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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA036720-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Center for Health Enhancement System Studies | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician coaching | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Rate of Opioid Prescribing | The proportion of patients with a chronic pain diagnosis receiving daily opioids. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Opioid / Benzodiazepine Co-prescribing | Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently. | Up to 3 years |
| Urine Drug Screening Rate |
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Inclusion Criteria:
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.
Exclusion Criteria:
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Clinicians with prescribing authority at community-based primary care clinics
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| Name | Affiliation | Role |
|---|---|---|
| Andrew R Quanbeck, PhD | Center for Health Enhancement Systems Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29370813 | Derived | 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. |
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Clinics were paired and randomly assigned to be grouped in the intervention or control group. The intervention group was invited. If clinics in this group refused to participate, the other clinic of the pair was invited to be a part of the intervention group. Once clinics agreed to take part in the study they were immediately assigned to a group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physician Coaching | This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period. Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
| FG001 | Control Group | This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics. |
| FG002 | Refused Group | Clinics were invited to join the study, but refused to receive the intervention. Clinics reason for refusal was lack of staff or time. Data was not collected or analyzed for clinics that refused the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants include patients and providers. Patient counts for Physician coaching, Control Group, and Refused group were 29956, 13296, and 9813, respectively. Provider counts for Physician coaching, Control Group, and Refused group were 34, 13, and 20, respectively.
| ID | Title | Description |
|---|---|---|
| BG000 | Physician Coaching | This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period. Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Overall Rate of Opioid Prescribing | The proportion of patients with a chronic pain diagnosis receiving daily opioids. | This is the number of patients in each group. | Posted | Number | Proportion of patients | Up to 3 years |
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Adverse event data was collected over the span of the study, 3 years.
Because the intervention of this study was aimed at changing prescribing practices of providers, adverse events of patients treated at the clinics were not collected. Only adverse events of providers were 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 | Physician Coaching | This group included 4 intervention primary care clinics that received an organizational coaching intervention that included in-person site visits and phone/email communication. Each participating clinic was designated one primary care physician to act as a clinic lead in working with the coach to coordinate an initial site visit, a follow-up site visit, and communicating with the coach throughout the 6-month follow-up period. Physician coaching: The coach presented the latest research on the benefits and risks of long-term opioid use. The coach helped the clinic team flowchart clinical workflows and determined the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing. The coach helped the team implement ideas using Plan-Do-Study-Act change cycles and maintained contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice. |
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The UWHealth system introduced a new opioid-prescribing policy concurrent with the beginning of the study period and included a standardized treatment agreement that included elements of the checklist developed during this research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Quanbeck | University of Wisconsin - Madison | 6082627385 | arquanbe@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 | Jun 14, 2016 | Feb 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Proportion of opioid patients completing urine drug screens prior to and during the study intervention
| Up to 3 years |
| Mental Health Screening Rate | Proportion of opioid patients screened for mental health/substance use problems | Up to 3 years |
| Use of Pain Management Agreements | Proportion of opioid patients signing pain management agreements | Up to 3 years |
| High-dose Patients | Proportion of opioid prescriptions above 120 mg daily morphine equivalent | Up to 3 years |
| Provider Drop-out Rate | Number and percentage of providers who drop out of study at 3 months | 3 months |
| Participating Patient Demographics | Characteristics of participating patients vs. general patient population (race, gender, ethnicity) | 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) | Up to 12 months |
| Participating Staff Characteristics | Characteristics of participating staff (profession) | Up to 12 months |
| Intervention Fidelity | Total hours of coaching delivered/received among all clinics that received physician coaching. | Up to 12 months |
| Intervention Cost | Total cost of coaching intervention among all clinics that received physician coaching. At clinic level. | 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. | Up to 12 months |
| Average Morphine Equivalent Daily Dose (MEDD) | The average MEDD in milligrams for patients with consistent opioid Rx. | Up to 12 months |
| BG001 | Control Group | This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics. |
| BG002 | Refused Group | This group included 3 primary care clinics that were approached to participate in the study, but refused to participate. |
| BG003 | Total | Total of all reporting groups |
| clinics |
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| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Proportion of patients with consistent opioid Rx | This measure analyzes at the patient level. The population not analyzed for this measure are providers of the clinic. The Refused group was not analyzed due to desire not to participate in the study. | Number | proportion of patients | Participants |
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| Proportion with mental health screen | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Number | proportion of patients | Participants |
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| Proportion with urine drug screen | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Number | proportion of patients | Participants |
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| Proportion with treatment agreement | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Number | proportion of patients | Participants |
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| Average morphine equivalent daily dose (MEDD) | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Mean | Standard Deviation | milligram | Participants |
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| Proportion with MEDD >120 mg | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Number | proportion of patients | Participants |
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| Proportion with co-prescribed benzodiazepines | This measure analyzes at the patient level and includes only the subset of patients with consistent opioid Rx. | Number | proportion of patients | Participants |
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| OG001 | Control Group | This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics. |
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| Secondary | Rate of Opioid / Benzodiazepine Co-prescribing | Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently. | This is the number of patients who fall in the subset of consistent opioid use. | Posted | Number | Proportion of patients | Up to 3 years |
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|
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| Secondary | Urine Drug Screening Rate | Proportion of opioid patients completing urine drug screens prior to and during the study intervention | This is the number of patients who fall in the subset of consistent opioid use. | Posted | Number | Proportion of patients | Up to 3 years |
|
|
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| Secondary | Mental Health Screening Rate | Proportion of opioid patients screened for mental health/substance use problems | This is the number of patients who fall in the subset of consistent opioid use. | Posted | Number | Proportion of patients | Up to 3 years |
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| Secondary | Use of Pain Management Agreements | Proportion of opioid patients signing pain management agreements | This is the number of patients who fall in the subset of consistent opioid use. | Posted | Number | Proportion of patients | Up to 3 years |
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| Secondary | High-dose Patients | Proportion of opioid prescriptions above 120 mg daily morphine equivalent | This is the number of patients who fall in the subset of consistent opioid use. | Posted | Number | Proportion of patients | Up to 3 years |
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| Secondary | Provider Drop-out Rate | Number and percentage of providers who drop out of study at 3 months | This is at the prescriber level. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Participating Patient Demographics | Characteristics of participating patients vs. general patient population (race, gender, ethnicity) | Posted | Number | percentage of patients | Up to 3 years |
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| Secondary | Participating Clinic Characteristics | Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate) | Posted | Number | participants | Up to 12 months |
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| Secondary | Participating Staff Characteristics | Characteristics of participating staff (profession) | These are clinic staff that made up the clinic change teams. Since change teams were specific to the physician coaching group, no change teams were constructed in the Control group, thus there is no data to be reported. | Posted | Count of Participants | Participants | Up to 12 months |
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| Secondary | Intervention Fidelity | Total hours of coaching delivered/received among all clinics that received physician coaching. | Four clinics were analyzed for this measure. Since the intervention was specific to the physician coaching group, no time was spent in the Control group, thus there is no data to be reported. | Posted | Number | hours spent delivering implementation | Up to 12 months | clinics | clinics |
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| Secondary | Intervention Cost | Total cost of coaching intervention among all clinics that received physician coaching. At clinic level. | Four clinics were analyzed. No intervention was given to control group clinics, so there is no reported data. | Posted | Number | Dollars | Up to 12 months | clinics | clinics |
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| Secondary | Proportion With MEDD >120 mg | The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg. | This is the number of patients who have a consistent opioid Rx. | Posted | Number | Proportion of participants | Up to 12 months |
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| Secondary | Average Morphine Equivalent Daily Dose (MEDD) | The average MEDD in milligrams for patients with consistent opioid Rx. | This is the number of patients who have a consistent opioid Rx. | Posted | Mean | Standard Deviation | milligrams | Up to 12 months |
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| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Control Group | This group included 4 control primary care clinics that did not receive any intervention. A de-identified dataset was created to examine differences in outcome variables between intervention and control clinics. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| % asian |
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| % black |
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| % native |
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| % other |
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| % white |
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| overall opioid prescribing rate |
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| Title | Measurements |
|---|---|
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| Licensed practical nurse |
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| Clinic operations assistant |
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| Clinic operations manager |
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| Lab staff |
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| Reception |
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| Medical assistant |
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