Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia
- Knee Arthroplasty, Total
- Opioid Use, Unspecified
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Randomized Controlled TrialMasking: 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner 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 d...
This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner 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.
Tracking Information
- NCT #
- NCT04564729
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Naida Cole, MD Brigham and Women's Hospital
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