eHealth Partnered Evaluation Initiative (eHealth PEI)

October 9, 2018 updated by: VA Office of Research and Development

eHealth Partnered Evaluation Initiative (PEC 15-470)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

eHealth is a model for the delivery and receipt of healthcare services with an expanding evidence base that suggests great potential to increase access and support the transition from episodic to continuous care. In this model, patients, their families, and clinical team members use eHealth technologies that support functions (e.g., communication, behavior support, transactions) that are critical to disease prevention and health management which in turn influences behaviors, processes and outcomes.

In October 2016, the existing Office of Telehealth and the Connected Health Office will merge to create a single Office to oversee the implementation and evaluation of eHealth technologies across VHA. The new combined Connected Health/Telehealth Office will manage the full spectrum of technologies included in the current Offices of Telehealth (e.g., clinical video telehealth, home telehealth, tele-ICU) and Connected Health (e.g., patient portal, secure messaging, mobile apps), as well as new technologies that span these offices (such as the new Automated Telehealth Texting System). Recognizing the importance of rigorous evaluation to its mission, the Connected Health/Telehealth Office is pledging funds 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, as well as Veteran and clinical team experiences, healthcare processes, and Veteran health outcomes.

Developed in close consultation with Connected Health/Telehealth Office leadership, 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. The evaluation work associated with each of these two objectives will be guided by the Practical, Robust Implementation and Sustainability Model (PRISM).

The implementation and evaluation of eHealth technologies is not just the mission of the new Connected Health/Telehealth Office, it is also the vision of VHA. In addition to addressing the needs of the investigators' operational partner, the aforementioned objectives map to key strategies and transformational actions detailed in the Blueprint for Excellence, and align with a recently developed Virtual Access Strategy Document intended to guide the efforts of the Connected Health/Telehealth Office. The proposed eHealth PEI team includes leadership and investigators from the eHealth Quality Enhancement Research Initiative (QUERI) who are recognized authorities in informatics, implementation science, and mixed methods evaluation, and have longstanding, collaborative relationships with constituents in the Connected Health/Telehealth Office.

Study Type

Interventional

Enrollment (Actual)

1196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Birmingham VA Medical Center, Birmingham, AL
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City, UT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1: Supported Adoption Intervention (SAI)
Supported adoption intervention
Behavioral: Supported adoption intervention
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)
Other Names:
  • SAI
Active Comparator: Arm 2: General wellness information
General wellness information
Behavioral: Active comparator control
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
Other Names:
  • General wellness information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rate of Use
Time Frame: Baseline and Six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self-reported Access to Communication
Time Frame: Six month follow-up
To explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, "How easy is it for you to communicate with your doctor when you need to?" and, "How easy is it for you to get to see your nurse when you need to?" Responses to scale were 1= "Never", 2= "Sometimes", 3= "Usually", 4= "Always"; where "Always" was the best score.
Six month follow-up
Care Coordination: Patient Assessment of Chronic Illness Care
Time Frame: Six month follow-up
To explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response.
Six month follow-up
Physician Accessibility and Engagement
Time Frame: Six months
To explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant's perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = "Strongly Disagree" to 7 = "Strongly Agree"; where in all but one question - 1 = "Strongly Agree" is the desired response. Responses were totaled, inverting the one question and mean was determined.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Timothy Patrick Hogan, PhD MS BS, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEX 16-001
  • PEC 15-470 (Other Grant/Funding Number: Office of Connected Care)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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