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

Sponsor
Miami VA Healthcare System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03109145
Collaborator
Pfizer (Industry)
859
1
2
64
13.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Menopause educational secure messaging
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
859 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Menopause educational secure messaging

Secure messages that provide information about menopause and treatment option for menopause symptoms.

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.

No Intervention: Usual care: Control

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. Usual care participants did not receive the educational secure messages.

Outcome Measures

Primary Outcome Measures

  1. Menopause Knowledge [6-months]

    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%)

  2. Feasibility of patient portal use for educating and tracking women regarding menopause and menopause related symptoms. [6-months]

    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.

Secondary Outcome Measures

  1. Shared decision making [Through study completion, an average of 3-years]

    Self-reported rate of shared decision making among women veteran and their providers.

  2. Menopause related diagnosis [Through study completion, an average of 3-years]

    Rates of diagnosis and appropriate management of menopause related symptoms and use of hormone therapy.

  3. Focus Group [6-months]

    Qualitative assessment of the interventions through participant semi-structure focus group interviews.

  4. Patient portal registration and authentication [Through study completion, an average of 3-years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Miami Veterans Affairs Healthcare System Miami Florida United States 33125

Sponsors and Collaborators

  • Miami VA Healthcare System
  • Pfizer

Investigators

  • Principal Investigator: Stuti Dang, MD, MPH, Miami VA Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stuti Dang, Physician, Miami VA Healthcare System
ClinicalTrials.gov Identifier:
NCT03109145
Other Study ID Numbers:
  • Pfizer-MEANS
  • 15911255
First Posted:
Apr 12, 2017
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stuti Dang, Physician, Miami VA Healthcare System

Study Results

No Results Posted as of Apr 13, 2021