Opioid-use Disorder Clinical Trial
— COMPUTEOfficial title:
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR
Verified date | February 2019 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | HealthPartners | Bloomington | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute | Hennepin Healthcare Research Institute., National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention PCP Confidence in Assessing and Treating OUD | # of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD. | This outcome measure was calculated at approximately month 10 of the pilot study | |
Primary | Intervention PCP Likeliness to Recommend Use of the OUD-CDS | # 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. | This was calculated after PCP surveys were completed, approximately month 10 | |
Secondary | Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 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. | This was calculated at the end of the pilot study (month 8). | |
Secondary | Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 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. | This was calculated at the end of the pilot study (month 8). | |
Secondary | Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 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. | This was calculated at the end of the pilot study (month 8). |
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