eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System (AnnieEval)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Annie text messaging system
Annie text messaging system with Usual implementation
Annie text messaging system with Augmented implementation
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis C focused on measuring Automated Text Messaging System, Implementation science, Hepatitis C
Eligibility Criteria
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
Sites / Locations
- VA Bedford HealthCare System, Bedford, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Non-Texters
Texters
Arm Description
Patients did not receive the automated text messaging system "Annie"
Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
Outcomes
Primary Outcome Measures
Perception of HCV Treatment Success
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03898349
First Posted
March 20, 2019
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Office of Connected Care
1. Study Identification
Unique Protocol Identification Number
NCT03898349
Brief Title
eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
Acronym
AnnieEval
Official Title
Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Office of Connected Care
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Automated Text Messaging System, Implementation science, Hepatitis C
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Four facilities were randomized to serve as intervention sites and receive 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. 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.
Masking
ParticipantCare Provider
Masking Description
Patients and providers did not know which facilitation group they were in
Allocation
Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Texters
Arm Type
No Intervention
Arm Description
Patients did not receive the automated text messaging system "Annie"
Arm Title
Texters
Arm Type
Active Comparator
Arm Description
Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
Intervention Type
Other
Intervention Name(s)
Annie text messaging system
Intervention Description
Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
Intervention Type
Other
Intervention Name(s)
Annie text messaging system with Usual implementation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Annie text messaging system with Augmented implementation
Intervention Description
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
Primary Outcome Measure Information:
Title
Perception of HCV Treatment Success
Description
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.
Time Frame
Post (after 12 weeks of Annie text messaging use)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Patrick Hogan, PhD MS BS
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Gillespie, PhD MA BS
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald K McInnes, ScD MS BA
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730-1114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34779779
Citation
Yakovchenko V, McInnes DK, Petrakis BA, Gillespie C, Lipschitz JM, McCullough MB, Richardson L, Vetter B, Hogan TP. Implementing Automated Text Messaging for Patient Self-management in the Veterans Health Administration: Qualitative Study Applying the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability Framework. JMIR Mhealth Uhealth. 2021 Nov 15;9(11):e31037. doi: 10.2196/31037.
Results Reference
derived
PubMed Identifier
31444872
Citation
Yakovchenko V, Hogan TP, Houston TK, Richardson L, Lipschitz J, Petrakis BA, Gillespie C, McInnes DK. Automated Text Messaging With Patients in Department of Veterans Affairs Specialty Clinics: Cluster Randomized Trial. J Med Internet Res. 2019 Aug 4;21(8):e14750. doi: 10.2196/14750.
Results Reference
derived
Learn more about this trial
eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
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