JMIR Publications

ABSTRACT

Background:

Individuals living with sickle cell disease (SCD) often require aggressive treatment of pain associated with vaso-occlusive episodes (VOEs) in the emergency department (ED). Frequently pain relief is poor. The 2014 National Heart, Lung, and Blood Institute (NHLBI) evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of VOEs. This study will implement an Electronic Health Record (EHR)–embedded individualized pain plan (E-IPP) with provider and patient access in the EDs of eight US academic centers to improve pain treatment for adult patients with SCD.

Objective:

This study will assess the overall effects of E-IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting and explore barriers and facilitators to the implementation process.

Methods:

A pre-post implementation study is being conducted by all eight sites that are members of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). Adults with SCD aged 18–45 who had an ED visit within 90 days prior to enrollment will be eligible for inclusion. Patients are enrolled in-clinic or remotely. This study’s target analytical sample size is 160 patient participants, 20 for each site, who have had an ED visit for VOE treatment at participating EDs during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The E-IPPs will be written by the patient’s SCD provider, and sites will work with the local informatics team to identify the best method to build the E-IPP with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an ED VOE visit, and selected qualitative interviews within two weeks of an ED visit will be performed to assess the primary outcome, patient perceived quality of ED pain treatment, and additional implementation and intervention outcomes. EHR data will be used to analyze ED provider E-IPP adherence and additional secondary outcomes, such as hospital admission and re-admission rates.

Results:

The study is currently enrolling study participants. The active implementation period is 18 months.

Conclusions:

This study proposes a structured, framework-informed approach to implement an E-IPP with both patient and provider access in routine ED practice. The results of the study will inform the implementation of E-IPPs at a larger scale outside of SCDIC centers. Clinical Trial: ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528