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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Annie text messaging system
* Other: Annie text messaging system with Usual implementation
* Other: Annie text messaging system with Augmented implementation


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Texters<br>Patients did not receive the automated text messaging system Annie | |
| Active Comparator: Texters<br>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<br>* Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.<br>Other: Annie text messaging system with Usual implementation<br>* 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<br>Other: Annie text messaging system with Augmented implementation<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Automated Text Messaging System, Implementation science, Hepatitis C