Safe Opioid Prescription Practice for Patients Discharged From Trauma Services

Opioids Clinical Trial

— SOPP  

Official title:

Safe Opioid Prescription Practice for Patients Discharged From Trauma Services With a Prescription for Opioids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02584881
• Other study ID #: UO1CE002516-01
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2014
• Last updated: October 21, 2015
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2014
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Discharged to home from in-patient trauma services with a prescription for opioids

• Responsible for own medication.

• Cognitively capable of giving informed consent, can be contacted by telephone

Exclusion Criteria:

• < 18 years

• Discharged to rehabilitative or nursing home care

• Not discharged with prescribed opioids

• Not responsible for own medication

• No English speaking

• Under arrest at time of in-patient care

• Cannot be contacted by phone.

Study Design

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

Related Conditions & MeSH terms

• Drug Prescription
• Opioids

Intervention

Other:
• safe opioid prescription protocol
When indicated a prescription for naloxone will be given to patients discharged with prescription opioids from the trauma services. All patients will receive information on safe opioid use and storage and methods for pain management.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of implementation of the SOPP checklist in the intervention site compared to standard care site		Up to 18 months	No