Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03559179
Other study ID # 0076-ot
Secondary ID 3UG1DA040316-03S
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2018
Est. completion date February 14, 2019

Study information

Verified date February 2019
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.

Locations

Country Name City State
United States HealthPartners Bloomington Minnesota

Sponsors (3)

Lead Sponsor Collaborator
HealthPartners Institute Hennepin Healthcare Research Institute., National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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).
See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A