Clinical Trials Logo

Clinical Trial Summary

Using a quasi-experimental design the investigators will compare the effect of adopting and implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma service team compared to a Level 1 trauma service team implementing standard care.


Clinical Trial Description

Prescribing opioids to injured patients who are discharged from an inpatient trauma admission is almost ubiquitous; however up to 26% of patients prescribed opioids for chronic pain abuse them leaving them at an increased risk of overdose and overdose fatality. Addressing this problem through an institutional level approach involving both patients and providers, including changes in physician prescription behaviors and directly intervening with the patients to increase knowledge of risks of opioid misuse and overdose, affords us the best opportunity to address this escalating public health concern.

Using a quasi-experimental design the investigators will compare the effect of adopting and implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma service team compared to a Level 1 trauma service team implementing standard care. Providers at both sites will complete web-based surveys to assess baseline knowledge, attitudes and barriers related to safe prescription practices. The intervention site will complete technical assistance activities to lead to the adoption and implementation of a SOPP protocol. The control site will continue to offer standard care to trauma patients throughout all phases. To measure institutional level changes, chart reviews will be conducted at both sites using a blinded medical review of discharged trauma service patients at baseline, early implementation, implementation and maintenance phases. To measure patient level changes, the investigators will assess patient perception of the discharge experience at both sites during the adoption phase (Cohort 1=100); implementation phase (Cohort 2=100) and maintenance phase (Cohort 3=100) via telephone interview within 7 days post discharge. Three month interviews will also be conducted with Cohort 2 to assess patient opioid usage, pain management strategies and Naloxone usage among Cohort 2. The aims of the proposed research study are to 1) examine and measure the adoption, implementation and maintenance of the SOPP protocol in the intervention site compared to standard care site and 2) to assess patient level outcomes of the SOPP protocol. The secondary aim of this study is to assess the effect the SOPP protocol on provider prescribing practices comparing the average dosage (in morphine milligram equivalents) and duration of dose from the chart review at baseline to the early implementation, implementation and maintenance phases of the study. The findings from this study will allow us to better understand the translation of a safe opioid prescription practice and has the potential to impact best practices for patient discharge within Level 1 trauma centers. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02584881
Study type Interventional
Source Rhode Island Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date December 2014
Completion date September 2016

See also
  Status Clinical Trial Phase
Completed NCT04227223 - Oxidative Balance in Opioid Therapy N/A
Completed NCT02277080 - The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids
Completed NCT00528177 - Morphine vs. Oxycodone for Postoperative Pain Management Phase 4
Recruiting NCT00911846 - Attitudes Towards Buprenorphine and Methadone N/A
Active, not recruiting NCT04878562 - I-COPE Study: Opioid Use and Pain Management in Older Adults N/A
Recruiting NCT04737473 - The Comparative Efficacy and Safety of Two General Anesthesia Protocols Consisting of Fentanyl Plus Propofol Plus Rococuronium Plus Isoflurane Versus Ketamime Plus Magnesium Sulphate Plus Lidocaine Plus Clonidine Plus Propofol Plus Rococuronium Plus Isoflurane for Gynaecology Surgery in Cameroon N/A
Completed NCT02928705 - Quality of Telemedically Guided Prehospital Analgesia N/A
Not yet recruiting NCT05529082 - The Attitudes and Beliefs of Hispanic/Latino Individuals Toward Prescription Opioids and Non-Medical Opioid Use