Clinical trial NCT02222246: Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Official title: Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Emergency Department
Vaso-occlusive Crisis
Pain Management
Pilot Project
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Cincinnati
name: Mount Sinai Hospital, New York
First posted: 2014-08-21
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.

Detailed description: In August 2012 the National Heart, Lung, and Blood Institute (NHBLI) released for public comment their "Management of Sickle Cell Disease" evidence-based recommendations that were developed with consensus panel expertise. Because of a lack of empirical data, most of the recommendations specific to vaso-occlusive crises (VOC) were based on consensus panel expertise. Recommendations included the use of a patient-specific protocol (specific agents and doses for an individual patient). While many attempts have been made to implement patient-specific analgesic protocols for use in emergency departments (EDs), anecdotally, these have been difficult to implement and maintain over time; a practical approach to development, implementation, and dissemination has not been determined. As patient-specific protocols are not available in most EDs, the guidelines go on to recommend a SCD specific standard analgesic protocol. Both of these recommended protocols provide more aggressive VOC pain management than a typical generic ED pain protocol. However, there is an urgent need to rigorously test the NHLBI recommendations and compare the two approaches for managing VOC in the ED. A large randomized clinical trial (RCT) is essential to test these protocols.

This pilot project will compare these two different, evidence-based, protocols which include opioid pain medicines routinely used as standard of care to treat VOC pain in the ED for individuals with SCD, and collect the data necessary to determine if a large RCT is feasible and required. This study is novel in that it will design an approach to develop and implement patient-specific and standard analgesic VOC protocols for use in the ED, will develop a bundle of information technology and education interventions to enhance protocol adoption for the pilot RCT, and also be the first RCT conducted in an ED setting to compare two different ED pain management protocols for SCD patients who experience a VOC.

The study consists of 3 aims:

1. Develop and implement patient specific VOC protocols for patients randomized to this arm,
2. Conduct a pilot RCT to determine the necessary sample size needed for a large RCT to compare the difference in reduction in pain score from ED arrival to discharge, hospitalization, clinical and safety outcomes, between subjects assigned randomly to either a standard SCD analgesic protocol or to a patient-specific analgesic protocol,
3. Measure feasibility of methods and acceptability of and fidelity to protocols by evaluating optimal recruitment and retention strategies, and assessing ED providers perceptions of facilitators and barriers to protocol use and protocol adherence.

The soon to be published NHBLI guidelines for managing SCD will be used as the standard protocol with the modification of basing the initial dose of pain medicine on patient weight. The standard protocol will recommend re-assessment, and re-dosing with possible dose escalation, every 20-30 minutes. Repeat doses for patients randomized to the weight-based protocol, when necessary, will be maintained or provided at 1 dose level increase (no more than 25%) above the initial dose. For patients randomized to the patient -specific protocol, the SCD provider has experience with the individual patient and is best qualified to make dosing and frequency recommendations based upon doses required during past ED and hospital visits for treatment of VOC, and on daily opioid use if applicable. There is no set maximum dose for patients randomized to the patient-specific protocols.

Both the patient-specific and standard protocols will be available in the ED via a patient's electronic medical record. Upon ED arrival, providers will retrieve the patient's study protocol (patient-specific, or standard) which will include the starting agents, and doses, the subsequent analgesic recommendations, and order medications according to the pre-determined protocol.

The study will be conducted at the emergency departments of the University of Cincinnati Medical Center and the Mt. Sinai Hospital in New York. Patients will be enrolled in the study for up to 12-months, but may contribute no more that five different ED visits for VOC pain control during enrollment to allow for a larger number of different patients.

Study outcomes will be compared between ED visits of patients randomized to a patient-specific vs. a standard SCD protocol. The primary outcome will be the difference in pain score from ED arrival to discharge, up to 6 hours, as measured using a visual analogue scale. The trajectories of average pain scores from immediately prior to administration of 1st analgesic dose to discharge by 30 minute increments for each treatment group will also be calculated.

Eligibility criteria: Inclusion Criteria:

* Adult SCD patients with genotypes SS, SC, SB+, or SB-

Exclusion Criteria:

* Patients with sickle cell trait
* Allergic to both morphine sulfate and hydromorphone,
* Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control,
* Non-English speaking,
* Patients admitted for a medical complication,
* Record of \>24 ED visits in the prior 12 months,
* Children

Primary outcomes:
measure: Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)
timeFrame: Arrival in ED to discharge from the ED, up to 6 hours
Secondary outcomes:
measure: Change in Pain Visual Analogue Scale (VAS) Scores Over Time
timeFrame: Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours
measure: Incidence of Nausea During Emergency Department Visits
timeFrame: From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours
measure: Incidence of Vomiting During Emergency Department Visits
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of Respiratory Distress (YES) During Emergency Department Visit
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of Sedation During Emergency Department Visit
timeFrame: From placement in ED treatment room to discharge from the ED, up to 6 hours
measure: Incidence of the Need for Supplemental Oxygen During Emergency Department Visit
timeFrame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
measure: Incidence of the Administration of Naloxone During Emergency Department Visit
timeFrame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
measure: Incidence of the Need for Assistive Ventilation
timeFrame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Duke University School of Nursing
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References: