Hepatitis CAnnieEvalNCT03898349
eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
A study testing Annie text messaging system, Annie text messaging system with Usual implementation and Annie text messaging system with Augmented implementation in people with Hepatitis C, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Annie text messaging system, Annie text messaging system with Usual implementation and Annie text messaging system with Augmented implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Starting HCV treatment at a VA clinic
- Have access/ability to text messaging
Who cannot join
- Not being treating for HCV
- No access/ability to use a cell phone
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
About this study
Official title: Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
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.
Read the 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
- Being tested
- Annie text messaging system, Annie text messaging system with Usual implementation, Annie text messaging system with Augmented implementation
- Keywords
- Automated Text Messaging System, Implementation science, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annie text messaging systemOther
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 implementationOther
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 implementationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Annie text messaging system; Other: Annie text messaging system with Usual implementation; Other: Annie text messaging system with Augmented implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post (after 12 weeks of Annie text messaging use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Oct 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Connected Care
- Responsible party
- Sponsor
- Investigators
- Timothy Patrick Hogan, PhD MS BS, Principal investigator, VA Bedford HealthCare System, Bedford, MAChristopher Gillespie, PhD MA BS, Principal investigator, VA Bedford HealthCare System, Bedford, MADonald K McInnes, ScD MS BA, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898349
- Sponsor's protocol ID
- PEX 19-001
- Acronym
- AnnieEval
- Status last verified
- Jul 2023
- First submitted
- 20 Mar 2019
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34779779Yakovchenko 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.
PubMed 31444872
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
- ClinicalTrials.gov ID
- NCT03898349
- Acronym / sponsor ID
- AnnieEval / PEX 19-001
- Conditions
- Hepatitis C
- Keywords
- Automated Text Messaging System, Implementation science, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Office of Connected Care
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Texters | No intervention | –Patients did not receive the automated text messaging system "Annie" |
| Texters | Active comparator | Other: Annie text messaging system, Other: Annie text messaging system with Usual implementation, Other: Annie text messaging system with Augmented implementationPatients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Starting HCV treatment at a VA clinic
- Have access/ability to text messaging
Key exclusion criteria (2 listed)
- Not being treating for HCV
- No access/ability to use a cell phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annie text messaging systemAnnie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. | Other | Texters |
| Annie text messaging system with Usual implementationThree 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 | Other | Texters |
| Annie text messaging system with Augmented implementationFour 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 | Other | Texters |
Primary outcome
Perception of HCV Treatment Success
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34779779Yakovchenko 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.
- Derived from this study: PubMed 31444872Yakovchenko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Patrick Hogan, PhD MS BS principal investigator
VA Bedford HealthCare System, Bedford, MA
Christopher Gillespie, PhD MA BS principal investigator
VA Bedford HealthCare System, Bedford, MA
Donald K McInnes, ScD MS BA principal investigator
VA Bedford HealthCare System, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annie text messaging system, Annie text messaging system with Usual implementation and Annie text messaging system with Augmented implementation in people with Hepatitis C, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of HCV Treatment Success (time frame: Post (after 12 weeks of Annie text messaging use)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.