eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System (AnnieEval)

July 19, 2023 updated by: VA Office of Research and Development

Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)

Conduct a rigorous formative evaluation of the initial deployment of the Annie texting system across several pilot test sites and from these findings, develop and test an augmented implementation strategy to facilitate more rapid adoption of Annie across VA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators examined patient and provider experiences with VA's automated text messaging system, named "Annie". The investigators aimed to describe early experiences using Annie and subsequently pilot and evaluate an augmented implementation strategy to improve implementation of the system. Then, seven new facilities implemented Annie. The investigators focused on specialty clinics serving patients with hepatitis-C virus (HCV). Working in collaboration with clinical team members and other Office of Connected Care stakeholders, the investigators developed a texting protocol for Veterans with HCV that included motivational messages, medication and lab appointment reminders. This protocol was made available to the seven new facilities. Four facilities were randomized to serve as intervention sites to receive augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance, described below. An additional three comparison sites received usual implementation of Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls run by the Office of Connected Care. Two control sites did not receive Annie. The investigators conducted a mixed-methods evaluation including pre and post patient and provider surveys and semi-structured interviews, medical chart abstraction, and process measure analysis. The investigators collected data on patient and clinician experiences with the Annie system, including usability, clinical workflow fit, and clinical benefits such as improved HCV medication adherence and rates of appropriately timed lab tests.

Study Type

Interventional

Enrollment (Actual)

750

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
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730-1114
        • VA Bedford HealthCare System, Bedford, MA

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Starting HCV treatment at a VA clinic
  • Have access/ability to text messaging

Exclusion Criteria:

  • Not being treating for HCV
  • No access/ability to use a cell phone

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-Texters
Patients did not receive the automated text messaging system "Annie"
Active Comparator: Texters
Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
Other: Annie text messaging system
Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
Other: Annie text messaging system with Usual implementation
Three comparison sites received usual implementation of the automated text messaging system "Annie" only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls
Other: Annie text messaging system with Augmented implementation
Four facilities received the automated text messaging system "Annie" and our augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of HCV Treatment Success
Time Frame: Post (after 12 weeks of Annie text messaging use)
The primary goal of the automated text messaging system is to improve patient self-management. As such, we measured illness perception and patient activation using a validated instrument adapted for HCV (Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med 2008;6(3):246-252). The item "Feeling that I am failing with my HCV treatment" represents patient perceptions about their ability to take medications as prescribed and reflects concerns about failing HCV treatment.
Post (after 12 weeks of Annie text messaging use)

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Collaborators

VA Office of Connected Care

Investigators

  • Principal Investigator: Timothy Patrick Hogan, PhD MS BS, VA Bedford HealthCare System, Bedford, MA
  • Principal Investigator: Donald K McInnes, ScD MS BA, VA Bedford HealthCare System, Bedford, MA
  • Principal Investigator: Christopher Gillespie, PhD MA BS, VA Bedford HealthCare System, 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

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)

October 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEX 19-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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