PMID- 35296983
OWN - NLM
STAT- MEDLINE
DCOM- 20221109
LR  - 20231102
IS  - 1525-1497 (Electronic)
IS  - 0884-8734 (Print)
IS  - 0884-8734 (Linking)
VI  - 37
IP  - 15
DP  - 2022 Nov
TI  - A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: 
      Improving the Safety of Opioid Therapy (ISOT).
PG  - 3805-3813
LID - 10.1007/s11606-022-07476-7 [doi]
AB  - BACKGROUND: Interventions to reduce harms related to prescription opioids are 
      needed in primary care settings. OBJECTIVE: To determine whether a multicomponent 
      intervention, Improving the safety of opioid therapy (ISOT), is efficacious in 
      reducing prescription opioid harms. DESIGN: Clinician-level, cluster randomized 
      clinical trial. ( ClinicalTrials.gov : NCT02791399) SETTING: Eight primary care 
      clinics at 1 Veterans Affairs health care system. PARTICIPANTS: Thirty-five 
      primary care clinicians and 286 patients who were prescribed long-term opioid 
      therapy (LTOT). INTERVENTION: All clinicians participated in a 2-hour educational 
      session on patient-centered care surrounding opioid adherence monitoring and were 
      randomly assigned to education only or ISOT. ISOT is a multicomponent 
      intervention that included a one-time consultation by an external clinician to 
      the patient with monitoring and feedback to clinicians over 12 months. MAIN 
      MEASURES: The primary outcomes were changes in risk for prescription opioid 
      misuse (Current Opioid Misuse Measure) and urine drug test results. Secondary 
      outcomes were quality of the clinician-patient relationship, other prescription 
      opioid safety outcomes, changes in clinicians' opioid prescribing 
      characteristics, and a non-inferiority analysis of changes in pain intensity and 
      functioning. KEY RESULTS: ISOT did not decrease risk for prescription opioid 
      misuse (difference between groups = -1.12, p = 0.097), likelihood of an aberrant 
      urine drug test result (difference between groups = -0.04, p=0.401), or measures 
      of the clinician-patient relationship. Participants allocated to ISOT were more 
      likely to discontinue prescription opioids (20.0% versus 8.1%, p = 0.007). ISOT 
      did not worsen participant-reported scores of pain intensity or function. 
      CONCLUSIONS: ISOT did not impact risk for prescription opioid misuse but did lead 
      to increased likelihood of prescription opioid discontinuation. More intensive 
      interventions may be needed to impact treatment outcomes.
CI  - (c) 2022. This is a U.S. government work and not under copyright protection in the 
      U.S.; foreign copyright protection may apply.
FAU - Morasco, Benjamin J
AU  - Morasco BJ
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA. benjamin.morasco@va.gov.
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, USA. 
      benjamin.morasco@va.gov.
FAU - Adams, Melissa H
AU  - Adams MH
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, USA.
FAU - Hooker, Elizabeth R
AU  - Hooker ER
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
FAU - Maloy, Patricia E
AU  - Maloy PE
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
FAU - Krebs, Erin E
AU  - Krebs EE
AD  - Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care 
      System, Minneapolis, USA.
AD  - Department of Medicine, Division of General Internal Medicine, University of 
      Minnesota Medical School, Minneapolis, USA.
FAU - Lovejoy, Travis I
AU  - Lovejoy TI
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, USA.
AD  - School of Public Health, Oregon Health & Science University and Portland State 
      University, Portland, USA.
FAU - Saha, Somnath
AU  - Saha S
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
AD  - Primary Care Division, VA Portland Health Care System, Portland, USA.
AD  - Division of General Internal Medicine, Department of Medicine, Oregon Health & 
      Science University, Portland, USA.
FAU - Dobscha, Steven K
AU  - Dobscha SK
AD  - Center to Improve Veteran Involvement in Care, VA Portland Health Care System, 
      Portland, OR, USA.
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02791399
GR  - I01 HX001583/HX/HSRD VA/United States
GR  - 1I01HX001583/HX/HSRD VA/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20220316
PL  - United States
TA  - J Gen Intern Med
JT  - Journal of general internal medicine
JID - 8605834
RN  - 0 (Analgesics, Opioid)
SB  - IM
MH  - Humans
MH  - Analgesics, Opioid/adverse effects/urine
MH  - *Chronic Pain/drug therapy
MH  - Practice Patterns, Physicians'
MH  - *Opioid-Related Disorders/prevention & control/drug therapy
MH  - *Prescription Drug Misuse
PMC - PMC9640488
OTO - NOTNLM
OT  - adverse effects
OT  - chronic pain
OT  - long-term opioid therapy
OT  - treatment guidelines
EDAT- 2022/03/18 06:00
MHDA- 2022/11/10 06:00
PMCR- 2023/11/01
CRDT- 2022/03/17 05:34
PHST- 2021/08/30 00:00 [received]
PHST- 2022/03/03 00:00 [accepted]
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/11/10 06:00 [medline]
PHST- 2022/03/17 05:34 [entrez]
PHST- 2023/11/01 00:00 [pmc-release]
AID - 10.1007/s11606-022-07476-7 [pii]
AID - 7476 [pii]
AID - 10.1007/s11606-022-07476-7 [doi]
PST - ppublish
SO  - J Gen Intern Med. 2022 Nov;37(15):3805-3813. doi: 10.1007/s11606-022-07476-7. 
      Epub 2022 Mar 16.