Clinical trial NCT03534102: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid Use
Opioid Dependence
Knee Pain Chronic
Knee Osteoarthritis
Keywords: Total Hip Arthroplasty
Total Knee Arthroplasty
Opioid Dependence
Opioid Tapering
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Opioid Consumption: Amount
timeFrame: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
measure: Opioid Usage After One Week
timeFrame: 7 days following surgery.
measure: Total Opioid Consumption: Days
timeFrame: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Secondary outcomes:
measure: Opioid Usage After Two Weeks
timeFrame: 14 days following surgery.
measure: Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"
timeFrame: 2-3 months following surgery (measured at second postoperative appointment).
measure: VAS Score 2: "How much pain do you feel in your operative site when moving?"
timeFrame: 2-3 months following surgery (measured at second postoperative appointment).
measure: VAS Score 3: "How well are you sleeping?"
timeFrame: 2-3 months following surgery (measured at second postoperative appointment).
measure: VAS Score 4: "How bad is your nausea?"
timeFrame: 2-3 months following surgery (measured at second postoperative appointment).
measure: VAS Score 5: "How satisfied are you with your pain management?"
timeFrame: 2-3 months following surgery (measured at second postoperative appointment).
measure: Questionnaire Answers
timeFrame: 3 months after surgery.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Wolfgang Fitz, MD
role: PRINCIPAL_INVESTIGATOR
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