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Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

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ClinicalTrials.gov Identifier: NCT04564729
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Naida Margaret Cole, Brigham and Women's Hospital

Study Description
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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 and Brigham and Women's Hospital. 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.

Condition or disease Intervention/treatment Phase
Knee Arthroplasty, Total Analgesia Opioid Use, Unspecified Other: Shared Decision Making Not Applicable

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 and Brigham and Women's Hospital 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 by law in Massachusetts i.e. no more than 7 days of pills).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Investigator)
Masking Description: Investigators not involved in administering the SDA and data collection will be blinded. The study subject and investigator(s) involved in administering the SDA and collecting outcomes data will be unblinded.
Primary Purpose: Treatment
Official Title: Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: 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.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Leftover opioid pills [ Time Frame: 30 days postoperatively ]
  2. Average 0-10 NRS pain score [ Time Frame: postoperative day 7 ]

Secondary Outcome Measures :
  1. Quantity of opioid consumed [ Time Frame: 30 days postoperatively ]
  2. Satisfaction with pain management [ Time Frame: 30 days postoperatively ]
  3. Quantity of opioid pills prescribed [ Time Frame: postoperative day 1 at hospital discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH) or Brigham and Women's Hospital 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
    • gabapentin
    • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564729


Contacts
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Contact: Naida Cole, MD 9176576692 nmcole@bwh.harvard.edu
Contact: Laura Mendez, MD 8574004065 lmendez-pino@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Naida M Cole, MD       nmcole@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Naida Cole, MD Brigham and Women's Hospital
More Information
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Responsible Party: Naida Margaret Cole, Anesthesiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04564729    
Other Study ID Numbers: 2020P002342
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No