Substance AbuseNCT02433496
Physician Coaching to Reduce Opioid-related Harms
An observational study of Substance Abuse and Chronic Pain, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Chronic Pain
- What is being tested?
- Physician coaching
- How many people
- 53,132 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 30 Jun 2017
- Phase
- Observational
- 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
Study population: Clinicians with prescribing authority at community-based primary care clinics
Who may be able to join
- At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Who cannot join
- Residents will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.
Read the detailed description
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
- Conditions
- Substance Abuse, Chronic Pain
- Being tested
- Physician coaching
- Keywords
- Opioid
- Medical subject headings
- Substance-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician coachingOther
The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.
The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice.
| Study group | Role | What they receive |
|---|---|---|
| Physician coaching | This group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine. These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication. Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email. Receives: Other: Physician coaching | |
| Control Group | This group includes 4 control primary care clinics that will not receive any intervention. A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Rate of Opioid Prescribing
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
Measured: Up to 3 years
Secondary outcomes (13)
Rate of Opioid / Benzodiazepine Co-prescribing
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
Measured: Up to 3 years
Urine Drug Screening Rate
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
Measured: Up to 3 years
Mental Health Screening Rate
Proportion of opioid patients screened for mental health/substance use problems
Measured: Up to 3 years
Use of Pain Management Agreements
Proportion of opioid patients signing pain management agreements
Measured: Up to 3 years
High-dose Patients
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
Measured: Up to 3 years
Provider Drop-out Rate
Number and percentage of providers who drop out of study at 3 months
Measured: 3 months
Participating Patient Demographics
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
Measured: Up to 3 years
Participating Clinic Characteristics
Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
Measured: Up to 12 months
Participating Staff Characteristics
Characteristics of participating staff (profession)
Measured: Up to 12 months
Intervention Fidelity
Total hours of coaching delivered/received among all clinics that received physician coaching.
Measured: Up to 12 months
Intervention Cost
Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
Measured: Up to 12 months
Proportion With MEDD >120 mg
The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
Measured: Up to 12 months
Average Morphine Equivalent Daily Dose (MEDD)
The average MEDD in milligrams for patients with consistent opioid Rx.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJul 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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 Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Center for Health Enhancement System Studies
- Responsible party
- Sponsor
- Investigators
- Andrew R Quanbeck, PhD, Principal investigator, Center for Health Enhancement Systems Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433496
- Sponsor's protocol ID
- 2015-0280
- Other IDs
- 1R34DA036720-01A1
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2015
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Quanbeck A, Brown RT, Zgierska AE, Jacobson N, Robinson JM, Johnson RA, Deyo BM, Madden L, Tuan WJ, Alagoz E. A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care. Implement Sci. 2018 Jan 25;13(1):21. doi: 10.1186/s13012-018-0713-1.
PubMed 29370813
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Coaching to Reduce Opioid-related Harms
- ClinicalTrials.gov ID
- NCT02433496
- Acronym / sponsor ID
- 2015-0280
- Conditions
- Substance Abuse, Chronic Pain
- Keywords
- Opioid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,132 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Center for Health Enhancement System Studies
- Study start
- Jul 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 6 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.
Detailed description
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.
The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician coaching | – | Other: Physician coachingThis group includes 4 intervention primary care clinics that are part of the University of Wisconsin's Department of Family Medicine. These clinics will receive an organizational coaching intervention that includes in-person site visits and phone/email communication. Each participating clinic will designate one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit (during project month 13, July 2015), a follow-up site visit (month 15, October, 2015), and communicating with the coach throughout the 6-month follow-up period via phone and email. |
| Control Group | – | –This group includes 4 control primary care clinics that will not receive any intervention. A de-identified dataset will be created to examine differences in outcome variables between intervention and control clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinicians with prescribing authority at community-based primary care clinics
Key inclusion criteria (1 listed)
- At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.
Key exclusion criteria (1 listed)
- Residents will be excluded.
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 |
|---|---|---|
| Physician coachingThe coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. | Other | Physician coaching |
Primary outcome
Overall Rate of Opioid Prescribing
Time frame: Up to 3 years
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
13 secondary outcomes
Rate of Opioid / Benzodiazepine Co-prescribing
Time frame: Up to 3 years
Urine Drug Screening Rate
Time frame: Up to 3 years
Mental Health Screening Rate
Time frame: Up to 3 years
Use of Pain Management Agreements
Time frame: Up to 3 years
High-dose Patients
Time frame: Up to 3 years
Provider Drop-out Rate
Time frame: 3 months
Participating Patient Demographics
Time frame: Up to 3 years
Participating Clinic Characteristics
Time frame: Up to 12 months
Participating Staff Characteristics
Time frame: Up to 12 months
Intervention Fidelity
Time frame: Up to 12 months
Intervention Cost
Time frame: Up to 12 months
Proportion With MEDD >120 mg
Time frame: Up to 12 months
Average Morphine Equivalent Daily Dose (MEDD)
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29370813Quanbeck A, Brown RT, Zgierska AE, Jacobson N, Robinson JM, Johnson RA, Deyo BM, Madden L, Tuan WJ, Alagoz E. A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care. Implement Sci. 2018 Jan 25;13(1):21. doi: 10.1186/s13012-018-0713-1.
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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 R Quanbeck, PhD principal investigator
Center for Health Enhancement Systems Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse and Chronic Pain, run by University of Wisconsin, Madison 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 1 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 6 Jul 2018. 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 6 Jul 2018). 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?
Overall Rate of Opioid Prescribing (time frame: Up to 3 years). 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 NCT02433496, 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 6 Jul 2018.