Decisionmaking for Abnormal Uterine Bleeding (AUB)

Abnormal Uterine Bleeding Clinical Trial

Official title:

Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721304
• Other study ID #: 1009001853 (0904-66B)
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: April 21, 2015
• Start date: May 2009
• Est. completion date: August 2012

Study information

• Verified date: April 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

Intervention

Other:
• Adaptive Conjoint Analysis
Computerized survey to elicit patient preferences

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	Southern Pines Women's Health Center	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in patient-reported satisfaction between treatment groups	Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)	6 weeks	No
Primary	Differences in decision regret between treatment groups	Decision regret is measured by the Decision Regret Scale	6 weeks	No

External Links

•   Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial.