Clinical trial NCT04564729: Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Official title: Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Arthroplasty, Total
Analgesia
Opioid Use, Unspecified
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.

Detailed description: This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center to determine the impact of using a SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7.

The SDA includes factual information about the World Health Organization pain ladder, the 0-10 NRS pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in TKA patients. The SDA has been developed by the principal investigator solely for the purpose of this study.

Patients will be enrolled on postoperative day 0 or 1 and randomized to intervention or control groups. The intervention group will view the SDA slides on the study iPad. SDA viewing will be guided by the research assistant, who will read a pre-written script as each slide is viewed. Following the guided viewing of the SDA, subjects in the intervention group will have the opportunity to ask questions to the research assistant to confirm their comprehension of the presented facts. The control group will receive no intervention and will receive standard of care and standard discharge prescriptions. The intervention group subjects will choose the number of opioid pills they wish to include in their discharge opioid prescription (anywhere from 0 to the maximum allowable as determined by clinical practice and/or state law).

Daily analgesic intake, adverse effects and numeric rating scale (NRS) pain scores will be collected and analyzed.

Eligibility criteria: Inclusion Criteria:

* Primary unilateral TKA under spinal anesthesia at Brigham \& Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
* \>18 years of age
* Planned discharge with the typical analgesic medications prescribed at discharge:

  * standing around-the clock Tylenol with or without an NSAID
  * tramadol PRN
  * hydromorphone (dilaudid) or oxycodone PRN

Exclusion Criteria:

* Diagnosis of dementia
* \<18 years old
* Contraindication or allergy to opioids
* Contraindication or allergy to Tylenol
* Contraindication or allergy to gabapentin
* History of substance use disorder
* Preoperative pain requiring a \>1-month prescription for \>/=45 daily MMEs
* 4 or more preoperative analgesic prescriptions
* Hospital admission \>1 day
* Discharge to a skilled nursing facility/inpatient rehabilitation center
* Non-English speaking patients
* Requirement for general anesthesia intra-operatively

Primary outcomes:
measure: Leftover opioid pills
timeFrame: 30 days postoperatively
measure: Average 0-10 NRS pain score
timeFrame: postoperative day 7
Secondary outcomes:
measure: Quantity of opioid consumed
timeFrame: 30 days postoperatively
measure: Satisfaction with pain management
timeFrame: 30 days postoperatively
measure: Quantity of opioid pills prescribed
timeFrame: postoperative day 1 at hospital discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: University of Chicago
name: Naida Cole, MD
role: PRINCIPAL_INVESTIGATOR
References: