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临床试验/NCT05525975
NCT05525975
已完成
不适用

The Impact of Pre-operative Opioid Education and Opioid Disposal Following Shoulder Arthroplasty

Brendan M. Patterson1 个研究点 分布在 1 个国家目标入组 140 人2022年11月21日
适应症Opioid Use

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Opioid Use
发起方
Brendan M. Patterson
入组人数
140
试验地点
1
主要终点
Difference in Proportion of Participants With > 10 Pills Left Unused.
状态
已完成
最后更新
3个月前

概览

简要总结

Opioid medications are widely used after many orthopedic procedures and are routinely prescribed after shoulder replacement surgery. Despite the high prevalence of opioid abuse and misuse, there is no standardized mechanism for patients to dispose of unused opioid medications safely and securely and the average number of opioid pills required after shoulder replacement surgery is still unknown. In a prior pilot study conducted by our group (IRB# 202012142), opioid consumption patterns of patients undergoing shoulder arthroplasty were analyzed, as well as their adherence to a safe and secure disposal mechanism for excess opioid pills. A 94% retention rate was achieved and preliminary results showed that most of the subjects were 60 years of age and older.

The objective of the current proposal is to: (1) develop pre-operative education materials related to post-operative opioid use following shoulder arthroplasty; (2) pilot the impact of this educational intervention; (3) examine the effect of providing disposal mechanisms for unused opioid pain medications following shoulder arthroplasty. The proposal is to conduct a single blinded randomized controlled trial of patients undergoing total shoulder replacement, both anatomic total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA), and Hemiarthroplasty at UIHC. This randomized controlled trial will compare: (1) education plus opioid disposal to the standard of care (SC). The investigators hypothesize that pre-operative opioid education modules combined with a structured opioid disposal program will decrease opioid consumption following shoulder arthroplasty.

详细描述

Patients will be identified as potential research subjects by one of the the two Shoulder Surgeons (BMP, JVN) during their visit to the Shoulder Surgery Clinic at University of Iowa Hospitals and Clinics, according to the indication of a shoulder arthroplasty. During their preoperative work-up visit, patients will be invited to participate in the research study. The research coordinator will discuss the study with potential subjects in a private office or exam room. If the patient shows interest in participating, the research coordinator and the patient will go through the process of consent of participants. After agreeing to participate and signing informed consent, participants will be randomized into one of the 2 study arms at their preoperative work-up visit. Participants in Arm 1 (control group) will go through all procedures before and after their surgery as they usually do in standard of care practice, and all procedures will continue as scheduled. The standard of care practice of the Shoulder Surgery department at UIHC is that for patients that will undergo a surgical procedure NOT to receive any type of education on Opioid consumption, disposal or risks prior to the surgery. Participants in Arm 2 (education + disposal), at their work-up visit, will receive a brochure, will watch an educational video, and will also receive an envelope in which they will be able to dispose their unused opioid pills. These envelopes will be the same ones used in the team's previous pilot study (IRB# 202012142). The disposal method consists of secured, labeled envelopes to dispose of the excess of Opioid medication. These envelopes will be provided by "Sharps Compliance, Inc.", a company that manages pharmaceutical waste disposal programs for healthcare facilities. Through their "TakeAway Medication Recovery System Envelope (USPS)" they allow the collection and disposal of controlled substances (Schedules II-IV) and non-controlled medications. Subjects will be explained how to use the envelope and that since it is labeled they will not have to pay for anything when using it. The brochure will address opioid risks, side effects, disposal and explain non-opioid pain management strategies. The educational video will consist of a short video to educate patients on the current opioid crisis, explain how to safely dispose of excess opioids and will teach them about drug-free pain management techniques. All participants (Arm 1 and Arm2), after their surgery and after being discharged from the hospital, will receive daily text messages with a link to a REDCap survey. This texts will be delivered during the first 2 weeks following surgery. The survey will assess postoperative pain in the last 24 hours through Pain VAS, number of pills taken during the last 24 hours, number of pills disposed, method for disposal. For participants who did not answer the daily survey and for the ones who are still taking opioids after 2 weeks following surgery, will be able to answer the survey at their postoperative appointment at Shoulder Surgery clinic (2-weeks postop or 6-weeks postop). Patients in the education group will be emailed after their 6 week post-op visit to inquire as to their overall satisfaction with the education module and post-op buddy app/text program. Disposal envelops will be tracked via tracking number just to confirm they were received by the disposal center (Sharps Compliance Inc.).

注册库
clinicaltrials.gov
开始日期
2022年11月21日
结束日期
2024年4月26日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Brendan M. Patterson
责任方
Sponsor Investigator
主要研究者

Brendan M. Patterson

Assistant Professor

University of Iowa

入排标准

入选标准

  • Patients seen at UIHC Shoulder Surgery Clinic that are indicated for primary total shoulder arthroplasty procedures.

排除标准

  • revision shoulder arthroplasty
  • arthroplasty for proximal humerus fractures
  • patients with a history of chronic opioid consumption
  • patients with contraindications for opioid consumption.

结局指标

主要结局

Difference in Proportion of Participants With > 10 Pills Left Unused.

时间窗: 2 weeks or 6 weeks after surgery

Educational materials will be developed and their impact will be tested on opioid consumption patterns after total shoulder arthroplasty. By comparing Arm 1 and Arm 2 the investigators will determine the difference in opioid consumption between groups of patients who receive education and those who do not. Opioid consumption will be determined via patient self-reported opioid use on questionnaires completed during the first 2 weeks following surgery or at 6 weeks after surgery. The number of pills taken will be documented and will then be calculated by the research staff into MUE.

次要结局

  • Opioid Disposal(2-weeks or 6-weeks post-operative.)

研究点 (1)

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