Clinical trial NCT01721304: Decisionmaking for Abnormal Uterine Bleeding (AUB)
Official title: Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Keywords: decision making
abnormal uterine bleeding
adaptive conjoint analysis
satisfaction
regret
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in patient-reported satisfaction between treatment groups
timeFrame: 6 weeks
measure: Differences in decision regret between treatment groups
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Southern Pines
country: United States
facility: Southern Pines Women's Health Center
state: North Carolina
Study officials:
affiliation: Indiana University
name: Lisa M Hess, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.