Clinical trial NCT04584528: Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Genetic Disease
Hematologic Diseases
Anemia, Sickle Cell
Keywords: sickle cell disease
vaso occlusive-episodes
Individualized Pain Plans
implementation science
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: RTI International
First posted: 2020-10-14
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Change in Patient-perceived quality of ED pain treatment.
timeFrame: Baseline, 96 hours
Secondary outcomes:
measure: ED revisit rate as measured by EHR retrieval
timeFrame: Day 7
measure: ED revisit rate as measured by EHR retrieval
timeFrame: Day 30
measure: Hospital readmission rate measured by EHR retrieval
timeFrame: Day 7
measure: Hospital readmission rate measured by EHR retrieval
timeFrame: Day 30
measure: Time to first dose of pain medication measured by EHR retrieval
timeFrame: Baseline
Other outcomes:
Locations:
city: Oakland
country: United States
facility: University of California San Francisco
state: California
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: St. Jude's
state: Tennessee
Study officials:
affiliation: Duke University School of Nursing
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo L, King AA, Carroll Y, Baumann AA, Brambilla D, Carpenter CR, Colla J, Gibson RW, Gollan S, Hall G, Klesges L, Kutlar A, Lyon M, Melvin CL, Norell S, Mueller M, Potter MB, Richesson R, Richardson LD, Ryan G, Siewny L, Treadwell M, Zun L, Armstrong-Brown J, Cox L, Tanabe P. Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study. JMIR Res Protoc. 2021 Apr 16;10(4):e24818. doi: 10.2196/24818.