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

A Patient Self-Assessment Software Combining Compliance Protocols to Improve Prescriber Confidence, Reduce Liability, and Improve Patient Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use; Opioid-use Disorder; Opioid Misuse
• Intervention / Treatment: Other: Care Continuity Program

• Study Type: Interventional
• Enrollment (Anticipated): 1840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Bowman, BS; Phone Number: 866-517-2771; Email: jbowman@suremedcompliance.com
• Study Contact Backup: Name: Amy Elliott, PhD; Phone Number: 866-517-2771; Email: aelliott@suremedcompliance.com

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36619
      • Recruiting
      • Sure Med Compliance
      • Contact: John Bowman, BS; Phone Number: 866-517-2771; Email: jbowman@suremedcompliance.com
      • Contact: Amy Elliott, PhD; Phone Number: 866-517-2771; Email: aelliott@suremedcompliance.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Care Continuity Program + Education; 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.	Other: Care Continuity Program; The Care Continuity Program is an online patient self-assessment tool used by prescribers of opioids to better identify patient risk factors and opioid 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. Prescribers may use the summary page to help them identify the appropriateness of initiating opioid therapy and/or continuing opioid therapy.
No Intervention: Education Alone; Participating clinics (and their prescribers and patients) will be randomly selected to the control group, 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 and prescribers will continue treatment as usual in their clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Milligram Equivalent	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.	Approximately 4 Months
Physical Functioning	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.	Approximately 4 Months
Prescriber Risk	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.	Approximately 4 Months
Prescriber Confidence	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.	Approximately 4 Months

Collaborators and Investigators

• Sponsor: Sure Med Compliance
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Abraham Hartzema, PhD, Sure Med Compliance; Study Director: John Bowman, BS, Sure Med Compliance

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Patient Safety; Intervention; Pain Management; Digital; Self Assessment; Electronic Health Record; Opioid Misuse; Patient Care; Documentation; Medication Compliance; Outcomes Research; Monitor; Opioid Epidemic; Patient Risk; Patient-Focused Outcomes; Prescription Opioid; Software Development; Opioid Prescriber; Legitimate Medical Purpose; Computer Software; Laws; Chart Documentation; Prescriber Confidence; NIH Heal Initiative
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: 1289337; 1R44DA051272-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As an NIH Helping to End Addiction Long-Term (HEAL) Initiative study, we are committed to making our publications and data available to researchers. Electronic copies of publications will be deposited (within four weeks of acceptance by a journal) in PubMed Central with proper metadata to be made discoverable and accessible upon publication. Publications will be made publicly available immediately without any embargo period. Underlying primary data for the publications that are free of identifiers but contain sensitive information will be made broadly available through the NIH HEAL Initiative central data repository. Underlying primary data will be deposited in the NIH HEAL Initiative central data repository after it is stripped of all identifiers in accordance with HIPAA regulations and the Department of Health and Human Services Regulations for the Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained from the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No