MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)

Menopause Clinical Trial

— MEANS  

Official title:

MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109145
• Other study ID #: Pfizer-MEANS
• Secondary ID: 15911255
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2021
• Source: Miami VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to examine the impact of educational secure messages on menopause. In particular, the investigators will examine whether the secure messages increase menopause knowledge and communication between patients and their providers.

Description:

The overall goal of this project is to determine the effectiveness of the MEANS (MyHealtheVet to Enable And Negotiate for Shared decision making) intervention in improving women's self-reported knowledge and rates of diagnosis and appropriate management of menopause symptoms. The proposed intervention is an educational and shared decision making platform for menopause symptoms to improve communication between patients and their providers regarding menopause symptoms. MEANS combines educational secure messages through the Veterans Affairs online Personal Health Record called MyHealtheVet, along with face-to-face and print interventions.

MEANS will be applied in target population consisting of postmenopausal women Veterans ages 45 to 60 who receive primary care at the Miami Veterans Affairs Healthcare System. This project will enroll women in MyHealtheVet, develop a library of menopause symptoms material for distribution, and evaluate how useful of MyHealtheVet use for educating and tracking women regarding menopause symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women Veterans, age 45-60

• Receive primary care at the Miami Veterans Affairs Healthcare System

• Able to communicate in English

• Already or willing to register and become authenticated in the patient health portal, MyHealtheVet.

• Able to use read, understand, and respond to secure messages using patient health portal.

Exclusion Criteria:

• Not willing to register and become authenticated for patient health portal.

• Not willing to receive educational secure messages from patient health portal.

Related Conditions & MeSH terms

• Menopause

Intervention

Other:
• Menopause educational secure messaging
Participants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.

Locations

Country	Name	City	State
United States	Miami Veterans Affairs Healthcare System	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Miami VA Healthcare System	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause Knowledge	Total menopause knowledge score (a) before and after the intervention, an average of 6-months and (b) compared to a control group of eligible women patients between 45-60 years who do not receive the intervention at the West Palm Beach and Orlando Veterans Healthcare System. Score is the percent of knowledge questions answered correctly (0 - 100%)	6-months
Primary	Feasibility of patient portal use for educating and tracking women regarding menopause and menopause related symptoms.	The study will send weekly secure messages regarding menopause, and ask participants to report their menopause related symptoms by secure messaging. The research study will track the number of times participants read the weekly information sent via MyHealtheVet and the proportion of times they respond.	6-months
Secondary	Shared decision making	Self-reported rate of shared decision making among women veteran and their providers.	Through study completion, an average of 3-years
Secondary	Menopause related diagnosis	Rates of diagnosis and appropriate management of menopause related symptoms and use of hormone therapy.	Through study completion, an average of 3-years
Secondary	Focus Group	Qualitative assessment of the interventions through participant semi-structure focus group interviews.	6-months
Secondary	Patient portal registration and authentication	Measure the number of eligible women patients in the Miami Veterans Healthcare System who are enrolled and authenticated in the patient portal before and after the intervention.	Through study completion, an average of 3-years