Outcomes (2)

  • Satisfaction with contraceptive method

    immediately following clinical enocunter and at 2 months

  • Satisfaction with provider

    immediately following clinical encounter and at 2 months

Study Arms (2)

Usual contraceptive counseling

ACTIVE COMPARATOR

subjects received usual contraceptive counseling

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

Behavioral: Physician self-disclosure of personal IUC use

Interventions

Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling

Physician self-disclosure of IUC use

all subjects recieved usual contraceptive counseling

Also known as: contraceptive counseling
Usual contraceptive counseling

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • reproductive age
  • currently sexually active
  • scheduled for benign gynecology visit, annual exam, or family planning visit

You may not qualify if:

  • seeking pregnancy within 1 year
  • currently using IUC
  • prior sterilization procedure
  • currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations