Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial.

BACKGROUND: The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting. METHODS: TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination). RESULTS: PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs). CONCLUSIONS: CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.

What physicians need to implement safer opioid prescribing: A qualitative study.

INTRODUCTION: In response to the US opioid epidemic, the Centers for Disease Control and Prevention issued a guideline (CDCG) for prescribing opioids for chronic pain. Successful implementation of the CDCG requires identification of the information, skills, and support physicians need to carry out its recommendations. However, such data are currently lacking. METHODS: The authors performed one-on-one interviews with nine practicing physicians regarding their needs and perspectives for successful CDCG implementation, including the perceived barriers, focusing on communication strategies. Interviews were audio recorded, transcribed, and a thematic qualitative analysis was performed. FINDINGS: Three major themes were identified: communication, knowledge, and information technology (IT). Physicians reported that open communication with patients about opioids was difficult and burdensome, but essential; they shared their communication strategies. Knowledge gaps included patient-specific topics (eg, availability of/insurance coverage for non-opioid treatments) and more general areas (eg, opioid dosing/equivalencies, prescribing naloxone). Finally, physicians discussed the importance of innovation in IT, focusing on the electronic medical record for decision support and to allow safer opioid prescribing within the time constraints of clinical practice. DISCUSSION: These qualitative data document practical issues that should be considered in the development of implementation plans for safer opioid prescribing practices. Specifically, healthcare systems may need to provide opioid-relevant communication strategies and training, education on key topics such as naloxone prescribing, resources for referrals to appropriate nonpharmacologic treatments, and innovative IT solutions. Future research is needed to establish that such measures will be effective in producing better outcomes for patients on opioids for chronic pain.

Decreasing risk among HIV patients on opioid therapy for chronic pain: Development of the TOWER intervention for HIV care providers.

Many people with HIV (PWH) experience chronic pain that limits daily function and quality of life. PWH with chronic pain have commonly been prescribed opioids, sometimes for many years, and it is unclear if and how the management of these legacy patients should change in light of the current US opioid epidemic. Guidelines, such as the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain (CDCG), provide recommendations for the management of such patients but have yet to be translated into easily implementable interventions; there is also a lack of strong evidence that adhering to these recommendations improves patient outcomes such as amount of opioid use and pain levels. Herein we describe the development and preliminary testing of a theory-based intervention, called TOWER (TOWard SafER Opioid Prescribing), designed to support HIV primary care providers in CDCG-adherent opioid prescribing practices with PWH who are already prescribed opioids for chronic pain. TOWER incorporates the content of the CDCG into the theoretical and operational framework of the Information Motivation and Behavioral Skills (IMB) model of health-related behavior. The development process included elicitation research and incorporation of feedback from providers and PWH; testing is being conducted via an adaptive feasibility clinical trial. The results of this process will form the basis of a large, well-powered clinical trial to test the effectiveness of TOWER in promoting CDCG-adherent opioid prescribing practices and improving outcomes for PWH with chronic pain.

Relationships between behavioral risk factors and dental care costs in a Japanese worksite.

PURPOSE: To identify the magnitude of dental care costs and examine the relationship between behavioral risk factors and dental care costs in a Japanese corporation. DESIGN: A one-time cross-sectional design was used with each employee as a unit of analysis. SETTING: The setting was a large Japanese corporation where Japan's standard health care insurance, including dental care coverage, was provided for all employees. SUBJECTS: A full-time employee population of 6543 was included. Seventy-six percent were men, and the majority were white-collar workers. MEASURES: Data were available on dental care costs and self-reported behavioral dental care risk, including smoking and oral self-care, obtained from the company's annual physical checkups in the 2000 fiscal year Dichotomous variables of expenditures for employees having no dental claims and those having high claims defined as 90th percentile or above were created. RESULTS: The dental care costs made up approximately 24.3% of the health care costs. Thirty-five percent of the employees were smokers. Employees who were at least 40 years old and employees who were women were associated with the likelihood of using dental care services (odds ratio [OR] = 1.622 and 0.783, respectively), and no behavioral risk was associated. The likelihood of incurring high dental care costs was associated with smoking when including all employees in addition to those who used any dental care services (OR = 1.315 and 1.386, respectively). CONCLUSIONS: This study suggests the relationships of smoking as well as age and sex to dental care costs in an employer setting. To provide a strong case for health promotion in Japan, future research should address critical issues such as reliable and valid risk measurement and the use of longitudinal designs and intervention studies.

The association between health risks and medical expenditures in a Japanese corporation.

PURPOSE: To examine the relationship between health risks and medical care expenditures in an employer setting in Japan. DESIGN: A cross-sectional, correlational study. SETTING: A large Japanese corporation. SUBJECTS: A total of 6543 employees of a large Japanese electronics company, for whom medical expenditures, lifestyle risks and biometric data were available, were included in the analysis. Seventy-six Percent were male, and subjects were primarily white-collar workers. MEASURES: Medical expenditure data were available for fiscal year 2000, including inpatient, outpatient, and total expenditures, measured in Japanese yen. Binary expenditure indicators for those having no claims and those having high claims (90th percentile) were also created. Risk measures included biometric assessment of high blood pressure and high body mass index (BMI, body weight and height) and self-reported stress, lack of exercise, excess alcohol consumption, poor nutrition, current smoking, and recent quitting. High cholesterol and high blood glucose measures were also available for some subjects from company physicals. RESULTS: Average total expenditures were 48,017 yen (US$445). The 90th percentile of the expenditure distribution was approximately 111,750yen (US$1037). The most commonly reported risk factors were lack of exercise (52.9%), current smoking (35 %), stress (33%), and poor nutritional habits (23.6%). Least common were recently quitting smoking (2%), high blood pressure (4.1 %), and high blood glucose (9.4 %). The prevalence of overweight or obesity was 15.9%. High blood pressure and recent quitting were consistently related to high expenditures, after adjusting for the influence of other predictors. Adjusted expenditures were 76 % higher for recent quitters and 22.6% higher for employees with high blood pressure. Males and younger employees had consistently lower expenditures. Current smoking poor nutrition, and alcohol risk were also associated with lower expenditures. Those with multiple cardiovascular risk factors had adjusted medical expenditures that were 128% higher than those with no cardiovascular risks. Those who had multiple risk factors for stroke had expenditures that were 13% lower than those without stroke risk factors. CONCLUSIONS: This paper represents a first step in examining the association between health risks and medical expenditures in Japanese employees. The investigation uncovered some significant levels of risk for lack of exercise, smoking, and stress. Although results indicate some significant associations between health risks and medical expenditures, several unexpected assocations were noted that require further study. Such information provides a solid foundation for health promotion efforts in Japan and direction for subsequent investigations of health risks and medical expenditures. Future studies should address important issues of health risk measurement, data collection, and research design.

Association between lifestyle-disease diagnosis or risk status and medical care costs in a Japanese corporation.

PURPOSE: This study examined the differences in medical care costs among (1) individuals who carried the diagnosis of selected lifestyle diseases (diabetes mellitus, hypertension, and hyperlipidemia), (2) individuals whose levels of risks (blood glucose, blood pressure, and total cholesterol) satisfied the diagnosis guidelines yet who did not carry the diagnoses, (3) individuals who had these risks but whose risk levels were not high enough to satisfy the diagnosis guidelines, and (4) individuals without the risks. DESIGN: A one-time cross-sectional design was used. Health checkup data and medical-claims data obtained from the fiscal year 2000 were examined for correlations. SAMPLE: A total of 3292 employees aged 34 years and older were selected from the entire employee population of 6543 in a Japanese corporation. Employees younger than 34 years old were excluded because their clinical risk data were not available. MEASURES: On the basis of their absence or presence of diagnoses (obtained from medical claims) and underlying risk levels (obtained from health checkups), employees were categorized into (1) the diagnosed group, (2) the extremely high-risk group, (3) the high-risk group, or (4) the no-risk group. Reimbursement points on medical care claims were summed for each individual during the study period and multiplied by 10 to calculate the total medical care costs, as each point in the reimbursement request form represents 10 yen. ANALYSIS: The high-cost case analysis was used. First, the high costs were determined as the costs at or above the 90th percentile. The diagnosis or risk status was examined in its relation to the newly created dichotomous variable (whether the medical costs were at or above the threshold or were lower than the threshold) by using a chi2 test. Furthermore, excluding the diagnosed group, a chi2 test was performed to examine the relationships between the levels of risk and the likelihood of incurring any medical care costs (use vs. nonuse). RESULTS: Approximately 15% of employees were already diagnosed with at least one of the three diseases (the diagnosed group; n = 490). One-quarter of employees had at least one risk that was high enough to be diagnosed with the corresponding disease if they had sought medical care (the extremely high-risk group; n = 809). There were 1343 employees in the high-risk group and 650 employees in the no-risk group. The diagnosed group had much higher chances of incurring medical care costs at or above the 90th percentile than did any other risk or no-risk group. No difference among the three risk or no-risk groups was found in mean medical care costs or in the likelihood of any use of medical care services after controlling for the effect of diagnosis. CONCLUSIONS: In a Japanese employee population, the diagnosis status of diabetes mellitus, hyperlipidemia, and hypertension was found to be associated with higher medical care costs while risk levels for the diseases were not in a 1-year time period.

Tobacco control: recent movements in Japan.

Tobacco control in Japan has not kept pace with the rest of the global community in the past several decades. Although recent movements in Japan suggest that some changes will occur, most of the initiatives are still circumspect at best. The motivations driving most of these changes come from concern for morals about obeying the law and propriety of consideration for nonsmokers in public places, rather than for health. Moreover, the complicated relationship between the government and the tobacco industry, as well as between the two ministries that oversee the industry, may act as obstacles to any real comprehensive tobacco control.

[Identifying perceived needs among nurses in providing their patients with smoking cessation support in a Japanese hospital results from focus group interviews].

OBJECTIVE: To identify perceived needs among nurses in providing their patients with smoking cessation support in a Japanese hospital. SUBJECTS: Thirty-three female nurses who were interested in providing their patients with smoking cessation support in the hospital setting participated in focus group interviews. They conducted six focus group interviews segmented by age, working conditions (e.g., outpatient or inpatient sections) and occupational class (e.g., administrative post or not). DESIGN: An experienced researcher moderated two focus groups and another researcher who received training moderated four focus groups. At least two observers hand-recorded participants' conversations in each group and all groups were also tape-recorded. Moderators and observers analyzed the focus group data together. RESULTS: We found that smoking cessation counseling or health education on effects of smoking to be rarely conducted in the hospital. The study participants ordinarily just told patients to stop smoking. They mentioned several barriers to conducting smoking cessation support and suggested a number of ideas to promote this aim in the hospital. CONCLUSIONS: The focus group interview is an effective means to determine the needs and interests of Japanese health professionals. Nurses have many opinions and insights for supporting smoking patients. To introduce a smoking cessation program into hospitals, there are various problems that should be solved. First, nurses and other health professionals should have accurate knowledge, positive attitudes and appropriate skills for smoking cessation support. Second, smoking cessation support should be programmed as part of treatment or nursing. Third, healthcare professionals, especially doctors, should collaborate in supporting patients to stop smoking. Fourth, the hospital environment should be modified to promote smoking cessation. Finally, hospitals should develop a consensus among all staff about the importance of smoking cessation support and smoking control activities. As the result, multidimensional strategies are needed to effectively promote smoking cessation support in the hospital setting.