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PCC 98-039 – HSR&D Study

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PCC 98-039
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
Marilyn M. Schapira MD MPH
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, WI
Funding Period: October 1999 - March 2004

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.

FINDINGS/RESULTS:
One-hundred and seventy-seven (177) women were enrolled in the study and follow-up data was obtained on 172 participants. Over the course of the study, more patients discontinued than started HT (p=0.02): 104 subjects were off at baseline and follow-up, 41 were on HT at baseline and follow-up, 7 started HT during the course of the study, and 20 discontinued HT during the study. There was no effect of the experimental intervention on decisions regarding HT. In multivariate analysis, participants exposed to the written pamphlet intervention had greater follow-up knowledge than those exposed to the CD-ROM decision-aid. In multivariate analyses, there was no effect of the intervention on Satisfaction with Decision-Making, Decisional Conflict, or HT Decision. Enrollment in the study after publication of key Women’s Health Initiative trial results was associated with increased factors of uncertainty, a component of decisional conflict.

IMPACT:
This work will ultimately have an impact by: 1) supporting informed decision-making among women veterans considering options to the management of menopause; and 2) developing a prototype risk communication and decision-making tool for preventive health interventions.

PUBLICATIONS:

Journal Articles

  1. Schapira MM, Gilligan MA, McAuliffe TL, Nattinger AB. Menopausal hormone therapy decisions: insights from a multi-attribute model. Patient education and counseling. 2004 Jan 1; 52(1):89-95.


DRA: Aging, Older Veterans' Health and Care
DRE: Prevention, Technology Development and Assessment
Keywords: Chronic disease (other & unspecified), Women - or gender differences
MeSH Terms: none

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