Feasibility of implementing a screening tool for risk of opioid misuse in a trauma surgical population.

Background: As the opioid crisis continues to affect communities across the United States, new interventions for screening and prevention are needed to mitigate its impact. Mental health diagnoses have been identified as a risk factor for opioid misuse, and surgical populations and injury survivors are at high risk for prolonged opioid use and misuse. This study investigated the implementation of a novel opioid risk screening tool that incorporated putative risk factors from a recent study in four trauma units across Wisconsin. Method: The screening tool was implemented across a 6-month period at four sites. Data was collected via monthly meeting notes and "Plan, Do, Study, Act" (PDSA) forms. Following implementation, focus groups reflected on the facilitators and barriers to implementation. Meeting notes, PDSA forms, and focus group data were analyzed using the consolidated framework for implementation research, followed by thematic analyses, to generate themes surrounding the facilitators and barriers to implementing an opioid misuse screener. Results: Implementation facilitators included ensuring patient understanding of the screener, minimizing staff burden from screening, and educating staff to encourage engagement. Barriers included infrastructure limitations that prevented seamless administration of the screener within current workflows, overlap of the screener with existing measures, and lack of guidance surrounding treatment options corresponding to risk. Recommended solutions to address barriers include careful timing of screener administration, accommodating workflows, integration of the screening tool within the electronic health record, and evidence-based interventions guided by screener results. Conclusion: Four trauma centers across Wisconsin successfully implemented a pilot opioid misuse screening tool. Trauma providers and unit staff members believe that this tool would be a beneficial addition to their repertoire if their recommendations were adopted. Future research should refine opioid misuse risk factors and ensure screening items are well-validated with psychometric research supporting treatment responses to screener-indicated risk categories.

As the opioid crisis continues to affect communities across the United States, new interventions for early screening and prevention are needed to minimize the related harms. Prior research has identified risk factors associated with opioid misuse among a trauma surgical patient population, with the highest risk associated with distress-related posttraumatic stress disorder symptoms. A pilot screening tool was created based on this prior research, which was then administered at four trauma surgical units across the state of Wisconsin. Each of the four trauma units successfully implemented the pilot screening tool, and each identified a number of facilitators and barriers to the implementation process. Recommendations for improvement of the implementation process were also gathered. If their recommended changes were to be adopted, trauma providers and trauma unit staff members believed that such a screener for opioid misuse would be a beneficial addition to their current workflow among traumatic injury patients. Future research should refine opioid misuse risk factors and develop a psychometrically sound, validated screener to detect varying levels of risk and tailor treatment approaches based on a patient's risk score. Additionally, future research in the field of opioid misuse prevention should prioritize the recruitment of a more diverse population to support the translation of study findings across populations.

Screening in Trauma for Opioid Misuse Prevention (STOMP): Results from a prospective cohort of victims of traumatic injury.

BACKGROUND: Traumatic injury frequently requires opioid analgesia to manage pain and avoid catastrophic complications. Risk screening for opioid misuse and the development of use disorder remains uninvestigated. METHODS: Participants were Trauma/Orthopedic Surgical Services patients at a Level I Trauma Center who were English speaking, aged 18-75, received an opioids prescription at discharge, and were under control of their own medications at discharge. Baseline measures included validated self-report instruments for psychosocial factors, such as anxiety, depression, pain coping, and social support. Health record data included diagnosis codes, procedures, Injury Severity Score, and pain severity (0-10 scale). Opioid use disorder (by Clinical International Diagnostic Interview-Substance Abuse Module) or opioid misuse (Current Opioid Misuse Measure (COMM) and survey items) were assessed at 24 weeks post-discharge. RESULTS: 295 patients enrolled with 237 completing the 24 week assessments. Stepwise regression modeling demonstrated pre-injury PTSD symptoms, Opioid Risk score, medication use behaviors, social support, and length of stay predicted opioid misuse. Pre-injury PTSD symptoms, pain coping, and length of stay predicted use disorder. The final regression models for opioid misuse by COMM, opioid misuse via survey items, and for opioid use disorder had highly favorable areas under the receiver operating curve (0.880, 0.790, and 0.943 respectively). CONCLUSIONS: Pre-injury presence of PTSD-related symptoms, impaired pain coping, social support, and hospitalization > 6 days predicted opioid misuse and opioid addiction at 6 months after hospital discharge. Behavioral screening and management strategies appear warranted in the population of traumatic injury victims to reduce opioid-related risks.

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.

BACKGROUND: Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. METHODS/DESIGN: The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. DISCUSSION: Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. TRIAL REGISTRATION: NCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.

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.

BACKGROUND: This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. METHODS: We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. RESULTS: Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. CONCLUSIONS: The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Screening in Trauma for Opioid Misuse Prevention (STOMP): study protocol for the development of an opioid risk screening tool for victims of injury.

BACKGROUND: Opioid addiction and overdose are epidemic in the U.S. Victims of traumatic injury are at greater than average risk for opioid misuse and related complications. Potential risk screens and preventive interventions in this clinical population remain under-investigated. The current project seeks to develop and pilot the implementation of a screening tool for opioid risk at American College of Surgeons (ACS) Level I and Level II trauma centers. METHODS: The project began with an online survey, which was sent to Wisconsin trauma center medical directors and trauma coordinators for the purpose of gathering information on current substance use screening practices. Next, a focus group of trauma center staff was convened to discuss barriers and facilitators to screening, resources available and needed to support trauma patients with opioid use disorders, and measurable clinical observations that could indicate a patient's potential risk for opioid misuse. Data from the surveys and focus group were combined to inform the data collection instruments that are currently being administered to patients recruited from the University of Wisconsin Hospital Trauma Inpatient and Orthopedic Surgery Services. Eligible and consenting patients complete standardized measures of socio-demographics, substance use history, opioid misuse risk, mental health, medical history, and injury and pain severity. Follow up visits at weeks 4, 12, and 24 after hospital discharge assess hypothesized risk factors for opioid addiction and opioid use disorder diagnosis. At the completion of patient data collection, a forward stepwise regression will identify factors of most significant risk of the development of opioid use disorder after traumatic injury. This modeling will inform the development of a novel opioid risk screening tool, which will undergo pilot implementation at 4 Wisconsin ACS Level I and Level II trauma centers, using an evidence-based implementation strategy with roots in systems engineering. DISCUSSION: Positive findings from the proposed work would lead to improved, standardized opioid risk screening practices among victims of traumatic injury. The ultimate goal of this and future work is to reduce the likelihood of opioid misuse, addiction, and related complications, such as overdose and death. Trial registration Clinicaltrials.gov registration number: NCT02861976. Date of registration: Feb 9, 2016.

Predischarge Injectable Versus Oral Naltrexone to Improve Postdischarge Treatment Engagement Among Hospitalized Veterans with Alcohol Use Disorder: A Randomized Pilot Proof-of-Concept Study.

BACKGROUND: Injectable naltrexone for alcohol use disorders (AUDs) has been efficacious in several studies. It has not been (i) compared head-to-head with oral naltrexone or (ii) examined in the hospital setting as an intervention that might facilitate treatment attendance after hospital discharge. METHODS: Fifty-four hospitalized veterans identified as having DSM-IV-TR alcohol dependence were randomized to receive (i) a 50 mg oral naltrexone plus a 30-day prescription or (ii) a 380 mg intramuscular naltrexone injection prior to discharge. Of 113 veteran inpatients deemed eligible based on screening criteria, 54 met final eligibility criteria and were enrolled and randomized. Baseline data included demographics, alcohol consumption, and comorbidity. Measures of treatment initiation and engagement and alcohol consumption were reassessed at 14- and 45-day follow-ups. RESULTS: Thirty-five participants (64.8%) completed the entire study protocol (received a study medication and completed 14- and 45-day follow-ups). Among those who received a study medication (n = 45), 77.8% completed all follow-up interviews. This pilot study was not designed to have sufficient statistical power for hypothesis testing, and thus, as expected, there were no significant differences between groups in medication adherence (self-report of >80% of daily doses taken in oral group; receipt of second injection in the injection group), treatment engagement (at least treatment 3 visits in the 30 days postdischarge, and 2 or more visits per month in each of the 3 months following discharge) or alcohol consumption at 14 or at 45 days (p > 0.05). The median number of drinks among the entire cohort in the 2 weeks prior to hospitalization (128 drinks) was significantly higher than at day 14 (0 drinks, p < 0.001) or day 45 (0 drinks, p < 0.001). Rates of medication adherence were 62% in the oral group and 61% in the injection group. CONCLUSIONS: Results indicate feasibility for larger, more definitive study. Both groups had significant reductions in alcohol consumption over time and high-treatment engagement rates. Both oral and injectable formulations are feasible to initiate prior to discharge for hospital inpatients identified as having an AUD.