Trial Outcomes & Findings for Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy (NCT NCT05182606)

Last Updated: 2026-01-08

Results Overview

The number of algorithms used by physicians was assessed via a survey administered at the end of the 6- or 9-month implementation period, measuring self-reported toolkit utilization during the study. Our primary feasibility benchmark will be that 80% of physicians report using at least one algorithm during the study period.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

At the end of the 6- or 9-month implementation period

Results posted on

2026-01-08

Participant Flow

Three University of Pittsburgh Medical Center (UPMC) clinics were recruited for the study, with clinicians at these clinics participating in the implementation. The toolkit was sequentially integrated into the practices between September 2022 and September 2023.

We reduced our sample to 3 clinics: two community with the same director, and one larger academic practice. We started the intervention at the academic clinic 2 months before the two community clinics for logistical reasons. Because not all physicians reported information about clinic affiliation, data are presented into a single arm. The academic clinic implementation lasted 6 months and the two community clinics 9 months. All 3 clinics were assessed 12 months pre- and post-implementation.

Unit of analysis: clinics

Participant milestones

Participant milestones
Measure	Implementation Bundle The 'Implementation Bundle' was integrated into participating clinics over six or nine months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Pre-implementation (12 Months Before) STARTED	49 3
Pre-implementation (12 Months Before) COMPLETED	49 3
Pre-implementation (12 Months Before) NOT COMPLETED	0 0
Implementation STARTED	49 3
Implementation COMPLETED	49 3
Implementation NOT COMPLETED	0 0
Post-implementation (12 Months After) STARTED	49 3
Post-implementation (12 Months After) COMPLETED	20 3
Post-implementation (12 Months After) NOT COMPLETED	29 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Implementation Bundle The 'Implementation Bundle' was integrated into participating clinics over six or nine months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Post-implementation (12 Months After) Did not participate in the post-implementation survey	29

Baseline Characteristics

Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implementation Bundle n=49 Participants The 'Implementation Bundle' was integrated into participating clinics over six to nine months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Age, Categorical <=18 years	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Sex: Female, Male Female	20 Participants n=18 Participants
Sex: Female, Male Male	29 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	49 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants
Race (NIH/OMB) White	0 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	49 Participants n=18 Participants
Region of Enrollment United States	49 Participants n=18 Participants
Provider at UPMC	49 Participants n=18 Participants

PRIMARY outcome

Timeframe: At the end of the 6- or 9-month implementation period

Population: Physicians from the three participating clinics who agreed to participate in the post-implementation survey.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=20 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Feasibility of Algorithms Physicians who used at least one algorithm	7 Participants
Feasibility of Algorithms Physicians who did not use any algorithm or did not respond to this question	13 Participants

PRIMARY outcome

Timeframe: At the end of the 6- or 9-month implementation period

Population: Physicians from the three participating clinics who agreed to participate in post-implementation surveys.

Acceptability of the algorithms was assessed via a self-report survey administered at the end of the 6- or 9-month implementation period, measuring physicians' awareness of the algorithms and self-reported toolkit use within six months of implementation. Our primary acceptability benchmark is that at least 80% of physicians report awareness of the algorithm implementation and at least 50% report using the algorithms during the study period. Additionally, qualitative interviews with physicians and staff provided further insights, which were analyzed using thematic analysis.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=20 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Acceptability of Algorithms Physicians aware of algorithm implementation	19 Participants
Acceptability of Algorithms Physicians who used at least one algorithm	7 Participants

SECONDARY outcome

Timeframe: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

Population: Outcome values are aggregated from electronic health records (EHR) for LTOT patients attributed to participating physicians (n=49). Patients EHRs contributed outcome data but were not enrolled study participants. Number of LTOT patients whose 90-day average MMEs decreased at or above a margin of 10% from the start of the reporting period to the end of the reporting period.

Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) decreased at or above a margin of 10% from the start of the reporting period to the end of the reporting period.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=49 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Preliminary Effectiveness of Algorithms - MME Reduction ≥10% Pre-implementation Period	297 Clinic patients
Preliminary Effectiveness of Algorithms - MME Reduction ≥10% Implementation Period	122 Clinic patients
Preliminary Effectiveness of Algorithms - MME Reduction ≥10% Post-implementation Period	270 Clinic patients

SECONDARY outcome

Timeframe: Pre-implementation (12 months), implementation (6 or 9 months), post-implementation (12 months)

Population: Outcome values are aggregated from electronic health record (EHR) data for LTOT patients attributed to participating physicians (n=49). Patient EHR data contributed to the outcomes, but patients were not enrolled as study participants. Row values reflect patient-level means (SD) by period. Means aggregate monthly 90-day MME within each period.

Average morphine milligram equivalents (MME) among long-term opioid therapy (LTOT) patients during the last 90 days of each period.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=49 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Preliminary Effectiveness - Average MME Within Last 90 Days Pre-implementation Period	105.25 90-day average MME (mg/day) Standard Deviation 16.27
Preliminary Effectiveness - Average MME Within Last 90 Days Implementation Period	96.76 90-day average MME (mg/day) Standard Deviation 21.06
Preliminary Effectiveness - Average MME Within Last 90 Days Post-implementation Period	96.48 90-day average MME (mg/day) Standard Deviation 16.34

SECONDARY outcome

Timeframe: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) at the start of this reporting period was 0.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=49 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Preliminary Effectiveness of Algorithms - Opioid Discontinuation Implementation Period	109 Clinic patients
Preliminary Effectiveness of Algorithms - Opioid Discontinuation Post-implementation Period	166 Clinic patients
Preliminary Effectiveness of Algorithms - Opioid Discontinuation Pre-implementation Period	95 Clinic patients

SECONDARY outcome

Timeframe: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

New opioid use disorder (OUD) diagnoses documented in the electronic health record (EHR) among all patients seen by participating physicians, by period. No new OUD diagnoses were documented in any period.

Outcome measures

Outcome measures
Measure	Implementation Bundle n=49 Participants The 'Implementation Bundle' was integrated into participating clinics over 6-9 months. This algorithm implementation package included a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.
Preliminary Effectiveness of the Algorithms - New OUD Diagnoses Pre-implementation period	0 Diagnoses
Preliminary Effectiveness of the Algorithms - New OUD Diagnoses Implementation period	0 Diagnoses
Preliminary Effectiveness of the Algorithms - New OUD Diagnoses Post-implementation period	0 Diagnoses

Adverse Events

Implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Merlin

University of Pittsburgh

Phone: (412) 383-0617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place