Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04584528 |
Other study ID # |
Pro00073506_1 |
Secondary ID |
5U01HL133964-05 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 27, 2020 |
Est. completion date |
October 1, 2022 |
Study information
Verified date |
October 2022 |
Source |
Duke University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 1.a. 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 0.5 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 1.b. 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 2.a. 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 2.b. 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 2.c. 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.