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Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption

Primary Purpose

Opioid Use, Opioid Dependence, Knee Pain Chronic

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Improved Opioid-Tapering Instructions
Clinical Patient Educator
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Total Hip Arthroplasty, Total Knee Arthroplasty, Opioid Dependence, Opioid Tapering

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Date of surgery between 3 weeks and 8 weeks away
  • Undergoing total hip or total knee replacement [including simultaneous bilateral]
  • Eligible based on our standard Faulkner Hospital pre-op assessment

Exclusion Criteria:

  • If female, pregnant
  • Undergoing partial joint replacement

Sites / Locations

  • Brigham and Women's Faulkner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care

Improved Instructions

Improved Instructions and Educator

Arm Description

Standard instructions from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.

Improved opioid-tapering instructions given upon discharge from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.

Improved opioid-tapering instructions given upon discharge from hospital. Subject receives regular phone calls from educator for counseling in opioid tapering. Subjects record opioid tapering in diary.

Outcomes

Primary Outcome Measures

Total Opioid Consumption: Amount
Total amount of patients' opioid consumption, measured in mg of morphine equivalents.
Opioid Usage After One Week
The proportion of patients who have finished taking opioids by the first postoperative appointment, approximately one week after surgery.
Total Opioid Consumption: Days
The total number of days in which each patient took opioid medications after surgery.

Secondary Outcome Measures

Opioid Usage After Two Weeks
The proportion of patients who have finished taking opioids two weeks after surgery.
Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
VAS Score 2: "How much pain do you feel in your operative site when moving?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
VAS Score 3: "How well are you sleeping?"
Sleep quality. Scale 0-10 with 0 worst and 10 best.
VAS Score 4: "How bad is your nausea?"
Nausea. Scale 0-10, with 0 best and 10 worst.
VAS Score 5: "How satisfied are you with your pain management?"
Satisfaction. Scale 0-10 with 0 worst and 10 best.
Questionnaire Answers
Questionnaire given to patients 3 months after surgery. Patients are asked about how opioid medications are typically stored and consumed at home.

Full Information

First Posted
April 24, 2018
Last Updated
February 24, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03534102
Brief Title
Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption
Official Title
Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to limitations caused by COVID, enrollment targets could not be met.
Study Start Date
June 6, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction. All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and choose to participate will be assigned to a treatment group based on which arm of the study is being tested at the time; (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also weekly phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.
Detailed Description
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction. The enrollment of the study will depend on the amount of patients that fall into each treatment arm - each of which will last for a fixed period of time. The expected enrollment is approximately 1000-1200 patients. All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked whether they would like to participate. Those who agree will be assigned to a treatment group based on which arm of the study is being tested at the time (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also regular phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering. Each enrolled patient will be given verbal and written (printed and/or electronic format) instructions about narcotic medication by the nursing staff upon hospital discharge. The instructions will explain when to use such medications, how to taper off them, and how to document them. Following discharge, patients will record their opioid consumption on their own and document their pain, nausea, sleep and satisfaction. At the first post-operative appointment, patients' levels of opioid use will be recorded and actual tablets consumed compared with prescription received. If they receive a new prescription they will receive a matching diary for the total length of planned opioid treatment, including directions on how to wean themselves off the opioids. Outcome measures will be collected at both post-operative visits, the first a week after surgery and the second 2-3 months following. Additional data including length of stay, postoperative complications including infection and readmission, Emergency Department visits, and routinely collected postoperative functional outcome measures (PROMs) will be recorded. The Principal Investigator (PI) will review all pain, satisfaction, narcotic usage and proprioception data on a weekly basis with the research assistant (RA) as it is collected. These checks will help to ensure validity and patient safety. Privacy and confidentially will be assured by using codes as deidentifiers in place of identifying information on any data sheets used in analysis. Data which identifies the patient will be made available only to investigators and stored only in a private folder on department computers protected with a firewall. No data will be shared outside of Partners. Adverse events will be promptly reported to the Partners Human Research Committee (PHRC) as per PHRC rules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Dependence, Knee Pain Chronic, Knee Osteoarthritis
Keywords
Total Hip Arthroplasty, Total Knee Arthroplasty, Opioid Dependence, Opioid Tapering

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Testing 3 sequential standards of care; each of 3 arms lasts 4 months, and all patients recruited within an arm are assigned to the same treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard instructions from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.
Arm Title
Improved Instructions
Arm Type
Experimental
Arm Description
Improved opioid-tapering instructions given upon discharge from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.
Arm Title
Improved Instructions and Educator
Arm Type
Experimental
Arm Description
Improved opioid-tapering instructions given upon discharge from hospital. Subject receives regular phone calls from educator for counseling in opioid tapering. Subjects record opioid tapering in diary.
Intervention Type
Drug
Intervention Name(s)
Improved Opioid-Tapering Instructions
Intervention Description
Applied to first and second experimental groups in the form of discharge instructions and directions from nursing staff.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Patient Educator
Intervention Description
Applied to second experimental group in the form of regular calls about weaning off narcotic medications.
Primary Outcome Measure Information:
Title
Total Opioid Consumption: Amount
Description
Total amount of patients' opioid consumption, measured in mg of morphine equivalents.
Time Frame
2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Title
Opioid Usage After One Week
Description
The proportion of patients who have finished taking opioids by the first postoperative appointment, approximately one week after surgery.
Time Frame
7 days following surgery.
Title
Total Opioid Consumption: Days
Description
The total number of days in which each patient took opioid medications after surgery.
Time Frame
2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Secondary Outcome Measure Information:
Title
Opioid Usage After Two Weeks
Description
The proportion of patients who have finished taking opioids two weeks after surgery.
Time Frame
14 days following surgery.
Title
Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"
Description
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Time Frame
2-3 months following surgery (measured at second postoperative appointment).
Title
VAS Score 2: "How much pain do you feel in your operative site when moving?"
Description
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Time Frame
2-3 months following surgery (measured at second postoperative appointment).
Title
VAS Score 3: "How well are you sleeping?"
Description
Sleep quality. Scale 0-10 with 0 worst and 10 best.
Time Frame
2-3 months following surgery (measured at second postoperative appointment).
Title
VAS Score 4: "How bad is your nausea?"
Description
Nausea. Scale 0-10, with 0 best and 10 worst.
Time Frame
2-3 months following surgery (measured at second postoperative appointment).
Title
VAS Score 5: "How satisfied are you with your pain management?"
Description
Satisfaction. Scale 0-10 with 0 worst and 10 best.
Time Frame
2-3 months following surgery (measured at second postoperative appointment).
Title
Questionnaire Answers
Description
Questionnaire given to patients 3 months after surgery. Patients are asked about how opioid medications are typically stored and consumed at home.
Time Frame
3 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Date of surgery between 3 weeks and 8 weeks away Undergoing total hip or total knee replacement [including simultaneous bilateral] Eligible based on our standard Faulkner Hospital pre-op assessment Exclusion Criteria: If female, pregnant Undergoing partial joint replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Fitz, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Faulkner Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26719073
Citation
Gordon DB, de Leon-Casasola OA, Wu CL, Sluka KA, Brennan TJ, Chou R. Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline. J Pain. 2016 Feb;17(2):158-66. doi: 10.1016/j.jpain.2015.10.023. Epub 2015 Dec 21.
Results Reference
background
PubMed Identifier
26827847
Citation
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
Results Reference
background
PubMed Identifier
19481046
Citation
Reynolds MA. Postoperative pain management discharge teaching in a rural population. Pain Manag Nurs. 2009 Jun;10(2):76-84. doi: 10.1016/j.pmn.2008.07.003. Epub 2009 Jan 4.
Results Reference
background
PubMed Identifier
25134933
Citation
Wakim JH. Alleviating symptoms of withdrawal from an opioid. Pain Ther. 2012 Dec;1(1):4. doi: 10.1007/s40122-012-0004-5. Epub 2012 Sep 20.
Results Reference
background
PubMed Identifier
22248582
Citation
Ninkovic J, Roy S. Morphine decreases bacterial phagocytosis by inhibiting actin polymerization through cAMP-, Rac-1-, and p38 MAPK-dependent mechanisms. Am J Pathol. 2012 Mar;180(3):1068-1079. doi: 10.1016/j.ajpath.2011.11.034. Epub 2012 Jan 14.
Results Reference
background
PubMed Identifier
26871536
Citation
Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
Results Reference
background
Links:
URL
https://www.europeanpainfederation.eu/wp-content/uploads/2017/01/02.-What-Health-Care-Professionals-Should-Know-About-Pain-After-Surgery.pdf
Description
Carr DB, Morlion B. Pain After Surgery: What Health-Care Professionals Should Know.

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Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption

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