Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
- Conditions
- MenopauseHormone Replacement Therapy
- Interventions
- Behavioral: Hormone Replacement Therapy Decision-Aid
- Registration Number
- NCT00012909
- Lead Sponsor
- US Department of Veterans Affairs
- Brief Summary
The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.
- Detailed Description
Background:
The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.
Objectives:
The objectives of the study are to: 1) develop a model of the decision-making process for postmenopausal women considering hormone (HT), based on Multi-Attribute Utility Theory (MAUT); 2) produce an interactive CD-ROM decision-aid for HT; 3) evaluate the effect of the interactive CD-ROM decision-aid on patient satisfaction with decision (SWD) and knowledge about menopause and HT; and 4) test the effect of the interactive CD-ROM decision-aid on women�s decisions regarding use of HT.
Methods:
Phase I (completed) used structured interviews and surveys in the development of a decision model for HT. In phase II, an interactive CD-ROM decision-aid was developed and a randomized controlled trial (RCT) of its effect on decision processes was conducted. Postmenopausal women, aged 45-74 were recruited from the primary care clinics of the four participating Veterans Affairs hospitals: Milwaukee, Madison, Chicago-Hines, and Chicago-Westside. The primary hypothesis was that women who use the CD-ROM decision-aid would demonstrate increased satisfaction with their decision regarding hormone replacement therapy use compared to women receiving the control intervention.
Status:
Enrollment and follow-up assessments have been completed. The study is in the analysis phase. The study was presented to the VA HSR\&D Combined Monitoring Board on February 5, 2003 and the committee voted unanimously to recommend continuation of the trial. The study has had one publication and several scientific abstract presentations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- postmenopausal as defined by: Amenorrhea for 12 months or FSH greater than or equal to 25
- unable to speak English
- are assessed not to have capacity for making medical decisions for their own care
- had alcohol or drug abuse issues in past 6 months before baseline visit
- personal history of breast cancer, active liver disease, active vascular thrombosis, and/or active unexplained vaginal bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Hormone Replacement Therapy Decision-Aid -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Edward Hines Jr. VA Hospital, Hines, IL
🇺🇸Hines, Illinois, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
🇺🇸Madison, Wisconsin, United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
🇺🇸Milwaukee, Pennsylvania, United States