Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04584528
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2020-10-06
Brief Title:
Implementing an Individualized Pain Plan IPP for ED Treatment of VOEs in Sickle Cell Disease
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Improving SCD Care Using Web-based Guidelines Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
Status:
COMPLETED
Status Verified Date:
2022-10
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:
ALIGN
Brief Summary:
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes VOEs in adult EDs We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans IPPs in the electronic health record EHR The EHR-embedded IPP will serve as a record of patients SCD genotype and will include analgesic medication recommendations developed by the SCD provider In this project we will provide access to the IPP for both adult patients with SCD and ED providers The proposed multisite study will use a pre-post study design with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice and patients will be invited to participate and enroll in the study We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach Effectiveness Adoption Implementation and Maintenance of the intervention
Detailed Description:
The study aims are as follows
Aim 1 Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting We will evaluate the effectiveness of the intervention on both patients and providers using a pre-post study design
Sub-aim 1a To examine effectiveness of the EHR-embedded IPP on improving patients perceived quality of ED pain treatment We hypothesize that among enrolled patients with at least one ED VOE visit during the intervention period the perceived quality of ED pain treatment will increase by 05 standard deviation primary outcome after an ED VOE visit when compared with the last ED VOE visits made by these patients within 90 days before enrollment We will measure change pre- and post-intervention in secondary patient outcomes including hospital admission rate within 12 months ED VOE revisit rate ED VOE readmission rate and time to first dosage of pain medication provided in the ED
Sub-aim 1b To examine the effectiveness of the EHR-embedded IPP on improving providers self-efficacy in treating pain for patients with SCD and perceived quality of ED pain treatment We hypothesize that the intervention will increase providers self-efficacy in treating VOEs and managing pain for patients with SCD when compared with self-efficacy before the intervention We will also explore the effect of the intervention on ED providers perceived quality of ED pain treatment
Aim 2 Assess the reach adoption implementation and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site We will use the RE-AIM framework to evaluate intervention outcomes in addition to intervention effectiveness
Sub-aim 2a To assess the reach of the EHR-embedded IPP We will assess the reach of the intervention at the patient level by examining the proportion of patients enrolled in the study among all patients the team has reached out to recruit and at the clinic level by examining the proportion of clinics participating in the intervention
Sub-aim 2b To assess the adoption and implementation of the EHR-embedded IPP and track implementation strategies adopted by each site We will assess the adoption of the intervention by examining characteristics of individual EDs that participate relative to the number of individual EDs affiliated with each study site who could have been recruited We will assess implementation fidelity and outcomes such as the proportion of eligible hematologists and nurse practitioners who receive IPP training number of IPPs written and included in the EHR required and optional intervention elements that are implemented as planned IPP use by patients and providers provider IPP adherence and patients and providers perceived ease of use of the IPPs We will track and report strategies used by participating sites through both quantitative data collection and qualitative interviews
Sub-aim 2c To assess the intent to continue using the IPP from a multi-stakeholder perspective We will assess patients and providers intent to continue using the IPP during the implementation period At the end of the intervention we will assess ED administrators intent to continue using the IPP
Aim 3 Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs We will perform a Readiness Assessment to measure organization- and staff-level readiness at the beginning of the intervention to inform the selection and adaptation of implementation strategies We will assess facilitators and barriers in adopting and implementing the IPPs from multiple stakeholder perspectives patients providers and ED administrators
Embedding IPPs in the EHR that are accessible to both ED providers and patients is a promising intervention to support the NHLBI evidence-based recommendations to guide treatment of VOE in the ED setting and improve quality of pain treatment in the ED and better patient outcomes If EHR-embedded IPPs implemented and evaluated in this study show preliminary effectiveness they could be scaled up within SCDIC Centers and expanded to other institutions outside the SCDIC The results of this proposed study will accelerate the uptake of the NHLBI recommendation and establish standardized treatment in EDs for patients with SCD
Aim 1 Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting We will evaluate the effectiveness of the intervention on both patients and providers using a pre-post study design
Sub-aim 1a To examine effectiveness of the EHR-embedded IPP on improving patients perceived quality of ED pain treatment We hypothesize that among enrolled patients with at least one ED VOE visit during the intervention period the perceived quality of ED pain treatment will increase by 05 standard deviation primary outcome after an ED VOE visit when compared with the last ED VOE visits made by these patients within 90 days before enrollment We will measure change pre- and post-intervention in secondary patient outcomes including hospital admission rate within 12 months ED VOE revisit rate ED VOE readmission rate and time to first dosage of pain medication provided in the ED
Sub-aim 1b To examine the effectiveness of the EHR-embedded IPP on improving providers self-efficacy in treating pain for patients with SCD and perceived quality of ED pain treatment We hypothesize that the intervention will increase providers self-efficacy in treating VOEs and managing pain for patients with SCD when compared with self-efficacy before the intervention We will also explore the effect of the intervention on ED providers perceived quality of ED pain treatment
Aim 2 Assess the reach adoption implementation and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site We will use the RE-AIM framework to evaluate intervention outcomes in addition to intervention effectiveness
Sub-aim 2a To assess the reach of the EHR-embedded IPP We will assess the reach of the intervention at the patient level by examining the proportion of patients enrolled in the study among all patients the team has reached out to recruit and at the clinic level by examining the proportion of clinics participating in the intervention
Sub-aim 2b To assess the adoption and implementation of the EHR-embedded IPP and track implementation strategies adopted by each site We will assess the adoption of the intervention by examining characteristics of individual EDs that participate relative to the number of individual EDs affiliated with each study site who could have been recruited We will assess implementation fidelity and outcomes such as the proportion of eligible hematologists and nurse practitioners who receive IPP training number of IPPs written and included in the EHR required and optional intervention elements that are implemented as planned IPP use by patients and providers provider IPP adherence and patients and providers perceived ease of use of the IPPs We will track and report strategies used by participating sites through both quantitative data collection and qualitative interviews
Sub-aim 2c To assess the intent to continue using the IPP from a multi-stakeholder perspective We will assess patients and providers intent to continue using the IPP during the implementation period At the end of the intervention we will assess ED administrators intent to continue using the IPP
Aim 3 Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs We will perform a Readiness Assessment to measure organization- and staff-level readiness at the beginning of the intervention to inform the selection and adaptation of implementation strategies We will assess facilitators and barriers in adopting and implementing the IPPs from multiple stakeholder perspectives patients providers and ED administrators
Embedding IPPs in the EHR that are accessible to both ED providers and patients is a promising intervention to support the NHLBI evidence-based recommendations to guide treatment of VOE in the ED setting and improve quality of pain treatment in the ED and better patient outcomes If EHR-embedded IPPs implemented and evaluated in this study show preliminary effectiveness they could be scaled up within SCDIC Centers and expanded to other institutions outside the SCDIC The results of this proposed study will accelerate the uptake of the NHLBI recommendation and establish standardized treatment in EDs for patients with SCD
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01HL133964-05 | NIH | None | httpsreporternihgovquickSearch5U01HL133964-05 |