Personalized risk communication and opioid prescribing in association with nonprescribed opioid use: A secondary analysis of a randomized controlled trial.

BACKGROUND: To determine the impact of personalized risk communication and opioid prescribing on nonprescribed opioid use, we conducted a secondary analysis of randomized controlled trial participants followed prospectively for 90 days after an emergency department (ED) visit for acute back or kidney stone pain. METHODS: A total of 1301 individuals were randomized during an encounter at four academic EDs into a probabilistic risk tool (PRT) arm, a narrative-enhanced PRT arm, or a general risk information arm (control). In this secondary analysis, both risk tool arms were combined and compared with the control arm. We used logistic regressions to determine associations between receiving personalized risk information, receiving an opioid prescription in the ED, and nonprescribed opioid use in general and by race. RESULTS: Complete follow-up data were available for 851 participants; 23.3% (n = 198) were prescribed opioids (34.2% of White vs. 11.6% of Black participants, p < 0.001). Fifty-six (6.6%) participants used nonprescribed opioids. Participants in the personalized risk communication arms had lower nonprescribed opioid use odds (adjusted odds ratio [aOR] 0.58, 95% confidence interval [CI] 0.4-0.83). Black versus White participants had greater nonprescribed opioid use odds (aOR 3.47, 95% CI 2.05-5.87, p < 0.001). Black participants who were prescribed opioids had a lower marginal probability of using nonprescribed opioids versus those who were not (0.06, 95% CI 0.04-0.08, p < 0.001 vs. 0.10, 95% CI 0.08-0.11, p < 0.001). The absolute risk difference in nonprescribed opioid use for Black and White participants, respectively, in the risk communication versus the control arm, was 9.7% and 0.1% (relative risk ratio 0.43 vs. 0.95). CONCLUSIONS: Among Black but not White participants, personalized opioid risk communication and opioid prescribing were associated with lower odds of nonprescribed opioid use. Our findings suggest that racial disparities in opioid prescribing-which have been previously described within the context of this trial-may paradoxically increase nonprescribed opioid use. Personalized risk communication may effectively reduce nonprescribed opioid use, and future research should be designed specifically to explore this possibility in a larger cohort.

Patient Perceptions About Opioid Risk Communications Within the Context of a Randomized Clinical Trial.

Importance: Opioid overdose rates continue to increase, and extant literature suggests that many individuals who use heroin were first introduced to opioids through a medical prescription. Objective: To explore patient experiences related to decisions regarding analgesia after an emergency department visit within the context of a randomized clinical trial aimed to test the efficacy of risk communication interventions on treatment preference, risk recall, and use of opioids. Design, Setting, and Participants: This qualitative study of 36 patients making decisions regarding analgesia included qualitative interviews with participants in 2 risk intervention groups. Interviews were audio recorded, transcribed, and edited to remove identifying information to protect the confidentiality of participants. Interviews were conducted from June 4, 2019, to August 6, 2019. We conducted thematic analysis from August to December 2019 using a mixed inductive and deductive approach. Participants received $20 in compensation. The study was conducted in 4 geographically diverse emergency departments in the United States. Participants were adults presenting to the emergency department with either musculoskeletal back or neck pain or kidney stone-related pain. Eligibility criteria included being aged 18 to 70 years, capable of providing informed consent, English speaking or having English comprehension, eligible for emergency department discharge within 24 hours of enrollment, and able to access email or a smartphone. Interventions: Participants enrolled from the main randomized clinical trial received 1 of 2 risk interventions: a probabilistic opioid risk tool or a narrative-enhanced probabilistic risk tool (ie, participants viewed eight 1- to 3-minute short videos of patients discussing their experiences with pain treatment and positive and negative experiences with opioid use). Main Outcomes and Measures: Factors reported by participants to have influenced their decision-making regarding acute pain and treatment. Results: Thirty-six participants were interviewed, 18 in the group who received the probabilistic risk tool alone and 18 in the group who received the additional narrative-enhanced probabilistic risk tool intervention. The median age was 38 years (range, 21-67 years), 22 individuals were female (61%), 14 were Black or African American (39%), and 14 were White (39%). Five themes emerged from the analysis in the following domains: the factors associated with the risk interventions; clinician paternalism; analgesia attributes and previous experiences; individual self-identity, attitudes, and values; and perceptions of clinician bias. Conclusions and Relevance: Most participants commented on the powerful lessons they learned from the risk interventions. More research is needed to understand how patients incorporate risk information into their decision-making process.

A Multicentered Randomized Controlled Trial Comparing the Effectiveness of Pain Treatment Communication Tools in Emergency Department Patients With Back or Kidney Stone Pain.

Objectives. To compare the effectiveness of 3 approaches for communicating opioid risk during an emergency department visit for a common painful condition. Methods. This parallel, multicenter randomized controlled trial was conducted at 6 geographically disparate emergency department sites in the United States. Participants included adult patients between 18 and 70 years of age presenting with kidney stone or musculoskeletal back pain. Participants were randomly assigned to 1 of 3 risk communication strategies: (1) a personalized probabilistic risk visual aid, (2) a visual aid and a video narrative, or 3) general risk information. The primary outcomes were accuracy of risk recall, reported opioid use, and treatment preference at time of discharge. Results. A total of 1301 participants were enrolled between June 2017 and August 2019. There was no difference in risk recall at 14 days between the narrative and probabilistic groups (43.7% vs 38.8%; absolute risk reduction = 4.9%; 95% confidence interval [CI] = -2.98, 12.75). The narrative group had lower rates of preference for opioids at discharge than the general risk information group (25.9% vs 33.0%; difference = 7.1%; 95% CI = 0.64, 0.97). There were no differences in reported opioid use at 14 days between the narrative, probabilistic, and general risk groups (10.5%, 10.3%, and 13.3%, respectively; P = .44). Conclusions. An emergency medicine communication tool incorporating probabilistic risk and patient narratives was more effective than general information in mitigating preferences for opioids in the treatment of pain but was not more effective with respect to opioid use or risk recall. Trial Registration. Clinical Trials.gov identifier: NCT03134092. (Am J Public Health. 2022;112(S1):S45-S55. https://doi.org/10.2105/AJPH.2021.306511).

Patient Preference and Risk Assessment in Opioid Prescribing Disparities: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Although racial disparities in acute pain control are well established, the role of patient analgesic preference and the factors associated with these disparities remain unclear. Objective: To characterize racial disparities in opioid prescribing for acute pain after accounting for patient preference and to test the hypothesis that racial disparities may be mitigated by giving clinicians additional information about their patients' treatment preferences and risk of opioid misuse. Design, Setting, and Participants: This study is a secondary analysis of data collected from Life STORRIED (Life Stories for Opioid Risk Reduction in the ED), a multicenter randomized clinical trial conducted between June 2017 and August 2019 in the emergency departments (EDs) of 4 academic medical centers. Participants included 1302 patients aged 18 to 70 years who presented to the ED with ureter colic or musculoskeletal back and/or neck pain. Interventions: The treatment arm was randomized to receive a patient-facing intervention (not examined in this secondary analysis) and a clinician-facing intervention that consisted of a form containing information about each patient's analgesic treatment preference and risk of opioid misuse. Main Outcomes and Measures: Concordance between patient preference for opioid-containing treatment (assessed before ED discharge) and receipt of an opioid prescription at ED discharge. Results: Among 1302 participants in the Life STORRIED clinical trial, 1012 patients had complete demographic and treatment preference data available and were included in this secondary analysis. Of those, 563 patients (55.6%) self-identified as female, with a mean (SD) age of 40.8 (14.1) years. A total of 455 patients (45.0%) identified as White, 384 patients (37.9%) identified as Black, and 173 patients (17.1%) identified as other races. After controlling for demographic characteristics and clinical features, Black patients had lower odds than White patients of receiving a prescription for opioid medication at ED discharge (odds ratio [OR], 0.42; 95% CI, 0.27-0.65). When patients who did and did not prefer opioids were considered separately, Black patients continued to have lower odds of being discharged with a prescription for opioids compared with White patients (among those who preferred opioids: OR, 0.43 [95% CI, 0.24-0.77]; among those who did not prefer opioids: OR, 0.45 [95% CI, 0.23-0.89]). These disparities were not eliminated in the treatment arm, in which clinicians were given additional data about their patients' treatment preferences and risk of opioid misuse. Conclusions and Relevance: In this secondary analysis of data from a randomized clinical trial, Black patients received different acute pain management than White patients after patient preference was accounted for. These disparities remained after clinicians were given additional patient-level data, suggesting that a lack of patient information may not be associated with opioid prescribing disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT03134092.

Expectations and experiences with physician care among patients receiving post-acute care in US skilled nursing facilities.

BACKGROUND: In the US, post-acute care in skilled nursing facilities (SNFs) is common and outcomes vary greatly across facilities. Little is known about the expectations of patients and their caregivers about physician care during the hospital to SNF transition. Our objectives were to (1) describe the experiences and expectations of patients and their caregivers with SNF physicians in SNFs, and (2) identify patterns that differed between patients with vs. without cognitive impairment. METHODS: This qualitative study used grounded theory approach to analyze data collected from semi-structured interviews at five SNFs in January-August 2018. Patients admitted for short-term SNF care 5-10 days prior were eligible to participate. Thematic analysis was performed to detect recurrent themes with a focus on modifiable aspects of physician care. Analysis was stratified by patient cognitive impairment (measured by the Montreal Cognitive Assessment at the time of the interview). RESULTS: Fifty patients and six caregivers were interviewed. Major themes were: (1) patients had poor awareness of the physician in charge of their care; (2) they were dissatisfied with the frequency of interaction with the physician; and (3) participants valued the perception of receiving individualized care from the physician. Less cognitively impaired patients were more concerned about limited interactions with the physicians and were more likely to report attempts to seek out the physician. CONCLUSION: Patient and caregiver expectations of SNF physicians were not well aligned with their experiences. SNFs aiming to improve satisfaction with care may focus efforts in this area, such as facilitating frequent communication between physicians, patients and caregivers.

Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial.

BACKGROUND: Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. OBJECTIVE: Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. METHODS: This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. RESULTS: A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. CONCLUSIONS: This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19496.

The Role of the Physician in Patient Perceptions of Barriers to Primary Adherence With Acne Medications.

Importance: Primary nonadherence with acne medications is high but commonly underreported to prescribing physicians. Objectives: To describe patient experiences with primary nonadherence to medications for acne and to identify physician-level factors that may improve adherence in this population. Design, Setting, and Participants: A qualitative analysis was conducted from structured interviews with patients reporting nonadherence with acne medications at a large academic health system in the Philadelphia, Pennsylvania, area. Three hundred eighty-five patients from 4 dermatology practices in the Philadelphia area were screened for primary nonadherence with a newly prescribed acne medication. Twenty-six patients participated in structured interviews conducted between November 30, 2016, and January 31, 2017. Main Outcomes and Measures: Thematic analysis of the transcripts was performed to detect recurrent themes and divergent ideas with a focus on modifiable physician-level factors that might improve primary adherence to medications for acne. Results: Participants (19 [73%] women, 6 [23%] aged <26 years, 15 [58%] aged 26-40 years, and 5 [19%] aged >40 years) reported cost as the major barrier to initiating therapy. Despite anticipating this barrier, they rarely brought up costs with physicians during the initial visit and generally did not expect their physician to be knowledgeable in this area. Although patients experienced inconvenience and frustration when unable to fill their prescriptions, this experience did not appear to negatively affect their satisfaction with the prescribing physician. Nevertheless, warning patients that the preferred medication may be expensive, having a plan of action if patients were unable to fill the prescription, and securing the patient's commitment to the plan were described as actions that the physicians could take to improve primary adherence. Conclusions and Relevance: Physician-level interventions to improve primary adherence to medications for acne may have an impact on nonadherence with costly medications, although they may not affect patient satisfaction with the prescribing physician.

Intimate Partner Violence Detection and Care in the Veterans Health Administration: Patient and Provider Perspectives.

BACKGROUND: Women veterans experience high rates of intimate partner violence (IPV), with associated negative health impacts. The Veterans Health Administration (VHA) has recently developed plans to implement routine IPV screening and provide IPV-related follow-up services for VHA patients. Previous research has examined barriers and facilitators to health care provider screening for IPV. The next step is to examine patients' disclosure of IPV experiences to health care providers and effective response to such disclosures. We sought to identify VHA patients' and providers' perspectives on how to facilitate effective IPV detection and care in VHA. METHODS: We conducted semistructured, qualitative interviews with 25 female veteran patients and 15 VHA health care providers. We used an inductive approach to analyzing interview transcripts and identifying themes that constituted study findings. RESULTS: Themes fell in to two broad categories: 1) barriers to disclosure and 2) barriers to an adequate response to disclosure and providing follow-up care. Barriers to disclosure of IPV to health care providers included lack of provider inquiry, lack of comfort, and concerns about the consequences of disclosure and lack of privacy. Patients and providers both indicated a need for expanded resources to respond to IPV in VHA. CONCLUSIONS: Findings support current plans for IPV program implementation in VHA and point to recommendations for practice and implications for further research.

Comparative effectiveness research and healthcare reform: topics of the day.

The International Society for Pharmacoeconomics and Outcomes Research recently sponsored the 16th Annual International Meeting. Participants included industry, clinical practice, government, academia and health research professionals. The purpose of the conference is to share information on increasing the efficiency, effectiveness and fairness with which available healthcare resources are used to improve health.

Predictors of discontinuing overactive bladder medications.

OBJECTIVE: To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey. PATIENTS AND METHODS: In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents' sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage. Six months later, a phase 3 survey was sent to 3387 phase-2 respondents who were persistent with OAB medication or had discontinued within <18 months of phase 2; the phase 3 survey measured the same variables as phase 2. Only phase 3 respondents who were persistent with OAB medication at phase 2 were included in the analyses reported here. Assessed were the proportions of respondents who were still persistent with OAB medication at phase 3 and who discontinued OAB medication between phases 2 and 3. The variables measured during the phase 2 survey were screened as potential predictors of discontinuation at phase 3 using univariate analysis and then assessed using multivariate logistic regression. RESULTS: Among 2838 respondents at phase 3 (84% response rate), 1194 had recently discontinued and 1644 were persistent with medication at phase 2. Among phase-3 respondents who were persistent at phase 2, 1040 (66%) continued to be persistent at phase 3, 280 (18%) had discontinued between phases 2 and 3, and 261 (17%) had switched medication between phases 2 and 3; 63 respondents had missing prescription information at phase 3. Predictors of discontinuing at phase 3 included smoking (odds ratio 1.80; 95% confidence interval 1.15-2.83; P = 0.010), not knowing whether treating bladder problems requires multiple daily doses of medication (1.71, 1.10-2.67; P = 0.018), believing (2.11, 1.34-3.33; P = 0.001) or not knowing (1.76, 1.23-2.52; P = 0.002) whether adverse effects of OAB medications are often severe, and being bothered 'quite a bit or more' by a sudden urge to urinate (1.54, 1.05-2.26; P = 0.028). Respondents taking two or more medications were less likely to discontinue (odds ratio 0.45-0.58; P < 0.05). CONCLUSION: Persistence with OAB medications might be improved by addressing predictors of discontinuation in the management of OAB, by proactively informing patients about the severity of antimuscarinic adverse effects, and dosing regimens. Bother associated with the key OAB symptom, urgency, is a predictor of discontinuation of treatment.

Challenges for managing overactive bladder and guidance for patient support.

OBJECTIVE: Describe challenges to improving management of overactive bladder (OAB) outcomes and summarize research findings on critical success factors for supporting OAB treatment. STUDY DESIGN: A multidisciplinary team collected primary and secondary data, including an OAB-specific survey; a literature review; and an expert panel discussion. METHODS: A US survey of patients who were prescribed antimuscarinics included topics related to OAB, such as reasons for medication discontinuation. The PubMed database was searched for articles published in the past 10 years on OAB treatment and adherence, and additional publications were reviewed related to health behavior change models. An expert panel reviewed findings and provided perspective. RESULTS: The survey (n = 5392) showed that, among patients discontinuing OAB medications, 45.4% reported unmet treatment expectations as the reason for discontinuation. Literature review findings supported intervention at the beginning of OAB treatment, specific messages to increase treatment adherence, and involving the healthcare stakeholders most trusted by patients. Implications of OAB patient support were drawn from reviews of the Transtheoretical Model, the Health Belief Model, and social learning theory. The expert panel highlighted desirable attributes of OAB patient education delivered in the medical care setting. CONCLUSION: Challenges to improving OAB symptom burden and outcomes include underdiagnosis, undertreatment, and patient nonadherence with medications. Patient support of medication adherence may be enhanced by simultaneously supporting the use of nonpharmaceutical lifestyle modifications and behavioral interventions. Healthcare providers acknowledge the need for patient education but lack the time and resources to deliver interventions or monitor patients' progress outside the medical office. Patient support may be achieved through external programs that complement patient-physician interactions.

Patient medication adherence: the forgotten aspect of biologics.

The full benefit of biologic therapies isn't reached and quality of life is compromised if patients don't adhere to their medication regimen. Are adherence interventions in order?