Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Hormone Replacement Therapy; Menopause

Treatments: Behavioral: Hormone Replacement Therapy Decision-Aid

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00012909

PCC 98-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 45 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• postmenopausal as defined by: Amenorrhea for 12 months or FSH greater than or equal to 25

Exclusion criteria

• 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

Trial design

150 participants in 1 patient group

Arm 1

Other group

Treatment:

Behavioral: Hormone Replacement Therapy Decision-Aid