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The American Journal of Managed Care November 2018
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A Randomized, Pragmatic, Pharmacist-Led Intervention Reduced Opioids Following Orthopedic Surgery
David H. Smith, PhD, RPh; Jennifer L. Kuntz, PhD; Lynn L. DeBar, PhD, MPH; Jill Mesa; Xiuhai Yang, MS; Jennifer Schneider, MPH; Amanda Petrik, MS; Katherine Reese, PharmD; Lou Ann Thorsness, RPh; David Boardman, MD; and Eric S. Johnson, PhD
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A Randomized, Pragmatic, Pharmacist-Led Intervention Reduced Opioids Following Orthopedic Surgery

David H. Smith, PhD, RPh; Jennifer L. Kuntz, PhD; Lynn L. DeBar, PhD, MPH; Jill Mesa; Xiuhai Yang, MS; Jennifer Schneider, MPH; Amanda Petrik, MS; Katherine Reese, PharmD; Lou Ann Thorsness, RPh; David Boardman, MD; and Eric S. Johnson, PhD
This pharmacist-led, patient-directed intervention demonstrated a reduction in opioid dispensings in the 90 days following hip replacement but not knee replacement.
ABSTRACT

Objectives: To determine whether a pharmacist-led, patient-directed intervention can reduce opioid use following total hip arthroplasty (THA) or total knee arthroplasty (TKA).

Study Design: Randomized trial.

Methods: Patients scheduled to undergo THA or TKA (during 2015 and 2016) were randomized to usual care or intervention. We ranked patients according to predicted risk of persistent opioid use and selected the top 60% for inclusion (n = 561); all contributed to the analysis. Intervention patients were mailed materials 2 weeks before and after surgery, plus they received telephone intervention from specially trained pharmacists if they filled opioid prescriptions in the 28 to 90 days following surgery. Our primary outcome was the dispensed morphine equivalents (DME) in the 90 days following surgery, modeled using a natural log transformation.

Results: A total of 561 patients were randomized (286 usual care, 118 THA and 168 TKA; 275 intervention, 107 THA and 168 TKA); the mean age was 66 years, and 60% were female. Overall, we found no meaningful reduction in DME for intervention versus usual care (geometric mean ratio, 0.92 [95% CI, 0.69-1.21]). However, there was effect modification by whether the patient had TKA or THA (interaction P <.01). Those undergoing THA in the intervention group used significantly less DME than did those undergoing THA in the usual care group (geometric mean ratio, 0.52 [95% CI, 0.33-0.82]).

Conclusions: Our pharmacist-led, patient-directed intervention to reduce opioid use demonstrated a reduction in opioid dispensings in the 90 days following THA but not TKA.

Am J Manag Care. 2018;24(11):515-521
Takeaway Points
  • This randomized pragmatic trial showed that a pharmacist-led, patient-directed intervention demonstrated a reduction in opioid dispensings in the 90 days following hip replacement but not knee replacement.
  • We found little evidence that reductions in opioid dispensings from our health plan resulted in patients seeking opioid prescriptions outside of the health plan.
  • Our intervention was designed to be incorporated into existing clinical workflow, particularly in integrated care settings.
Opioid use has escalated greatly in the United States in recent years, from about 100 million prescriptions filled in 1992 to nearly 250 million in 2015.1 This escalation has been coincident with a 14% increase in opioid overdose fatalities.2 After primary care, orthopedic surgery generates the highest rates of opioid prescriptions among adults.3 Many patients use opioids both before and after surgery.4

Opioids clearly have a role in managing pain for orthopedic surgery patients, but evidence suggests that exposure should be kept as short-term as possible.5 Experts have noted that a key part of minimizing opioid exposure is for the orthopedic surgical team to set patient expectations for pain and its treatment.6 The American Academy of Orthopaedic Surgeons also recognized that making opioids the focus of pain management has led to unintended consequences and that research and education are needed for physicians, caregivers, and patients.7

In this article, we present the main outcomes for the FLOOD (FDA: Lowering Orthopaedic Opioid Dosing) study, a patient-level, pragmatic, randomized trial focused on patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA). We were interested in whether the promotion of targeted, specially designed, patient-focused education on opioid use and patient expectations for pain control, delivered around the time of surgery, would lead to reduced opioid use.

METHODS

Intervention Design and Funding

FLOOD was a 2-arm, randomized, pragmatic clinical trial funded by the FDA (FDA contract number: HHSF223201400146C) and registered with ClinicalTrials.gov (NCT02576392).

Setting

The setting for the trial was Kaiser Permanente Northwest (KPNW), a health maintenance organization serving about 580,000 members in northwest Oregon and southwest Washington. The local institutional review board reviewed and approved the study, including a waiver of informed consent. Study data were collected and managed using REDCap (Research Electronic Data Capture) tools hosted at KPNW’s Center for Health Research.8

Participant Selection and Randomization

Using the electronic health record (EHR), we identified, on a weekly basis, patients 20 years and older who were scheduled to undergo TKA or THA in the subsequent 14 to 21 days. Consistent with pragmatic trial principles, exclusions were minimized and limited to patients (1) already enrolled in a pain trial, (2) with less than 1 year of baseline KPNW membership (necessary to characterize the cohort), or (3) with a history of KPNW Pain Clinic visits. This resulted in 131 patients being excluded. Once patients were identified, we used a multivariable prediction model9 that we developed to rank them according to their risk of becoming persistent opioid users in the 90 to 180 days post surgery; we enrolled patients with a predicted risk in the top 60%.

Computer-generated randomization assignments were used within each weekly cohort to allocate patients (simple randomization; no blocking or stratification was used) in a 1:1 ratio to the intervention or usual care arm. Allocation was concealed from the investigators and clinicians providing care, although the pharmacists delivering the intervention were not blinded. We enrolled 561 patients in the study. A total of 495 patients were required to achieve 85% power to detect a 20% relative reduction in the primary outcome: a difference in means for the natural log-transformed dispensed morphine equivalents (DME) over the first 90 days (ie, difference between the trial arms). We assumed a 2-sided significance level of 5% and that 10% of patients would be nonadherent to the intervention, and we therefore increased the size to accommodate the dilution of effect using Lachin’s formula.10

The study enrollment period was July 15, 2015, to April 25, 2016. Intervention and outcome assessment continued through July 2016.


 
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