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

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ClinicalTrials.gov Identifier: NCT03898349
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
VA Office of Connected Care
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Treatment adherence (HCV medication) [ Time Frame: Post (after 12 weeks of Annie text messaging use) ]
HCV medication adherence via text message response rates (worse 0-100% better)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
User experiences (System Usability Scale) [ Time Frame: Post (after 12 weeks of Annie text messaging use) ]
Automated text messaging system usability as measured by System Usability Scale (score: below 0-100 above)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
Official Title  ICMJE Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: Double (Participant, Care Provider)
Masking Description:
Patients and providers did not know which facilitation group they were in
Primary Purpose: Health Services Research
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • 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.
  • Other: 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
  • Other: 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
Study Arms  ICMJE
  • No Intervention: Control
    Two control sites did not receive the automated text messaging system "Annie"
  • Active Comparator: 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
    Interventions:
    • Other: Annie text messaging system
    • Other: Annie text messaging system with Usual implementation
  • Experimental: 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
    Interventions:
    • Other: Annie text messaging system
    • Other: Annie text messaging system with Augmented implementation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2019)
71
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898349
Other Study ID Numbers  ICMJE PEX 19-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE VA Office of Connected Care
Investigators  ICMJE
Principal Investigator: Timothy Patrick Hogan, PhD MS BS Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Christopher Gillespie, PhD MA BS Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Donald K McInnes, ScD MS BA Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP