Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
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.
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.
Patient Inclusion Criteria:

 -  Age 18 years up to and including 45 years

 -  English speaking

 -  Confirmed SCD diagnoses . Confirmed is defined as supported by documentation in the
 medical record of a positive test for one of the following : Hb SS, Hb SC, Hb S
 -thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.

 -  Access to a cellular/mobile smart phone with access to text messaging (either Android
 or iPhone acceptable) .

 -  At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency
 Department (ED) the past 90 days from enrollment

 -  At least one visit at the study site sickle cell disease clinic within the past 12
 months

 -  Willing and cognitively able to give informed consent

 Patient Exclusion criteria:

 -  Patient's sickle cell provider states patient should not have a protocol or should not
 be administered opioids

 Provider Inclusion Criteria:

 -  Provides pain treatment in one of the participating study Emergency Departments for a
 patient participant with a qualified ED visit .