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Original research
Lean Six Sigma quality improvement approach to implement clinical practice guidelines for prescribing opiates for chronic pain in a primary care setting
  1. Smita Bakhai1,
  2. Jawdat Mustafa1,
  3. Meghan Cloutier1,
  4. Farhana Islam1,
  5. Gregory D Gudleski2,
  6. Jessica L Reynolds3
  1. 1Internal Medicine, University at Buffalo, The State University of New York, Buffalo, New York, USA
  2. 2University at Buffalo, The State University of New York, Buffalo, New York, USA
  3. 3Medicine, University at Buffalo, The State University of New York, Buffalo, New York, USA
  1. Correspondence to Dr Smita Bakhai; sybakhai{at}buffalo.edu

Abstract

Background Implementing guidelines for chronic opioid management during a clinic merger posed significant challenges. Our aim was to increase the percentage of chronic pain evaluations and urine toxicology tests in patients on chronic opioid therapy from the baseline rate of less than 20% to 50% within 1 year at an academic, primary care clinic.

Methods We applied the Define, Measure, Analyze, Improve, Control (DMAIC) approach of Lean Six Sigma for this quality improvement (QI) project. The QI tools included the creation of stakeholder mapping, root cause analysis, process flow mapping and a driver diagram. Lack of patient and provider education emerged as a significant barrier. The outcome measures were percentage of chronic pain evaluations and urine drug toxicology with an increase in controlled substance agreement completion rates as our process measures. Major interventions included patient and provider education, leveraging health information technology, care coordination and implementing new clinic protocols. Data analysis was performed by monthly run charts. Descriptive statistics were used to summarise clinical variables, while χ2 analyses were employed to determine statistically significant differences between preintervention and postintervention measures.

Results We observed an increase in completion rates of clinic visits for chronic pain, rising from 19.0% to 51.9% (p<0.001). During study period, we observed a steady increase in chronic pain evaluations with a median of 4.5. Urine toxicology completion rates increased from 19.9% to 65.8% (p<0.001) during the preintervention and postintervention periods. We observed variable changes in urine toxicology rates with a median of 5.19. Furthermore, we observed an increase in controlled substance agreement completion rates, increasing to 50% from the baseline rate of <10%.

Conclusions Education to patients and providers, shared decision-making using a patient-centred approach, enhancement of health information technology and system-based interventions in clinic protocols and workflows contributed to the success of this QI project. The DMAIC approach may facilitate the implementation of practice guidelines for chronic opioid therapy and enhance providers’ opioid prescribing practices.

  • Quality improvement
  • Clinical practice guidelines
  • Control charts/Run charts
  • Evidence-based medicine

Data availability statement

Data are available upon reasonable request. Not applicable.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjoq-2024-002912

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • While there are clinical practice guidelines for prescribing chronic opioid therapy for non-cancer pain, there are significant challenges in implementing these guidelines in a primary care setting.

    WHAT THIS STUDY ADDS

    • This study outlines the Define, Measure, Analyze, Improve, Control (DMAIC) approach of the Lean Six Sigma method of quality improvement (QI) in implementing opiate guidelines in an academic, primary care setting during a clinic merger. System-based interventions, such as changes in clinic protocols and workflows, were used for process improvement. Education for both patients and providers played a crucial role in the success of this QI project. Additionally, integrating a novel note template into the electronic health record proved pivotal in enhancing medical documentation and facilitating shared decision-making.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • DMAIC approach of Lean Six Sigma method of QI can effectively inform future healthcare QI projects. This study tackles barriers and population health issues and offers a framework for implementing guidelines for chronic opioid therapy, presenting opportunities for optimising practice guideline implementation.

    Introduction

    Background

    The opioid epidemic is a significant public health crisis in the USA1–3 fuelled by increased prescribing of opioid medications and resulting in widespread misuse and overdose.1 2 4–6 Despite guidelines from the Centers for Disease Control and Prevention (CDC) targeting primary healthcare providers in March 2016,7–9 these providers remain the leading prescribers of opioids and face challenges in reducing prescriptions.6 10 The COVID-19 pandemic further complicated opioid prescribing, with studies showing a decrease in non-pharmacological therapy and an increase in opioid prescriptions.5 11–15 Updated CDC guidelines in November 2022 prioritised individualised care for patients with chronic pain.16 17 Teaching patients about opioid reduction has proven effective in fostering collaboration, developing reduction strategies, tracking prescribing trends and mitigating overprescription. These educational efforts serve as invaluable assets in combating the opioid epidemic.4

    The current study outlines the application of the Define, Measure, Analyze, Improve, Control (DMAIC) approach of Lean Six Sigma quality improvement (QI) methodology18 in implementing opioid guidelines in an academic, primary care setting during a clinic merger amidst the pandemic that focused on provider and patient education and provider-patient shared decision-making. During the study period, providers were required to write naloxone prescriptions for opioid overdoses. However, significant shifts in accessibility occurred thereafter. In March 2023, the Food and Drug Administration (FDA) approved over-the-counter naloxone nasal spray,19 rendering it readily available without a prescription. Subsequently, in February 2024, the New York State implemented pharmacy standing orders, enabling the dispensing of naloxone without a provider’s prescription.20 Consequently, by the conclusion of this study in 2022, patients still were reliant on healthcare providers for naloxone prescriptions. However, the landscape underwent a drastic change after study, with naloxone now accessible without a prescription, both through FDA approval of over-the-counter availability and state-level policy of a pharmacy standing order.

    Problem description

    An abrupt closure of a hospital-based internal medicine clinic (IMC) led to the merger of these patients into an existing community-based IMC in November 2020. Following the clinic merger, the number of patients on chronic opioid therapy (COT) more than doubled at the community-based IMC. Furthermore, inadequate staffing and the surge of telemedicine visits posed a significant challenge to implementing evidence-based guidelines for COT. This led us to identify a major gap in adherence to clinical practice guidelines for COT in this academic, community-based IMC. These circumstances highlighted the necessity for adaptable, patient-centric approaches, emphasising alternative pain management methods and fostering collaboration among healthcare providers to ensure the safe and effective prescribing of opioids particularly in the setting of transition of care during clinic merger.

    The study’s objective was to increase the percentage of chronic pain evaluations and urine toxicology tests in patients on COT from the baseline rate of less than 20% to 50% within 1 year at an academic, primary care clinic. The overarching goal of this QI project was to optimise safe opioid prescribing and to mitigate the risk of opioid overdose and misuse in patients on COT for non-cancer pain using a patient-centred approach.

    Methods

    Setting and patient population

    This study was reviewed by the Human Subject Institutional Review Board and was classified as exempt. This community-based, academic IMC comprised a multidisciplinary care team consisting of 12 providers, 63 resident physicians, nursing staff, social workers, a mental health counsellor, information technology staff, a pharmacist and administrative staff. This clinic primarily serves an under-resourced urban population, with a significant proportion being immigrants, African American individuals, refugees, as well as individuals from diverse ethnic backgrounds.

    Clinic protocol

    During the clinic visit, the supervising attending physician sent an electronic prescription after sharing decision-making with the resident and patients. Resident physicians were educated about offering non-opioid options for chronic pain to patients and discussing the risks and benefits of COT. When residents’ patients were due for their monthly refills and not seen in the clinic, the supervising attending physician from the most recent clinic visit was responsible for evaluating the need by reviewing medical records and refilling medication as appropriate.

    Design

    The DMAIC approach of the Lean Six Sigma method was applied for this QI project (table 1).18 21 This QI project followed the Standards for Quality Improvement Reporting Excellence 2.0 guidelines.22 The inclusion criteria comprised adult patients on COT, prescribed by clinic providers for more than 3 months for non-cancer pain between 1 January 2022 and 31 December 2022. Patients on COT for cancer pain, opioids prescribed by another specialist including pain management, and patients who died over the course of the study period were excluded. A total of 231 patients were on COT in 2022. Each patient was counted once regardless of the number of opioid prescriptions. In this study, variables of interest included urine toxicology, prescription data, pain diagnosis, concurrent benzodiazepine use, a controlled substance treatment agreement, specialist referrals, medications and the number of clinic visits with provider documentation of chronic pain evaluation. Providers listed chronic pain in a problem list and few providers ordered urine toxicology during a prescheduled clinic visit for other comorbidities evaluation. All the components of a newly designed comprehensive pain management visit were not used during this clinic visit encounter.

    View this table:
    Table 1

    ’DMAIC’ approach of Lean Six Sigma method for safe opioid prescribing for chronic pain

    Our study involved the same group of patients before and after the intervention. Initially, we identified 231 patients on COT in 2022. We conducted a retrospective chart review of these exact 231 patients to gather data on various variables of interest from the preintervention period between 1 January 2021 and 31 December 2021. Therefore, both the preintervention and postintervention study groups consisted of the identical 231 patients. Due to the absence of an electronic patient registry, demographic data for the patients could not be collected. However, it is important to note that the study population remained consistent across both the preintervention and postintervention periods, consisting exclusively of these 231 patients identified during the intervention period. We analysed various variables that were documented during the preintervention period in 2021, ensuring continuity and comparability in our study design. We used the MD Calculator to convert morphine milligram equivalents (MME) data.23

    ‘Define’ phase (January 2022)

    During this phase, the QI team developed a project charter and a high-level map of current processes and clarified the need for process improvement. A stakeholder analysis (online supplemental figure 1) was constructed to define strategies for engaging various stakeholders. The QI team included the IMC multidisciplinary care team, the lead QI physician and three resident team leaders. Resident team leaders were responsible for collecting data from electronic health records (EHR) and creating a patient registry for patients on COT. Additionally, they facilitated clinic workflows, provided education to clinic staff and created patient agreement and note templates under the supervision and mentorship of the lead QI physician. An on-site mental health counsellor provided mental health support to patients on COT with associated depression or anxiety and discussed other coping skills related to chronic pain. Social workers coordinated plans of care and connected patients with community resources. They also assisted patients in arranging transportation for clinic appointments when needed. Our clinic has established collaborative relationships with community pain medicine specialists. Patients were referred for evaluation of alternative treatment options including opioid deprescribing in high-risk patients. Providers diagnosed specific medical conditions, such as rheumatoid arthritis, and referred patients to specialists for further evaluation and treatment, including non-opioid management. Furthermore, the entire team including the clinic’s administrative and medical leadership were highly engaged. The team used a Safe, Timely, Effective, Efficient, Equitable and Patient-centred framework,24 as well as the Institute of Medicine’s six domains of healthcare (online supplemental table 1), in the design. Our aim was defined by using Specific, Measurable, Achievable, Relevant and Timely techniques.25 The QI physician champion provided monthly updates on the progress to clinic leadership and received feedback.

    Supplemental material

    ‘Measurement’ phase (February 2022)

    During this phase, the team collected baseline metrics and defined outcome, process and balance measures. Patients on COT were identified from Electronic Prescriptions for Controlled Substances (EPCS) monthly reports. The QI resident team leaders retrieved information related to various variables of interest from EHRs and created a patient registry through manual entry.

    Baseline measurement

    The QI resident team conducted a retrospective, manual chart review of 231 patients identified on COT in 2022 and collected data for variables of interest between 1 January 2021 and 31 December 2021. Our baseline urine toxicology completion rate was 20% and clinic visit completion rate for medical evaluation of chronic pain was 9.5%. Our baseline-controlled substance agreement completion rates were <10% and 14.2% had a naloxone prescription at preintervention.

    Family of measures

    The outcome measures were an increase in the percentage of chronic pain evaluations and urine toxicology tests, with minimum of one test per year in patients on COT. Most evaluations for chronic pain were completed by providers during clinic visits for other comorbidities, and several components of comprehensive pain management visits were not addressed. The increase in controlled substance agreement completion rates from 10% to 40% and the percentage of patients on naloxone prescriptions in patients on opioid doses ≥50 MME and/or for patients on concurrent use of benzodiazepines was our process measure. Offering non-opioid treatment options and conducting medical evaluations resulting in specific diagnoses and treatments may lead to a reduction in the number of patients on COT.

    During the "define" and "measurement" phases, the QI physician leader educated clinic providers on offering non-opioid alternative treatments and referring patients to specialists for evidence-based chronic pain management during the weekly clinic huddle.

    ‘Analyze’ phase (March 2022)

    The team identified barriers to optimal COT management using a fishbone diagram (figure 1A). Significant barriers included a knowledge gap among providers and patients about chronic pain evaluation and evidence-based guidelines for COT, patients and providers’ expectations due to changes in clinic protocols, transitions between providers, lack of face-to-face clinic visits due to the COVID-19 pandemic and lack of interoperable EHR. Additionally, the team created a driver diagram and summarised key interventions under each primary and secondary driver (figure 1B).

    Figure 1
    Figure 1

    (A) Root cause analysis: barriers to optimal chronic opioid management. (B) Driver diagram to implement clinical guidelines for chronic opioid management. EHR, electronic health record; EMR, electronic medical record; IT, information technology; MME, morphine milligram equivalents; ORT, Opioid Risk Tool; PEG, Pain, Enjoyment of life and General activity; PHQ-9, 9-item Patient Health Questionnaire; SMART, Specific, Measurable, Achievable, Relevant and Timely; SDOH, Social Determinants of Health; SUD, Substance Use Disorder.

    ‘Improve’ phase (April to December 2022)

    The team developed and implemented innovative solutions to address the root causes of suboptimal implementation of chronic opioid guidelines in the IMC. These interventions included education for patients, clinic staff and providers; leveraging health information technology; care coordination; patient outreach; and implementing new clinic protocols and workflows.

    Intervention 1: provider and staff education

    The lead physician and resident team leader participated weekly in morning huddles with all residents, providers and nursing staff to review evidence-based management of chronic non-cancer pain. We educated clinic resident physicians and providers on strategies to deprescribe opioids when risks outweighed the benefits and offered evidence-based treatments using non-opioid medications for chronic non-cancer pain.

    Intervention 2: patient education and engagement

    Providers educated patients about the possible adverse effects of opioids, alternative modalities to non-cancer chronic pain management and prescription of naloxone for potential opioid overdose. Providers reviewed newly designed workflows and clinic protocols for managing chronic pain and chronic opioid prescriptions with the patients, emphasising the necessity of chronic pain evaluation visits and random urine toxicology tests. Patients diagnosed with serious mental illnesses such as schizophrenia and bipolar disorder were comanaged by a psychiatrist and primary care providers for chronic pain.

    Intervention 3: standardize processes and workflows

    Attending physicians forwarded the monthly EPCS reports to the lead QI physician and data were captured by manual entry into the database. The resident team leaders and the lead QI physician created a note template for a comprehensive pain management visit in EHR. Components of the comprehensive pain management visit included (1) completion of 9-item Patient Health Questionnaire (PHQ-9) form for depression screening, (2) assessment of the Pain, Enjoyment of life and General activity (PEG) score for evaluation of pain control, (3) administration of the Opioid Risk Tool (ORT) to evaluate the risk of substance use disorder (SUD), (4) use of a standardised note template, (5) minimum biannual, random urine toxicology, (6) prescription of naloxone patients with opioid doses ≥50 MME and/or concurrent use of benzodiazepines and (7) completion of a control substance treatment agreement form. The nursing staff received education on this visit and facilitated the completion of required components when checking patients into the examination room before the arrival of a provider. Providers were educated about the comprehensive pain visit.

    Intervention 4: patient outreach and leveraging EHR

    When a request for refill of chronic opioids was received from the patient and/or the pharmacy, the attending physician reviewed the medical records and sent a message to the front office staff to schedule comprehensive pain visit appointments if the patient had not been seen for this visit in the last 3–6 months. Furthermore, the nursing staff called patients to schedule visits as directed by the attending physician during monthly opioid refills.

    Control, sustainability and change (July to December 2022)

    We focused on continuous education and training for providers on optimising evidence-based management for chronic pain and the use of non-opioid alternative treatments. Emphasis was placed on the risks of COT with polypharmacy. This education was provided by the lead QI physician during a weekly huddle with resident physicians, providers and clinic staff. Furthermore, clinic preceptors educated resident physicians one on one during precepting sessions. Providers educated patients during face-to-face clinic visits for other comorbidities and visits for chronic pain evaluation. Patients’ responsibilities and expectations were discussed during clinic visits.

    Postintervention phase (January to June 2023)

    Most evaluations for chronic pain were completed by providers during clinic visits for other comorbidities, and several components of comprehensive pain management visits were not addressed. Therefore, clinic leadership attempted to schedule a stand-alone comprehensive pain management visit for patients. However, patients did not adhere to these appointments. The resident team leader and lead QI physician created a new process flow map for comprehensive pain visits (figure 2A). To improve adherence rates to comprehensive pain visit appointments, the QI team designed a patient notification letter for missed appointments and a clinic policy for COT. Clinic staff mailed the letters to patients on COT. Moreover, the clinic pharmacist was actively involved in these visits. A specific pharmacist visit note template was devised, enabling the pharmacist to complete a controlled substance agreement, perform urine toxicology tests and furnish naloxone kits to patients. The pharmacist also monitored urine toxicology results and promptly conveyed any abnormal findings to the primary care providers in the clinic. The new clinic policy mandated a minimum of two comprehensive pain visits per year with providers and one visit by the pharmacist. Furthermore, the clinic policy required a minimum of two urine toxicology tests per year.

    Figure 2
    Figure 2

    (A) Process flow map to optimise comprehensive pain management visit. (B) Bar graph comparing preintervention and postintervention rates of outcome and process measures for safe opioid prescribing. CPM, chronic pain management; EHR, electronic health record; I-STOP, Internet System for Tracking Over-Prescribing; MME, morphine milligram equivalents; ORT, Opioid Risk Tool; PEG, Pain, Enjoyment of life and General activity; PHQ, Patient Health Questionnaire; PMP, Prescription Monitoring Program.

    Data analysis

    Data analysis was performed by monthly run charts. Descriptive statistics were used to summarise clinical variables, while χ2 analyses were employed to determine statistically significant differences between preintervention and postintervention measures. A total of 231 patients were included in the pre-post intervention comparisons. Both the preintervention and postintervention study groups consisted of the identical 231 patients.

    Results

    The most common diagnosis was back pain (49.4%), and the most prescribed pain medication was hydrocodone (56.3%), followed by oxycodone (15.2%) and tramadol (13.4%). These data are displayed in table 2. The median MME dose was 30.0. The IQR for MME was 15–40.

    View this table:
    Table 2

    Variables of interest

    Outcome measures

    1. Urine toxicology completion rates: We observed an increase in urine toxicology completion rates from 19.9% to 65.8% (p<0.001) during the preintervention and postintervention periods, respectively.

    2. Chronic pain evaluation visit completion rates: Comparisons of visits with documented provider evaluation for patients on COT during the preintervention and postintervention study periods increased from 19.0% at preintervention to 51.9% at postintervention (p<0.001) (figure 2B).

    3. We observed variable changes in urine toxicology rates with a median of 5.19 in a monthly run chart (figure 3A). During study period, we observed a steady increase in chronic pain evaluations with a median of 4.5 (figure 3B).

    Figure 3
    Figure 3

    (A) Monthly run chart for urine toxicology completion rates. (B) Monthly run chart for chronic pain visit completion rates. Middle line indicates median values. CL, control limit.

    Process measures

    Comparisons of various process measures during the preintervention and postintervention study periods are shown in figure 2B. Controlled substance agreement completion rates improved from 9.5% at preintervention to 49.8% at postintervention (p<0.001) and the percentage of patients with at least one urine toxicology was increased from 19.9% to 65.8% (p<0.001). For patients with an MME dose of ≥50 and/or for patients on concurrent use of benzodiazepines, 14.2% had a naloxone prescription at preintervention compared with 29.3% at postintervention (p<0.001). Additionally, referrals to pain specialists also increased from 12.1% to 34.2% (p<0.001).

    Balancing measures

    Reduction in patients on COT

    During the 6-month poststudy period, we observed a 15.2% reduction (n=35/231) in patients on COT. There were several reasons for this reduction: (1) some patients changed their primary care physician or moved out of town; (2) chronic pain was managed by pain management providers or rheumatology specialists; (3) opioids were tapered and discontinued by patients due to a lack of response to treatment; (4) clinic providers tapered opioids and referred patients to pain management due to the presence of illicit substances in urine toxicology other than marijuana; (5) providers changed to a non-opioid treatment plan after shared decision-making with patients; (6) clinic providers tapered opioids and discontinued them, referring patients to pain management when the risks outweighed the benefits. Furthermore, throughout the 6-month poststudy period, six patients were using opioids every 2–3 months for pain Management with As Needed Medications (PRNs) and did not require monthly refills. Additionally, six patients died due to associated comorbidities.

    Discussion

    We identified a major gap in adherence to evidence-based protocols in the management of patients on COT for non-cancer pain. Through our concerted efforts, we implemented system-based changes and improved multiple process measures to ensure the safe prescribing of opioids, aligning with evidence-based guidelines. Remarkably, we surpassed our initial target for urine toxicology completion rate, achieving 66% compared with the baseline of 20%. Additionally, we successfully reached our goal to increase the percentage of chronic pain evaluations, achieving 50% from the baseline of 19.5% within 1 year. The results from the study are crucial as they examined the effects of a clinic closure and its subsequent impact on opioid prescribing in primary care. System-based interventions embedded within clinic protocols and workflows have become the norm for patients undergoing COT. Nevertheless, we still encounter hurdles in ensuring the fulfilment of all elements of a thorough pain management visit. Consistent training and education for new interns, resident physicians and clinic providers are essential to enhance compliance with these visits. The leading QI physician continues to gather data for COT patients through monthly reviews of provider EPCS reports. However, due to resource constraints and time limitations, ongoing manual entry of various pertinent variables is presently not conducted. Shared decision-making, a collaborative process between patients and healthcare providers, fosters the exchange of information and viewpoints, leading to mutual agreement on treatment plans.26 It is widely recognised for enhancing patient engagement and satisfaction in treatment decisions. Education on opioid reduction for patients has been shown to enhance collaboration, develop detailed reduction plans, monitor prescribing patterns and reduce overprescribing, serving as valuable tools for addressing the opioid epidemic.27 28 In our study, providers actively engaged patients and caregivers in discussions, weighing the risks and benefits of COT and educating them on the proper administration of naloxone during emergencies. Shared decision-making was also pivotal in conversations about deprescribing opioids and exploring evidence-based alternatives for comprehensive pain management, ultimately leading to the successful discontinuation of COT in some patients. Patients were also educated about the importance of adhering to prescribed opioid regimens, with early refills being explicitly discouraged for lost or stolen prescriptions or excessive use. This educational effort resulted in fewer requests for early refills. Providers reinforced the clinic’s protocol by refraining from issuing additional prescriptions and addressing patient resistance regarding the potential risks of continued opioid therapy when the risks outweighed the benefits. However, despite the importance of shared decision-making, our study revealed challenges in achieving optimal pain management, particularly amid disagreements regarding opioid use. Patients encountered difficulties in adapting to new clinic protocols that required comprehensive pain management visits, resulting in higher rates of missed appointments. These challenges are similar to what has been previously published.6

    Several studies have explored team-based care for chronic pain management in primary care settings.29 30 An interprofessional team focused on individualised, evidence-based pain management reduced opioid prescriptions in primary care.31 Our study aligns with this, showing improved patient care through collaboration among providers, including pharmacists, ensuring comprehensive support for patients on COT. Providers and nursing staff ensured safety and compliance with regulations by using the state’s Internet System for Tracking Over-Prescribing and Prescription Monitoring Program32 registry when refilling opioid prescriptions. Similarly, patients on COT benefited from this cohesive teamwork, undergoing checks in the same registry to promote safety and regulatory adherence.

    The involvement of pharmacists and pharmacy students played a crucial role in identifying high-risk medications and addressing polypharmacy, particularly in the geriatric population, using criteria such as the Beers list33 for patients on COT. Their contribution seamlessly aligned with the multidisciplinary approach, reinforcing the importance of comprehensive care. Evidence from a similar study further highlighted the effectiveness of a pharmacist-assisted approach in assisting primary care providers to minimise opioid use,5 34 35 validating the significance of their role within the team. There was a minimum cost involved in this study. There is evidence of internal validity in this study.

    Lessons learnt

    The implications of this QI initiative on opioid prescribing are substantial. It identifies effective strategies for reducing opioid prescriptions while ensuring patient safety and proper pain management. Emphasising evidence-based guidelines, multidisciplinary approaches and shared decision-making in improvement practices can optimise opioid prescribing. Healthcare organisations have a critical role to play by implementing robust monitoring systems, providing ongoing education and fostering a culture of responsible opioid use. Collaboration across research, improvement practices and healthcare organisations is essential to address the opioid epidemic and develop effective prescribing strategies.

    There are several study limitations. The findings from this study may not apply universally to various clinical settings with diverse patient populations. The absence of formal feedback from patients limits comprehensive insight into their experiences and perspectives. The study lacks electronic data capturing from clinic EHR for variable interests and patient demographics, potentially limiting the depth of analysis. We were not able to track attendance rates and missed visit appointment rates for the study population due to need for manual chart review and limited resources. We used preintervention and postintervention data analyses in this study; however, the statistical process control (SPC) charts and run charts are the analytical tools recommended for QI projects.36 Due to lack of electronic patient registry and available resources to perform manual chart audits, we were unable to collect weekly data for the SPC chart.

    Future directions

    Future directions will focus on establishing a robust population health electronic registry capable of continuous and accurate data capture. This registry will include patient demographics, various outcome variables such as attendance rates at clinic visits for chronic pain, trajectory of MME dosing of chronic opiate prescriptions, PHQ-9, PEG and ORT score, and the number of patients managed by primary care physicians in the clinic. Additionally, it will incorporate non-opioid pain management strategies and tapering plans for patients on COT.

    Sustainability and dissemination

    To ensure the sustainability of this study, we will leverage health information technology to establish an electronic patient dashboard, also known as a population health registry. This platform will facilitate ongoing education for resident physicians, providers, patients and clinic staff. This registry will address data collection challenges and time constraints. Additionally, the introduction of pharmacy-led visits, including naloxone prescriptions, urine testing and opioid agreements, has significantly enhanced provider and clinic efficiency. The physician leader, clinic administrative manager, medical directors, providers and clinic staff are all deeply committed to promoting safe opioid prescribing at the IMC. Furthermore, the lead QI physician will disseminate the study findings during grand rounds at the University’s internal medicine and family medicine residency programmes, sharing various tools and clinic protocols. Resident physicians will also showcase posters at local, state and national events, disseminating the resources developed during this study to a broader audience.

    Conclusions

    Education to patients and providers, shared decision-making using a patient-centred approach, enhancement of health information technology and system-based interventions in clinic protocols and workflows contributed to the success of this QI project. The DMAIC approach may facilitate implementation of practice guidelines for COT and enhance providers’ opioid prescribing practices. This study offers a plan for implementing safe opioid prescribing practices in an academic primary care clinic that serves a marginalised population. Our future plans include increasing comprehensive pain management visits and providing educational materials and videos in patients’ native language and at their health literacy level. We also aim to include pharmacists in patient visits. It is essential to build the necessary data monitoring system at the organisation level for patients on COT. We plan to create a population health dashboard that tracks patients on COT, considering factors like race, ethnicity, urine testing results, appointment data and comorbidities. This dashboard will help our QI team monitor progress and implement ongoing improvements.

    Data availability statement

    Data are available upon reasonable request. Not applicable.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study was reviewed by the Human Subject Institutional Review Board (HSIRB)and was classified as exempt.

    Acknowledgments

    We thank the residents, providers, pharmacists and clinic staff for their support in this QI project.

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    Footnotes

    • Contributors SB was responsible for conception/design of the work, data analysis, interpretation of data, manuscript draft and revisions and final approval of the version to be published. SB is the guarantor. JM and MC were responsible for data acquisition. GDG was responsible for data acquisition for analysis. JLR was responsible for interpretation of data for the work, drafting the manuscript and revising.

    • Funding Funding is through the Health Resources and Services Administration (HRSA) Primary Care and Enhancement Community Prevention and Maternal Health award T34HP42144-0200.Note. This publication/program was supported by the HRSA of the US Department of Health and Human Services (HHS) as part of an award totaling $2,840,574 with zero percentage financed with nongovernmental sources. Disclaimer: The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, HRSA, HHS, or the US government.Evan Calkins, MD Community-based research fellowship, Graduate Medical Education award

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.