Opioid-use DisorderCOMPUTENCT03559179

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

A study testing Opioid Wizard in people with Opioid-use Disorder, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Opioid-use Disorder
What is being tested?: Opioid Wizard
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2018to 14 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Less than half-time clinical primary care responsibilities

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthPartners
Bloomington, Minnesota, 55425

Other trials in United States

About this study

Official title: Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR

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.

Conditions: Opioid-use Disorder
Being tested: Opioid Wizard
Keywords: CDS, Medication Assisted Therapy
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03559179
Study group	Role	What they receive
Waivered Providers Receive the Opioid Wizard	Experimental	All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard). Receives: Other: Opioid Wizard
Does not Receive the Opioid Wizard	No intervention	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.
Non-Waivered Providers who receive Opioid Wizard	Experimental	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). Receives: Other: Opioid Wizard

What is being measured

The primary outcome is the main question the study is designed to answer.

Intervention PCP Confidence in Assessing and Treating OUD
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Measured: This outcome measure was calculated at approximately month 10 of the pilot study
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.
Measured: This was calculated after PCP surveys were completed, approximately month 10

Secondary outcomes (3)

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.
Measured: This was calculated at the end of the pilot study (month 8).
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.
Measured: This was calculated at the end of the pilot study (month 8).
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.
Measured: This was calculated at the end of the pilot study (month 8).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 201814 Feb 2019

First posted18 Jun 2018
Study start30 Apr 2018
Primary completion14 Feb 2019
Study completion14 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03559179
Sponsor's protocol ID: 0076-ot
Other IDs: 3UG1DA040316-03S1
Acronym: COMPUTE
Status last verified: Feb 2019
First submitted: 9 May 2018
Last updated: 17 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rossom RC, Sperl-Hillen JM, O'Connor PJ, Crain AL, Nightingale L, Pylkas A, Huntley KV, Bart G. A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Addict Sci Clin Pract. 2021 Jun 15;16(1):37. doi: 10.1186/s13722-021-00245-7.
PubMed 34130758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse

All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR
ClinicalTrials.gov ID: NCT03559179
Acronym / sponsor ID: COMPUTE / 0076-ot
Conditions: Opioid-use Disorder
Keywords: CDS, Medication Assisted Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Hennepin Healthcare Research Institute
Study start: 30 Apr 2018 (actual)
Primary completion: 14 Feb 2019 (actual)
Study completion: 14 Feb 2019 (actual)
First posted: 18 Jun 2018 (actual)
Results: Posted 10 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Waivered Providers Receive the Opioid Wizard	Experimental	Other: Opioid WizardAll providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard).
Does not Receive the Opioid Wizard	No intervention	–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.
Non-Waivered Providers who receive Opioid Wizard	Experimental	Other: Opioid WizardAll 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).

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Less than half-time clinical primary care responsibilities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opioid WizardThe Opioid Wizard is an OUD clinical decision support tool for primary care providers.	Other	Non-Waivered Providers who receive Opioid Wizard, Waivered Providers Receive the Opioid Wizard

Primary outcome

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.
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.

3 secondary outcomes

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).
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).
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
Time frame: This was calculated at the end of the pilot study (month 8).

Results and safety

Results posted to the registry on 10 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Waivered Providers Received the Opioid Wizard	8	8
Non-Waivered Providers Received The Opioid Wizard	24	23
Non-Waivered Providers Who Did Not Receive the Opioid Wizard	23	23

Primary outcome: Intervention PCP Confidence in Assessing and Treating OUD

Time frame: This outcome measure was calculated at approximately month 10 of the pilot study. Count of participants. Unit: Participants

Measure	Waivered Providers Received the Opioid Wizard n = 8	Non-Waivered Providers Who Received the Opioid Wizard n = 21
# of INT PCPs reporting confidence assessing OUD	6	11
# of INT PCPs reporting confidence treating OUD	8	1

Population analysed: This outcome was to help show proof of the OUD-CDS concept using responses from intervention PCPs. One intervention provider stopped working for the organization during the intervention. Two additional intervention providers in the "Non-Waivered providers who received the Opioid Wizard" arm did not complete follow-up surveys.

Primary outcome: Intervention PCP Likeliness to Recommend Use of the OUD-CDS

Time frame: This was calculated after PCP surveys were completed, approximately month 10. Count of participants. Unit: Participants

Measure	Waivered Providers Receive the Opioid Wizard n = 8	Non-Waivered Providers Who Receive Opioid Wizard n = 21
Value	6	13

Population analysed: One non-waivered intervention provider stopped working for the organization and two additional non-waivered intervention providers did not complete the follow-up survey.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: These data were collected during the entire active intervention period, from 6/6/2018-12/6/2018. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Waivered Providers Who Received the Opioid Wizard	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Non-Waivered Providers Who Received the Opioid Wizard	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Non-Waivered Providers Who Did Not Receive the Opioid Wizard	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34130758Rossom RC, Sperl-Hillen JM, O'Connor PJ, Crain AL, Nightingale L, Pylkas A, Huntley KV, Bart G. A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Addict Sci Clin Pract. 2021 Jun 15;16(1):37. doi: 10.1186/s13722-021-00245-7.

Related trials for Opioid-use Disorder

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Opioid Wizard in people with Opioid-use Disorder, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention PCP Confidence in Assessing and Treating OUD (time frame: This outcome measure was calculated at approximately month 10 of the pilot study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03559179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.