Opioid UseNCT04044521
Promoting Clinical Guidelines for Opioid Prescribing
A study testing Systems consultation in people with Opioid Use, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Systems consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2020to 1 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinics will be eligible for the study if they:
- are a primary care clinic (non-pediatric primary care, internal medicine, or family medicine);
- have not received the systems consultation intervention;
- do not explicitly prohibit initiating opioid therapy;
- do not exceed the performance on key measures of guideline concordance (fewer than 80% of long-term opioid patients have treatment agreements and a urine drug screen in the past 12 months)
- Prescribers will be eligible if they:
Show all 12Show fewer
- are a primary care provider at the clinic;
- are not temporary providers who do not manage stable panels or patients;
- While patients are not subjects of study, de-identified prescriber panel data will be used to assess outcome measures. To be included in the de-identified prescriber panel data, patients must:
- have a primary care provider at the clinic;
- are prescribed opioid therapy for at least 3 consecutive months;
- do not have a cancer diagnosis or are receiving hospice care.
Who cannot join
- Clinics will be excluded if they are not a primary care clinic, have received the systems consultation intervention, prohibit initiating opioid therapy, or exceed the threshold on key measures of guideline concordance.
- Prescribers will be excluded if they don't have prescribing privileges or are temporary providers who do not manage stable panels or patients.
- De-identified prescriber panel data will be excluded from outcome measures if they do not have a primary care provider at the clinic, are not prescribed opioid therapy for at least 3 consecutive months, or have a cancer diagnosis or are receiving hospice care.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellin Health Systems
Green Bay, Wisconsin, 54305
UW Health
Madison, Wisconsin, 53792
About this study
Official title: Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation
This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. The pragmatic goal is to give health systems a tool they can use to predict which clinics and prescribers will benefit most from which sequence and combination of implementation strategies.
Read the detailed description
The proposed study evaluates a sequence and combination of implementation strategies that is tailored to the needs of stakeholders at different levels (health system, clinic, and prescriber). We will deliver an adaptive version of systems consultation that progressively and adaptively drills down to offer more and more personalized levels of implementation support. The intervention starts with academic detailing, a systems-level strategy consisting of an expert-led training session plus distance-based follow up support. This strategy continues for the 21-month intervention for all clinics, but at 3 months, half of the clinics will be randomized to receive practice facilitation. Practice facilitation is a clinic-level strategy in which a highly-skilled external change agent helps clinics improve processes related to opioid prescribing. At 6 months, half of prescribers will be randomized to receive physician peer coaching. Physician peer coaching is a clinic-level strategy in which a physician expert gives one-on-one support to prescribers in managing their patients on long-term opioid therapy. These 3 discrete strategies will be delivered in a sequential, multiple-assignment randomized trial to 38 clinics from 2 Wisconsin health systems. The study has 3 specific aims:
- Compare the effect over 21 months of (1). An adaptive systems consultation implementation strategy (intervention group) vs. (2). Academic detailing alone (control group) on average morphine milligram equivalent dose (the primary outcome).
- Develop an assessment of contextual factors that influence the effectiveness of different implementation strategies. This aim will test 4 moderators and assess other factors that affect implementation. The goal is to develop a tool that decision-makers can use to predict which implementation strategies will be most effective in different settings.
- Estimate the costs of delivering 4 different sequences and combinations of strategies, including the incremental cost effectiveness of adding facilitation and physician peer coaching. Results will help decision-makers weigh the costs and effects of using different implementation strategies.
- Conditions
- Opioid Use
- Being tested
- Systems consultation
- Keywords
- implementation, primary care, organizational change, Centers for Disease Control opioid prescribing guidelines, clinical guidelines, systems consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systems consultationOther
Systems consultation consists of three implementation strategies: academic detailing (AD), practice facilitation (PF), and physician peer consulting (PPC). Clinics will receive a combination of these strategies for 21 months.
AD: Clinicians will attend an educational meeting that will detail the study and Center for Disease Control guidelines for opioid prescribing in primary care. Clinicians will then will get a monthly audit \& feedback report on their prescribing.
PF: clinics will be randomized to receive practice facilitation. Facilitators will meet with each clinic. Facilitators walk through the clinic, identify areas of opioid prescribing workflow improvement, conduct a nominal group technique with the change team, and set a Plan-Do-Study-Act cycle. Clinics will follow-up with the facilitators monthly.
PPC: Clinicians of the clinics will meet quarterly with the physician peer consultant to discuss tough patient cases and panels regarding opioid prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Academic detailing only | Experimental | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. Receives: Other: Systems consultation |
| Academic detailing+practice facilitation | Experimental | Clinicians of this group will attend an educational meeting and receive a monthly audit and feedback report for 18 months.
At month 3, clinics will be randomized to receive practice facilitation. Clinics will be asked to follow-up with the facilitators via phone or video chat monthly for months 4-9, then quarterly for months 10-18. Receives: Other: Systems consultation |
| Academic detailing+practice facilitation+physician peer consul | Experimental | Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 9, clinics will be randomized to receive physician peer consulting. Clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Receives: Other: Systems consultation |
| Academic detailing+physician peer consulting | Experimental | Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months.
At month 9, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Receives: Other: Systems consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics
The average morphine milligram equivalent will be reported at the clinic level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months.
For a comparison of opioids doses, a conversion factors were developed to equate the many different opioids into one standard value. This standard value is based on morphine and its potency, referred to as morphine milligram equivalents (MME) or morphine equivalent doses (MED).
Measured: up to 30 months
Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers
The average morphine milligram equivalent will be reported at the prescriber level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months.
Measured: up to 30 months
Secondary outcomes (7)
Number of Eligible Clinics That Participated
The number of eligible clinics that participated in the study.
Measured: up to 30 months
Number of Clinicians Who Participated in the Study
The number of eligible clinicians who participated in the study
Measured: up to 30 months
Number of Patients at Clinics
The total number of patients seen at clinics will be used to assess clinic size.
Measured: up to 30 months
Number of Clinicians Who Attended the Intervention Meetings
The number of clinicians who attended the meeting for practice facilitation, physician peer consulting, and follow-up meetings.
Measured: up to 30 months
Average Hours of Intervention Received Per Clinic
The average time (in hours) of intervention that clinics received.
Measured: up to 30 months
Average Hours of Intervention Received Per Prescriber
The average time (in hours) of intervention that prescribers received. The average time the prescriber received the intervention (in hours) is the same amount of time as the average intervention time that each clinic receives, because our intervention is at the clinic level.
Measured: up to 30 months
Estimated Cost of Each Study Arm in US Dollars
The estimated cost of each implementation sequence and combination in US dollars. The result is derived from the number of intervention hours calculated for each arm, multiplied by the average salary of the staff who gave the intervention (e.g., the facilitators, providers, and IT coordinator), referenced from publicly reported data (Medscape Family Medicine Physician Compensation Report).
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start31 Jan 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Andrew Quanbeck, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044521
- Sponsor's protocol ID
- 2018-1276
- Other IDs
- R01DA047279, A532007, SMPH/FAMILY MED/RES GRANTS, Protocol Version 8/31/2020
- Status last verified
- May 2024
- First submitted
- 1 Aug 2019
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Publications
Quanbeck A, Almirall D, Jacobson N, Brown RT, Landeck JK, Madden L, Cohen A, Deyo BMF, Robinson J, Johnson RA, Schumacher N. The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care. Implement Sci. 2020 Apr 25;15(1):26. doi: 10.1186/s13012-020-00990-4.
PubMed 32334632Quanbeck A, Li X, Cohen A, Butzine E, Brown RT. Budget Impact Analysis of the Balanced Opioid Initiative: A Cluster Randomized Trial Aimed at Deprescribing Opioids for Chronic Pain in Primary Care Settings. Ann Fam Med. 2026 Jan 26;24(1):36-43. doi: 10.1370/afm.250171.
PubMed 41587849Quanbeck A, Robinson J, Jacobson N, Li X, Hennessy-Garza R, Landeck J, Cohen A, Madden L, Pulvermacher A, Brown R. Strategies to Deimplement Opioid Prescribing in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438325. doi: 10.1001/jamanetworkopen.2024.38325.
PubMed 39388183
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation
- ClinicalTrials.gov ID
- NCT04044521
- Acronym / sponsor ID
- 2018-1276
- Conditions
- Opioid Use
- Keywords
- implementation, primary care, organizational change, Centers for Disease Control opioid prescribing guidelines, clinical guidelines, systems consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Posted 3 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. The pragmatic goal is to give health systems a tool they can use to predict which clinics and prescribers will benefit most from which sequence and combination of implementation strategies.
Detailed description
The proposed study evaluates a sequence and combination of implementation strategies that is tailored to the needs of stakeholders at different levels (health system, clinic, and prescriber). We will deliver an adaptive version of systems consultation that progressively and adaptively drills down to offer more and more personalized levels of implementation support. The intervention starts with academic detailing, a systems-level strategy consisting of an expert-led training session plus distance-based follow up support. This strategy continues for the 21-month intervention for all clinics, but at 3 months, half of the clinics will be randomized to receive practice facilitation. Practice facilitation is a clinic-level strategy in which a highly-skilled external change agent helps clinics improve processes related to opioid prescribing. At 6 months, half of prescribers will be randomized to receive physician peer coaching. Physician peer coaching is a clinic-level strategy in which a physician expert gives one-on-one support to prescribers in managing their patients on long-term opioid therapy. These 3 discrete strategies will be delivered in a sequential, multiple-assignment randomized trial to 38 clinics from 2 Wisconsin health systems. The study has 3 specific aims:
- Compare the effect over 21 months of (1). An adaptive systems consultation implementation strategy (intervention group) vs. (2). Academic detailing alone (control group) on average morphine milligram equivalent dose (the primary outcome).
- Develop an assessment of contextual factors that influence the effectiveness of different implementation strategies. This aim will test 4 moderators and assess other factors that affect implementation. The goal is to develop a tool that decision-makers can use to predict which implementation strategies will be most effective in different settings.
- Estimate the costs of delivering 4 different sequences and combinations of strategies, including the incremental cost effectiveness of adding facilitation and physician peer coaching. Results will help decision-makers weigh the costs and effects of using different implementation strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.
| Arm | Type | Receives |
|---|---|---|
| Academic detailing only | Experimental | Other: Systems consultationClinicians will attend an educational meeting and receive audit and feedback reports for 18 months. |
| Academic detailing+practice facilitation | Experimental | Other: Systems consultationClinicians of this group will attend an educational meeting and receive a monthly audit and feedback report for 18 months. At month 3, clinics will be randomized to receive practice facilitation. Clinics will be asked to follow-up with the facilitators via phone or video chat monthly for months 4-9, then quarterly for months 10-18. |
| Academic detailing+practice facilitation+physician peer consul | Experimental | Other: Systems consultationClinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 9, clinics will be randomized to receive physician peer consulting. Clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. |
| Academic detailing+physician peer consulting | Experimental | Other: Systems consultationClinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 9, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- are a primary care clinic (non-pediatric primary care, internal medicine, or family medicine);
- have not received the systems consultation intervention;
- do not explicitly prohibit initiating opioid therapy;
- do not exceed the performance on key measures of guideline concordance (fewer than 80% of long-term opioid patients have treatment agreements and a urine drug screen in the past 12 months)
- are a primary care provider at the clinic;
Key exclusion criteria (3 listed)
- Clinics will be excluded if they are not a primary care clinic, have received the systems consultation intervention, prohibit initiating opioid therapy, or exceed the threshold on key measures of guideline concordance.
- Prescribers will be excluded if they don't have prescribing privileges or are temporary providers who do not manage stable panels or patients.
- De-identified prescriber panel data will be excluded from outcome measures if they do not have a primary care provider at the clinic, are not prescribed opioid therapy for at least 3 consecutive months, or have a cancer diagnosis or are receiving hospice care.
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 |
|---|---|---|
| Systems consultationSystems consultation consists of three implementation strategies: academic detailing (AD), practice facilitation (PF), and physician peer consulting (PPC). Clinics will receive a combination of these strategies for 21 months. AD: Clinicians will attend an educational meeting that will detail the study and Center for Disease Control guidelines for opioid prescribing in primary care. Clinicians will then will get a monthly audit \& feedback report on their prescribing. PF: clinics will be randomized to receive practice facilitation. Facilitators will meet with each clinic. Facilitators walk through the clinic, identify areas of opioid prescribing workflow improvement, conduct a nominal group technique with the change team, and set a Plan-Do-Study-Act cycle. Clinics will follow-up with the facilitators monthly. PPC: Clinicians of the clinics will meet quarterly with the physician peer consultant to discuss tough patient cases and panels regarding opioid prescribing. | Other | Academic detailing only, Academic detailing+physician peer consulting, Academic detailing+practice facilitation, Academic detailing+practice facilitation+physician peer consul |
Primary outcome
Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics
Time frame: up to 30 months
The average morphine milligram equivalent will be reported at the clinic level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months. For a comparison of opioids doses, a conversion factors were developed to equate the many different opioids into one standard value. This standard value is based on morphine and its potency, referred to as morphine milligram equivalents (MME) or morphine equivalent doses (MED).
Average Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers
Time frame: up to 30 months
The average morphine milligram equivalent will be reported at the prescriber level. Patients included in this outcome are those who are prescribed at least 3 opioid orders in the last 3 consecutive months.
7 secondary outcomes
Number of Eligible Clinics That Participated
Time frame: up to 30 months
Number of Clinicians Who Participated in the Study
Time frame: up to 30 months
Number of Patients at Clinics
Time frame: up to 30 months
Number of Clinicians Who Attended the Intervention Meetings
Time frame: up to 30 months
Average Hours of Intervention Received Per Clinic
Time frame: up to 30 months
Average Hours of Intervention Received Per Prescriber
Time frame: up to 30 months
Estimated Cost of Each Study Arm in US Dollars
Time frame: up to 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32334632Quanbeck A, Almirall D, Jacobson N, Brown RT, Landeck JK, Madden L, Cohen A, Deyo BMF, Robinson J, Johnson RA, Schumacher N. The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care. Implement Sci. 2020 Apr 25;15(1):26. doi: 10.1186/s13012-020-00990-4.
- Derived from this study: PubMed 41587849Quanbeck A, Li X, Cohen A, Butzine E, Brown RT. Budget Impact Analysis of the Balanced Opioid Initiative: A Cluster Randomized Trial Aimed at Deprescribing Opioids for Chronic Pain in Primary Care Settings. Ann Fam Med. 2026 Jan 26;24(1):36-43. doi: 10.1370/afm.250171.
- Derived from this study: PubMed 39388183Quanbeck A, Robinson J, Jacobson N, Li X, Hennessy-Garza R, Landeck J, Cohen A, Madden L, Pulvermacher A, Brown R. Strategies to Deimplement Opioid Prescribing in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438325. doi: 10.1001/jamanetworkopen.2024.38325.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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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.
Andrew Quanbeck, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systems consultation in people with Opioid Use, run by University of Wisconsin, Madison at 2 sites 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 12 inclusion and 3 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 Jun 2024). 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?
Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics (time frame: up to 30 months). 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 NCT04044521, which also lists 3 linked publications.
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 Jun 2024.