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FractureNCT00115180

Racial and Ethnic Disparities in Acute Pain Control

An observational study of Fracture and Pain, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We aim to compare pain management among three groups of ethnic disparity (ED) patients, Hispanics, non-Hispanic Blacks, non-Hispanic Whites, and assess whether the observed association between pain management and race/ethnicity is independent of potentially important confounding variables (e.g., age, sex, insurance… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Fracture, Pain
How many people
285 participants
Where
2 sitesUnited States
Study dates
Sep 2003to Nov 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Emergency Department patients with radiologically confirmed long bone fractures

Who may be able to join

  • 18 to 55 years;
  • Acute pain starting no more than 24 hours before presenting to the ED;
  • Have isolated long-bone fracture documented on x-ray;
  • Have a complaint of pain at triage or complaining of pain to the physician;
  • English and Spanish speaking

Who cannot join

  • Participating in another clinical study at the same site time of entry;
  • Unable to complete the pain intensity scale, or complete the questionnaire because of inability to understand the task and questions;
  • Intoxication with alcohol or other drug;
  • Pregnancy;
  • Methadone use;
  • Use of opioids or tramadol in past seven days;
  • Patients who are allergic to any analgesics;
  • Patients with a chronic pain syndrome (sickle cell anemia, fibromyalgia, migraine, peripheral neuropathies)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Jacobi Medical Center Emergency Department

    The Bronx, New York, 10461

  • Montefiore Medical Center Emergency Department

    The Bronx, New York, 10467

Other trials in United States

About this study

We aim to compare pain management among three groups of ethnic disparity (ED) patients, Hispanics, non-Hispanic Blacks, non-Hispanic Whites, and assess whether the observed association between pain management and race/ethnicity is independent of potentially important confounding variables (e.g., age, sex, insurance status, education). We also aim to assess whether the effect of race/ethnicity on adequacy of pain management is explained by patients' initial pain intensity or by discordance between patient and physician's: a) race/ethnicity; b) perception of patient's pain. To do this 285 patients with long-bone fractures will be recruited in the EDs of one municipal and one voluntary hospital serving an inner-city, disadvantaged population in the Bronx. Data will be collected on pain using self-reported pain and non-verbal pain expressions at baseline, one hour post-baseline, and discharge. Data on analgesics administered, patient and physician characteristics will also be collected.

We plan to conduct a chart review of long bone fractures in 2000 and 2001 so that we can analyze the association between race/ethnicity and pain management using the same design as published studies. Comparison of the retrospective and prospective studies will strengthen inferences that can be drawn.

We hypothesize that Black and Hispanic patients will be less likely to receive opioid analgesics than white patients.

Read the detailed description

The study was conducted at two urban academic Emergency Departments associated with Montefiore Medical Center. Emergency Medicine residents and full-time Emergency Medicine faculty are present at both sites. One of the sites is a municipal hospital Level 1 Trauma Center managing approximately 50,000 adult patients per year. The other site is the primary academic medical center, managing approximately 80,000 adult patients per year, many of them requiring tertiary care. Both departments serve an urban population that is predominantly African-American and Hispanic.

Study Protocol Data were obtained from a convenience sample of patients from September, 2003 through November, 2006. Patients were eligible if the provider suspected an isolated long-bone fracture and long-bone films were obtained. Because it was not possible to determine which patients would have positive films in advance, all patients with suspected fractures who met other inclusion criteria were initially considered eligible and enrolled. Only those with confirmed fractures were included in the final study sample. Patients were considered to have fractures if the radiology report by an attending radiologist specified an isolated long-bone fracture defined as a fracture of the humerus, radius, ulna, femur, tibia, or fibula (ICD-9 codes: 812, 813, 821, 823, and 824).

Data collection took place from 8:00 am to midnight seven days a week at one institution and 24 hours a day, seven days a week at the other. Data were collected on a standardized data collection instrument by trained fluently bilingual (Spanish and English) Research Associates. The Research Associates attended a three-day course in research ethics, and specific data collection procedures of the study. This was followed by a two-week internship during which new Research Associates were paired with more experienced Research Associates.

Research Associates approached patients whose triage note indicated an extremity injury, extremity pain, if the Research Associate observed a physical indication of extremity injury, or if a provider identified a patient who was potentially eligible for the study. Eligible patients were asked to sign informed consent. Data were collected from patients at the time of the physician's examination of the patient (baseline) and at discharge. At discharge the treating physician was asked to rate the patient's pain when he/she first examined the patient. If the physician's shift ended before the patient was discharged he/she was asked to rate the patient's initial pain before leaving the ED.

Measurements The names of all medications, dose, route, and time administered were obtained in real time from the chart and ED staff. Patients were categorized as receiving: 1) no analgesics; 2) NSAIDS or acetaminophen; or 3) opioids. If both NSAIDS or acetaminophen and opioids were administered, patients were categorized as having received opioids. Analgesics given solely for fracture reduction were not used to categorize patients. Opioid analgesics were transformed into morphine equivalents as follows: 1 mg morphine = 3 mg of oxycodone; 0.15 mg of hydromorphone, and 13 mg of codeine. No other opioid analgesics were used with the exception of fentanyl, which was only used for fracture reduction.

The primary predictor variable was self-reported race/ethnicity of the patient. This was measured by the response to the question: "Do you consider yourself to be: Hispanic/Latino, White/Caucasian, Black/African-American, multi-racial, or other?"

Covariates: Patients' pain and provider assessment of patients' pain are determinants of treatment and thus have the potential of confounding the relationship between race/ethnicity and treatment if they vary systematically by race/ethnicity.10 Pain was measured in several ways: Patients were asked to rate their pain intensity on a validated and reproducible 11-point numerical rating scale (NRS) ranging from 0 "no pain", to 10 "worst imaginable pain".18 They were also asked to describe pain categorically as: "no pain", "mild pain", "moderate pain", or "severe pain". Change in pain was measured by response to the question: "How does your pain feel now compared to when you entered the Emergency Room?" It was also measured by the difference between the patient's rating of pain at entry and pain at discharge. At time of discharge the treating physicians were asked to recall and rate the patient's initial pain using the same verbal descriptors used by the patients We reasoned that asking doctors to rate patients' pain before they made treatment decisions might bias treatment.

Other clinically plausible confounders of the relationship between pain management and race/ethnicity include: sex, age, educational level (some high school, high school or General Equivalency Diploma (GED), some college, Bachelor's degree or higher), insurance status (self-pay, health maintenance organization (HMO) or private insurance, Medicaid, other insurance), accompanied to the ED by someone who might act as a patient advocate, mechanism of injury (fall, sports, motor vehicle, other), fracture reduction in ED, and arrival by ambulance.

Data Analysis:

Patient characteristics are reported as means with standard deviations, medians with interquartile ranges (IQR) and percentages. We used chi-square tests to compare discrete patient characteristic by race/ethnicity. One-way analysis of variance was used to compare continuous characteristics and the Kruskal-Wallis test to compare medians of non-normally distributed variables.

Logistic models were used to test for the presence of an independent (adjusted) association between race/ethnicity and the treatment of pain. We used forced entry into the model of initial patient rating of pain intensity, provider rating of patient's pain at baseline, hospital, sex, age, education, insurance status, whether accompanied to the ED, mechanism of injury, fracture reduction in ED, and arrival by ambulance. Hosmer Lemeshow's test was used to assess model fit. We used Zhang and Kai's method for estimating relative risks from the odds ratios.

Sample size calculation: There is no consensus about what constitutes a clinically significant difference in treatment between racial and ethnic groups. In the absence of such a consensus we based our estimates of effect size on previous findings.11, 12 We used estimates of 75%, 50% and 60% respectively for proportion of whites, African-American, and Hispanics treated with any analgesic, a two-tailed significance level of 0.05, and a power of 80% to calculate a sample size of at least 70 patients with long-bone fractures in each of the three groups.

Two individuals independently entered data into the Statistical Package for the Social Sciences (SPSS) Data Entry(Chicago, IL). Transcription errors were reconciled by referral to the original hardcopy of the data collection instrument. We used NQuery 6.0 ( Saugus, MA) for the sample size calculation, and SPSS version 15.0 (Chicago, IL).

Conditions
Fracture, Pain
Being tested
No intervention
Keywords
analgesia, adult, opioid, Long Bone Fractures
Medical subject headings
Fractures, Bone, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT00115180
Study groupRoleWhat they receive
HispanicHispanic patients with long bone fractures no intervention
Receives: Other: No intervention
WhiteWhite patients with long bone fractures no intervention
Receives: Other: No intervention
African-AmericanAfrican-American patients with long bone fracture no intervention
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Receipt of any analgesics

    The names of all medications, dose, route, and time administered were obtained in real time from the chart and ED staff. Patients were categorized as receiving: 1) no analgesics; 2) NSAIDS or acetaminophen; or 3) opioids. If both NSAIDS or acetaminophen and opioids were administered, patients were categorized as having received opioids. Analgesics given solely for fracture reduction were not used to categorize patients. Opioid analgesics were transformed into morphine equivalents as follows: 1 mg morphine = 3 mg of oxycodone; 0.15 mg of hydromorphone, and 13 mg of codeine. No other opioid analgesics were used with the exception of fentanyl, which was only used for fracture reduction.

    Measured: During Emergency Room visit

Secondary outcomes (4)
  1. Receipt of opioid analgesics

    Morphine, hydromorphone, oxycodone, codeine

    Measured: During Emergency Room visit

  2. Time to first treatment with analgesic

    Time from triage to first analgesic in minutes

    Measured: During Emergency Room visit

  3. Receipt of parenteral analgesics

    Analgesic administered parenterally

    Measured: During Emergency Room visit

  4. Initial dose of opioid analgesic mg/kg

    Initial dose of opioid analgesic converted to morphine equivalent units as follows: : 1 mg morphine = 3 mg of oxycodone; 0.15 mg of hydromorphone, and 13 mg of codeine.

    Measured: During Emergency Room visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionNov 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115180
Sponsor's protocol ID
R01HS013924
Status last verified
Nov 2005
First submitted
21 Jun 2005
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bijur P, Berard A, Esses D, Calderon Y, Gallagher EJ. Race, ethnicity, and management of pain from long-bone fractures: a prospective study of two academic urban emergency departments. Acad Emerg Med. 2008 Jul;15(7):589-97. doi: 10.1111/j.1553-2712.2008.00149.x.

    PubMed 18691208
  • Bijur P, Berard A, Nestor J, Calderon Y, Davitt M, Gallagher EJ. No racial or ethnic disparity in treatment of long-bone fractures. Am J Emerg Med. 2008 Mar;26(3):270-4. doi: 10.1016/j.ajem.2007.05.010.

    PubMed 18358935
  • Bijur PE, Berard A, Esses D, Nestor J, Schechter C, Gallagher EJ. Lack of influence of patient self-report of pain intensity on administration of opioids for suspected long-bone fractures. J Pain. 2006 Jun;7(6):438-44. doi: 10.1016/j.jpain.2006.01.451.

    PubMed 16750800

Questions about this trial

What is this clinical trial studying?

An observational study of Fracture and Pain, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receipt of any analgesics (time frame: During Emergency Room visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115180, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

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