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

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04945525

Acronym / sponsor ID

1289337

Conditions

Opioid-use Disorder, Opioid Misuse, Opioid Use, Chronic Pain

Keywords

Pain, Pain Management, Patient Risk, Patient-Focused Outcomes, Outcomes Research, Patient Care, Self Assessment, Digital

Study type

Interventional

Recruitment status

Unknown status

Enrolment

1,840 participants (estimated)

Lead sponsor

Sure Med ComplianceIndustry (pharma, biotech, devices)

Collaborators

National Institute on Drug Abuse (NIDA)

Study start

26 May 2021 (actual)

Primary completion

31 Mar 2022 (estimated)

Study completion

31 Jul 2022 (estimated)

First posted

30 Jun 2021 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Health services research

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Model description

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.

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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.

2. 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.

3. 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.

4. 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.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.