Hormone Replacement Therapy (HRT) Website Tool

Testing an Interactive Website for Hormone Replacement

The purpose of this study is to evaluate a prototype web-based module for patients to generate appropriate and focused health information along with a customized set of questions to take to their health care provider for discussion on hormone replacement therapy.

Study Overview

• Status: Completed
• Conditions: Communication; Menopause; Hormone Replacement Therapy
• Intervention / Treatment: Behavioral: TalkToYourDoc(sm) hormone therapy module

Detailed Description

Patient-centered care may be enhanced by medically accurate, personalized health information generated by specialized software on the Internet. This study assessed the effect of a web-based interactive tool about menopausal hormone therapy (HT) on patient and provider communication and satisfaction.

The controlled, randomized evaluation of the TalkToYourDoc(sm) (TTYD) interactive website module on communication, satisfaction and efficiency of office visits involved 288 women born between 1930 and 1960 and 26 health care providers in an outpatient, academic setting. Women were randomized after stratification by HT use to usual care or access to the TTYD website. The TTYD website built a personalized series of questions based on participant input regarding health status and generated a printout of health issues, medications and questions about HT for participants to bring to the visit with their health care provider.

Results of the study found that women who participated in the intervention were more likely to come prepared to the clinic appointment with appropriate questions (80% vs. 96%) than women receiving usual care. Participants found the website easy to use, the questions generated were useful in the discussion of HT, and they felt that providers had a positive response to the printout. Providers felt that women who participated in the intervention were more engaged in the discussion and asked more relevant questions regarding HT. Providers had a higher level of satisfaction with the discussion with intervention participants, and felt that these office visits were more efficient.

Therefore, it was determined that the TalkToYourDoc(sm) module enhanced communication between women and their providers, led to greater visit satisfaction for both patient and provider, and improved visit efficiency.

• Study Type: Interventional
• Enrollment: 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women born between 1930 to 1960
• Scheduled appointment at the OB/GYN or Family and Community Medicine out-patient clinics between 11/9/2004 to 12/2/2005

Exclusion Criteria:

• Men
• Current pregnancy
• Diagnosed cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Educational/Counseling/Training
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Communication and satisfaction parameters from post-visit surveys of both patients and providers.

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Elaine Eaker, ScD, Eaker Epidemiology Enterprises, LLC; Study Director: Vanessa M. Barnabei, MD, PhD, Medical College of Wisconsin

Publications and helpful links

General Publications

• Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. doi: 10.1001/jama.291.14.1701.
• Mechanic D. Physician discontent: challenges and opportunities. JAMA. 2003 Aug 20;290(7):941-6. doi: 10.1001/jama.290.7.941.
• Mechanic D, McAlpine DD, Rosenthal M. Are patients' office visits with physicians getting shorter? N Engl J Med. 2001 Jan 18;344(3):198-204. doi: 10.1056/NEJM200101183440307.
• Heisler M, Bouknight RR, Hayward RA, Smith DM, Kerr EA. The relative importance of physician communication, participatory decision making, and patient understanding in diabetes self-management. J Gen Intern Med. 2002 Apr;17(4):243-52. doi: 10.1046/j.1525-1497.2002.10905.x.
• Martin LR, DiMatteo MR, Lepper HS. Facilitation of patient involvement in care: development and validation of a scale. Behav Med. 2001 Fall;27(3):111-20. doi: 10.1080/08964280109595777.

Helpful Links

• The Benton Foundation

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion: December 1, 2005

Study Registration Dates

• First Submitted: April 26, 2006
• First Submitted That Met QC Criteria: April 26, 2006
• First Posted (Estimate): April 27, 2006

Study Record Updates

• Last Update Posted (Estimate): April 27, 2006
• Last Update Submitted That Met QC Criteria: April 26, 2006
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: AG0065; R44AG019082-03 (U.S. NIH Grant/Contract)