Knee Arthroplasty, TotalNCT04564729
Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
A study testing Shared Decision Making in people with Knee Arthroplasty, Total and Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Analgesia, Opioid Use, Unspecified
- What is being tested?
- Shared Decision Making
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jose Zeballos, MD, jzeballos@bwh.harvard.edu
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Naida Cole, MD, nmcole@bsd.uchicago.edu
About this study
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.
Read the 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
- Being tested
- Shared Decision Making
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | 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. Receives: Other: Shared Decision Making |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leftover opioid pills
Measured: 30 days postoperatively
Average 0-10 NRS pain score
Measured: postoperative day 7
Secondary outcomes (3)
Quantity of opioid consumed
Measured: 30 days postoperatively
Satisfaction with pain management
Measured: 30 days postoperatively
Quantity of opioid pills prescribed
Measured: postoperative day 1 at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start2 Nov 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naida Margaret Cole, University of Chicago
- Investigators
- Naida Cole, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564729
- Sponsor's protocol ID
- 2020P002342
- Status last verified
- May 2022
- First submitted
- 21 Sep 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
- ClinicalTrials.gov ID
- NCT04564729
- Acronym / sponsor ID
- 2020P002342
- Conditions
- Knee Arthroplasty, Total, Analgesia, Opioid Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Other: Shared Decision MakingThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (12 listed)
- Diagnosis of dementia
- <18 years old
- Contraindication or allergy to opioids
- Contraindication or allergy to Tylenol
- Contraindication or allergy to gabapentin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision MakingThe 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. | Other | Decision Aid |
Primary outcome
Leftover opioid pills
Time frame: 30 days postoperatively
Average 0-10 NRS pain score
Time frame: postoperative day 7
3 secondary outcomes
Quantity of opioid consumed
Time frame: 30 days postoperatively
Satisfaction with pain management
Time frame: 30 days postoperatively
Quantity of opioid pills prescribed
Time frame: postoperative day 1 at hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naida Cole, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making in people with Knee Arthroplasty, Total and Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naida Cole, MD (9176576692, nmcole@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leftover opioid pills (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.