Chronic Pain, Substance Abuse
Conditions
Keywords
Opioid
Brief summary
This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.
Detailed description
This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings. The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.
Interventions
OTHERPhysician coaching
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Center for Health Enhancement System Studies
University of Wisconsin, Madison
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
* Residents will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of Opioid Prescribing | Up to 3 years | The proportion of patients with a chronic pain diagnosis receiving daily opioids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Drug Screening Rate | Up to 3 years | Proportion of opioid patients completing urine drug screens prior to and during the study intervention |
| Mental Health Screening Rate | Up to 3 years | Proportion of opioid patients screened for mental health/substance use problems |
| Use of Pain Management Agreements | Up to 3 years | Proportion of opioid patients signing pain management agreements |
| High-dose Patients | Up to 3 years | Proportion of opioid prescriptions above 120 mg daily morphine equivalent |
| Provider Drop-out Rate | 3 months | Number and percentage of providers who drop out of study at 3 months |
| Participating Patient Demographics | Up to 3 years | Characteristics of participating patients vs. general patient population (race, gender, ethnicity) |
| Rate of Opioid / Benzodiazepine Co-prescribing | Up to 3 years | Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently. |
| Participating Staff Characteristics | Up to 12 months | Characteristics of participating staff (profession) |
| Intervention Fidelity | Up to 12 months | Total hours of coaching delivered/received among all clinics that received physician coaching. |
| Intervention Cost | Up to 12 months | Total cost of coaching intervention among all clinics that received physician coaching. At clinic level. |
| Proportion With MEDD >120 mg | Up to 12 months | The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg. |
| Average Morphine Equivalent Daily Dose (MEDD) | Up to 12 months | The average MEDD in milligrams for patients with consistent opioid Rx. |
| Participating Clinic Characteristics | Up to 12 months | Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29,990 |
| 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. | 4 |
| 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. | 13,309 |
| 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. | 4 |
| Refused Group This group included 3 primary care clinics that were approached to participate in the study, but refused to participate. | 9,833 |
| Refused Group This group included 3 primary care clinics that were approached to participate in the study, but refused to participate. | 3 |
| Total | 53,143 |
Baseline characteristics
| Characteristic | Physician Coaching | Control Group | Refused Group | Total |
|---|---|---|---|---|
| Age, Customized Age of participants < 18 years old | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age of participants >= 18 years old | 29990 Participants | 13309 Participants | 9833 Participants | 53132 Participants |
| Average morphine equivalent daily dose (MEDD) | 86.3 milligram STANDARD_DEVIATION 18.7 | 58.8 milligram STANDARD_DEVIATION 10.1 | — | 72.5 milligram STANDARD_DEVIATION 16.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 660 Participants | 333 Participants | 246 Participants | 1239 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29330 Participants | 12976 Participants | 9587 Participants | 51893 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Proportion of patients with consistent opioid Rx | 0.013 proportion of patients | 0.014 proportion of patients | — | 0.013 proportion of patients |
| Proportion with co-prescribed benzodiazepines | 0.08 proportion of patients | 0.055 proportion of patients | — | 0.072 proportion of patients |
| Proportion with MEDD >120 mg | 0.215 proportion of patients | 0.137 proportion of patients | — | 0.190 proportion of patients |
| Proportion with mental health screen | 0.226 proportion of patients | 0.220 proportion of patients | — | 0.224 proportion of patients |
| Proportion with treatment agreement | 0.428 proportion of patients | 0.368 proportion of patients | — | 0.409 proportion of patients |
| Proportion with urine drug screen | 0.399 proportion of patients | 0.374 proportion of patients | — | 0.391 proportion of patients |
| Race (NIH/OMB) American Indian or Alaska Native | 150 Participants | 67 Participants | 49 Participants | 266 Participants |
| Race (NIH/OMB) Asian | 720 Participants | 213 Participants | 69 Participants | 1002 Participants |
| Race (NIH/OMB) Black or African American | 720 Participants | 306 Participants | 69 Participants | 1095 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3569 Participants | 1597 Participants | 1121 Participants | 6287 Participants |
| Race (NIH/OMB) White | 24831 Participants | 11126 Participants | 8525 Participants | 44482 Participants |
| Sex: Female, Male Female | 14125 Participants | 6615 Participants | 4504 Participants | 25244 Participants |
| Sex: Female, Male Male | 15865 Participants | 6694 Participants | 5329 Participants | 27888 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 13 |
| other Total, other adverse events | 0 / 34 | 0 / 13 |
| serious Total, serious adverse events | 0 / 34 | 0 / 13 |
Outcome results
Primary
Overall Rate of Opioid Prescribing
The proportion of patients with a chronic pain diagnosis receiving daily opioids.
Time frame: Up to 3 years
Population: This is the number of patients in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Overall Rate of Opioid Prescribing | 0.012 Proportion of patients |
| Control Group | Overall Rate of Opioid Prescribing | 0.013 Proportion of patients |
Secondary
Average Morphine Equivalent Daily Dose (MEDD)
The average MEDD in milligrams for patients with consistent opioid Rx.
Time frame: Up to 12 months
Population: This is the number of patients who have a consistent opioid Rx.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician Coaching | Average Morphine Equivalent Daily Dose (MEDD) | 84.3 milligrams | Standard Deviation 16.8 |
| Control Group | Average Morphine Equivalent Daily Dose (MEDD) | 60.2 milligrams | Standard Deviation 20.1 |
Secondary
High-dose Patients
Proportion of opioid prescriptions above 120 mg daily morphine equivalent
Time frame: Up to 3 years
Population: This is the number of patients who fall in the subset of consistent opioid use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | High-dose Patients | 0.191 Proportion of patients |
| Control Group | High-dose Patients | 0.125 Proportion of patients |
Secondary
Intervention Cost
Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.
Time frame: Up to 12 months
Population: Four clinics were analyzed. No intervention was given to control group clinics, so there is no reported data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Intervention Cost | 29379 Dollars |
Secondary
Intervention Fidelity
Total hours of coaching delivered/received among all clinics that received physician coaching.
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Physician Coaching | Intervention Fidelity | Facilitator hours | 237.7 hours spent delivering implementation |
| Physician Coaching | Intervention Fidelity | physician consultant hours | 85.7 hours spent delivering implementation |
Secondary
Mental Health Screening Rate
Proportion of opioid patients screened for mental health/substance use problems
Time frame: Up to 3 years
Population: This is the number of patients who fall in the subset of consistent opioid use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Mental Health Screening Rate | 0.574 Proportion of patients |
| Control Group | Mental Health Screening Rate | 0.394 Proportion of patients |
Secondary
Participating Clinic Characteristics
Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)
Time frame: Up to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Physician Coaching | Participating Clinic Characteristics | number of providers | 34 participants |
| Physician Coaching | Participating Clinic Characteristics | number of patients | 29956 participants |
| Physician Coaching | Participating Clinic Characteristics | overall opioid prescribing rate | 359 participants |
| Control Group | Participating Clinic Characteristics | overall opioid prescribing rate | 160 participants |
| Control Group | Participating Clinic Characteristics | number of patients | 13296 participants |
| Control Group | Participating Clinic Characteristics | number of providers | 13 participants |
| Refused Group | Participating Clinic Characteristics | number of providers | 20 participants |
| Refused Group | Participating Clinic Characteristics | overall opioid prescribing rate | NA participants |
| Refused Group | Participating Clinic Characteristics | number of patients | 9813 participants |
Secondary
Participating Patient Demographics
Characteristics of participating patients vs. general patient population (race, gender, ethnicity)
Time frame: Up to 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Physician Coaching | Participating Patient Demographics | % female | 47.1 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % asian | 2.4 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % white | 82.8 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % black | 2.4 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % hispanic | 2.2 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % native | 0.5 percentage of patients |
| Physician Coaching | Participating Patient Demographics | % other | 11.9 percentage of patients |
| Control Group | Participating Patient Demographics | % native | 0.5 percentage of patients |
| Control Group | Participating Patient Demographics | % other | 12.2 percentage of patients |
| Control Group | Participating Patient Demographics | % white | 83.6 percentage of patients |
| Control Group | Participating Patient Demographics | % female | 49.7 percentage of patients |
| Control Group | Participating Patient Demographics | % hispanic | 2.5 percentage of patients |
| Control Group | Participating Patient Demographics | % asian | 1.6 percentage of patients |
| Control Group | Participating Patient Demographics | % black | 2.3 percentage of patients |
Secondary
Participating Staff Characteristics
Characteristics of participating staff (profession)
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Physician Coaching | Participating Staff Characteristics | Medical doctor | 6 Participants |
| Physician Coaching | Participating Staff Characteristics | Nurse practitioner | 1 Participants |
| Physician Coaching | Participating Staff Characteristics | Registered nurse | 4 Participants |
| Physician Coaching | Participating Staff Characteristics | Licensed practical nurse | 3 Participants |
| Physician Coaching | Participating Staff Characteristics | Clinic operations assistant | 1 Participants |
| Physician Coaching | Participating Staff Characteristics | Clinic operations manager | 2 Participants |
| Physician Coaching | Participating Staff Characteristics | Lab staff | 2 Participants |
| Physician Coaching | Participating Staff Characteristics | Reception | 3 Participants |
| Physician Coaching | Participating Staff Characteristics | Medical assistant | 5 Participants |
Secondary
Proportion With MEDD >120 mg
The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.
Time frame: Up to 12 months
Population: This is the number of patients who have a consistent opioid Rx.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Proportion With MEDD >120 mg | 0.191 Proportion of participants |
| Control Group | Proportion With MEDD >120 mg | 0.125 Proportion of participants |
Secondary
Provider Drop-out Rate
Number and percentage of providers who drop out of study at 3 months
Time frame: 3 months
Population: This is at the prescriber level.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physician Coaching | Provider Drop-out Rate | 0 Participants |
| Control Group | Provider Drop-out Rate | 0 Participants |
Secondary
Rate of Opioid / Benzodiazepine Co-prescribing
Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.
Time frame: Up to 3 years
Population: This is the number of patients who fall in the subset of consistent opioid use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Rate of Opioid / Benzodiazepine Co-prescribing | 0.074 Proportion of patients |
| Control Group | Rate of Opioid / Benzodiazepine Co-prescribing | 0.061 Proportion of patients |
Secondary
Urine Drug Screening Rate
Proportion of opioid patients completing urine drug screens prior to and during the study intervention
Time frame: Up to 3 years
Population: This is the number of patients who fall in the subset of consistent opioid use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Urine Drug Screening Rate | 0.645 Proportion of patients |
| Control Group | Urine Drug Screening Rate | 0.440 Proportion of patients |
Secondary
Use of Pain Management Agreements
Proportion of opioid patients signing pain management agreements
Time frame: Up to 3 years
Population: This is the number of patients who fall in the subset of consistent opioid use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Coaching | Use of Pain Management Agreements | 0.782 Proportion of patients |
| Control Group | Use of Pain Management Agreements | 0.542 Proportion of patients |