Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
Condition: Sickle Cell Disease; Genetic Disease; Hematologic Diseases; Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Hematologic Diseases; Genetic Diseases, Inborn
Study type: Interventional

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 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.
    

Intervention name(s): Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)
Intervention type(s): Other
Intervention description(s): The IPPs will be developed by the Sickle Cell Disease providers at each study site based on patients' outpatient chronic opioid use and analgesic agent normally required for treatment of VOE in the ED. The Sickle Cell Disease provider will review the IPP with the patient, then upload the IPP to the patient's EHR in a location that will be accessible by the patient and ED provider. Each participating site will train patients and Emergency Department (ED) providers on how to access the IPP in the Electronic Health Record. The following required elements will be included in the EHR-embedded IPP:
Genotype
Individual pain plan-preferred analgesic agent, route, dose and dosing interval, last update time
Name and contact information for the SCD provider
If the enrolled patient has a VOE visit at a nonparticipating ED, the patient will be able to access their IPP via the web or the patient portal app through their EHR. However, data will not be collected from these visits.
Intervention model: Sequential Assignment
Intervention model description: Multi-site pre-post study design, with a core set of mandatory patient and provider intervention strategies for each participating site, and optional strategies to allow for intervention adaptation to local needs and resources.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sickle cell disease; vaso occlusive-episodes; Individualized Pain Plans; implementation science