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OpioidsSOPPNCT02584881

Safe Opioid Prescription Practice for Patients Discharged From Trauma Services

A study testing safe opioid prescription protocol in people with Opioids and Drug Prescription, run by Rhode Island Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioids, Drug Prescription
What is being tested?
safe opioid prescription protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Dec 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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.

About this study

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

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.

Read the detailed 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.

Being tested
safe opioid prescription protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • safe opioid prescription protocolOther

    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.

Study groups in NCT02584881
Study groupRoleWhat they receive
InterventionExperimentalA safe opioid prescription protocol will be implemented with these trauma patients
Receives: Other: safe opioid prescription protocol
ControlNo interventionStandard care at discharge will be implemented with these trauma patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The frequency of implementation of the SOPP checklist in the intervention site compared to standard care site

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionAug 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584881
Sponsor's protocol ID
U01CE002516-01
Acronym
SOPP
Status last verified
Oct 2014
First submitted
28 Oct 2014
Last updated
23 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing safe opioid prescription protocol in people with Opioids and Drug Prescription, run by Rhode Island Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency of implementation of the SOPP checklist in the intervention site compared to standard care site (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.

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