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Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR (COMPUTE)

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ClinicalTrials.gov Identifier: NCT03559179
Recruitment Status : Completed
First Posted : June 18, 2018
Results First Posted : March 10, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Hennepin Healthcare Research Institute
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and acceptability. The OUD-CDS is based on the NIDA-Blending Initiative white paper, "Clinical Decision Support for Opioid Use Disorders: Working Group Report," which itself is based on national evidence-based guidelines (American Society of Addiction Medicine (ASAM 2015), VA (VA 2015). As such, this pilot study aims to help PCPs achieve accepted standards of care in OUD treatment. The secondary objectives of this pilot study are to evaluate the usefulness of the tool by comparing OUD case-finding, medication-assisted therapy (MAT) and referral patterns pre- and post-CDS deployment for PCPs with and without CDS access.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Other: Opioid Wizard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 14, 2019

Arm Intervention/treatment
Experimental: Waivered Providers Receive the Opioid Wizard
All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.

No Intervention: Does not Receive the Opioid Wizard
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid Wizard. This arm of providers will continue to treat their patients as usual.
Experimental: Non-Waivered Providers who receive Opioid Wizard
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid. This arm of providers will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.




Primary Outcome Measures :
  1. Intervention PCP Confidence in Assessing and Treating OUD [ Time Frame: This outcome measure was calculated at approximately month 10 of the pilot study ]
    # of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.

  2. Intervention PCP Likeliness to Recommend Use of the OUD-CDS [ Time Frame: This was calculated after PCP surveys were completed, approximately month 10 ]
    # of PCPs with CDS access who rate the OUD-CDS >4 on a 5-point Likert scale of likeliness to recommend use of the tool to their colleagues. The scale ranges from 1-"not at all likely" to 5-"very likely," with higher values representing a higher likelihood of recommending the OUD-CDS to other colleagues.


Secondary Outcome Measures :
  1. Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. [ Time Frame: This was calculated at the end of the pilot study (month 8). ]
    Calculate and compare the number of patients diagnosed with OUD pre- and post-intervention. This will be presented as rate of OUD diagnoses per patient year.

  2. Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. [ Time Frame: This was calculated at the end of the pilot study (month 8). ]
    Calculate and compare the rate of MAT use among patients with OUD pre- and post-intervention. This is presented as a pre/post ratio of MAT rx per patient year.

  3. Compare Post-intervention Referral Patterns Between Intervention and Control Groups [ Time Frame: This was calculated at the end of the pilot study (month 8). ]
    Calculate and compare how often patients diagnosed with OUD are referred to specialty care or inpatient treatment post-intervention. Compare these rates between intervention and control groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be an MD, Doctor of Osteopathy, Nurse Practitioner or Physician's Assistant engaged in independent primary care of adults at HealthPartners or Park Nicollet
  • Have at least schedule 3 DEA prescribing privileges
  • Voluntarily provide written informed consent to participate in this study

Exclusion Criteria:

  • Less than half-time clinical primary care responsibilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559179


Locations
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United States, Minnesota
HealthPartners
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
National Institute on Drug Abuse (NIDA)
Hennepin Healthcare Research Institute
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
Study Protocol  [PDF] May 8, 2018
Statistical Analysis Plan  [PDF] May 8, 2018
Informed Consent Form  [PDF] April 17, 2018

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03559179    
Other Study ID Numbers: 0076-ot
3UG1DA040316-03S1 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2018    Key Record Dates
Results First Posted: March 10, 2020
Last Update Posted: March 17, 2020
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
CDS
Medication Assisted Therapy
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents