Developing an Intervention to Optimize Virtual Care Adoption for COPD Management
NCT ID: NCT05986214
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-03-01
2028-08-31
Brief Summary
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Detailed Description
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Setting and design.
This feasibility pilot will be conducted at the VA Bedford and/or Boston Healthcare Systems. This pilot study will use quantitative data to assess patient and team perceptions of feasibility and acceptability, and preliminary effectiveness of the intervention. VC-OPTIONS will include patient- and team-facing strategies. The core component will be the delivery of educational content about VC for COPD via Annie text messaging. Other patient- and healthcare team-facing strategies will be refined in prior, preparatory aims.
Patient level. 40 eligible and interested Veterans will be assigned to the core patient-facing implementation strategy, the Annie texting protocol. Preparatory work will shape final length of protocol, content, and frequency of messages. The texting protocol as currently envisioned will span 12 weeks (1 module \[Appendix 5\] with up to 5 messages per week, and 2 messages every 4 weeks that ask about behavioral intention). Participants will receive compensation for initial baseline assessments and additional compensation after completion of the follow-up assessments.
Team-level. Pre-implementation meetings with local clinical team stakeholders (e.g., leadership, clinical team members, local telehealth/connected care coordinators) will be held to discuss site-level needs and contextual factors. Potential team-facing strategy components, developed during preparatory aims, will be presented and discussed to reach consensus and finalize the team-facing strategy components that are tailored to the site-level needs and resources.
Data collection. Patient-level. Recruitment procedures will be evaluated to inform a subsequent larger trial by examining how many potential participants agreed to participate in the intervention (feasibility and acceptability), and documenting reasons Veterans declined to participate. Participants will complete a baseline survey in person or over the phone to gather participant characteristics, VC awareness, current use of VC, and intent to use VC. Using Annie's two-way texting feature and dashboard, objective data will be collected on participant engagement during the protocol (i.e., how frequently participants respond to the texts, which patients received which modules, and completion rates). Engagement will also be assessed via survey at the post-evaluation. After completion of the texting protocol and clinical visit, data will be obtained via survey on the feasibility and acceptability of the core implementation component using the Feasibility of Intervention, Acceptability of Intervention, and Intervention Appropriateness measures. Preliminary effectiveness data will be gathered via surveys and clinical chart review on participants' awareness of VC, intention to adopt one or more VC options, intention to discuss VC with their clinical team, occurrence of patient-team communication about VC, and impact on COPD management.
Team-level. Clinical team perceptions of feasibility and acceptability will be measured quantitatively, such as through a brief survey to clinical team members who were exposed to the implementation components (e.g., those who attended the educational meetings, those who participated in clinical visits with participants who were enrolled in the texting protocol). Engagement will be measured by examining attendance of educational meetings. Preliminary effectiveness outcomes data will also be collected, including survey and chart-review to identify occurrence of conversations with patients about VC services (anticipated primary outcome of future IIR) and referrals to the Virtual Health Resource Centers or telehealth services and surveys to evaluate awareness of VC services before/after strategy deployment.
Data analysis. Summary statistics will be used to examine measurements and assess for perceptions of feasibility, acceptability, and preliminary effectiveness of the implementation strategy. The strategy components (the texting protocol, recruitment, and data collection procedures) will further be refined based on what is learned. Inferential analyses (paired t-tests or Wilcoxon signed rank tests) will be used to estimate effect sizes of changes between pre/post timepoints within individual participant. This feasibility pilot is not intended or powered to detect statistically significant changes in outcomes. Additionally, this pilot with no prospective control arm cannot definitively ascertain whether VC-OPTIONS causes leads to changes in effectiveness. These preliminary analyses seek to inform the design and generate effect size estimates.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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VC-OPTIONS
Participants will be enrolled in the Annie texting VC-OPTIONS protocol
VC-OPTIONS
Participants will be enrolled in the Annie texting VC-OPTIONS protocol
Interventions
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VC-OPTIONS
Participants will be enrolled in the Annie texting VC-OPTIONS protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* US Veteran
* COPD diagnosis
* the ability to speak and understand English
* own a text-enabled phone
Exclusion Criteria
40 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Stephanie Robinson, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Bedford HealthCare System, Bedford, MA
Locations
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VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDA 21-187
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDX 23-001
Identifier Type: -
Identifier Source: org_study_id
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