Article, Neurology

Opioid free treatment algorithm for ED headache management: Effect on revisit rate

a b s t r a c t

Background: The opioid epidemic is a crisis leading to over utilization of resources within emergency departments (EDs). We assessed how implementation of an opioid-free headache and migraine treat- ment algorithm in the ED impacted patient centered outcomes.

Methods: This was a retrospective review of patients presenting to EDs across a health network with a primary diagnosis of headache or migraine. Two analyses were completed comparing patients presenting before and after implementation of an opioid-free treatment algorithm and patients treated with or with- out opioids in the ED. The primary outcome was incidence of an ED revisit within thirty days. Secondary outcomes included ED length of stay, admission rate, and incidence of revisit during the entire study period.

Results: In total, 2953 patient encounters were included. Incidence of revisit within thirty days was lower in the post- (84/1339, 6.3%) versus pre-algorithm group (133/1614, 8.2%; odds ratio [OR] 0.75, 95% con- fidence interval [CI] 0.56-0.99; p = 0.049), as was the incidence of revisit within the entire study period (9.2% vs. 12.1%; OR 0.74, CI 0.58-0.93; p = 0.014). In the secondary analysis, patients treated with opioids had a higher incidence of revisit within thirty days (51/335, 15.2%) compared to those not treated with opioids (166/2618, 6.3%). The opioid group also had a higher incidence of admission rates and median ED length of stay.

Conclusions: Opioid use in the ED to treat patients with headaches or migraines may have several nega- tive ramifications including increased risk of revisit, hospital admission, and increased ED length of stay.

(C) 2019

Introduction

Background

Headaches and migraines are two of the most common Disease states experienced by Americans, with 14.2% of adults reporting having a migraine or Severe headache within the previous three months [1]. Although headaches and migraines may be thought

q All authors have satisfied the requirements for authorship set forth by the ICJME: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

qq The views expressed in this article are the authors’ own and do not necessarily

represent the views of St. Luke’s University Health Network or Wilkes University. qqq The authors have nothing to disclose, and no financial support was required or accepted for the completion of this project.

* Corresponding author.

E-mail address: [email protected] (L. Koons).

of as minor ailments that can be treated without professional med- ical intervention, for some patients the severity of their symptoms can be debilitating. Headaches account for 3.1% of all ED visits in the United States annually, which ranks fourth among causes of ED visits [1].

Importance

Managing patients who present to the ED with either a head- ache or migraine represents a disconnect between consensus treat- ment recommendations and clinical practice, particularly with regard to the utilization of opioids [2-5]. Even though many profes- sional organizations, including the American Headache Society and the American Academy of Neurology, have recommended against the use of opioids for the treatment of Chronic headache disorders [2], recent studies show that opioid use in EDs may actually be increasing [3,4]. An analysis of the most recent data available from The National Hospital Ambulatory Medical Care Survey from 2010 showed that opioids were administered to 59% of ED patients with migraines, and 6.7% of patients were treated with more than one

https://doi.org/10.1016/j.ajem.2019.03.053 0735-6757/(C) 2019

opioid [4]. Hydromorphone was the most commonly used agent (25%) for the treatment of migraine in 2010 [3]. Meanwhile, non- opioid alternatives such as metoclopramide and triptans, which have proven to be effective, were used in far fewer patients (17% and 7%, respectively) [3]. Factors that have been associated with higher rates of first line opioid use include patients who have taken headache mitigating medications prior to ED presentation and those who have other migraine symptoms (nausea, vomiting, and photophobia) [6].

Evidence suggests that opioid use may be associated with an increased risk of developing chronic daily headaches or medication-overuse headaches [7,8]. Additionally, chronic opioid use for migraines can lead to Opioid dependence and more severe headache-related disability [9]. There is limited research assessing the impact of opioid administration in the emergency department on the frequency of headaches and migraines. In January 2017, Ahmed and colleagues published a retrospective, single center study that evaluated the amount of opioids and barbiturates administered for the treatment of headaches in the ED before and after implementation of an opioid and barbiturate-free treat- ment protocol [10]. The authors found that after the introduction of the opioid and barbiturate-free treatment protocol there was a significant decrease in the number of patients treated with opioids and barbiturates (66% vs. 6.8%) [10]. However, this study did not assess patient outcomes associated with decreasing opioid administration.

Goals of this investigation

The purpose of this study was to assess if the implementation of an opioid-free headache and migraine treatment algorithm in the ED affected the incidence of ED revisit within thirty days, admis- sion rate, ED length of stay, change in pain score, opioid prescribing habits, or incidence of ED revisit within the entire study period among patients with a primary diagnosis of headache or migraine. The secondary purpose of this study was to assess if the adminis- tration of an opioid in the ED for the treatment of headache or migraine affected the incidence of ED revisit within thirty days, admission rate, ED length of stay, change in pain score, or ED revisit within the entire study period.

Methods

Study design and setting

We conducted a retrospective chart review of patients present- ing to any emergency department in a multi-hospital network. At the start of the study, the network consisted of seven hospitals, including community medical centers and a large academic, ter- tiary care, level 1 trauma center all located in the United States. The network had approximately 300,000 ED visits annually at that time.

An opioid-free headache and migraine treatment algorithm was developed in November 2017 by a hospital-sanctioned group including ED providers, neurologists, acute pain specialists, phar- macists, hospitalists, and nurses. Although strongly encouraged, it was not mandated that providers use the algorithm and all clin- ician Treatment decisions were made independent of this study. The study period consisted of two separate time periods: pre- algorithm (November 1, 2016 through March 31, 2017) and post-

algorithm (November 14, 2017 through April 13, 2018). This study was approved by the network’s institutional review board.

Selection of participants

Patient encounters were identified using a report generated by our electronic health record. All adult patients, at least 18 years of age, with a primary diagnosis of headache or migraine presenting to an ED were included in the analysis. Patients with a primary or secondary diagnosis of one of the following were excluded: Ischemic or hemorrhagic stroke, head trauma, any infection, can- cer, glaucoma or other eye pain, Dental pain, drug/alcohol use, or Hypertensive emergency. Encounters were also excluded if the patient was pregnant, left against medical advice, or if the patient’s chart was incomplete. An encounter flowchart is provided in Fig. 1.

Interventions

The opioid-free headache and migraine treatment algorithm was developed by an interdisciplinary team of healthcare profes- sionals. Recommendations in the algorithm were based on both

Fig. 1. Patient encounter flowchart. *Patients who were coded with a primary diagnosis of headache, but whose secondary diagnosis was their primary problem.

expert opinion and best available evidence [11]. The algorithm was distributed to ED providers and promoted during departmental meetings. Emergency department and other resident physicians received a lecture including information about the algorithm and the evidence behind its recommendations. In an effort to increase algorithm adherence, an order panel was created in our electronic health record that mirrored the algorithm. Discussions with ED clinical leaders began in September 2017 and the order panel was released on November 13, 2017. The algorithm can be found in the Supplemental appendix.

Measurements

A single member of the research team screened all identifiED patient encounters and collected data from each patient’s elec- tronic chart. Variables collected included age, sex, diagnosis, pre- senting campus, date of encounter, contraindications to any of the algorithm medications, prior to admission Opioid prescriptions, first ED pain score, last ED pain score, medications administered (including dose, route, and time), and disposition. The standardized approach to pain assessment at our health network is to use a numeric pain scale ranging from zero to ten. During data collection pain scores documented as ”worst pain imaginable” or ”no pain” were transcribed as a 10 or 0, respectively. Patients who did not have a documented first and last ED pain score were excluded from the analysis of change in pain score.

Outcomes

The primary outcome was incidence of ED revisit within thirty days. An ED revisit was defined as a subsequent ED encounter in which the patient had a primary diagnosis of headache or migraine. The secondary outcomes were admission rate, ED length of stay, opioid administration in the ED, Opioid prescriptions writ- ten at discharge, change in pain score, and incidence of ED revisit within the entire study period. ED revisit within the entire study period was defined as any subsequent ED encounter during the study period in which the patient had a primary diagnosis of head- ache or migraine regardless of when the patient’s original visit occurred.

Analysis

We used descriptive statistics to summarize study outcomes. Patient demographics and continuous data are reported as means with standard deviations (SD) or medians with interquartile ranges (IQR), as appropriate. Continuous variables were compared using either the student’s t-test or Mann Whitney U test, as appropriate.

Categorical data was compared using the v2 test and is reported as

the number of occurrences and the percentage. All analyses were conducted with SPSS (version 22.0; IBM Corporation, Armonk, NY). Our primary analysis compared all patient encounters that occurred during the pre-algorithm time period to those that occurred during the post-algorithm time period. We then con- ducted a secondary analysis that compared all patients treated with opioids to those treated without opioids, regardless of when the patient presented, to specifically assess the impact of opioid administration on the study outcomes. Finally, we conducted a per protocol analysis for all post-algorithm encounters to compare patients treated with the algorithm recommendations versus those

treated with alternate regimens.

Results

Characteristics of study subjects

Of the 4017 screened ED encounters, 1064 met exclusion crite- ria and were not included in the analysis. The most common exclu- sion criteria met included age, diagnosis of head trauma, and diagnosis of infection (Fig. 1.) Therefore, 2953 patient encounters were included in the primary analysis (1614 in the pre-algorithm group and 1339 in the post-algorithm group). The two groups were similar in baseline characteristics (Table 1). Patients had a mean age of 40.8 years, 75.9% were female, and 10.7% were taking opi- oids prior to their ED visit.

Main results

Primary analysis (Table 2)

The primary outcome of incidence of ED revisit within thirty days was lower in the post-algorithm group (84/1339, 6.3%) com- pared to the pre-algorithm group (133/1614, 8.2%; odds ratio [OR]

Table 1

Baseline characteristics and demographics of pre-algorithm and post-algorithm groups.

Demographics

Pre-algorithm (n = 1614)

Post-algorithm (n = 1339)

Total (n = 2953)

p-Value

Age, mean +- SD

40.6 +- 14.9

40.9 +- 14.9

40.8 +- 14.9

0.586

Female, n (%)

1239 (76.8)

1001 (74.8)

2240 (75.9)

0.220

Outpatient opioid prescription, n (%)

187 (11.6)

130 (9.7)

317 (10.7)

0.114

Initial pain score, mean +- SD

7.6 +- 2.6

7.5 +- 4.1

7.6 +- 2.6

0.421

Table 2

Primary and secondary outcomes compared between pre-algorithm and post-algorithm groups.

Outcome

Pre-algorithm (n = 1614)

Post-algorithm (n = 1339)

Odds ratio (95% CI)

p-Value

30-Day ED revisits, n (%)

133 (8.2)

84 (6.3)

0.75 (0.56-0.99)

0.049

Overall ED revisits, n (%)

195 (12.1)

123 (9.2)

0.74 (0.58-0.93)

0.014

Treated with an opioid, n (%)

266 (16.5)

69 (5.2)

0.28 (0.21-0.36)

<0.001

Opioid discharge prescriptions, n (%)

116 (7.2)

30 (2.2)

0.29 (0.19-0.43)

<0.001

Admissions, n (%)

76 (4.7)

50 (3.7)

0.79 (0.55-1.13)

0.225

Outcome

Pre-algorithm (n = 1614)

Post-algorithm (n = 1339)

Mean difference (95% CI)

p-Value

Change in pain score, mean +- SD

–3.0 +- 2.7

–3.2 +- 3.4

0.2 (–0.1-0.4)

0.075

ED length of stay, mean +- SD

211 +- 136

210 +- 123

1 (-8 – 10)

0.834

Table 3

Primary and secondary outcomes compared between patients treated with opioids and those who were not.

Outcome

Opioid (n = 335)

Non-opioid (n = 2618)

Odds ratio (95% CI)

p-Value

30-Day ED revisits, n (%)

51 (15.2)

166 (6.3)

2.65 (1.89-3.72)

<0.001

Overall ED revisits, n (%)

65 (19.4)

253 (9.7)

2.25 (1.67-3.04)

<0.001

Admissions, n (%)

41 (12.2)

85 (3.2)

4.16 (2.81-6.15)

<0.001

Outcome

Opioid (n = 335)

Non-opioid (n = 2618)

Mean difference (95% CI)

p-Value

Change in pain score, mean +- SD

–3.4 +- 3.2

–3.0 +- 3.4

0.4 (–0.1-0.8)

0.105

ED length of stay, mean +- SD

279 +- 208

201 +- 114

78 (61-95)

<0.001

Table 4

Primary and secondary outcomes compared between patients treated with the algorithm recommendations and those who were not.

Outcome

Algorithm (n = 233)

Non-algorithm (n = 1106)

Odds ratio (95% CI)

p-Value

30-Day ED revisits, n (%)

15 (6.4)

69 (6.2)

1.03 (0.58-1.84)

0.909

Overall ED revisits, n (%)

23 (9.9)

100 (9.0)

1.10 (0.68-1.78)

0.690

Treated with an opioid, n (%)

0 (0)

69 (6.2)

0.94 (0.92-0.95)

<0.001

Opioid discharge prescriptions, n (%)

0 (0)

29 (2.6)

0.82 (0.80-0.84)

0.012

Admissions, n (%)

12 (5.2)

38 (3.4)

1.15 (0.79-2.97)

0.210

Outcome

Algorithm (n = 233)

Non-algorithm (n = 1106)

Mean difference (95% CI)

p-Value

Change in pain score, mean +- SD

–4.9 +- 3.5

–2.8 +- 3.4

2.1 (1.5-2.6)

<0.001

ED length of stay, mean +- SD

239 +- 104

204 +- 125

35 (18.8-49.5)

<0.001

0.75, 95% confidence interval [CI] [0.56-0.99]; p = 0.049). The inci- dence of ED revisit within the entire study period (9.2% vs. 12.1%; OR 0.74, CI [0.58-0.93]; p = 0.014), the number of patients treated with opioids in the ED (5.2% vs. 16.5%; OR 0.28, CI [0.21-0.36]; p < 0.001), and the number of patients receiving opioid prescrip- tions at discharge (2.2% vs. 7.2%; OR 0.29, CI [0.19-0.43]; p < 0.001) were all lower in the post-algorithm group versus the pre-algorithm group. The admission rate (3.7% vs. 4.7%), mean change in pain score (–3.2 +- 3.4 vs. –3.0+- 2.7), and ED length of stay (210 min vs. 211 min) were similar between groups.

Secondary analysis (Table 3)

A total of 2953 patient encounters were evaluated in our sec- ondary analysis. 335 patient encounters showed the patient received an opioid during their ED stay compared to 2618 who did not. Patients in the opioid group had a higher incidence of ED revisit within thirty days (51/335, 15.2%) compared to those who were not treated with opioids (166/2618, 6.3%; OR 2.65, CI [1.89-3.72]; p < 0.001). The opioid group also had a higher inci- dence of ED revisit within the entire study period (19.4% vs. 9.7%; OR 2.25, CI [1.67-3.04]; p < 0.001), admission rate (12.2%

vs. 3.2%; OR 4.16, CI [2.81-6.15]; p < 0.001), and mean ED length of stay (279 min vs. 201 min; absolute difference 378 min, CI [61-95]; p < 0.001). The mean change in pain score (–3.4 +- 3.2 vs. –3.0 +- 3.4) was similar between groups.

Per protocol analysis (Table 4)

Over a 5-month period, 1339 patients were evaluated as part of the post-algorithm implementation phase. Of those, 117 patients (8.7%) were treated using the algorithm integrated into the elec- tronic health record (EHR). Additionally, 116 patients (8.7%) were treated following the algorithm’s structure without engaging the actual order panel in the health record. Patients treated with the algorithm, either via the EHR or self-constructed (n = 233, 17.4%) were significantly less likely to receive an opioid at ED discharge as compared to those treated without the use of the prescribed algorithm (0% vs. 2.6%; OR 0.82, CI [0.80-0.84]; p = 0.012). Another benefit seen in those treated with the guidane of the algorithm was a substantially greater decrease in absolute pain score (-4.9 +- 3.5 vs. -2.8 +- 3.4; absolute difference 2.1, CI [1.5-2.6]; p < 0.001).

However, patients treated with the algorithm had a longer ED length of stay (239 min vs. 204 min, absolute difference 35 min; CI [18.8 – 49.5]; p < 0.001), and the incidence of ED revisit within thirty days and the entire study period were similar between groups.

Limitations

This study has several important limitations to consider. First, as the study was a non-blinded retrospective chart review, we were unable to show a causal relationship between variables. A single author reviewed and abstracted data from all patient charts. Understanding the risk of introducing bias and errors by utilizing a single reviewer, the research team objectively defined all variables to be collected prior to abstraction. Additionally, the data that was collected was limited to what was documented at the time of the patient encounter, and therefore was subject to possible documen- tation errors and omissions.

We were unable to collect information from patient encounters that occurred outside of our health network, which may have affected the observed incidence of revisits. However, this limita- tion was consistent across all groups and therefore is unlikely to be the sole cause of the substantial differences seen between groups.

While this study took place at multiple centers, including a mix of rural community hospitals and large academic medical centers, they are all located in the same health network in Eastern Pennsyl- vania and Western New Jersey which may limit the external valid- ity of these results.

Discussion

The implementation of an opioid-free headache and migraine treatment algorithm in the ED was associated with a decrease in the incidence of ED revisit within thirty days, incidence of ED revi- sit within the entire study period, opioid administration in the ED, and opioid prescriptions written at discharge. The decreases in opi- oids administered in the ED and prescribed at discharge that we observed post-algorithm implementation are consistent with the findings of Ahmed, et al. [10] Of note, the algorithm developed

by Ahmed et al. [10] was similar but not the identical to our algorithm. Opioid administration decreased by 11.3% after imple- mentation of our algorithm, compared to 59% seen by Ahmed, et al. [10] However, Ahmed, et al. reported a substantially higher pre-algorithm opioid administration rate than what we observed (66% versus 16.5%) [10], which is likely why they observed a much greater absolute reduction. Similarly, Ahmed, et al. reported a 37% pre-algorithm opioid discharge prescription rate and a 25% decrease after implementing their algorithm [10] compared to the 7.2% pre-algorithm rate and 5.0% decrease observed within our network. Although Ahmed, et al. did not report ED revisit rates specifically, they did note that there appeared to be a decrease in the number of patients presenting to their ED with a headache after algorithm implementation [10]. To the best of our knowledge, this is the first study to explore the effect of implementing an opioid-free headache and migraine treatment algorithm on the incidence of ED revisits. We observed a statistically significant absolute difference of 1.9% in revisits within thirty days, but this may not be clinically important.

The results of our secondary analysis showed that patients diag- nosed with a headache or migraine that were treated with opioids were more than twice as likely to return to the ED within 30 days for another headache or migraine compared to those who were not treated with opioids. The absolute difference in the incidence of ED revisits within thirty days was 8.9%. Patients receiving opioids were also twice as likely to revisit the ED at any point during the study period (9.7% absolute increase). Additionally, opioids were associated with an increase in admission rate (9% absolute increase) and ED length of stay (78 min). Disease severity may be a confounding factor for the results found surrounding the increase in admission rate and ED length of stay. As patients with refractory headache or migraine unresponsive to other interventions are more likely to receive opioids as Rescue therapy and are also more likely to be admitted for their disease, we are unable to determine if opioids alone are the sole contributing factor to the observed increase in admission rate and ED length of stay.

This is the first study to evaluate the effect of using opioids in the ED for the treatment of headaches or migraines on these clinical outcomes. Although there are currently no other clinical studies in this area, these results do support the current recom- mendation from the American Academy of Neurology and the American Headache Society to avoid using opioids as first line agents for the treatment of chronic headache disorders [2]. Finally, the average decrease in pain score was similar between groups, which suggests that there is little benefit to using opioids in this patient population.

The per protocol analysis showed that only 17.4% of patients in the post-algorithm phase were treated with the algorithm. These results demonstrate the difficulty of implementing a treatment algorithm using informal education alone. On average, the patients treated with the algorithm for headache or migraine spent 35 more minutes in the ED but had a greater decrease in pain

score (4.9 versus 2.8) compared to those who were not treated with the algorithm. There was no difference seen in the primary outcome of revisit within 30 days. These results suggest that this algorithm may provide more effective relief than non- protocolized treatment strategies for patients presenting to the ED with a headache or migraine.

When combining the results from all three analyses, it appears that the decrease in ED revisits within thirty days seen when implementing an opioid-free headache and migraine treatment algorithm is more likely associated with the decrease in opioid administration rather than the utilization of the algorithm itself. However, implementing an algorithm gave ED providers non- opioid options when treating patients with a headache or migraine, which was proven in this study to be of clinical benefit.

In conclusion, the implementation of an opioid-free headache and migraine treatment algorithm in the ED was associated with a decrease in the incidence of ED revisit within thirty days and the entire study period, opioid administration, and opioid prescrip- tions written at discharge. Additionally, opioid use in the ED for the treatment of headache or migraine was associated with an increased incidence of ED revisits, admission rate, and ED length of stay.

Supplementary data to this article can be found online at https://doi.org/10.1016/j.ajem.2019.03.053.

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