Training Health Center Staff in the Provision of Culturally Responsive Care for Sexual and Gender Minority Patients: Results of a Randomized Controlled Trial.

Purpose: The study was designed to evaluate whether an educational intervention to train the health center (HC) staff to optimize care for sexual and gender minority (SGM) patients could improve documentation of sexual orientation and gender identity (SOGI) and increase preventive screenings. Methods: Twelve HCs were matched and randomized to either receive a tailored, multicomponent educational intervention or a 1-hour prerecorded webinar. Documentation of SGM status and clinical testing was measured through analysis of data that HCs report annually. Nonparametric statistics were used to assess associations between baseline HC characteristics and outcome measures. Results: The HCs were geographically, racially, and ethnically diverse. In all but one HC, <10% of the patients were identified as SGM. Intervention HCs underwent between 3 and 10 trainings, which were highly acceptable. In 2018, 9 of 12 HCs documented SO and 11 of 12 documented GI for at least 50% of their patients. Five of 6 intervention HCs increased SO documentation by 2020, compared to 3 of 6 control HCs (nonsignificant, NS). Five intervention HCs increased GI documentation, although generally by less than 10%, compared to 2 of the controls (NS). Intervention HCs tended to increase documentation of preventive services more than control HCs, but the changes were NS. Conclusions: An educational intervention designed to train the HC staff to provide culturally responsive services for SGM patients was found to be acceptable, with favorable, but nonsignificant changes. Further refinement of the intervention using a larger sample of HCs might demonstrate the effectiveness of this approach. Clinical trial registration #: NCT03554785.

Wide Variability in Documentation of Sexual Orientation, Gender Identity, and Preventive Health Screenings in a Diverse Sample of U.S. Community Health Centers.

Purpose: This study was conducted to characterize documentation of sexual orientation and gender identity (SOGI) and provision of screening and preventive services in a diverse sample of community health centers (CHCs). Methods: Twelve CHCs provided data submitted to the Health Resources and Services Administration (HRSA) in 2018 from their Uniform Data System (UDS) reports. Prevalence of SOGI documentation, screenings, and preventive services were calculated. Sociodemographic correlates of documentation were analyzed using Fisher's exact test and Wilcoxon rank sum/Mann-Whitney U test. Results: Patient data recording sexual orientation (SO) were missing in 2%-93% of UDS reports from the 12 CHCs, and gender identity (GI) data were missing from 0% to 96% of UDS reports. CHCs were most likely to report body mass index and tobacco screening and least likely to report hepatitis A or B vaccination, independent of SO or GI. Transgender females were less likely to have mammography documented than cisgender females. Transgender males were less likely to have anal Pap tests, be vaccinated for hepatitis B, or be referred for risky alcohol use compared to cisgender males. Patients who identified as "another gender" were less likely to be referred for risky alcohol use, undergo mammography or anal Pap testing, or receive hepatitis A vaccination than cisgender people. Individuals who did not disclose their GI were less likely to be vaccinated for hepatitis A or B than cisgender people. Conclusion: SOGI status was often not documented by a diverse array of CHCs. However, when SOGI status was documented, we saw evidence of disparities in preventive interventions and referrals, particularly for transgender patients. Clinical trial registration number: NCT03554785.

Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial.

CONTEXT: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on risk of developing gestational diabetes. OBJECTIVE: This work aims to determine whether prepregnancy weight loss improved the early metabolic environment as measured by early gestational diabetes diagnosis. METHODS: This was a secondary analysis of a pragmatic randomized clinical trial conducted between May 2015 and October 2019 in an integrated health system that encouraged first-trimester gestational diabetes screening for high-risk women, including those with obesity. Women aged 18 to 40 years with a body mass index (BMI) greater than or equal to 27 who were planning pregnancy were randomly assigned to a behavioral weight loss intervention or usual care. Clinical care decisions and data collection were blind to condition assignment. We compared rates of diagnosis with gestational diabetes in early pregnancy between the groups using logistic regression. RESULTS: Of 326 participants, 168 (89 in the intervention and 79 in usual care) had singleton pregnancies during the study period. At baseline, mean age was 31.3 ±â€…3.5 years and BMI was 34.8 ±â€…5.8. Fifty-nine (66%) intervention participants and 57 (72%) usual care participants underwent early screening. Among those, intervention participants were 73% less likely to be diagnosed with gestational diabetes than usual care participants (adjusted odds ratio [aOR], 0.27; 95% CI, 0.09-0.80). There was no difference in diagnosis of gestational diabetes in later pregnancy (aOR, 1.08; 95% CI, 0.41-2.81). CONCLUSION: Participation in a prepregnancy weight loss intervention led to lower rates of gestational diabetes diagnosis in early pregnancy. This suggests positive effects of prepregnancy weight loss on the early metabolic environment, a critical factor in offspring metabolic risk.

Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial.

BACKGROUND: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes. OBJECTIVE: This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. STUDY DESIGN: Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m2 who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes. RESULTS: Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m2. Participants in the intervention group lost more weight before pregnancy than those in the control group (-0.25±0.51 vs -0.03±0.21 kg/wk; P<.001). However, participants in the intervention group gained more weight than those in the control group in the second trimester (0.42±0.26 vs 0.33±0.28 kg/wk; P=.04) and third trimester (0.56±0.37 vs 0.43±0.33 kg/wk; P=.02) and overall (13.2±8.20 vs 10.3±7.41 kg; P=.03). Nevertheless, arms did not differ in rates of exceeding gestational weight gain guidelines at any time point. Spontaneous pregnancy loss was less common in the intervention arm than in the control arm (8 [4.9%] vs 19 [11.8%]; odds ratio, 0.39 [0.16-0.92]), but we found no other differences in the secondary or exploratory outcomes. CONCLUSION: Participation in the prepregnancy weight loss intervention had no effect on women's likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.

Prevalence and Correlates of Low Pain Interference Among Patients With High Pain Intensity Who Are Prescribed Long-Term Opioid Therapy.

The pain experience may vary greatly among individuals reporting equally high levels of pain. We sought to examine the demographic and clinical characteristics associated with pain interference in patients with high pain intensity. Among patients with chronic musculoskeletal pain who were prescribed long-term opioid therapy and who were recruited from 2 health care systems, we identified a subset who reported high pain intensity (n = 189). All individuals completed self-report assessments of clinical and demographic factors. Analyses examined characteristics associated with pain interference. Within this group of patients with high reported pain intensity, 16.4% (n = 31) had low pain interference, 39.2% (n = 74) had moderate pain interference, and 44.4% (n = 84) had high pain interference. In bivariate analyses, patients with lower pain interference had fewer symptoms of depression and anxiety, less pain catastrophizing, a better quality of life, and greater self-efficacy for managing pain. In multivariate analyses, variables most strongly associated with low pain interference, relative to high interference, were depression severity (odds ratio 0.90; 95% confidence interval 0.82-0.99) and pain self-efficacy (odds ratio 1.07; 95% confidence interval 1.02-1.12). Study results suggest that chronic pain treatments that address symptoms of depression and enhance pain self-efficacy may be prioritized, particularly among patients who are prescribed long-term opioid therapy. PERSPECTIVE: This article describes the prevalence and correlates of pain interference categories (low, medium, and high) among patients with high pain intensity who are prescribed long-term opioid therapy. Findings reveal that 16.4% of participants with high pain intensity had low impairment. Multivariate analyses indicate that variables significantly associated with low pain interference were lower depression scores and greater pain self-efficacy.

Correlates of Use and Perceived Effectiveness of Non-pharmacologic Strategies for Chronic Pain Among Patients Prescribed Long-term Opioid Therapy.

OBJECTIVE: Non-pharmacologic treatments (NPTs) are recommended for chronic pain. Information is limited on patient use or perceptions of NPTs. We examined the frequency and correlates of use and self-rated helpfulness of NPTs for chronic pain among patients who are prescribed long-term opioid therapy (LTOT). METHODS: Participants (n = 517) with musculoskeletal pain who were prescribed LTOT were recruited from two integrated health systems. They rated the frequency and utility of six clinician-directed and five self-directed NPTs for chronic pain. We categorized NPT use at four levels based on number of interventions used and frequency of use (none, low, moderate, high). Analyses examined clinical and demographic factors that differed among groups for both clinician-directed and self-directed NPTs. RESULTS: Seventy-one percent of participants reported use of any NPT for pain within the prior 6 months. NPTs were rated as being helpful by more than 50% of users for all treatments assessed (range 51-79%). High users of clinician-directed NPTs were younger than non-users or low-frequency users and had the most depressive symptoms. In both clinician-directed and self-directed categories, high NPT users had significantly higher pain disability compared to non-NPT users. No significant group differences were detected on other demographic or clinical variables. In multivariable analyses, clinician-directed NPT use was modestly associated with younger age (OR = 0.97, 95% CI = 0.96-0.98) and higher pain disability (OR = 1.01, 95% CI = 1.00-1.02). Variables associated with greater self-directed NPT use were some college education (OR = 1.80, 95% CI = 1.13-2.84), college graduate or more (OR = 2.02, 95% CI = 1.20-3.40), and higher pain disability (OR = 1.01, 95% CI = 1.01-1.02). CONCLUSIONS: NPT use was associated with higher pain disability and younger age for both clinician-directed and self-directed NPTs and higher education for self-directed NPTs. These strategies were rated as helpful by those that used them. These results can inform intervention implementation and be used to increase engagement in NPTs for chronic pain.

Patterns and correlates of medical cannabis use for pain among patients prescribed long-term opioid therapy.

OBJECTIVE: Little is known about co-occurring long-term opioid therapy (LTOT) and medical cannabis use. We compared characteristics of patients prescribed LTOT who endorsed using medical cannabis for pain to patients who did not report cannabis use. METHOD: Participants (n=371) prescribed LTOT completed self-report measures about pain, substance use, and mental health. RESULTS: Eighteen percent of participants endorsed using medical cannabis for pain. No significant differences were detected on pain-related variables, depression, or anxiety between those who endorsed medical cannabis use and those who did not. Medical cannabis users had higher scores of risk for prescription opioid misuse (median=17.0 vs. 11.5, p<0.001), rates of hazardous alcohol use (25% vs. 16%, p<0.05), and rates of nicotine use (42% vs. 26%, p=0.01). Multivariable analyses indicated that medical cannabis use was significantly associated with risk of prescription opioid misuse (ß=0.17, p=0.001), but not hazardous alcohol use (aOR=1.96, 95% CI=0.96-4.00, p=0.06) or nicotine use (aOR=1.61, 95% CI=0.90-2.88, p=0.11). CONCLUSION: There are potential risks associated with co-occurring LTOT and medical cannabis for pain. Study findings highlight the need for further clinical evaluation in this population. Future research is needed to examine the longitudinal impact of medical cannabis use on pain-related and substance use outcomes.

Insomnia is associated with an increased risk of type 2 diabetes in the clinical setting.

OBJECTIVE: To determine the possible association between insomnia and risk of type 2 diabetes mellitus (T2DM) in the naturalistic clinical setting. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study to examine the risk of developing T2DM among patients with pre-diabetes with and without insomnia. Participants with pre-diabetes (identified by a physician or via two laboratory tests) between January 1, 2007 and December 31, 2015 and without sleep apnea were followed until December 31, 2016. Patients were determined to have T2DM when two of the following occurred within a 2-year window: physician-entered outpatient T2DM diagnosis (International Classification of Diseases [ICD]-9 250.00; ICD-10 E11), dispensing of an antihyperglycemia agent, and hemoglobin A1c (A1c) >6.5% (48 mmol/mol) or fasting plasma glucose (FPG) >125 mg/dL. One hospital inpatient stay with an associated T2DM diagnosis was also sufficient for classification of T2DM. RESULTS: Our cohort consisted of 81 233 persons with pre-diabetes, 24 146 (29.7%) of whom had insomnia at some point during the 4.3-year average observation period. After adjustment for traditional risk factors, those with insomnia were 28% more likely to develop T2DM than those without insomnia (HR 1.28; 95% CI 1.24 to 1.33). The estimate was essentially unchanged after adjusting for baseline A1c level (HR 1.32; 95% CI 1.25 to 1.40) or FPG (HR 1.28; 95% CI 1.23 to 1.33). CONCLUSIONS: Insomnia imparts an increased risk of T2DM comparable with that conferred by traditional risk factors (eg, overweight, non-white race, cardiovascular risk factors). This association could have clinical importance because it suggests a new potentially modifiable risk factor that could be targeted to prevent diabetes.

Higher Prescription Opioid Dose is Associated With Worse Patient-Reported Pain Outcomes and More Health Care Utilization.

Some previous research has examined pain-related variables on the basis of prescription opioid dose, but data from studies involving patient-reported outcomes have been limited. This study examined the relationships between prescription opioid dose and self-reported pain intensity, function, quality of life, and mental health. Participants were recruited from 2 large integrated health systems, Kaiser Permanente Northwest (n = 331) and VA Portland Health Care System (n = 186). To be included, participants had to have musculoskeletal pain diagnoses and be receiving stable doses of long-term opioid therapy. We divided participants into 3 groups on the basis of current prescription opioid dose in daily morphine equivalent dose (MED): low dose (5-20 mg MED), moderate dose (20.1-50 mg MED), and higher dose (50.1-120 mg MED) groups. A statistically significant trend emerged where higher prescription opioid dose was associated with moderately sized effects including greater pain intensity, more impairments in functioning and quality of life, poorer self-efficacy for managing pain, greater fear avoidance, and more health care utilization. Rates of potential alcohol and substance use disorders also differed among groups. Findings from this evaluation reveal significant differences in pain-related and substance-related factors on the basis of prescription opioid dose. PERSPECTIVE: This study included 517 patients who were prescribed long-term opioid therapy and compared differences on pain- and mental health-related variables on the basis of prescription opioid dose. Findings reveal small- to medium-sized differences on pain-related variables, alcohol and substance use, and health care utilization on the basis of the dose of opioid prescribed.