Hepatitis C
Conditions
Keywords
Automated Text Messaging System, Implementation science, Hepatitis C
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.
Interventions
OTHERAnnie text messaging system
Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
OTHERAnnie 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
OTHERAnnie 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
Sponsors
VA Office of Connected Care
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients and providers did not know which facilitation group they were in
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perception of HCV Treatment Success | Post (after 12 weeks of Annie text messaging use) | 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. |
Countries
United States
Participant flow
Recruitment details
This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).
Participants by arm
| Arm | Count |
|---|---|
| Non-Texters Patients did not receive the automated text messaging system Annie | 15 |
| Texters Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Non-Texters | Texters | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11 | 62 years STANDARD_DEVIATION 6 | 62 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized African American or Black | 6 Participants | 13 Participants | 19 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 625 |
| other Total, other adverse events | 0 / 125 | 0 / 625 |
| serious Total, serious adverse events | 0 / 125 | 0 / 625 |
Outcome results
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.
Time frame: Post (after 12 weeks of Annie text messaging use)
Population: This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-texters | Perception of HCV Treatment Success | 8 Participants |
| Texters | Perception of HCV Treatment Success | 13 Participants |