NCT02665468

Brief Summary

On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge to create a single entity that will be responsible for the implementation and evaluation of eHealth technologies across the healthcare system. In an effort to successfully fulfill its mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of eHealth technologies across VHA, and to measure their impacts on dimensions of access and other outcomes. Developed in close consultation with leadership of the new office, the proposed objectives of the eHealth PEI are to (1) implement a patient-level "supported adoption intervention" for secure messaging and evaluate the impact of secure messaging use through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's automated telehealth text messaging system to Veterans and clinical team members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

January 5, 2016

Results QC Date

October 25, 2017

Last Update Submit

October 9, 2018

Conditions

Keywords

Supported adoptionSecure messagingPatient aligned care team (PACT)My HealtheVet Coordinator

Outcome Measures

Primary Outcomes (1)

  • Change in Rate of Use

    Measure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.

    Baseline and Six months

Secondary Outcomes (3)

  • Patient Self-reported Access to Communication

    Six month follow-up

  • Care Coordination: Patient Assessment of Chronic Illness Care

    Six month follow-up

  • Physician Accessibility and Engagement

    Six months

Study Arms (2)

Arm 1: Supported Adoption Intervention (SAI)

OTHER

Supported adoption intervention

Behavioral: Supported adoption intervention

Arm 2: General wellness information

ACTIVE COMPARATOR

General wellness information

Behavioral: Active comparator control

Interventions

An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)

Also known as: SAI
Arm 1: Supported Adoption Intervention (SAI)

The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention

Also known as: General wellness information
Arm 2: General wellness information

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Authenticated My HealtheVet users who have not sent a secure message
  • Active patients who have an appointment scheduled in the following year

You may not qualify if:

  • Authenticated My HealtheVet users who have sent a secure message
  • Inactive patients (who do not have an appointment scheduled in the following year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

  • Shimada SL, Zocchi MS, Hogan TP, Kertesz SG, Rotondi AJ, Butler JM, Knight SJ, DeLaughter K, Kleinberg F, Nicklas J, Nazi KM, Houston TK. Impact of Patient-Clinical Team Secure Messaging on Communication Patterns and Patient Experience: Randomized Encouragement Design Trial. J Med Internet Res. 2020 Nov 18;22(11):e22307. doi: 10.2196/22307.

Related Links

Limitations and Caveats

Participants were recruited at only three VA facilities, which limits generalizability.

Results Point of Contact

Title
Dr. Timothy P. Hogan
Organization
VA-CHOIR

Study Officials

  • Timothy Patrick Hogan, PhD MS BS

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 27, 2016

Study Start

February 1, 2016

Primary Completion

October 31, 2016

Study Completion

September 30, 2017

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2018-01

Locations