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

NCT ID: NCT03898349

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-09-30

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Non-Texters

Patients did not receive the automated text messaging system "Annie"

Group Type: NO_INTERVENTION

No interventions assigned to this group

Texters

Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.

Group Type: ACTIVE_COMPARATOR

Annie text messaging system

Intervention Type: OTHER

Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.

Annie text messaging system with Usual implementation

Intervention Type: OTHER

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

Annie text messaging system with Augmented implementation

Intervention Type: OTHER

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

Interventions

Annie text messaging system

Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Connected Care

UNKNOWN

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Patrick Hogan, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Christopher Gillespie, PhD MA BS

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Donald K McInnes, ScD MS BA

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34779779 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31444872 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PEX 19-001

Identifier Type: -

Identifier Source: org_study_id