scholarly journals 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

2020 ◽  
Author(s):  
Andrew Quanbeck ◽  
Daniel Almirall ◽  
Nora Jacobson ◽  
Randall T. Brown ◽  
Jillian K. Landeck ◽  
...  

Abstract Background Rates of opioid prescribing tripled in the United States 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 NCT 04044521 (ClinicalTrial.gov). Registered 05 August 2019.

2020 ◽  
pp. 106286062095945
Author(s):  
Carolyn A. Berry ◽  
Ann M. Nguyen ◽  
Allison M. Cuthel ◽  
Charles M. Cleland ◽  
Nina Siman ◽  
...  

Few studies have assessed the fidelity of practice facilitation (PF) as an implementation strategy, and none have used an a priori definition or conceptual framework of fidelity to guide fidelity assessment. The authors adapted the Conceptual Framework for Implementation Fidelity to guide fidelity assessment in HealthyHearts NYC, an intervention that used PF to improve adoption of cardiovascular disease evidence-based guidelines in primary care practices. Data from a web-based tracking system of 257 practices measured fidelity using 4 categories: frequency, duration, content, and coverage. Almost all (94.2%) practices received at least the required 13 PF visits. Facilitators spent on average 26.3 hours at each site. Most practices (95.7%) completed all Task List items, and 71.2% were educated on all Chronic Care Model strategies. The majority (65.8%) received full coverage. This study provides a model that practice managers and implementers can use to evaluate fidelity of PF, and potentially other implementation strategies.


2018 ◽  
Vol 28 (5) ◽  
pp. 397-404 ◽  
Author(s):  
Nora Jacobson ◽  
Roberta Johnson ◽  
Bri Deyo ◽  
Esra Alagoz ◽  
Andrew Quanbeck

BackgroundIn order to promote guideline-concordant opioid prescribing practices, a blended implementation strategy called systems consultation was pilot tested in four primary care clinics in one US health system.ObjectivesTo describe (1) how systems consultation worked during the pilot test and (2) the modifications necessary to adapt this implementation strategy to primary care.MethodsA team of investigators conducted observations (n=24), focus groups (n=4) and interviews (n=2). The team; kept contact logs documenting all interactions with the intervention clinics and preserved all work products resulting from the intervention. Initial analysis was concurrent with data collection and findings were used to modify the intervention in real time. At the conclusion of the pilot test, a pragmatic descriptive analysis of all data was performed to explore key modifications.ResultsTime constraints, entrenched hierarchical structures and a lack of quality improvement skills among clinical staff were the main barriers to implementing systems consultation. Modifications made to address these conditions included creating a consulting team, giving change teams more direction, revising process improvement tools, supporting the use of electronic health record (EHR) functionalities and providing opportunities for shared learning among clinics.Discussion and conclusionWith the lessons of this research in mind, our goal in future iterations of systems consultation is to give clinics a combination of clinical, organisational change and EHR expertise optimised according to their needs. We believe a streamlined process for assessing the key characteristics identified in this study can be used to develop a plan for this kind of optimisation, or tailoring, and we will be developing such a process as part of an upcoming clinical trial.


2020 ◽  
Vol 41 (6) ◽  
pp. 672-679 ◽  
Author(s):  
Hayli R. Hruza ◽  
Tania Velasquez ◽  
Karl J. Madaras-Kelly ◽  
Katherine E. Fleming-Dutra ◽  
Matthew H. Samore ◽  
...  

AbstractBackground:Acute respiratory tract infections (ARIs) are commonly diagnosed and major drivers of antibiotic prescribing. Clinician-focused interventions can reduce unnecessary antibiotic prescribing for ARIs. We elicited clinician feedback to design sustainable interventions to improve ARI management by understanding the mental framework of clinicians surrounding antibiotic prescribing within Veterans’ Health Administration clinics.Methods:We conducted one-on-one interviews with clinicians (n = 20) from clinics targeted for intervention at 5 facilities. The theory of planned behavior guided interview questions. Interviews were audio recorded and transcribed for qualitative analysis. An iterative coding approach identified 6 themes.Results:Emergent themes: (1) barriers to appropriate prescribing are multifactorial and include challenges of behavior change; (2) antibiotic prescribing decisions are perceived as autonomous yet, diagnostic uncertainty and perceptions of patient demand can make prescribing decisions difficult; (3) clinicians perceive variation in peer prescribing practices and influences; (4) clinician-focused interventions are valuable if delivered with sensitivity; (5) communication strategies for educating patients are preferred to a shared decisions process; and (6) team standardization of practice and communication are key to facilitate appropriate prescribing. Clinicians perceived audit-and-feedback with peer comparison, academic detailing, and enhanced patient communication strategies as viable approaches to improving appropriate prescribing.Conclusion:Implementation strategies that enable clinicians to overcome diagnostic uncertainty, perceived patient demand, and improve patient education are desired. Implementation strategies were welcomed, and some were more readily accepted (eg, audit feedback) than others (eg, shared decision making). Implementation strategies should address clinicians’ perceptions of antibiotic prescribing practices and should enhance their patient communication skills.


Author(s):  
Christopher F Akiba ◽  
Byron J Powell ◽  
Brian W Pence ◽  
Minh X B Nguyen ◽  
Carol Golin ◽  
...  

Abstract Implementation strategies are systematic approaches to improve the uptake and sustainability of evidence-based interventions. They frequently focus on changing provider behavior through the provision of interventions such as training, coaching, and audit-and-feedback. Implementation strategies often impact intermediate behavioral outcomes like provider guideline adherence, in turn improving patient outcomes. Fidelity of implementation strategy delivery is defined as the extent to which an implementation strategy is carried out as it was designed. Implementation strategy fidelity measurement is under-developed and under-reported, with the quality of reporting decreasing over time. Benefits of fidelity measurement include the exploration of the extent to which observed effects are moderated by fidelity, and critical information about Type-III research errors, or the likelihood that null findings result from implementation strategy fidelity failure. Reviews of implementation strategy efficacy often report wide variation across studies, commonly calling for increased implementation strategy fidelity measurement to help explain variations. Despite the methodological benefits of rigorous fidelity measurement, implementation researchers face multi-level challenges and complexities. Challenges include the measurement of a complex variable, multiple data collection modalities with varying precision and costs, and the need for fidelity measurement to change in-step with adaptations. In this position paper, we weigh these costs and benefits and ultimately contend that implementation strategy fidelity measurement and reporting should be improved in trials of implementation strategies. We offer pragmatic solutions for researchers to make immediate improvements like the use of mixed methods or innovative data collection and analysis techniques, the inclusion of implementation strategy fidelity assessment in reporting guidelines, and the staged development of fidelity tools across the evolution of an implementation strategy. We also call for additional research into the barriers and facilitators of implementation strategy fidelity measurement to further clarify the best path forward.


2021 ◽  
Vol 17 (2) ◽  
pp. 155-167
Author(s):  
Lisa B. E. Shields, MD ◽  
Timothy A. Johnson, BS ◽  
Michael W. Daniels, MS ◽  
Alisha Bell, MSN, RN, CPN ◽  
Diane M. Siemens, PharmD ◽  
...  

Objective: Prescription opioid misuse represents a social and economic challenge in the United States. We evaluated Schedule II opioid prescribing practices by primary care providers (PCPs), orthopedic and general surgeons, and pain management specialists.Design: Prospective evaluation of prescribing practices of PCPs, orthopedic and general surgeons, and pain management specialists over 5 years (October 1, 2014-September 30, 2019) in an outpatient setting.Methods: An analysis of Schedule II opioid prescribing following the implementation of federal and state guidelines and evidence-based standards at our institution. Results: There were significantly more PCPs, orthopedic and general surgeons, and pain management specialists with a significantly increased number who prescribed Schedule II opioids, whereas there was a simultaneous significant decline in the average number of Schedule II opioid prescriptions per provider, Schedule II opioid pills prescribed per provider, and Schedule II opioid pills prescribed per patient by providers. The average number of Schedule II opioid prescriptions with a quantity 90 and Opana/Oxycontin prescriptions per PCP, orthopedic surgeon, and pain management specialist significantly decreased. The total morphine milligram equivalent (MME)/day of Schedule II opioids ordered by PCPs, orthopedic and general surgeons, and pain management specialists significantly declined. The ages of the providers remained consistent throughout the study. Conclusions: This study reports the implementation of federal and state regulations and institutional evidence-based guidelines into primary care and medical specialty practices to reduce the number of Schedule II opioids prescribed. Further research is warranted to determine alternative therapies to Schedule II opioids that may alleviate a patient’s pain without initiating or exacerbating a potentially lethal opioid addiction.


2016 ◽  
Vol 12 (4) ◽  
pp. 269 ◽  
Author(s):  
Brian Penti, MD, MS ◽  
Jane M. Liebschutz, MD, MPH, FACP ◽  
Brian Kopcza, PharmD, BCACP ◽  
Ziming Xuan, ScD ◽  
Christine Odell, MD, MSc ◽  
...  

Objective: Determine if peer feedback through a chart review tool (CRT) can impact opioid prescribing for patients with chronic noncancer pain in an outpatient family medicine clinic at an urban, safety-net teaching hospital and to assess providing practices.Design: A quality improvement (QI) project, comparing preopioid and postopioid prescribing practices.Setting: Outpatient family medicine clinic at urban, safety-net teaching hospital. Patients, Participants: A convenience sample of 16 family medicine physicians. Interventions: A CRT was developed to allow physicians to give peer feedback to one another about their opioid prescribing practices as part of a 1-year QI project. We assessed the deidentified data gathered from the CRT.Main Outcome Measure(s): Primary study outcome measures were the amount of opioids prescribed at the end of the QI project compared to the time of initial chart review. We also describe overall prescribing practices.Results: Ninety-nine patient charts from 14 different physicians were reviewed over 1 year. Sixty percent of patients had at least one violation of the clinic's controlled substance prescribing policy in the prior 6 months, and half of the violations were due to missed appointments with specialists to help manage pain. The mean dose of opioids decreased 2.6 mg morphine equivalent dose (MED)/day from time of chart review until the end of project, compared to a 6.9 mg MED/day increase that occurred from 12 months prior to chart review to the time of chart review (p = 0.01). Fourteen patients (16 percent) of patients prescribed opioids were takenoff of opioids after the chart review.Conclusions: Use of a CRT in an urban primary care clinic provided helpful insight on prescribing practices and has promise to improve quality of opioid prescribing.


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