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

Not Applicable

• Conditions: Opioid Misuse; Opioid-use Disorder; Chronic Pain; Opioid Use
• Interventions: Other: Care Continuity Program

• Registration Number: NCT04945525
• Lead Sponsor: Sure Med Compliance

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2021-06
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30
• Primary Completion: 2022-03-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Continuity Program + Education	Care Continuity Program	Participating clinics (and their prescribers and patients) will be randomly selected to implement the Care Continuity Program (CCP) intervention, at which time prescribers 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. Then patients will receive welcome letters and be required to complete CCP self-assessments before each appointment. Prescribers will begin using the generated CCP summary page at each appointment to help make decisions about initiating or maintaining an opioid prescription for an individual patient.

Primary Outcome Measures

Name	Time	Method
Prescriber Confidence	Approximately 4 Months	This outcome will be assessed via a survey developed based on the Opioid Therapy Survey (OTS). Our survey is a 19-item questionnaire that assesses prescriber confidence and fear of regulatory, civil, and criminal investigations. The post-intervention survey includes an additional 5 items on the effectiveness of the Care Continuity Program. At the end of the 4 month intervention, we will compare average prescriber confidence scores between groups.
Morphine Milligram Equivalent	Approximately 4 Months	This is a measure of the dosage of opioid medication prescribed, with higher Morphine Milligram Equivalent (MME) representing higher dosage. For this project, MME will be calculated using the Centers for Disease Control and Prevention Opioid Guidelines smartphone app, which includes an MME calculator. We will compare average MME of the groups at the end of the four month intervention.
Physical Functioning	Approximately 4 Months	In a survey adapted from the PDI (pain disability index) and the BPI (brief pain inventory) interference items, patients rate how much difficulty they have had in the past two weeks with each of seven life activity categories (family/home responsibilities, recreational activities, social activities, work-related activities, sex life, self-care activities, and life-supporting activities) because of pain. These items are measured from 0-10.
Prescriber Risk	Approximately 4 Months	Prescriber risk will be assessed as the completion of 26 data elements including: pain measurement, physical functional impairment, physical exam, onset of pain, duration of pain, failure on alternate treatment, assessment of affect, PTSD screening, assessment of substance use disorder risk, assessment of alcohol use, drug testing, consulting of state prescription drug monitoring program, patient history, informed consent to opioid therapy, controlled substance agreement, patient opioid education, treatment goals properly established, opioids initiated properly, starting MME under 90, no concomitant benzodiazepine use, side effects or adverse events evaluation, patient seen in office with proper frequency based on risk, opioid use disorder patients referred for treatment, and patient stratified into level of risk for misuse. At the end of the 4 month intervention, we will compare the proportion of each group's medical encounter notes that are complete.

Trial Locations

Locations (1)

Sure Med Compliance; 🇺🇸 Mobile, Alabama, United States