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

June 25, 2021 updated by: Sure Med Compliance

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1840

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine Milligram Equivalent
Time Frame: 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.
Approximately 4 Months
Physical Functioning
Time Frame: 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.
Approximately 4 Months
Prescriber Risk
Time Frame: 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.
Approximately 4 Months
Prescriber Confidence
Time Frame: 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.
Approximately 4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sure Med Compliance

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abraham Hartzema, PhD, Sure Med Compliance
  • Study Director: John Bowman, BS, Sure Med Compliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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