Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05986214
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-07-31
Brief Title:
Developing an Intervention to Optimize Virtual Care Adoption for COPD Management
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing an Intervention to Optimize Virtual Care Adoption for COPD Management CDA 21-187
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VC-OPTIONS
Brief Summary:
VA is a leader in virtual care VC including the patient portal mobile apps and telehealth programs VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease COPD However adoption of many VC services has been slow Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC This study will develop refine and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC referred to as VC-OPTIONS Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial The core component of VC-OPTIONS will be the provision of information via VAs Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management It is hypothesized that this strategy will be acceptable and feasible This work will improve patient and team awareness of and communication about VC services and support patient access to VC services for COPD management
Detailed Description:
VA is a leader in virtual care VC including the patient portal mobile apps and telehealth programs VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease COPD However adoption of many VC services has been slow Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC This study will develop refine and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC referred to as VC-OPTIONS Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support This single-arm pilot will assess the feasibility and acceptability of VC-OPTIONS as well as engagement and preliminary effectiveness specific to VC adoption such as change in patient awareness of VC services The investigators hypothesize that developing educational content about VC that can be delivered via text messaging will be an effective way to empower Veterans with knowledge and support them in their decision to adopt VC if they are interested
Setting and design
This feasibility pilot will be conducted at the VA Bedford andor 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 eg leadership clinical team members local telehealthconnected 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 Annies two-way texting feature and dashboard objective data will be collected on participant engagement during the protocol ie 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 eg 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 beforeafter 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 prepost 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
Setting and design
This feasibility pilot will be conducted at the VA Bedford andor 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 eg leadership clinical team members local telehealthconnected 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 Annies two-way texting feature and dashboard objective data will be collected on participant engagement during the protocol ie 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 eg 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 beforeafter 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 prepost 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDA 21-187 | OTHER_GRANT | VA HSRD | None |