Comparing a Patient Self-Assessment Software to Treatment as Usual in Opioid Prescriber and Patient Opioid Outcomes

Last updated: June 25, 2021
Sponsor: Sure Med Compliance
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Opioid Use Disorder

Treatment

N/A

Clinical Study ID

NCT04945525
1289337
1R44DA051272-01
  • Ages > 18
  • All Genders

Study Summary

The Care Continuity Program (CCP), a product of Sure Med Compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. This tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. Results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber's electronic health records, mitigating the prescriber's civil and criminal risk. A brief of findings is displayed within the software through a dashboard and on the summary page of the report. This software offering includes a mobile and standard web-based application. The objective of the proposed research is to validate the protocols and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings, pre and post implementation of the CCP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prescribed an opioid at a participating clinic
  • Completed a baseline CCP assessment
  • Report functional impairment due to chronic pain
  • Report at least a 4 out of 10 on pain intensity
  • Have no psychiatric, mental, or physical limitation that precludes participation inthe trial

Exclusion

Exclusion Criteria:

  • Current cancer diagnosis
  • Palliative or end of life care

Study Design

Total Participants: 1840
Study Start date:
May 26, 2021
Estimated Completion Date:
July 31, 2022

Connect with a study center

  • Sure Med Compliance

    Mobile, Alabama 36619
    United States

    Active - Recruiting

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