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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

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Annie text messaging system Other: Annie text messaging system with Usual implementation Other: Annie text messaging system with Augmented implementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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
Official Title: Evaluation of the Initial Deployment of VA's Annie Texting System (PEC 15-470)
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898349


Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
VA Office of Research and Development
VA Office of Connected Care
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03898349     History of Changes
Other Study ID Numbers: PEX 19-001
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Automated Text Messaging System
Implementation science
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections