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

NCT ID: NCT04945525

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2022-07-31

Brief Summary

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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

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Conditions

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Opioid-use Disorder Opioid Misuse Opioid Use Chronic Pain

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Care Continuity Program

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Sure Med Compliance

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Hartzema, PhD

Role: PRINCIPAL_INVESTIGATOR

Sure Med Compliance

John Bowman, BS

Role: STUDY_DIRECTOR

Sure Med Compliance

Locations

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Sure Med Compliance

Mobile, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John Bowman, BS

Role: CONTACT

Phone: 866-517-2771

Email: [email protected]

Amy Elliott, PhD

Role: CONTACT

Phone: 866-517-2771

Email: [email protected]

Facility Contacts

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John Bowman, BS

Role: primary

Amy Elliott, PhD

Role: backup

Other Identifiers

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1R44DA051272-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1289337

Identifier Type: -

Identifier Source: org_study_id