Clinical trial NCT03898349: eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
Official title: Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Automated Text Messaging System
Implementation science
Hepatitis C
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Office of Connected Care
First posted: 2019-04-02
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Perception of HCV Treatment Success
timeFrame: Post (after 12 weeks of Annie text messaging use)
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Timothy Patrick Hogan, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Christopher Gillespie, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Donald K McInnes, ScD MS BA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.