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(444) Informing clinical decision support for chronic pain in primary care: how do physicians decide when to initiate opioids?
Abstracts
F17 Opioids in Non-Cancer Pain (444) Informing clinical decision support for chronic pain in primary care: how do physicians decide when to initiate opioids? C Harle, R Cook, and R Fillingim; University of Florida, Gainesville, FL In this study, our objective was to identify and describe different decision making strategies that primary care physicians use when deciding whether or not to initiate opioids in patients with chronic pain. This formative understanding may inform the design of electronic health record-based decision support tools that help primary care physicians decide if and when opioids are most appropriate. We conducted a qualitative interview study of family medicine and general internal medicine physicians. The 30-45 minute interviews included probing questions that asked what information physicians seek, consider, and use when deciding whether or not to initiate opioids. Interview transcripts were analyzed by two coders using an open coding process to identify themes. Recruitment stopped after reaching saturation of emergent themes. Seven men and eight women from nine different practices participated. Key differences in participants’ decision making emerged across two dimensions. First, some physicians were opioid avoiders while others were more frequent opioid prescribers. Second, some physicians employed relatively intuitive decision processes in arriving at their care decisions while others employed more detailed and explicit decision strategies. For example, an intuitive opioid prescriber said: ‘‘I’ve known some of my patients for over 20 years. Whether it’s right or wrong, I guess I have a sense of whether they’re someone that I feel could or would appropriately use these medicines.’’ In contrast, an explicit opioid avoiding physician demanded decision support, such as a ‘‘standardized format of well-established tools or questionnaires that have been validated.’’ Consistent with dual processing models of decision making, this study found that physicians vary in their use of explicit versus intuitive strategies when prescribing opioids. Therefore, in developing clinical decision support tools to aid physicians in opioid prescribing decisions, designers must create flexible tools that accommodate different attitudes and approaches to clinical decision making.
The Journal of Pain
S87
(446) Recent opioid use is specifically associated with greater thermal temporal summation in sickle cell disease patients P Carroll, C Campbell, P Finan, V Mathur, R Edwards, S and J Haythornthwaite; Johns Hopkins University, Baltimore, MD
Lanzkron,
People with sickle cell disease (SCD) have a high burden of chronic and acute pain. In both animals and humans, SCD is associated with reduced pain thresholds. Patients with SCD often have high lifetime levels of exposure to opioids, and under certain circumstances, opioids may cause hyperalgesia. These analyses were designed to determine if opioid therapy was associated with lower pain thresholds and greater temporal summation in quantitative sensory testing of pain in patients with SCD. Quantitative sensory testing of pain thresholds and temporal summation were compared between SCD patients who had taken opioids within the last 24 hours (n=24) and participants who had not (n=60) using multivariable models controlling for age, sex, clinical pain severity (derived from the Brief Pain Inventory), and education. Sickle cell disease patients who had taken opioids did not demonstrate greater pressure or heat hyperalgesia on threshold testing compared to patients not taking opioids. Thermal temporal summation, but not mechanical temporal summation, was greater in those who had taken opioids. The association between thermal temporal summation was statistically significant when tested at the individual’s heat pain threshold (sample mean 40.65oC, SD 2.85 oC) and at 2oC above threshold, but was not statistically significant at 45oC (a stimulus intensity that exceeded heat pain threshold for 98.5% of the SCD patients). However, at greater stimulus intensity, participant dropout also increased with resulting loss of power; further suggesting a greater, and relatively specific, response to thermal temporal summation testing in participants on opioids.
(445) Chronic opioid therapy urine drug testing in primary care: rates and predictors of aberrant results
(447) Symptom improvement following naloxegol treatment in noncancer pain patients with opioid-induced constipation
J Turner, K Saunders, S Shortreed, L LeResche, and M Von Korff; Group Health Research Institute, Seattle, WA
J Tack, W Chey, J Lappalainen, M Sostek, P Barker, and L Webster; University of Leuven, Leuven, Belgium
Although urine drug tests (UDTs) are widely recommended for patients on chronic opioid therapy (COT), there is little evidence to guide healthcare system policy or opioid prescriber decision-making regarding the optimal frequency of UDTs for different patient subgroups. We examined the associations of patient and opioid regimen characteristics (obtained from electronic databases) with results of all ‘‘pain management’’ UDTs performed in 2011-2012 for COT patients aged 20+ at a large Washington State (WA) healthcare system. Among all 5,420 UDTs, 26.4% were aberrant, including 12.1% with no opioid detected and 4.8% too dilute to interpret. Among 5,162 confirmatory (LC-MS/MS) tests of samples not too dilute to interpret, 0.6% (29) detected an illicit drug; 11.2% (576) detected marijuana (legal in WA); and 1.7% (90) detected a benzodiazepine in a patient with no benzodiazepine prescription filled in the prior 90 days. We used multivariate logistic regression models to examine predictors (patient age; gender; prior mental health, alcohol, and substance use disorder diagnoses; smoking status; and opioid dose, days’ supply, and type) of UDT results of (a) marijuana but no illicit drug and (b) no opioid. Risks for marijuana were male gender (adjusted OR = 2.23, 95% CI = 1.79-2.78; P <0.0001); substance use disorder diagnosis (1.64, 1.23-2.19; P=0.003); and current smoking (1.96, 1.57-2.44; P <0.0001). Risk decreased with increasing age (P <0.0001) and opioid days’ supply (P= 0.01). Odds of no opioid were greater for patients with a substance use disorder diagnosis (1.60, 1.24-2.08; P=0.001), and less for patients aged 65+ (P <0.0001), on higher doses (P<0.0001), and using longacting opioids (P <0.0001). In sum, detection of illicit drugs and benzodiazepine use without a recent prescription was rare. The more common findings of marijuana and no opioid are of uncertain clinical significance without further investigation. Supported by NIH/NIA grant R01AG034181.
Opioid-induced constipation (OIC) is a deleterious consequence of opioid treatment in patients with chronic pain. Naloxegol is a peripherally acting mu-opioid receptor antagonist (PAMORA) in clinical evaluation for the treatment of OIC. In two phase 3 randomized, double-blind, 12-week studies conducted in outpatients with noncancer pain and OIC (KODIAC-04, n=652 [NCT01309841]; KODIAC-05, n=700 [NCT01323790]), we compared the effect of daily oral administration of naloxegol 12.5 or 25 mg vs placebo on signs and symptoms of OIC in the intent-to-treat population over 12 weeks of treatment. Changes from baseline in rectal straining (measured on a 5-point scale), stool form and consistency (measured with the Bristol Stool Scale), and sensation of completeness of postdefecation rectal evacuation (percentage of days with a complete spontaneous bowel movement) on daily diaries were analyzed for differences between treatment groups using a mixed model for repeated measures, with fixed effects for baseline, baseline laxative response, treatment, and treatment by time interaction, and study pooled center as a random effect. P-values are presented with no adjustment for multiplicity. Baseline symptoms were similar across treatment groups. Straining, stool consistency and completeness of evacuation showed improvement versus placebo for the 25mg dose in KODIAC-04 (all P<0.05) and for both the 12.5- and 25-mg doses in KODIAC-05 (all P<0.005). Naloxegol treatment improves constipation symptoms in patients with OIC. Sponsored by AstraZeneca.
F17 Opioids in Non-Cancer Pain (444) Informing clinical decision support for chronic pain in primary care: how do physicians decide when to initiate opioids? C Harle, R Cook, and R Fillingim; University of Florida, Gainesville, FL In this study, our objective was to identify and describe different decision making strategies that primary care physicians use when deciding whether or not to initiate opioids in patients with chronic pain. This formative understanding may inform the design of electronic health record-based decision support tools that help primary care physicians decide if and when opioids are most appropriate. We conducted a qualitative interview study of family medicine and general internal medicine physicians. The 30-45 minute interviews included probing questions that asked what information physicians seek, consider, and use when deciding whether or not to initiate opioids. Interview transcripts were analyzed by two coders using an open coding process to identify themes. Recruitment stopped after reaching saturation of emergent themes. Seven men and eight women from nine different practices participated. Key differences in participants’ decision making emerged across two dimensions. First, some physicians were opioid avoiders while others were more frequent opioid prescribers. Second, some physicians employed relatively intuitive decision processes in arriving at their care decisions while others employed more detailed and explicit decision strategies. For example, an intuitive opioid prescriber said: ‘‘I’ve known some of my patients for over 20 years. Whether it’s right or wrong, I guess I have a sense of whether they’re someone that I feel could or would appropriately use these medicines.’’ In contrast, an explicit opioid avoiding physician demanded decision support, such as a ‘‘standardized format of well-established tools or questionnaires that have been validated.’’ Consistent with dual processing models of decision making, this study found that physicians vary in their use of explicit versus intuitive strategies when prescribing opioids. Therefore, in developing clinical decision support tools to aid physicians in opioid prescribing decisions, designers must create flexible tools that accommodate different attitudes and approaches to clinical decision making.
The Journal of Pain
S87
(446) Recent opioid use is specifically associated with greater thermal temporal summation in sickle cell disease patients P Carroll, C Campbell, P Finan, V Mathur, R Edwards, S and J Haythornthwaite; Johns Hopkins University, Baltimore, MD
Lanzkron,
People with sickle cell disease (SCD) have a high burden of chronic and acute pain. In both animals and humans, SCD is associated with reduced pain thresholds. Patients with SCD often have high lifetime levels of exposure to opioids, and under certain circumstances, opioids may cause hyperalgesia. These analyses were designed to determine if opioid therapy was associated with lower pain thresholds and greater temporal summation in quantitative sensory testing of pain in patients with SCD. Quantitative sensory testing of pain thresholds and temporal summation were compared between SCD patients who had taken opioids within the last 24 hours (n=24) and participants who had not (n=60) using multivariable models controlling for age, sex, clinical pain severity (derived from the Brief Pain Inventory), and education. Sickle cell disease patients who had taken opioids did not demonstrate greater pressure or heat hyperalgesia on threshold testing compared to patients not taking opioids. Thermal temporal summation, but not mechanical temporal summation, was greater in those who had taken opioids. The association between thermal temporal summation was statistically significant when tested at the individual’s heat pain threshold (sample mean 40.65oC, SD 2.85 oC) and at 2oC above threshold, but was not statistically significant at 45oC (a stimulus intensity that exceeded heat pain threshold for 98.5% of the SCD patients). However, at greater stimulus intensity, participant dropout also increased with resulting loss of power; further suggesting a greater, and relatively specific, response to thermal temporal summation testing in participants on opioids.
(445) Chronic opioid therapy urine drug testing in primary care: rates and predictors of aberrant results
(447) Symptom improvement following naloxegol treatment in noncancer pain patients with opioid-induced constipation
J Turner, K Saunders, S Shortreed, L LeResche, and M Von Korff; Group Health Research Institute, Seattle, WA
J Tack, W Chey, J Lappalainen, M Sostek, P Barker, and L Webster; University of Leuven, Leuven, Belgium
Although urine drug tests (UDTs) are widely recommended for patients on chronic opioid therapy (COT), there is little evidence to guide healthcare system policy or opioid prescriber decision-making regarding the optimal frequency of UDTs for different patient subgroups. We examined the associations of patient and opioid regimen characteristics (obtained from electronic databases) with results of all ‘‘pain management’’ UDTs performed in 2011-2012 for COT patients aged 20+ at a large Washington State (WA) healthcare system. Among all 5,420 UDTs, 26.4% were aberrant, including 12.1% with no opioid detected and 4.8% too dilute to interpret. Among 5,162 confirmatory (LC-MS/MS) tests of samples not too dilute to interpret, 0.6% (29) detected an illicit drug; 11.2% (576) detected marijuana (legal in WA); and 1.7% (90) detected a benzodiazepine in a patient with no benzodiazepine prescription filled in the prior 90 days. We used multivariate logistic regression models to examine predictors (patient age; gender; prior mental health, alcohol, and substance use disorder diagnoses; smoking status; and opioid dose, days’ supply, and type) of UDT results of (a) marijuana but no illicit drug and (b) no opioid. Risks for marijuana were male gender (adjusted OR = 2.23, 95% CI = 1.79-2.78; P <0.0001); substance use disorder diagnosis (1.64, 1.23-2.19; P=0.003); and current smoking (1.96, 1.57-2.44; P <0.0001). Risk decreased with increasing age (P <0.0001) and opioid days’ supply (P= 0.01). Odds of no opioid were greater for patients with a substance use disorder diagnosis (1.60, 1.24-2.08; P=0.001), and less for patients aged 65+ (P <0.0001), on higher doses (P<0.0001), and using longacting opioids (P <0.0001). In sum, detection of illicit drugs and benzodiazepine use without a recent prescription was rare. The more common findings of marijuana and no opioid are of uncertain clinical significance without further investigation. Supported by NIH/NIA grant R01AG034181.
Opioid-induced constipation (OIC) is a deleterious consequence of opioid treatment in patients with chronic pain. Naloxegol is a peripherally acting mu-opioid receptor antagonist (PAMORA) in clinical evaluation for the treatment of OIC. In two phase 3 randomized, double-blind, 12-week studies conducted in outpatients with noncancer pain and OIC (KODIAC-04, n=652 [NCT01309841]; KODIAC-05, n=700 [NCT01323790]), we compared the effect of daily oral administration of naloxegol 12.5 or 25 mg vs placebo on signs and symptoms of OIC in the intent-to-treat population over 12 weeks of treatment. Changes from baseline in rectal straining (measured on a 5-point scale), stool form and consistency (measured with the Bristol Stool Scale), and sensation of completeness of postdefecation rectal evacuation (percentage of days with a complete spontaneous bowel movement) on daily diaries were analyzed for differences between treatment groups using a mixed model for repeated measures, with fixed effects for baseline, baseline laxative response, treatment, and treatment by time interaction, and study pooled center as a random effect. P-values are presented with no adjustment for multiplicity. Baseline symptoms were similar across treatment groups. Straining, stool consistency and completeness of evacuation showed improvement versus placebo for the 25mg dose in KODIAC-04 (all P<0.05) and for both the 12.5- and 25-mg doses in KODIAC-05 (all P<0.005). Naloxegol treatment improves constipation symptoms in patients with OIC. Sponsored by AstraZeneca.