Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | December 2016 |
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.
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.
In August 2012 the National Heart, Lung, and Blood Institute 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.
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.
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
We found this trial at
2
sites
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234 Goodman Dr
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
(513) 584-1000
Phone: 513-584-5700
University of Cincinnati Medical Center Opening in 1823 as the country
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