Recruiting

Self-Assessment Software

Sponsor:

Sure Med Compliance

Code:

NCT04945525

Conditions

Opioid-use Disorder

Opioid Misuse

Opioid Use

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Care Continuity Program

Study Details

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.

Conditions

Opioid-use Disorder

Opioid Misuse

Opioid Use

Chronic Pain

Study ID

NCT04945525

Start date

May 26, 2021

Status verified date

Jun, 2021

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1840 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Morphine Milligram Equivalent [ Time Frame: Approximately 4 Months ]
  • Physical Functioning [ Time Frame: Approximately 4 Months ]
  • Prescriber Risk [ Time Frame: Approximately 4 Months ]
  • Prescriber Confidence [ Time Frame: Approximately 4 Months ]

Central Contacts and Locations

Central contacts

John Bowman, BS

866-517-2771jbowman@suremedcompliance.com

Amy Elliott, PhD

866-517-2771aelliott@suremedcompliance.com

Locations

Sure Med Compliance

Recruiting

Mobile, Alabama, United States, 36619

Contacts

John Bowman, BS

866-517-2771jbowman@suremedcompliance.com

Amy Elliott, PhD

866-517-2771aelliott@suremedcompliance.com

More Information

Sponsor

Sure Med Compliance

Last update posted

Jun 30, 2021

Last verified

Jun, 2021

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sure Med Compliance on 2021-06-30.