CompletedNot Applicable

Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review

590 participantsStarted 2014-11-06

Plain-language summary

To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012
✓. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first.
✓. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period.
✓. Patients with continuous enrollment during the follow-up period of 18 months

Exclusion criteria

✕. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories
✕. Patients for whom no medical records can be accessed
✕. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.

What they're measuring

The percentages of patients in each category having at least one and up to 34 (all) of the prespecified list of behaviors suggestive of misuse, diversion, abuse and/or addiction in their medical records

Timeframe: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

The correlation among the behaviors suggestive of misuse, diversion, abuse and/or addiction

Timeframe: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

Trial details

NCT IDNCT02667210

SponsorMember Companies of the Opioid PMR Consortium

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-06-21

View on ClinicalTrials.gov More Opioid-Related Disorders trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012
✓. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first.
✓. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period.
✓. Patients with continuous enrollment during the follow-up period of 18 months

Exclusion criteria

✕. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories
✕. Patients for whom no medical records can be accessed
✕. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.

What they're measuring

Timeframe: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

The correlation among the behaviors suggestive of misuse, diversion, abuse and/or addiction

Timeframe: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up