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Promoting Clinical Guidelines for Opioid Prescribing

Promoting the Implementation of Clinical Guidelines for Opioid Prescribing in Primary Care Using Systems Consultation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04044521
Enrollment
268
Registered
2019-08-05
Start date
2020-01-31
Completion date
2022-09-01
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

Keywords

implementation, primary care, organizational change, Centers for Disease Control opioid prescribing guidelines, clinical guidelines, systems consultation

Brief 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. 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: 1. 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). 2. 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. 3. 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.

Interventions

OTHERSystems 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 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The intervention will assess outcomes at the clinic and prescriber level. Prescribers are the population of interest.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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: * 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Average Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinicsup to 30 monthsThe 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 Prescribersup to 30 monthsThe 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.

Secondary

MeasureTime frameDescription
Number of Clinicians Who Participated in the Studyup to 30 monthsThe number of eligible clinicians who participated in the study
Number of Patients at Clinicsup to 30 monthsThe total number of patients seen at clinics will be used to assess clinic size.
Average Hours of Intervention Received Per Clinicup to 30 monthsThe average time (in hours) of intervention that clinics received.
Average Hours of Intervention Received Per Prescriberup to 30 monthsThe 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.
Estimated Cost of Each Study Arm in US Dollarsup to 30 monthsThe 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).
Number of Clinicians Who Attended the Intervention Meetingsup to 30 monthsThe number of clinicians who attended the meeting for practice facilitation, physician peer consulting, and follow-up meetings.
Number of Eligible Clinics That Participatedup to 30 monthsThe number of eligible clinics that participated in the study.

Other

MeasureTime frameDescription
Number of Emergency Room Visits and Hospitalizations Per Patientup to 30 monthsThe number of hospital or emergency room visits per patient among patients who are prescribed at least 3 opioid orders in 3 consecutive months.
Number of Patients Who Attend Their Scheduled Clinic Visitsup to 30 monthsThe number of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who attend their scheduled clinic visits.
Quality Improvement Experience of the Clinicsup to 30 monthsA assessment tool is under development to capture the quality improvement experience level of clinics.
Average Morphine Milligram Equivalent of Patients Who Are Co-prescribed Opioids and Benzodiazepinesup to 30 monthsThe average morphine milligram equivalent of patients who are prescribed at least 3 opioid orders in 3 consecutive months at the clinic level.
Total Number of Patients in a Clinic Who Have Chronic Opioid Prescriptionsup to 30 monthsThe 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.
Components of System-level Opioid Prescribing Policy of the Health Systemsup to 30 monthsA list and count of the components of the participating health systems' opioid prescribing policy.
Number of Adaptations Made to the Intervention During Intervention Periodup to 30 monthsA list and count of adaptations that were made to the intervention during the intervention period will be documented.
Number of Patients of a Prescriber Who Have Chronic Opioid Prescriptionsup to 30 monthsThe number of patients who are prescribed at least 3 opioid orders in 3 consecutive months. The number will be reported at the prescriber level.
Number of Patients Completing Urine Drug Screens in the Past 12 Monthsup to 30 monthsNumber 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.
Number of Patients Completing Screening for Mental Health and Substance Abuse Within the Past 12 Monthsup to 30 monthsNumber 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.
Number of Patients With Treatment Agreements Within the Past 12 Monthsup to 30 monthsThe 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.
Number of Patients With a Daily Morphine Milligram Equivalent Above 90 Milligramsup to 30 monthsThe 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.
Number of Patients Who Are Co-prescribed Opioids and Benzodiazepinesup to 30 monthsNumber of patients who are prescribed at least 3 opioid orders in 3 consecutive months, who also have a concurrent benzodiazepine prescription.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
60
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.
8
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.
65
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.
8
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.
66
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.
8
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.
77
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.
8
Total300

Baseline characteristics

CharacteristicAcademic Detailing OnlyTotalAcademic Detailing+Physician Peer ConsultingAcademic Detailing+Practice Facilitation+Physician Peer ConsulAcademic Detailing+Practice Facilitation
Average MME per day for most recent 3 months44.9938 morphine milligram equivalents per day
STANDARD_DEVIATION 22.4591
43.3 morphine milligram equivalents per day
STANDARD_DEVIATION 19.7
48.9800 morphine milligram equivalents per day
STANDARD_DEVIATION 20.1475
36.6330 morphine milligram equivalents per day
STANDARD_DEVIATION 15.7656
39.6526 morphine milligram equivalents per day
STANDARD_DEVIATION 17.2418
Percent of patients with average MME greater than or equal to 90 mg/day0.1142 percent of patients
STANDARD_DEVIATION 0.1175
0.109 percent of patients
STANDARD_DEVIATION 0.109
0.1326 percent of patients
STANDARD_DEVIATION 0.108
0.0741 percent of patients
STANDARD_DEVIATION 0.0954
0.1033 percent of patients
STANDARD_DEVIATION 0.1014
Percent of patients with co-prescribed Benzodiazepine in the last quarter0.1600 percent of patients
STANDARD_DEVIATION 0.092
0.132 percent of patients
STANDARD_DEVIATION 0.1
0.1178 percent of patients
STANDARD_DEVIATION 0.1095
0.1351 percent of patients
STANDARD_DEVIATION 0.1097
0.1123 percent of patients
STANDARD_DEVIATION 0.0817
Percent of patients with PEG-3 pain screen in last 12 months0.1234 percent of patients
STANDARD_DEVIATION 0.207
0.069 percent of patients
STANDARD_DEVIATION 0.151
0.0919 percent of patients
STANDARD_DEVIATION 0.1602
0.0073 percent of patients
STANDARD_DEVIATION 0.0157
0.0291 percent of patients
STANDARD_DEVIATION 0.0596
Percent of patients with PHQ-8/9 depression screen in last 12 months0.2791 percent of patients
STANDARD_DEVIATION 0.1936
0.258 percent of patients
STANDARD_DEVIATION 0.18
0.2346 percent of patients
STANDARD_DEVIATION 0.1563
0.2673 percent of patients
STANDARD_DEVIATION 0.2101
0.2464 percent of patients
STANDARD_DEVIATION 0.1584
Percent of patients with treatment in last 12 months0.3302 percent of patients
STANDARD_DEVIATION 0.1946
0.16 percent of patients
STANDARD_DEVIATION 0.188
0.1341 percent of patients
STANDARD_DEVIATION 0.1711
0.1982 percent of patients
STANDARD_DEVIATION 0.1593
0.1316 percent of patients
STANDARD_DEVIATION 0.2047
Percent of patients with urine drug screen in last 12 months0.3302 percent of patients
STANDARD_DEVIATION 0.2577
0.298 percent of patients
STANDARD_DEVIATION 0.234
0.3276 percent of patients
STANDARD_DEVIATION 0.2087
0.2628 percent of patients
STANDARD_DEVIATION 0.2089
0.2555 percent of patients
STANDARD_DEVIATION 0.2343
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

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).

Time frame: up to 30 months

Population: Outcome measure provides clinic-level data. Participants enrolled are providers.

ArmMeasureValue (MEAN)Dispersion
Academic Detailing+Practice FacilitationAverage Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics320.69 average MME/dayStandard Deviation 11.8
Academic Detailing OnlyAverage Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics372.33 average MME/dayStandard Deviation 20.04
Academic Detailing+Practice Facilitation+Physician Peer ConsulAverage Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics275.55 average MME/dayStandard Deviation 16.78
Academic Detailing+Physician Peer ConsultingAverage Morphine Milligram Equivalent (MME) Per Day of Chronic Opioid Prescriptions of Clinics455.62 average MME/dayStandard Deviation 19.59
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.

Time frame: up to 30 months

Population: Outcome measure provides prescriber-level data. Participants enrolled are providers.

ArmMeasureValue (MEAN)Dispersion
Academic Detailing+Practice FacilitationAverage Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers39.65 average MME/dayStandard Deviation 17.24
Academic Detailing OnlyAverage Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers45.00 average MME/dayStandard Deviation 22.46
Academic Detailing+Practice Facilitation+Physician Peer ConsulAverage Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers36.63 average MME/dayStandard Deviation 15.77
Academic Detailing+Physician Peer ConsultingAverage Morphine Milligram Equivalent of Chronic Opioid Prescriptions of Prescribers48.98 average MME/dayStandard Deviation 20.15
Secondary

Average Hours of Intervention Received Per Clinic

The average time (in hours) of intervention that clinics received.

Time frame: up to 30 months

ArmMeasureValue (MEAN)Dispersion
Academic Detailing+Practice FacilitationAverage Hours of Intervention Received Per Clinic12.5 hoursStandard Deviation 17.5
Academic Detailing OnlyAverage Hours of Intervention Received Per Clinic4.571428571 hoursStandard Deviation 1.673469388
Academic Detailing+Practice Facilitation+Physician Peer ConsulAverage Hours of Intervention Received Per Clinic14.875 hoursStandard Deviation 31.609375
Academic Detailing+Physician Peer ConsultingAverage Hours of Intervention Received Per Clinic6.125 hoursStandard Deviation 9.609375
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.

Time frame: up to 30 months

ArmMeasureValue (MEAN)Dispersion
Academic Detailing+Practice FacilitationAverage Hours of Intervention Received Per Prescriber12.5 hoursStandard Deviation 17.5
Academic Detailing OnlyAverage Hours of Intervention Received Per Prescriber4.571428571 hoursStandard Deviation 1.673469388
Academic Detailing+Practice Facilitation+Physician Peer ConsulAverage Hours of Intervention Received Per Prescriber14.875 hoursStandard Deviation 31.609375
Academic Detailing+Physician Peer ConsultingAverage Hours of Intervention Received Per Prescriber6.125 hoursStandard Deviation 9.609375
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).

Time frame: up to 30 months

ArmMeasureValue (NUMBER)
Academic Detailing+Practice FacilitationEstimated Cost of Each Study Arm in US Dollars7933.2 dollars
Academic Detailing OnlyEstimated Cost of Each Study Arm in US Dollars2307.84 dollars
Academic Detailing+Practice Facilitation+Physician Peer ConsulEstimated Cost of Each Study Arm in US Dollars9015 dollars
Academic Detailing+Physician Peer ConsultingEstimated Cost of Each Study Arm in US Dollars4399.32 dollars
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.

Time frame: up to 30 months

ArmMeasureValue (MEAN)Dispersion
Academic Detailing+Practice FacilitationNumber of Clinicians Who Attended the Intervention Meetings6.118461538 average participantsStandard Deviation 11.36059744
Academic Detailing OnlyNumber of Clinicians Who Attended the Intervention Meetings6.741935484 average participantsStandard Deviation 18.26451613
Academic Detailing+Practice Facilitation+Physician Peer ConsulNumber of Clinicians Who Attended the Intervention Meetings6.228070175 average participantsStandard Deviation 22.34556254
Academic Detailing+Physician Peer ConsultingNumber of Clinicians Who Attended the Intervention Meetings6.15 average participantsStandard Deviation 28.32195122
Secondary

Number of Clinicians Who Participated in the Study

The number of eligible clinicians who participated in the study

Time frame: up to 30 months

ArmMeasureValue (NUMBER)
Academic Detailing+Practice FacilitationNumber of Clinicians Who Participated in the Study65 participants
Academic Detailing OnlyNumber of Clinicians Who Participated in the Study60 participants
Academic Detailing+Practice Facilitation+Physician Peer ConsulNumber of Clinicians Who Participated in the Study66 participants
Academic Detailing+Physician Peer ConsultingNumber of Clinicians Who Participated in the Study77 participants
Secondary

Number of Eligible Clinics That Participated

The number of eligible clinics that participated in the study.

Time frame: up to 30 months

ArmMeasureValue (COUNT_OF_UNITS)
Academic Detailing+Practice FacilitationNumber of Eligible Clinics That Participated8 Clinics
Academic Detailing OnlyNumber of Eligible Clinics That Participated7 Clinics
Academic Detailing+Practice Facilitation+Physician Peer ConsulNumber of Eligible Clinics That Participated8 Clinics
Academic Detailing+Physician Peer ConsultingNumber of Eligible Clinics That Participated8 Clinics
Secondary

Number of Patients at Clinics

The total number of patients seen at clinics will be used to assess clinic size.

Time frame: up to 30 months

ArmMeasureValue (NUMBER)
Academic Detailing+Practice FacilitationNumber of Patients at Clinics2486 patients
Academic Detailing OnlyNumber of Patients at Clinics2427 patients
Academic Detailing+Practice Facilitation+Physician Peer ConsulNumber of Patients at Clinics2044 patients
Academic Detailing+Physician Peer ConsultingNumber of Patients at Clinics2021 patients
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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

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.

Time frame: 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.

Time frame: up to 30 months

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.

Time frame: up to 30 months

Population: 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.

ArmMeasureValue (NUMBER)
Academic Detailing+Practice FacilitationTotal Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions985 patients
Academic Detailing OnlyTotal Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions1175 patients
Academic Detailing+Practice Facilitation+Physician Peer ConsulTotal Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions681 patients
Academic Detailing+Physician Peer ConsultingTotal Number of Patients in a Clinic Who Have Chronic Opioid Prescriptions925 patients

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026