Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Naida Cole, MD
- Telefonnummer: 9176576692
- E-post: nmcole@bsd.uchicago.edu
Studera Kontakt Backup
- Namn: Laura Mendez, MD
- Telefonnummer: 8574004065
- E-post: lmendez-pino@bwh.harvard.edu
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60637
- Rekrytering
- University of Chicago Medical Center
-
Kontakt:
- Naida Cole, MD
- E-post: nmcole@bsd.uchicago.edu
-
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Brigham and Women's Hospital
-
Kontakt:
- Jose Zeballos, MD
- E-post: jzeballos@bwh.harvard.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Leftover opioid pills
Tidsram: 30 days postoperatively
|
30 days postoperatively
|
|
Average 0-10 NRS pain score
Tidsram: postoperative day 7
|
postoperative day 7
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Quantity of opioid consumed
Tidsram: 30 days postoperatively
|
30 days postoperatively
|
|
Satisfaction with pain management
Tidsram: 30 days postoperatively
|
30 days postoperatively
|
|
Quantity of opioid pills prescribed
Tidsram: postoperative day 1 at hospital discharge
|
postoperative day 1 at hospital discharge
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Naida Cole, MD, University Of Chicago
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2020P002342
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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