Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115180
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2005-06-21
Brief Title:
Racial and Ethnic Disparities in Acute Pain Control
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
Racial and Ethnic Disparities in Acute Pain Control
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 raceethnicity is independent of potentially important confounding variables eg age sex insurance status education We also aim to assess whether the effect of raceethnicity on adequacy of pain management is explained by patients initial pain intensity or by discordance between patient and physicians a raceethnicity b perception of patients 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 raceethnicity 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
We plan to conduct a chart review of long bone fractures in 2000 and 2001 so that we can analyze the association between raceethnicity 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
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 50000 adult patients per year The other site is the primary academic medical center managing approximately 80000 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 800 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 physicians examination of the patient baseline and at discharge At discharge the treating physician was asked to rate the patients pain when heshe first examined the patient If the physicians shift ended before the patient was discharged heshe was asked to rate the patients 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 015 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 raceethnicity of the patient This was measured by the response to the question Do you consider yourself to be HispanicLatino WhiteCaucasian BlackAfrican-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 raceethnicity and treatment if they vary systematically by raceethnicity10 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 pain18 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 patients rating of pain at entry and pain at discharge At time of discharge the treating physicians were asked to recall and rate the patients 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 raceethnicity include sex age educational level some high school high school or General Equivalency Diploma GED some college Bachelors 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 raceethnicity 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 raceethnicity and the treatment of pain We used forced entry into the model of initial patient rating of pain intensity provider rating of patients 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 Lemeshows test was used to assess model fit We used Zhang and Kais 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 findings11 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 005 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 EntryChicago IL Transcription errors were reconciled by referral to the original hardcopy of the data collection instrument We used NQuery 60 Saugus MA for the sample size calculation and SPSS version 150 Chicago IL
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 800 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 physicians examination of the patient baseline and at discharge At discharge the treating physician was asked to rate the patients pain when heshe first examined the patient If the physicians shift ended before the patient was discharged heshe was asked to rate the patients 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 015 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 raceethnicity of the patient This was measured by the response to the question Do you consider yourself to be HispanicLatino WhiteCaucasian BlackAfrican-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 raceethnicity and treatment if they vary systematically by raceethnicity10 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 pain18 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 patients rating of pain at entry and pain at discharge At time of discharge the treating physicians were asked to recall and rate the patients 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 raceethnicity include sex age educational level some high school high school or General Equivalency Diploma GED some college Bachelors 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 raceethnicity 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 raceethnicity and the treatment of pain We used forced entry into the model of initial patient rating of pain intensity provider rating of patients 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 Lemeshows test was used to assess model fit We used Zhang and Kais 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 findings11 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 005 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 EntryChicago IL Transcription errors were reconciled by referral to the original hardcopy of the data collection instrument We used NQuery 60 Saugus MA for the sample size calculation and SPSS version 150 Chicago IL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None