Clinical trial NCT03109145: MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)
Official title: MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Shared decision making
Knowledge
Patient portal
Secure messaging
Lead sponsor: Miami VA Healthcare System
Sponsor class: FED
Collaborators: name: Pfizer
First posted: 2017-04-12
Enrollment: 859
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Menopause Knowledge
timeFrame: 6-months
measure: Feasibility of patient portal use for educating and tracking women regarding menopause and menopause related symptoms.
timeFrame: 6-months
Secondary outcomes:
measure: Shared decision making
timeFrame: Through study completion, an average of 3-years
measure: Menopause related diagnosis
timeFrame: Through study completion, an average of 3-years
measure: Focus Group
timeFrame: 6-months
measure: Patient portal registration and authentication
timeFrame: Through study completion, an average of 3-years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Affairs Healthcare System
state: Florida
Study officials:
affiliation: Miami VA Healthcare System
name: Stuti Dang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamba AH, Muralidhar K, Jain A, Tang F, Gomez-Marin O, Levis S, Dang S. Characteristics of Women Enrolled in a Patient Portal Intervention for Menopause. Womens Health Rep (New Rochelle). 2020 Oct 26;1(1):500-510. doi: 10.1089/whr.2020.0091. eCollection 2020.
citation: Dang S, Thavalathil B, Ruiz D, Gomez-Orozco C, Gomez-Marin O, Levis S. A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making. J Womens Health (Larchmt). 2019 Dec;28(12):1614-1622. doi: 10.1089/jwh.2018.7461. Epub 2019 Aug 7.