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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047279 | U.S. NIH Grant/Contract | View source | |
| A532007 | Other Identifier | UW Madison | |
| SMPH/FAMILY MED/RES GRANTS | Other Identifier | UW Madison | |
| Protocol Version 8/31/2020 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Academic detailing only | Experimental | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systems consultation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Clinics That Participated | The number of eligible clinics that participated in the study. | up to 30 months |
| Number of Clinicians Who Participated in the Study | The number of eligible clinicians who participated in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Quality Improvement Experience of the Clinics | A assessment tool is under development to capture the quality improvement experience level of clinics. | up to 30 months |
| Components of System-level Opioid Prescribing Policy of the Health Systems |
Inclusion Criteria:
Clinics will be eligible for the study if they:
Prescribers will be eligible if they:
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:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Quanbeck, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellin Health Systems | Green Bay | Wisconsin | 54305 | United States | ||
| UW Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32334632 | Background | 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. | |
| 41587849 | Derived |
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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.
Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.
Proposals should be directed to PI Andrew Quanbeck at arquanbe@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
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The study team focused outreach efforts toward clinics to build awareness about this study. An email was sent to clinic medical directors of the health system to instruct them how to opt-out if they wish to decline participation in the study and future contact from the study team. The study team enrolled 'providers' as participants and focused on clinic-level data.
| ID | Title | Description |
|---|---|---|
| FG000 | Academic Detailing Only | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. Systems consultation: 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 18 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 travel to each clinics. 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. |
| FG001 | Academic Detailing+Practice Facilitation | 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 4-6, then quarterly for months 7-18. Systems consultation: 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 18 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 travel to each clinics. 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. |
| FG002 | Academic Detailing+Practice Facilitation+Physician Peer Consul | Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 6, 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. Systems consultation: 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 18 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 travel to each clinics. 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. |
| FG003 | Academic Detailing+Physician Peer Consulting | Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 6, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Systems consultation: 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 18 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 travel to each clinics. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline measures are based on clinic-level data, participant-level data not collected.
| ID | Title | Description |
|---|---|---|
| BG000 | Academic Detailing Only | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. Systems consultation: 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 18 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 travel to each clinics. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | unknown and not applicable |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Outcome measure provides clinic-level data. Participants enrolled are providers. | Posted | Mean | Standard Deviation | average MME/day | up to 30 months | Clinics | Clinics |
|
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not applicable - clinic level data collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Academic Detailing Only | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. Systems consultation: 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 18 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 travel to each clinics. 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. |
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All eligible clinics in two health systems were invited to participate. Clinics that volunteered may have been more motivated to change. Also, the interventions began in Feb. 2020 shortly before COVID forcing the implementation interactions to be done virtually rather than in person. In addition, the 2016 CDC guidelines that formed the basis of the intervention were the subject of considerable debate in the medical community and were revised in Feb. 2022, near the end of the intervention period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Quanbeck | University of Wisconsin-Madison | 608-609-7308 | andrew.quanbeck@fammed.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 | Oct 4, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2020 | Oct 4, 2023 | ICF_001.pdf |
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The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.
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|
| up to 30 months |
| Number of Patients at Clinics | The total number of patients seen at clinics will be used to assess clinic size. | 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. | up to 30 months |
| Average Hours of Intervention Received Per Clinic | The average time (in hours) of intervention that clinics received. | 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. | 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). | up to 30 months |
A list and count of the components of the participating health systems' opioid prescribing policy.
| up to 30 months |
| Number of Adaptations Made to the Intervention During Intervention Period | A list and count of adaptations that were made to the intervention during the intervention period will be documented. | up to 30 months |
| Number of Patients of a Prescriber Who Have Chronic Opioid Prescriptions | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the prescriber level. | up to 30 months |
| Number of Patients Completing Urine Drug Screens in the Past 12 Months | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have had a urine drug screen documented within the past 12 months. | up to 30 months |
| Number of Patients Completing Screening for Mental Health and Substance Abuse Within the Past 12 Months | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have a Patient Health Questionnaire (PHQ-9) documented within the past 12 months. The study team is not administering the screening tool, data will be provided by Wisconsin Collaborative for Healthcare Quality (WCHQ). The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the Patient Health Questionnaire. Total score can range from 1-27. Interpretation of total scores is as follows: 1-4=Minimal depression, 5-9=Mild depression, 10-14= Moderate depression, 15-19=Moderately severe depression, 20-27= Severe depression. | up to 30 months |
| Number of Patients With Treatment Agreements Within the Past 12 Months | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have documented treatment agreements within the past 12 months. | up to 30 months |
| Number of Patients With a Daily Morphine Milligram Equivalent Above 90 Milligrams | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months and have a daily morphine milligram equivalent over 90 milligrams. | up to 30 months |
| Number of Patients Who Are Co-prescribed Opioids and Benzodiazepines | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who also have a concurrent benzodiazepine prescription. | up to 30 months |
| Number of Emergency Room Visits and Hospitalizations Per Patient | The number of hospital or emergency room visits per patient among patients who are prescribed at least 3 opioid orders in 3 consecutive months. | up to 30 months |
| Number of Patients Who Attend Their Scheduled Clinic Visits | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who attend their scheduled clinic visits. | up to 30 months |
| Total Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions | The total number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the clinic level. | up to 30 months |
| Average Morphine Milligram Equivalent of Patients Who Are Co-prescribed Opioids and Benzodiazepines | The average morphine milligram equivalent of patients who are prescribed at least 3 opioid orders in 3 consecutive months at the clinic level. | up to 30 months |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| Quanbeck 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. |
| 39388183 | Derived | Quanbeck 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. |
| BG001 | Academic Detailing+Practice Facilitation | 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 4-6, then quarterly for months 7-18. Systems consultation: 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 18 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 travel to each clinics. 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. |
| BG002 | Academic Detailing+Practice Facilitation+Physician Peer Consul | Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 6, 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. Systems consultation: 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 18 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 travel to each clinics. 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. |
| BG003 | Academic Detailing+Physician Peer Consulting | Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 6, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Systems consultation: 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 18 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 travel to each clinics. 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. |
| BG004 | Total | Total of all reporting groups |
| Clinics |
|
Participant level data not collected
| Mean |
| Standard Deviation |
| years |
| Participants |
|
| Sex: Female, Male | unknown and not applicable | unknown and not applicable | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Average MME per day for most recent 3 months | morphine milligram equivalents (MME) | Mean | Standard Deviation | morphine milligram equivalents per day | Clinics |
|
|
| Percent of patients with average MME greater than or equal to 90 mg/day | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| Percent of patients with co-prescribed Benzodiazepine in the last quarter | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| Percent of patients with urine drug screen in last 12 months | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| Percent of patients with treatment in last 12 months | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| Percent of patients with PHQ-8/9 depression screen in last 12 months | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| Percent of patients with PEG-3 pain screen in last 12 months | Mean | Standard Deviation | percent of patients | Clinics |
|
|
| OG001 | Academic Detailing Only | Clinicians will attend an educational meeting and receive audit and feedback reports for 18 months. Systems consultation: 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 18 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 travel to each clinics. 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. |
| OG002 | Academic Detailing+Practice Facilitation+Physician Peer Consul | Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 6, 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. Systems consultation: 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 18 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 travel to each clinics. 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. |
| OG003 | Academic Detailing+Physician Peer Consulting | Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 6, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Systems consultation: 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 18 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 travel to each clinics. 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. |
|
|
| Primary | 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. | Outcome measure provides prescriber-level data. Participants enrolled are providers. | Posted | Mean | Standard Deviation | average MME/day | up to 30 months |
|
|
|
| Secondary | Number of Eligible Clinics That Participated | The number of eligible clinics that participated in the study. | Posted | Count of Units | Clinics | up to 30 months | Clinics | Clinics |
|
|
|
| Secondary | Number of Clinicians Who Participated in the Study | The number of eligible clinicians who participated in the study | Posted | Number | participants | up to 30 months | clinics | clinics |
|
|
|
| Secondary | Number of Patients at Clinics | The total number of patients seen at clinics will be used to assess clinic size. | Posted | Number | patients | up to 30 months | clinics | clinics |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | average participants | up to 30 months |
|
|
|
| Secondary | Average Hours of Intervention Received Per Clinic | The average time (in hours) of intervention that clinics received. | Posted | Mean | Standard Deviation | hours | up to 30 months | Clinics | Clinics |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours | up to 30 months |
|
|
|
| Secondary | 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). | Posted | Number | dollars | up to 30 months |
|
|
|
| Other Pre-specified | Quality Improvement Experience of the Clinics | A assessment tool is under development to capture the quality improvement experience level of clinics. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Components of System-level Opioid Prescribing Policy of the Health Systems | A list and count of the components of the participating health systems' opioid prescribing policy. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Adaptations Made to the Intervention During Intervention Period | A list and count of adaptations that were made to the intervention during the intervention period will be documented. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients of a Prescriber Who Have Chronic Opioid Prescriptions | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the prescriber level. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients Completing Urine Drug Screens in the Past 12 Months | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have had a urine drug screen documented within the past 12 months. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients Completing Screening for Mental Health and Substance Abuse Within the Past 12 Months | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have a Patient Health Questionnaire (PHQ-9) documented within the past 12 months. The study team is not administering the screening tool, data will be provided by Wisconsin Collaborative for Healthcare Quality (WCHQ). The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the Patient Health Questionnaire. Total score can range from 1-27. Interpretation of total scores is as follows: 1-4=Minimal depression, 5-9=Mild depression, 10-14= Moderate depression, 15-19=Moderately severe depression, 20-27= Severe depression. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients With Treatment Agreements Within the Past 12 Months | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who have documented treatment agreements within the past 12 months. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients With a Daily Morphine Milligram Equivalent Above 90 Milligrams | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months and have a daily morphine milligram equivalent over 90 milligrams. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients Who Are Co-prescribed Opioids and Benzodiazepines | Number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who also have a concurrent benzodiazepine prescription. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Emergency Room Visits and Hospitalizations Per Patient | The number of hospital or emergency room visits per patient among patients who are prescribed at least 3 opioid orders in 3 consecutive months. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Number of Patients Who Attend Their Scheduled Clinic Visits | The number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who attend their scheduled clinic visits. | Not Posted | up to 30 months | Participants |
| Other Pre-specified | Total Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions | The total number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the clinic level. | In this outcome measure, we report the number of patients who are prescribed at least 3 opioid orders in 3 consecutive months at the clinic level. | Posted | Number | patients | up to 30 months | Clinics | Clinics |
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| Other Pre-specified | Average Morphine Milligram Equivalent of Patients Who Are Co-prescribed Opioids and Benzodiazepines | The average morphine milligram equivalent of patients who are prescribed at least 3 opioid orders in 3 consecutive months at the clinic level. | Not Posted | up to 30 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Academic Detailing+Practice Facilitation | 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 4-6, then quarterly for months 7-18. Systems consultation: 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 18 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 travel to each clinics. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Academic Detailing+Practice Facilitation+Physician Peer Consul | Clinicians will receive academic detailing at month 0 and practice facilitation at month 3. At month 6, 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. Systems consultation: 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 18 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 travel to each clinics. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Academic Detailing+Physician Peer Consulting | Clinicians of this group will attend an educational meeting and will receive a monthly audit and feedback report for 18 months. At month 6, clinicians of the clinics will meet up to 4 times, quarterly, with the physician peer consultant. Systems consultation: 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 18 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 travel to each clinics. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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