Electronic Intervention to Chronic Opioid Therapy

November 5, 2021 updated by: Huiqiong Deng, Stanford University

An Electronic Chart Intervention to Improve Safety for Patients on Chronic Opioid Therapy

This pilot study will attempt to apply an electronic chart intervention to improve safety for patients on chronic opioid medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients prescribed long-term opioid therapy of doses greater than 90 morphine equivalent daily dose (MEDD)

Exclusion Criteria:

  • Patients prescribed short-term opioid medications for acute pain (less than a 90-day supply over the past 120 days), sublingual buprenorphine, methadone maintenance for opioid use disorder or with oncology or palliative care diagnoses will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic Intervention
Individualized opioid taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.
Other: opioid prescribing
Individualized taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of patients who receives naloxone prescription
Time Frame: baseline, 1, 3- and 6-months and 12 months
Change in the number of patients who receives naloxone prescription
baseline, 1, 3- and 6-months and 12 months
change of number of documentation about safety discussions
Time Frame: baseline, 1, 3- and 6-months and 12 months
change of number of documentation about safety discussions
baseline, 1, 3- and 6-months and 12 months
change of number of order for urine toxicology screening
Time Frame: baseline, 1, 3- and 6-months and 12 months
change of number of order for urine toxicology screening
baseline, 1, 3- and 6-months and 12 months
change of number of documentation of prescription drug monitoring program (CURES) results
Time Frame: baseline, 1, 3- and 6-months and 12 months
change of number of documentation of prescription drug monitoring program (CURES) results
baseline, 1, 3- and 6-months and 12 months
change of number of signed opioid informed consent forms
Time Frame: baseline, 1, 3- and 6-months and 12 months
change of number of signed opioid informed consent forms
baseline, 1, 3- and 6-months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of patients on long-term high risk doses of opioid pain medications
Time Frame: baseline, 1, 3- and 6-months and 12 months
decreases in daily dose of opioids and number of patients on opioids ≥ 90mg MEDD
baseline, 1, 3- and 6-months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Huiqiong Deng, MD, PHD, Stanford Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Actual)

June 17, 2021

Study Completion (Actual)

June 17, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-54148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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