Decisionmaking for Abnormal Uterine Bleeding (AUB)

Not Applicable

Completed

• Conditions: Abnormal Uterine Bleeding
• Interventions: Other: Adaptive Conjoint Analysis

• Registration Number: NCT01721304
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.

Detailed Description

The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study was designed to develop and test the use of ACA as part of routine clinical care for women diagnosed with AUB. After pilot testing, the ACA survey is administered in this study where patients are assigned to receive the ACA or to usual care.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 380

Inclusion Criteria

• Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is recommended for treatment
• Have not yet selected or initiated treatment for current AUB diagnosis
• Be at least 18 years of age.
• Be possible candidates for either medical or surgical therapy
• Able to provide informed consent for treatment options for oneself

Exclusion Criteria

• Are currently being treated for cancer
• Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer)
• AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options
• Are not recommended for surgical intervention
• Are not recommended for medical intervention
• Are under 18 years of age
• Have not received a diagnosis of AUB
• Are currently being treated for AUB

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive Conjoint Analysis	Adaptive Conjoint Analysis	Computerized survey to elicit preferences

Primary Outcome Measures

Name	Time	Method
Differences in decision regret between treatment groups	6 weeks	Decision regret is measured by the Decision Regret Scale
Differences in patient-reported satisfaction between treatment groups	6 weeks	Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Southern Pines Women's Health Center; 🇺🇸 Southern Pines, North Carolina, United States