Clinical trial NCT04945525: Comparing a Patient Self-Assessment Software to Treatment as Usual in Opioid Prescriber and Patient Opioid Outcomes
Official title: A Patient Self-Assessment Software Combining Compliance Protocols to Improve Prescriber Confidence, Reduce Liability, and Improve Patient Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-use Disorder
Opioid Misuse
Opioid Use
Chronic Pain
Keywords: Pain
Pain Management
Patient Risk
Patient-Focused Outcomes
Outcomes Research
Patient Care
Self Assessment
Digital
Opioid Epidemic
Opioid Misuse
Patient Safety
Prescription Opioid
Software Development
Opioid Prescriber
Documentation
Legitimate Medical Purpose
Computer Software
Electronic Health Record
Laws
Monitor
Medication Compliance
Intervention
Chart Documentation
Prescriber Confidence
NIH Heal Initiative
Lead sponsor: Sure Med Compliance
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-30
Enrollment: 1840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty-six clinics with chronic, non-cancer pain patients in both pain management and general practice settings will be randomized to the Care Continuity Program (CCP) intervention or control group. Both groups will view an Accreditation Council for Continuing Medical Education (ACCME) accredited educational video about the safe initiation, continuation, and discontinuation of opioid therapy, as well as the data elements required by law and regulation to be included in the medical records of patients prescribed opioids. After four months of intervention, the CCP's ability to lower morphine milligram equivalents (MME), improve physical functioning in patients, mitigate the opioid prescriber's legal risk, and increase confidence levels in opioid prescribing among prescribers will be measured by completing medical record audits.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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 in the trial

Exclusion Criteria:

* Current cancer diagnosis
* Palliative or end of life care

Primary outcomes:
measure: Morphine Milligram Equivalent
timeFrame: Approximately 4 Months
measure: Physical Functioning
timeFrame: Approximately 4 Months
measure: Prescriber Risk
timeFrame: Approximately 4 Months
measure: Prescriber Confidence
timeFrame: Approximately 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Sure Med Compliance
state: Alabama
Study officials:
affiliation: Sure Med Compliance
name: Abraham Hartzema, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sure Med Compliance
name: John Bowman, BS
role: STUDY_DIRECTOR
References: