Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.
How does this treatment for surgical pain differ from other treatments?
This treatment is unique because it aims to address the unmet need for effective surgical pain management by potentially incorporating new guidelines and best practices identified by the Surgical Pain Congress™, which focuses on improving patient outcomes and satisfaction.
147911Is the treatment generally safe for humans?
Research shows that while older pain treatments like opioids and NSAIDs have known safety profiles, newer treatments such as pregabalin and gabapentin are still being evaluated for safety in surgical settings. Incident reporting in pain management has identified preventable issues, often related to human factors, highlighting the importance of careful monitoring and reporting to ensure safety.
28101213Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment COMPAS Participants for pain management in surgery?
Research shows that improving postoperative pain management through quality improvement projects and evidence-based interventions can lead to better patient outcomes and satisfaction. For example, a project in Wisconsin hospitals showed significant improvements in pain management quality indicators, and a nationwide project demonstrated increased use of effective pain management practices.
3561114Eligibility Criteria
This trial is for English-reading adults aged 18-90 who are scheduled for elective orthopedic surgery at Duke Health and own a smartphone. It aims to identify those at risk of chronic opioid use after surgery.Inclusion Criteria
I am between 18 and 90 years old and will have elective orthopedic surgery at Duke Health.
Participant Groups
The COMPAS Participants study measures pain, psychosocial outcomes, functionality, and actual opioid usage post-surgery to predict the risk of long-term opioid use in patients.
1Treatment groups
Experimental Treatment
Group I: COMPAS ParticipantsExperimental Treatment1 Intervention
Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Duke OrthopaedicsDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
References
Management of perioperative pain in hospitalized patients: a national survey. [2019]A survey was carried out to provide "benchmark" data on current practices of in-hospital perioperative pain management. The 59-item survey questionnaire incorporated all key points contained in the Agency for Health Care Policy and Research and the American Society of Anesthesiologists published guidelines concerning institutional policies as well as practice patterns. The questionnaire was mailed to designated pain specialists in a sample of 400 hospitals that were systematically stratified by bed size and geographic region. Of the 400 questionnaires mailed, 223 (56%) were returned. Of the 223 respondents, 85% were board-certified anesthesiologists. There was good to excellent overall adherence to most of the guideline recommendations; significant exceptions were the infrequent use of nonpharmacologic techniques for pain control and the relatively high frequency of intramuscular opioid use. In general, large hospitals have a greater adherence to the recommendations of the guidelines than do smaller hospitals. No noteworthy variations in institutional policies or practice patterns were evident. These results provide comprehensive baseline data against which future developments in the field of perioperative pain management can be assessed.
Incident reporting in acute pain management. [2022]Incident reporting is an effective tool for continuous quality improvement in clinical practice. A prospective study on voluntary incident reporting in pain management was conducted at a major teaching hospital in Hong Kong. Over a 12-month period, 53 incidents were reported in 1275 patients who received pain relief treatments which were supervised by the acute pain service. The majority of the incidents were first detected by the pain team. The most common incidents involved delivery circuits, delivery pump and drug administration. A large proportion (81.4%) of the incidents were thought to be preventable. Human factors were involved in 41.9% of the patients reported, most commonly associated with unfamiliar technique/inexperience, inattention and inadequate communication. Four patients developed major morbidity of which two were attributed to inadequate analgesia, while three others had major physiological changes without morbidity. Strategies have been formulated to prevent further occurrence of these incidents. We propose that incident reporting is a potentially useful tool in identifying and preventing adverse events in postoperative pain management.
Evaluation of a local cooperative project to improve postoperative pain management in Wisconsin hospitals. [2019]The effectiveness of a local collaborative quality improvement project in improving the management of postoperative pain for Wisconsin Medicare patients was assessed. Six quality indicators were evaluated on the basis of baseline data from 714 subjects at 15 collaborating hospitals and follow-up data from 406 subjects from the same 15 hospitals. After efforts to improve postoperative pain management, there was statistically significant improvement in all six quality indicators.
[Postoperative pain therapy in Germany]. [2019]A survey was performed to obtain information on the organization and practice of postoperative pain management.
Institutionalizing pain management: the Post-Operative Pain Management Quality Improvement Project. [2019]Clinical practice and quality improvement (QI) guidelines for acute postoperative pain management have been developed to address the well-documented problem of undertreatment of postoperative pain. The Post-Operative Pain Management Quality Improvement Project (the POP Project) was initiated to determine whether an intervention designed to support hospitals in the development of QI efforts would lead to improvements in structures, processes, and outcomes consistent with recommended guidelines. A nationwide sample of 233 hospitals joined the project. The intervention consisted of written resource materials accompanied by support services that included an e-mail list server, a resource Web page, and assistance from POP Project staff via telephone. Data regarding critical structures, processes (practice patterns), and patient outcomes were collected at baseline before the intervention began and at follow-up 12 to 18 months later. Results showed a statistically significant increase from baseline (45%) to follow-up (72%) in the presence of structural elements that are critical to improving pain management. There were statistically significant improvements in practices including documented use of pain rating scales, decreased use of intramuscular opioids, and increased use of nonpharmacologic strategies. Patient survey data showed no change in pain outcomes. Evaluation data showed that 70% of hospitals were very or extremely satisfied with their participation in the POP Project and 90% of them planned to continue efforts to improve pain management after the POP Project ended. Further research is needed to determine how to translate the excellent results obtained for structure and process into meaningful outcomes for patients.
[Does patient satisfaction correlate with pain level during patient-monitored epidural analgesia. Evaluation of data from postoperative pain service]. [2018]The evaluation of patients' satisfaction and outcome after surgery is of increasing importance. An optimized postoperative pain management may contribute substantially to this important goal.
Pain prevalence in hospitalized patients in a German university teaching hospital. [2022]Forty-eight units were enrolled in a descriptive, cross-sectional study to identify strengths and weaknesses of pain management in a German university teaching hospital. Patients had to be > or =18 years old and able to speak German; intensive care, psychiatric, obstetric and pediatric units were excluded. Structured interviews were conducted by an independent researcher not involved in patient care. Patients were asked about prevalence of pain during the interview at rest, on movement, and during the 24 hours before the interview; patients rated pain intensity at rest and on movement as well as the worst pain 24 hours before the interview by using a 10 cm visual analogue scale (VAS). In addition, patients indicated localization, duration, and causes of pain. Chart analysis was carried out to check for pain medication, ICD-10 diagnoses, and demographic data. To evaluate the adequacy of pain management, the Pain Management Index (PMI) was assessed. A total of 561 of the 825 inpatients who were contacted participated in the study. Fifty percent experienced pain during the interview and 63% reported pain during the preceding 24 hours. Fifty-eight percent had moderate or severe pain (VAS > or = 45 mm) and 36% reported severe pain (VAS > or = 65 mm). Thirty-three percent had pain for more than six months. The most prevalent localization of the strongest pain was in the lower extremities (20%). Fifty percent of patients with pain received pain medication. Patients on the surgical wards (P = 0.002) and those having severe pain (P or =65 mm received no analgesic and only 24% had adequate medication. A negative PMI, indicating inadequate pain therapy, was found in 44% (246/559) of the sample. Sex and age did not influence pain prevalence, pain intensity, or pain therapy. Pain prevalence and intensity in this German university hospital were high and pain therapy was inadequate in many cases. Pain management needs to be improved by continuous assessment and adequate pain medication.
Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. [2022]Opioid analgesics remain a mainstay in the treatment of pain associated with surgical procedures. Such use is associated with adverse drug events (ADEs).
[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. [2021]Demonstration of improved postoperative pain management by implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, by the integrated quality management concept "quality management acute pain" of the TÜV Rheinland or by participation in the benchmark project "Quality improvement in postoperative pain management" (QUIPS).
COX-2 inhibitor and non-selective NSAID use in those at increased risk of NSAID-related adverse events: a retrospective database study. [2021]Adverse events related to analgesic use represent a challenge for optimizing treatment of pain in older people.
Defining new directions for more effective management of surgical pain in the United States: highlights of the inaugural Surgical Pain Congress™. [2014]Despite advances in pharmacologic options for the management of surgical pain, there appears to have been little or no overall improvement over the last two decades in the level of pain experienced by patients. The importance of adequate and effective surgical pain management, however, is clear, because inadequate pain control 1) has a wide range of undesirable physiologic and immunologic effects; 2) is associated with poor surgical outcomes; 3) has increased probability of readmission; and 4) adversely affects the overall cost of care as well as patient satisfaction. There is a clear unmet need for a national surgical pain management consensus task force to raise awareness and develop best practice guidelines for improving surgical pain management, patient safety, patient satisfaction, rapid postsurgical recovery, and health economic outcomes. To comprehensively address this need, the multidisciplinary Surgical Pain Congress™ has been established. The inaugural meeting of this Congress (March 8 to 10, 2013, Celebration, Florida) evaluated the current surgical pain management paradigm and identified key components of best practices.
Adverse event assessment and reporting in trials of newer treatments for post-operative pain. [2018]Assessment and reporting of adverse events (AEs) in studies of perioperative interventions is critical given the potential for unintended and preventable iatrogenic morbidity and mortality. This focused review evaluated the quality of AE assessment and reporting in acute post-operative pain treatment trials. Since older analgesics (e.g., opioids, NSAIDs) already have a well-characterized safety profile, we concentrated on trials of pregabalin and gabapentin as a representative sample of studies where the perioperative safety profile was relatively unknown.
Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. [2023]Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting.
The Perioperative Pain Management Bundle is Feasible: Findings From the PAIN OUT Registry. [2023]The quality of postoperative pain management is often poor. A "bundle," a small set of evidence-based interventions, is associated with improved outcomes in different settings. We assessed whether staff caring for surgical patients could implement a "Perioperative Pain Management Bundle" and whether this would be associated with improved multidimensional pain-related patient-reported outcomes (PROs).