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| Name | Class |
|---|---|
| VA Office of Connected Care | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Texters | No Intervention | Patients did not receive the automated text messaging system "Annie" | |
| Texters | Active Comparator | Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Annie text messaging system | Other | Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Patrick Hogan, PhD MS BS | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Christopher Gillespie, PhD MA BS | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Donald K McInnes, ScD MS BA | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34779779 | Derived | 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. | |
| 31444872 |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-texters | Patients who did not receive the automated text messaging system "Annie" |
| FG001 | Texters | Patients who did receive the automated text messaging system "Annie" 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2017 |
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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.
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Patients and providers did not know which facilitation group they were in
| Annie text messaging system with Usual implementation | 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 | 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 |
|
| Derived |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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"Non-texters" could come from UI or AI clinics (patients who agreed to participate in the project but never completed the last step of authenticating themselves with the aTS, and thus never received any text messages), as well as from the two comparison clinics that did not implement the aTS. "Texter" could come from either UI or AI clinics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Texters | Patients did not receive the automated text messaging system "Annie" |
| BG001 | Texters | Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The 30 are those in the 2 arms who were analyzed. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | we did not have demographic characteristics for the overall population | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | The 30 are those in the 2 arms who were analyzed. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Post (after 12 weeks of Annie text messaging use) |
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1 year
Definition is consistent with clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-texters | Patients who did not receive Annie text messages for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. | 0 | 125 | 0 | 125 | 0 | 125 |
| EG001 | Texters | Patients who did receive Annie text messages for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. | 0 | 625 | 0 | 625 | 0 | 625 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vera Yakovchenko | VA | 7816873374 | vera.yakovchenko@va.gov |
| Jul 12, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| White |
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| Other |
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