Decisionmaking for Abnormal Uterine Bleeding (AUB)

Indiana University

Status: Completed

Conditions: Abnormal Uterine Bleeding

Treatments: Other: Adaptive Conjoint Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01721304

1009001853 (0904-66B)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

380 participants in 2 patient groups

Adaptive Conjoint Analysis

Experimental group

Description:

Computerized survey to elicit preferences

Treatment:

Other: Adaptive Conjoint Analysis

Usual care

No Intervention group

Description:

Patients are counseled by their physician as usual