A Patient-Centered Intervention to Improve Opioid Safety



Status:Active, not recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 23, 2016
End Date:March 31, 2020

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This is a randomized controlled trial of a multifaceted intervention designed to improve the
safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a
multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid
safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship,
and (c) explore to what extent ISOP is associated with changes in pain and pain-related
function.

The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care
System to either ISOP or the control condition; patients will be nested by clinician status.
All PCPs who enroll will participate in either a two-hour educational workshop or the
two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of
enrolled patients, track opioid medication-related events from the medical record, and
provide decision support to PCPs for issues related to prescription opioid safety. The NCM
will also meet individually with enrolled participants to discuss strategies for
preventing/reducing opioid side effects, preventing diversion, and providing rationale for
screening for prescription opioid misuse. The investigators will recruit patients who are
already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be
enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after
enrollment.

Inclusion Criteria:

- Enrollment in primary care at the VA Portland Health Care System

- Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated
to a life-limiting disease

- Able to read and write in English

Exclusion Criteria:

- Age younger than 18 years old

- On opioid therapy for palliative or end-of-life care

- Current enrollment in an opioid substitution program

- Lack of access to a telephone
We found this trial at
1
site
Portland, Oregon 97201
Principal Investigator: Benjamin J. Morasco, PhD MA
Phone: 503-220-8262
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mi
from
Portland, OR
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