Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

NCT ID: NCT04564729

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-09-30

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.

Conditions

Knee Arthroplasty, Total; Analgesia; Opioid Use, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Decision Aid

The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients. Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.

Group Type: EXPERIMENTAL

Shared Decision Making

Intervention Type: OTHER

The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator. The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.

Control

Subjects in the control group will undergo standard care and discharge practices. Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shared Decision Making

The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator. The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Naida Margaret Cole

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naida Cole, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Naida Cole, MD

Role: CONTACT

nmcole@bsd.uchicago.edu

9176576692

Laura Mendez, MD

Role: CONTACT

lmendez-pino@bwh.harvard.edu

8574004065

Facility Contacts

Naida Cole, MD

Role: primary

nmcole@bsd.uchicago.edu

Jose Zeballos, MD

Role: primary

jzeballos@bwh.harvard.edu

Other Identifiers

2020P002342

Identifier Type: -

Identifier Source: org_study_id