Promoting Clinical Guidelines for Opioid Prescribing

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044521
• Other study ID #: 2018-1276
• Secondary ID: R01DA047279A5320
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
United States	Bellin Health Systems	Green Bay	Wisconsin
United States	UW Health	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	up to 30 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
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).	up to 30 months
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.	up to 30 months
Secondary	Number of Eligible Clinics That Participated	The number of eligible clinics that participated in the study.	up to 30 months
Secondary	Number of Clinicians Who Participated in the Study	The number of eligible clinicians who participated in the study	up to 30 months
Secondary	Number of Patients at Clinics	The total number of patients seen at clinics will be used to assess clinic size.	up to 30 months
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.	up to 30 months
Secondary	Average Hours of Intervention Received Per Clinic	The average time (in hours) of intervention that clinics received.	up to 30 months
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.	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).	up to 30 months