Optimizing evidence-based practice implementation: a case study on simulated patient protocols in long-term opioid therapy.

BACKGROUND: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. OBJECTIVE: The goal of this study is to describe the use of standardized/simulated patient/person (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. DESIGN: We observed 12 clinicians' first-time experiences with six unique decision-making algorithms, developed previously using rigorous Delphi methods, for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain. Clinicians were paired with two SPs trained to portray individuals with one of the concerning behaviors addressed by the algorithms in a telehealth environment. The SP evaluations were followed by individual interviews, guided by the Consolidated Framework for Implementation Research (CFIR), with each of the clinician participants. PARTICIPANTS: Twelve primary care clinicians and 24 SPs in Western Pennsylvania. MAIN MEASUREMENT: The primary outcome was identifying likely facilitators for the successful implementation of the EBP using the SP methodology. Our secondary outcome was to assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. RESULTS: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. CONCLUSIONS: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients. SETTING: Zoom simulated patient evaluations.

"To prescribe or not to prescribe, that is the question": Perspectives on opioid prescribing for chronic, cancer-related pain from clinicians who treat pain in survivorship.

BACKGROUND: Opioid pain management in cancer survivorship is a complex and understudied topic. METHODS: The authors conducted in-depth, qualitative interviews to understand clinician approaches to opioid pain management in chronic cancer pain and to generate ideas for improvement. They used a rigorous, inductive, qualitative, descriptive approach to examine clinician (n = 20) perspectives about opioid pain management in survivorship, including oncologists (n = 5), palliative care clinicians (n = 8), primary care clinicians (n = 5), and pain management specialists (n = 2). RESULTS: The findings indicated that no consistent medical home exists for chronic pain management in cancer survivors and that there are fundamental differences in how each subspecialty approaches chronic pain management in survivorship (e.g., "Do we think of this as noncancer pain or cancer pain?… This is in this limbo zone-this gray zone-because it's cancer-related pain, right?"). Simultaneously, clinicians are influenced by their peers' perceptions of their opioid prescribing decisions, sparking intraprofessional tension when disagreement occurs. In these instances, clinicians described overthinking and doubting their clinical decision-making as well as a sense of judgment, pressure, and/or shame. Finally, clinicians acknowledged a fear of consequences for opioid prescribing decisions. Specifically, participants cited conflict with patients, sometimes escalating to aggression and threats of violence, as well as potential disciplinary actions and/or legal consequences. CONCLUSIONS: Participants suggested that opportunities to improve chronic cancer pain care include developing clear, systematic guidance for chronic cancer pain management, facilitating clinician communication and consultation, creating tailored survivorship care plans in partnership with patients, and developing accessible, evidence-based, complementary pain treatments.

Benefits, Harms, and Stakeholder Perspectives Regarding Opioid Therapy for Pain in Individuals With Metastatic Cancer: Protocol for a Descriptive Cohort Study.

BACKGROUND: Opioids are a key component of pain management among patients with metastatic cancer pain. However, the evidence base available to guide opioid-related decision-making in individuals with advanced cancer is limited. Patients with advanced cancer or cancer that is unlikely to be cured frequently experience pain. Opioids are a key component of pain management among patients with metastatic cancer pain. Many individuals with advanced cancer are now living long enough to experience opioid-related harm. Emerging evidence from chronic noncancer pain literature suggests that longer-term opioid therapy may have limited benefits for pain and function, and opioid-related harms are also a major concern. However, whether these benefits and harms of opioids apply to patients with cancer-related pain is unknown. OBJECTIVE: This manuscript outlines the protocol for the "Opioid Therapy for Pain in Individuals With Metastatic Cancer: The Benefits, Harms, and Stakeholder Perspectives (BEST) Study." The study aims to better understand opioid decision-making in patients with advanced cancer, along with opioid benefits and harms, through prospective examination of patients' pain experiences and opioid side effects and understanding the decision-making by patients, care partners, and clinicians. METHODS: This is a multicenter, prospective cohort study that aims to enroll 630 patients with advanced cancer, 20 care partners, and 20 clinicians (670 total participants). Patient participants must have an advanced solid cancer diagnosis, defined by the American Cancer Society as cancer that is unlikely to be cured. We will recruit patient participants within 12 weeks after diagnosis so that we can understand opioid benefits, harms, and perspectives on opioid decision-making throughout the course of their advanced cancer (up to 2 years). We will also specifically elicit information regarding long-term opioid use (ie, opioids for ≥90 consecutive days) and exclude patients on long-term opioid therapy before an advanced cancer diagnosis. Lived-experience perspectives related to opioid use in those with advanced cancer will be captured by qualitative interviews with a subset of patients, clinicians, and care partners. Our data collection will be grounded in a behavioral decision research approach that will allow us to develop future interventions to inform opioid-related decision-making for patients with metastatic cancer. RESULTS: Data collection began in October 2022 and is anticipated to end by November 2024. CONCLUSIONS: Upon successful execution of our study protocol, we anticipate the development of a comprehensive evidence base on opioid therapy in individuals with advanced cancer guided by the behavioral decision research framework. The information gained from this study will be used to guide interventions to facilitate opioid decisions among patients, clinicians, and care partners. Given the limited evidence base about opioid therapy in people with cancer, we envision this study will have significant real-world implications for cancer-related pain management and opioid-related clinical decision-making. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54953.

Adolescent, Parent, and Provider Perceptions of a Predictive Algorithm to Identify Adolescent Suicide Risk in Primary Care.

OBJECTIVE: To understand adolescent, parent, and provider perceptions of a machine learning algorithm for detecting adolescent suicide risk prior to its implementation primary care. METHODS: We conducted semi-structured, qualitative interviews with adolescents (n = 9), parents (n = 12), and providers (n = 10; mixture of behavioral health and primary care providers) across two major health systems. Interviews were audio recorded and transcribed with analyses supported by use of NVivo. A codebook was developed combining codes derived inductively from interview transcripts and deductively from implementation science frameworks for content analysis. RESULTS: Reactions to the algorithm were mixed. While many participants expressed privacy concerns, they believed the algorithm could be clinically useful for identifying adolescents at risk for suicide and facilitating follow-up. Parents' past experiences with their adolescents' suicidal thoughts and behaviors contributed to their openness to the algorithm. Results also aligned with several key Consolidated Framework for Implementation Research domains. For example, providers mentioned barriers inherent to the primary care setting such as time and resource constraints likely to impact algorithm implementation. Participants also cited a climate of mistrust of science and health care as potential barriers. CONCLUSIONS: Findings shed light on factors that warrant consideration to promote successful implementation of suicide predictive algorithms in pediatric primary care. By attending to perspectives of potential end users prior to the development and testing of the algorithm, we can ensure that the risk prediction methods will be well-suited to the providers who would be interacting with them and the families who could benefit.

Mental health, pain and likelihood of opioid misuse among adults with sickle cell disease.

Depressive symptoms are prevalent in individuals living with sickle cell disease (SCD) and may exacerbate pain. This study examines whether higher depressive symptoms are associated with pain outcomes, pain catastrophizing, interference and potential opioid misuse in a large cohort of adults with SCD. The study utilized baseline data from the 'CaRISMA' trial, which involved 357 SCD adults with chronic pain. Baseline assessments included pain intensity, daily mood, the Patient Health Questionnaire (PHQ), the Generalized Anxiety Disorders scale, PROMIS Pain Interference, Pain Catastrophizing Scale, the Adult Sickle Cell Quality of Life Measurement Information System and the Current Opioid Misuse Measure. Participants were categorized into 'high' or 'low' depression groups based on PHQ scores. Higher depressive symptoms were significantly associated with increased daily pain intensity, negative daily mood, higher pain interference and catastrophizing, poorer quality of life and a higher likelihood of opioid misuse (all p < 0.01). SCD patients with more severe depressive symptoms experienced poorer pain outcomes, lower quality of life and increased risk of opioid misuse. Longitudinal data from this trial will determine whether addressing depressive symptoms may potentially reduce pain frequency and severity in SCD.

Stakeholder-Driven Intervention Development for Dialysis Trials Using a Design Sprint Methodology.

Rationale & Objective: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly with buprenorphine pain treatment. To address stigma, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. Study Design: Adapted Design Sprint which clarified the problem to be solved, proposed solutions, and created a blueprint for the selected solution. Settings & Participants: Five individuals with pain and kidney disease receiving dialysis, 5 physicians (nephrology, palliative care, and addiction medicine) and 4 large dialysis organization leaders recruited for specific expertise or experience. Conducted through online platform (Zoom) and virtual white board (Miro board). Analytical Approach: Descriptions of the Design Sprint adaptations and processes. Results: To facilitate patient comfort, a patient-only phase included four 90-minute sessions over 2-weeks, during which patient participants used a mapping process to define the critical problem and sketch out solutions. In a physician-only phase, consisting of two 120-minute sessions, participants accomplished the same tasks. During a combined phase of two 120-minute sessions, patients, physicians, and large dialysis organization representatives vetted and developed solutions from earlier phases, leading to an intervention blueprint. Videoconferencing technology allowed for geographically diverse representation and facilitated participation from patients experiencing medical illness. The electronic whiteboard permitted interactive written contributions and voting on priorities instead of only verbal discussion, which may privilege physician participants. A skilled qualitative researcher facilitated the sessions. Limitations: Challenges included the time commitment of the sessions, absences owing to illness or emergencies, and technical difficulties. Conclusions: An adapted Design Sprint is a novel method of efficiently and rapidly incorporating multiple stakeholders to develop solutions for clinical challenges in kidney disease. Plain Language Summary: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly when using buprenorphine, an opioid pain medicine with a lower risk of sedation used to treat addiction. To develop a stigma intervention, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. We conducted 3 sprints with (1) patients alone, (2) physicians alone, and (3) combined patients, physicians, and dialysis organization representatives. This paper describes the adaptations and products of sprints as a method for gathering diverse stakeholder voices to create an intervention blueprint efficiently and rapidly.

A Simulated Patient Protocol for Implementing Evidence-Based Practices in Health Care Delivery.

Background: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. The goal of this study is to describe the use of simulated patient (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. The primary outcome was identifying likely facilitators for the successful implementation of EBP. Our secondary outcome was the assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. Methods: We observed 12 primary care clinicians' first-time experiences with six unique decision-making algorithms for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain over Zoom. Each clinician was paired with two simulated patients trained to portray individuals with one of the concerning behaviors addressed by the algorithms. The Standardized Patient-evaluations were followed by CFIR guided one-on-one interviews with the clinicians. Results: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. Conclusions: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients.

Intrusive social support among Black and White individuals with type 2 diabetes: A "Control issue" or a sign of "Concern and love"?

Family members and friends play an important supportive role in the management of chronic illnesses like diabetes, which often require substantial lifestyle changes. Some studies suggest that there may be racial differences in the kinds of support people receive, though little research has examined this idea within a chronic illness context. The current research takes a qualitative approach to examining similarities and differences between Black and White individuals with type 2 diabetes in the dimensions of support received from their family members, with a particular focus on better understanding more intrusive forms of support, such as unsolicited and overprotective support. Semi-structured interviews were conducted (N = 32) to characterize differences in support received by Black and White individuals with type 2 diabetes. The results of the thematic analysis suggested that unsolicited and overprotective support were not universally perceived to be negative, as previous work on White populations seemed to suggest. Rather, if the support provided was perceived as inhibiting autonomy, it was generally undesired by participants from both racial groups-however, for Black participants, knowing that the support was provided out of love could make it more acceptable. The analysis also revealed several underexplored dimensions of received support, including the directiveness of support and the tone used to deliver support. The current study provides an initial step towards grounding social support theory in the experiences of marginalized populations and will inform further development of a culturally sensitive measure of social support for individuals with chronic illness.

Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial.

BACKGROUND: Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods. OBJECTIVE: The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)-led deprescribing of sedative-hypnotic medications. METHODS: In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up. RESULTS: The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use. CONCLUSIONS: Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47636.

A qualitative crossroads of rhythm and race: Black patients' experiences living with atrial fibrillation.

Importance: Race-based disparities in atrial fibrillation (AF) outcomes are well-documented, but few studies have investigated individuals' experiences of living with the condition, particularly among Black individuals. Objective: We aimed to identify common themes and challenges experienced by individuals of Black race with AF. Design: A tailored, qualitative script was developed to assess the perspectives of participants in focus groups. Setting: Virtual focus groups. Participants: Three focus groups of 4-6 participants (16 participants total) were recruited from the racial/ethnic minority participants in the Mobile Relational Agent to Enhance Atrial Fibrillation Self-care Trial. Main outcomes and measures: Focus group transcripts were inductively coded to identify common themes. Results: Nearly all participants self-identified as Black race (n = 15, 93.8 %). Participants were mostly male (62.5 %) with mean age of 67 (range 40-78) years. Three themes were identified. First, participants described physical and mental burdens associated with having AF. Second, participants described AF as being a condition that is difficult to manage. Lastly, participants identified key tenets to support self-management of AF (self-education, community support, and patient-provider relationships). Conclusions and relevance: Participants reported AF is unpredictable and challenging to manage, and that social and community supports are essential. The social and behavioral themes identified in this qualitative research highlight the need for tailored clinical strategies for AF self-management which incorporate individuals' social contexts. Trial registration: National Clinical Trial number 04075994.

Barriers to rural health care from the provider perspective.

INTRODUCTION: Rural populations routinely rank poorly on common health indicators. While it is understood that rural residents face barriers to health care, the exact nature of these barriers remains unclear. To further define these barriers, a qualitative study of primary care physicians practicing in rural communities was performed. METHODS: Semistructured interviews were conducted with primary care physicians practicing in rural areas within western Pennsylvania, the third largest rural population within the USA, using purposively sampling. Data were then transcribed, coded, and analyzed by thematic analysis. RESULTS: Three key themes emerged from the analysis addressing barriers to rural health care: (1) cost and insurance, (2) geographic dispersion, and (3) provider shortage and burnout. Providers mentioned strategies that they either employed or thought would be beneficial for their rural communities: (1) subsidize services, (2) establish mobile and satellite clinics (particularly for specialty care), (3) increase utilization of telehealth, (4) improve infrastructure for ancillary patient support (ie social work services), and (5) increase utilization of advanced practice providers. CONCLUSION: There are numerous barriers to providing rural communities with quality health care. Barriers that are encountered are multidimensional. Patients are unable to obtain the care they need because of cost-related barriers. More providers need to be recruited to rural areas to combat the shortage and burnout. Advanced care-delivery methods such as telehealth, satellite clinics, or advanced practice providers can help bridge the gaps caused by geographic dispersion. Policy efforts should target all these aspects in order to appropriately address rural healthcare needs.

Comparing survey data to qualitative themes in patient stories to help researchers better identify pressing community healthcare needs.

BACKGROUND: Narrative medicine is a powerful approach for strengthening clinicians' therapeutic alliances with patients and helping them understand others' perspectives by giving patients a voice. MyPaTH Story Booth is a cross-sectional observational study that uses narrative medicine concepts to allow community participants to share their health and healthcare-related experiences through relatively unstructured interviews (i.e., stories). The archive forms a qualitative research 'commons' where researchers can learn about patient and caregiver perspectives and tailor research goals to better address community needs. Brief surveys allow storytellers to classify their stories so that the archive is searchable. METHODS: This study assessed sensitivity, specificity, positive predictive and negative predictive values of self-reported surveys for categorizing 83 stories, compared with a 'gold standard' (most commonly accepted method for interpreting narratives) of qualitative coding. Stories were classified as either having or not having each of 38 different classifications based on US National Library of Medicine (NLM) Health Topics (Type of disorder or condition and Part of the body discussed) or developed with stakeholder input (Type of health/healthcare experience). RESULTS: Survey data assessing 'Part of the body discussed' and 'Type of disorder or condition' typically was highly sensitive (64%-95%) and specific (73%-99%) suggesting high adequacy of surveys in identifying stories. Questions focused on 'Type of health/healthcare experience' showed inconsistent and relatively lower sensitivities (48%-93%) and specificities (30%-79%) suggesting lower adequacy of surveys in identifying stories. CONCLUSION: Survey items based on NLM Health Topics allowed people to categorize their health narratives into relevant, searchable topics making the database more accessible.

Barriers and facilitators to interhospital transfer of acute pulmonary embolism: An inductive qualitative analysis.

Background: Interhospital transfer (IHT) of patients with acute life-threatening pulmonary embolism (PE) is necessary to facilitate specialized care and access to advanced therapies. Our goal was to understand what barriers and facilitators may exist during this transfer process from the perspective of both receiving and referring physicians. Methods: This qualitative descriptive study explored physician experience taking care of patients with life threatening PE. Subject matter expert physicians across several different specialties from academic and community United States hospitals participated in qualitative semi-structured interviews. Interview transcripts were subsequently analyzed using inductive qualitative description approach. Results: Four major themes were identified as barriers that impede IHT among patients with life threatening PE. Inefficient communication which mainly pertained to difficulty when multiple points of contact were required to complete a transfer. Subjectivity in the indication for transfer which highlighted the importance of physicians understanding how to use standardized risk stratification tools and to properly triage these patients. Delays in data acquisition were identified in regards to both obtaining clinical information and imaging in a timely fashion. Operation barriers which included difficulty finding available beds for transfer and poor weather conditions inhibiting transportation. In contrast, two main facilitators to transfer were identified: good communication and reliance on colleagues and dedicated team for transferring and treating PE patients. Conclusion: The most prominent themes identified as barriers to IHT for patients with acute life-threatening PE were: (1) inefficient communication, (2) subjectivity in the indication for transfer, (3) delays in data acquisition (imaging or clinical), and (4) operational barriers. Themes identified as facilitators that enable the transfer of patients were: (1) good communication and (2) a dedicated transfer team. The themes presented in our study are useful in identifying opportunities to optimize the IHT of patients with acute PE and improve patient care. These opportunities include instituting educational programs, streamlining the transfer process, and formulating a consensus statement to serve as a guideline regarding IHT of patients with acute PE.

"I Refused to Get Addicted to Opioids": Exploring Attitudes About Opioid Use Disorder in Patients With Advanced Cancer Pain and Their Support People.

Patients with advanced cancer are commonly prescribed opioids, yet patient attitudes about opioid risks (eg, opioid use disorder, or OUD) are understudied. Our objective was to use in-depth qualitative interviews to understand perceptions of opioid prescribing and OUD in patients with advanced, solid-tumor cancers and their support people. We conducted a qualitative study using a rigorous inductive, qualitative descriptive approach to examine attitudes about OUD in patients with advanced cancer (n = 20) and support providers (n = 11). Patients with cancer hold 2 seemingly distinct views: prescription opioids are addictive, yet OUD cannot happen to me or my loved one. Participants described general concerns about the addictive nature of prescription opioids ("My biggest concern… would just be the risk of getting addicted to the medication or even like, overdosing it"), while separating cancer pain management from OUD when considering prescription opioid risks and benefits ("They need to make sure they get the right ones, when they're taking it away from you."). Finally, participants identified personal characteristics and behaviors that they felt were protective against developing OUD (commonly control, willpower, and responsibility). This rigorous qualitative study demonstrates that patients with advanced cancer and their support people simultaneously hold concerns about the addictive nature of prescription opioids, while distancing from perceptions of OUD risks when using opioids for cancer pain management. Given high rates of opioid exposure during advanced cancer treatment, it is important to explore opportunities to promote a balanced understanding of prescription opioid use and OUD risks in this population. PERSPECTIVE: Though prescription opioids carry risk of OUD, there is little data to help guide patients with advanced cancer. Findings suggest that there is a need to develop new, innovative strategies to promote effective pain management and minimize opioid risks in this complex population.

U.S. physicians' perspectives on the complexities and challenges of permanent contraception provision.

OBJECTIVES: Evidence shows many misconceptions exist around permanent contraception, and there are numerous barriers to accessing the procedure. This qualitative study explored physician perspectives regarding patients' informational and decision-support needs, the complexities and challenges of counseling and access, and how these factors may differ for people living on lower incomes. STUDY DESIGN: We conducted 15 semistructured, telephone interviews with obstetrician-gynecologists in three geographic regions of the United States to explore their perspectives on providing permanent contraception counseling and care. We analyzed the interviews using content analysis. RESULTS: Physicians discussed a tension between respecting individual reproductive autonomy and concern for future regret; they wanted to support patients' desire for permanent contraception but were frequently concerned patients did not have the information they needed or the foresight to make high-quality decisions. Physicians also identified barriers to counseling including lack of time, lack of continuity over the course of prenatal care, and baseline misinformation among patients. Physicians identified additional barriers in providing a postpartum procedure even after thedecision was made including lack of personnel and operating room availability. Finally, physicians felt that people living on lower incomes faced more challenges in access primarily due to the sterilization consent regulations required by Medicaid. CONCLUSIONS: Physicians report numerous challenges surrounding permanent contraception provision and access. Strategies are needed to support physicians and patients to enhance high-quality, patient-centered sterilization decision making and ensure that patients are able to access a permanent contraceptive procedure when desired. IMPLICATIONS: This qualitative study demonstrates the various challenges faced by physicians to support permanent contraception decision making. These challenges may limit patients' access to the care they desire. This study supports the need to transform care delivery models and improve the federal sterilization policy to ensure equitable patient-centered access to desired permanent contraception. DISCLAIMER: Although the term permanent contraception has increasingly replaced the word sterilization in clinical settings, we use sterilization in some places throughout this paper as that was the standard terminology at the time the interviews were conducted and the language the interviewed physicians used.

Sleep intervention and glycemic control in gestational diabetes mellitus: a feasibility study.

BACKGROUND: Over 50% of pregnant people report poor sleep quality and insomnia, with approximately 25% reporting short sleep (<7 hours per night). Short sleep duration is associated with impaired glucose functioning, insulin resistance, and type 2 diabetes mellitus. Although short sleep is associated with elevated blood glucose in patients with gestational diabetes mellitus, it is not known whether education on healthy sleep habits during pregnancy can improve sleep and thus glycemic control in these patients. OBJECTIVE: We developed a sleep education program specific to pregnancy and targeted to patients with gestational diabetes mellitus. We aimed to evaluate the feasibility of this intervention in the setting of a randomized controlled trial. STUDY DESIGN: A sleep education program specific to pregnancy, "Sleep-4-2," was developed via multidisciplinary collaboration between specialists in maternal-fetal medicine, sleep medicine, and psychiatry. The program was presented to focus groups of pregnant people and a separate group of healthcare providers to gauge acceptability of the program and to modify content. This program was then tested on a group of patients diagnosed with gestational diabetes mellitus. Participants were randomized to a group receiving standard gestational diabetes mellitus care or a group participating in the sleep education program. Baseline demographics, sleep knowledge, and self-reported sleep quality information were obtained from all participants at enrollment and again at 35 weeks of pregnancy. Change in sleep knowledge and quality and degree of glycemic control were compared between groups. RESULTS: Between December 2017 and July 2019, 140 patients were screened and 74 were enrolled in the study and randomized. Recruitment to the study was acceptable, with >50% of eligible approached patients agreeing to participate, and retention in the intervention group was high at 94%. We did not demonstrate any difference in sleep knowledge or in the proportion of patients achieving glycemic control during pregnancy. CONCLUSION: Implementation of a sleep education program specific to pregnancy for patients with gestational diabetes mellitus was feasible in the context of typical care. A definitive trial could be developed on the basis of this pilot study to evaluate whether a sleep intervention in pregnancy can improve glycemic control in patients with gestational diabetes mellitus.

How to Provide Sexual and Reproductive Health Care to Patients: Focus Groups With Rheumatologists and Rheumatology Advanced Practice Providers.

OBJECTIVE: Rheumatologists have identified challenges to providing sexual and reproductive health (SRH) care to patients with gestational capacity. We conducted focus groups with rheumatologists and rheumatology advanced practice providers (APPs) to elicit their solutions to overcoming barriers to SRH care. METHODS: Qualitative focus groups were conducted with rheumatologists (3 groups) and APPs (2 groups) using videoconferencing. Discussions were transcribed and 2 trained research coordinators developed a content-based codebook. The coordinators applied the codebook to transcripts, and discrepancies were adjudicated to full agreement. The codes were synthesized and used to conduct a thematic analysis. Differences in codes were also identified between the clinician groups by provider type. RESULTS: A total of 22 clinicians were included in the sample, including 12 rheumatologists and 10 APPs. Four themes emerged: (1) clinicians recommended preparing patients to engage in SRH conversations before and during clinic visits; (2) consultation systems are needed to facilitate rapid SRH care with women's health providers; (3) clinicians advised development of training opportunities and easy-to-access resources to address SRH knowledge gaps; and (4) clinicians recommended that educational materials about SRH in the rheumatology context are provided for patients. Although similar ideas were generated between the APP and rheumatologist groups, the rheumatologists were generally more interested in additional training and education, whereas APPs were more interested in electronic health record prompts and tools. CONCLUSION: Providers identified many potential solutions and facilitators to enhancing SRH care in rheumatology that might serve as a foundation for intervention development.

The ACTIV-6 Stakeholder Advisory Committee: a model for virtual engagement in decentralized clinical trials.

Introduction: Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings. Methods: Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications. Results: Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement. Conclusions: The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.

Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial.

Importance: Prescription opioids can treat acute pain in primary care but have potential for unsafe use and progression to prolonged opioid prescribing. Objective: To compare clinician-facing interventions to prevent unsafe opioid prescribing in opioid-naive primary care patients with acute noncancer pain. Design Setting and Participants: We conducted a multisite, cluster-randomized, 2 × 2 factorial, clinical trial in 3 health care systems that comprised 48 primary care practices and 525 participating clinicians from September 2018 through January 2021. Patient participants were opioid-naive outpatients, 18 years or older, who presented for a qualifying clinic visit with acute noncancer musculoskeletal pain or nonmigraine headache. Interventions: Practices randomized to: (1) control; (2) opioid justification; (3) monthly clinician comparison emails; or (4) opioid justification and clinician comparison. All groups received opioid prescribing guidelines via the electronic health record at the time of a new opioid prescription. Main Outcomes and Measures: Primary outcome measures were receipt of an initial opioid prescription at the qualifying clinic visit. Other outcomes were opioid prescribing for more than 3 months and a concurrent opioid/benzodiazepine prescription over 12-month follow-up. Results: Among 22 616 enrolled patient participants (9740 women [43.1%]; 64 American Indian/Alaska Native [0.3%]; 590 Asian [2.6%], 1120 Black/African American [5.0%], 1777 Hispanic [7.9%], 225 Native Hawaiian/Pacific Islander [1.0%], and 18 981 White [83.9%] individuals), the initial opioid prescribing rates at the qualifying clinic visit were 3.1% in the total sample, 4.2% in control, 3.6% in opioid justification, 2.6% in clinician comparison, and 1.9% in opioid justification and clinician comparison. Compared with control, the adjusted odds ratio (aOR) for a new opioid prescription was 0.74 (95% CI, 0.46-1.18; P = .20) for opioid justification and 0.60 (95% CI, 0.38-0.96; P = .03) for clinician comparison. Compared with control, clinician comparison was associated with decreased odds of opioid therapy of more than 3 months (aOR, 0.79; 95% CI, 0.69-0.91; P = .001) and concurrent opioid/benzodiazepine prescription (aOR, 0.85; 95% CI, 0.72-1.00; P = .04), whereas opioid justification did not have a significant effect. Conclusions and Relevance: In this cluster randomized clinical trial, comparison emails decreased the proportion of opioid-naive patients with acute noncancer pain who received an opioid prescription, progressed to treatment with long-term opioid therapy, or were exposed to concurrent opioid and benzodiazepine therapy. Health care systems can consider adding clinician-targeted nudges to other initiatives as an efficient, scalable approach to further decrease potentially unsafe opioid prescribing. Trial Registration: ClinicalTrials.gov Identifier: NCT03537573.