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

Hepatitis C Clinical Trial

— AnnieEval  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898349
• Other study ID #: PEX 19-001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Office of Connected Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post (after 12 weeks of Annie text messaging use)