Menopause Clinical Trial
Official title:
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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