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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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