Enhanced Primary Care for People With Serious Mental Illness: A Propensity Weighted Cohort Study.

Objective: People with serious mental illness (SMI) have high rates of cardiometabolic illness, receive low quality care, and experience poor outcomes. Nevertheless, studies of existing integrated care models have not consistently shown improvements in cardiometabolic health for people with SMI. This study assessed the effect of a novel model of enhanced primary care for people with SMI on cardiometabolic outcomes. Enhanced primary care is a model of integrated care wherein comprehensive primary care delivery is adapted to the needs of people with SMI in coordination with behavioral care.Methods: We conducted a propensity-weighted cohort study comparing 234 patients with SMI receiving enhanced primary care to 4,934 patients with SMI receiving usual primary care using electronic health data from a large academic medical system covering the years 2014-2018. The propensity-weighted models controlled for baseline differences in outcome measures and patient characteristics between groups.Results: Compared to usual primary care, enhanced primary care increased hemoglobin A1c (HbA1c) screening by 18 percentage points (95% confidence interval [CI], 10 to 25), low-density lipoprotein (LDL) screening by 16 percentage points (CI, 8.8 to 24), and blood pressure screening by 7.8 percentage points (CI, 5.8 to 9.9). Enhanced primary care reduced HbA1c by 0.27 percentage points (CI, -0.47 to -0.060) and systolic blood pressure by 3.9 mm Hg (CI, -5.2 to -2.5) compared to usual primary care. We did not find evidence that enhanced primary care consistently affected glucose screening, LDL values, or diastolic blood pressure.Conclusions: Enhanced primary care can achieve clinically meaningful improvements in cardiometabolic health compared to usual primary care.

Effect of Enhanced Primary Care for People with Serious Mental Illness on Service Use and Screening.

BACKGROUND: Strategies are needed to better address the physical health needs of people with serious mental illness (SMI). Enhanced primary care for people with SMI has the potential to improve care of people with SMI, but evidence is lacking. OBJECTIVE: To examine the effect of a novel enhanced primary care model for people with SMI on service use and screening. DESIGN: Using North Carolina Medicaid claims data, we performed a retrospective cohort analysis comparing healthcare use and screening receipt of people with SMI newly receiving enhanced primary care to people with SMI newly receiving usual primary care. We used inverse probability of treatment weighting to estimate average differences in outcomes between the treatment and comparison groups adjusting for observed baseline characteristics. PARTICIPANTS: People with SMI newly receiving primary care in North Carolina. INTERVENTIONS: Enhanced primary care that includes features tailored for individuals with SMI. MAIN MEASURES: Outcome measures included outpatient visits, emergency department (ED) visits, inpatient stays and days, and recommended screenings 18 months after the initial primary care visit. KEY RESULTS: Compared to usual primary care, enhanced primary care was associated with an increase of 1.2 primary care visits (95% confidence interval [CI]: 0.31 to 2.1) in the 18 months after the initial visit and decreases of 0.33 non-psychiatric inpatient stays (CI: - 0.49 to - 0.16) and 3.0 non-psychiatric inpatient days (CI: - 5.3 to - 0.60). Enhanced primary care had no significant effect on psychiatric service and ED use. Enhanced primary care increased the probability of glucose and HIV screening, decreased the probability of lipid screening, and had no effect on hemoglobin A1c and colorectal cancer screening. CONCLUSIONS: Enhanced primary care for people with SMI can increase receipt of some preventive screening and decrease use of non-psychiatric inpatient care compared to usual primary care.

Impact of STEADI-Rx: A Community Pharmacy-Based Fall Prevention Intervention.

OBJECTIVES: To evaluate the effects of a community pharmacy-based fall prevention intervention (STEADI-Rx) on the risk of falling and use of medications associated with an increased risk of falling. DESIGN: Randomized controlled trial. SETTING: A total of 65 community pharmacies in North Carolina (NC). PARTICIPANTS: Adults (age ≥65 years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565). INTERVENTION: Pharmacy staff screened patients for fall risk using questions from the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) algorithm. Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review. MEASUREMENTS: At intervention pharmacies, pharmacy staff used standardized forms to record participant responses to screening questions and information concerning the medication reviews. For participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls. RESULTS: Among intervention group participants (n = 4,719), 73% (n = 3,437) were screened for fall risk. Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review. A total of 716 specific medication recommendations were made. DBI scores decreased from the pre- to postintervention period in both the control and the intervention group. However, the amount of change over time did not differ between these two groups (P = .66). Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58). CONCLUSION: We successfully implemented STEADI-Rx in the community pharmacy setting. However, we found no differences in fall risk or the use of medications associated with increased risk of falling between the intervention and control groups. J Am Geriatr Soc 68:1778-1786, 2020.

Testing the organizational theory of innovation implementation effectiveness in a community pharmacy medication management program: a hurdle regression analysis.

BACKGROUND: Many state Medicaid programs are implementing pharmacist-led medication management programs to improve outcomes for high-risk beneficiaries. There are a limited number of studies examining implementation of these programs, making it difficult to assess why program outcomes might vary across organizations. To address this, we tested the applicability of the organizational theory of innovation implementation effectiveness to examine implementation of a community pharmacy Medicaid medication management program. METHODS: We used a hurdle regression model to examine whether organizational determinants, such as implementation climate and innovation-values fit, were associated with effective implementation. We defined effective implementation in two ways: implementation versus non-implementation and program reach (i.e., the proportion of the target population that received the intervention). Data sources included an implementation survey administered to participating community pharmacies and administrative data. RESULTS: The findings suggest that implementation climate is positively and significantly associated with implementation versus non-implementation (AME = 2.65, p < 0.001) and with program reach (AME = 5.05, p = 0.001). Similarly, the results suggest that innovation-values fit is positively and significantly associated with implementation (AME = 2.17, p = 0.037) and program reach (AME = 11.79, p < 0.001). Some structural characteristics, such as having a clinical pharmacist on staff, were significant predictors of implementation and program reach whereas other characteristics, such as pharmacy type or prescription volume, were not. CONCLUSIONS: Our study supported the use of the organizational theory of innovation implementation effectiveness to identify organizational determinants that are associated with effective implementation (e.g., implementation climate and innovation-values fit). Unlike broader environmental factors or structural characteristics (e.g., pharmacy type), implementation climate and innovation-values fit are modifiable factors and can be targeted through intervention-a finding that is important for community pharmacy practice. Additional research is needed to determine what implementation strategies can be used by community pharmacy leaders and practitioners to develop a positive implementation climate and innovation-values fit for medication management programs.

Continuity of Medication Management among Adults with Schizophrenia and Comorbid Cardiometabolic Conditions.

OBJECTIVES: Adults with schizophrenia and cardiometabolic conditions may be good candidates for co-management by primary care prescribers and specialists. Associated risks for discontinuity in medication management have not been well-studied. This study examines whether medication adherence, inpatient admissions, and emergency department (ED) visits vary by the number and types of prescribers seen by adults with schizophrenia and cardiometabolic conditions. METHODS: This study used a retrospective cohort of 4,223 adult Medicaid enrollees with schizophrenia and hypertension, hyperlipidemia, and/or diabetes from three states in 2009-2010. Logistic regression models were run on outcome variables reflecting medication adherence, ED utilization, and inpatient admissions as a function of the number and types of prescribers. KEY FINDINGS: Increases in number of psychiatric specialists were associated with better antipsychotic adherence, but decreasing statin adherence. Increases in number of psychiatric specialists were also associated with a higher probability of inpatient admission and ED visits, while increases in number of primary care prescribers were associated with increases in the probability of ED visits. CONCLUSION: Greater antipsychotic adherence for adults receiving prescriptions from multiple psychiatric specialists was counteracted by lower statin adherence and greater risk of ED and inpatient utilization. This may help inform optimal care models for these complex individuals.

Continuity of medication management in Medicaid patients with chronic comorbid conditions: An examination by mental health status.

OBJECTIVE: Patients with serious mental illness (SMI) often have comorbid cardiometabolic conditions (CMCs) that may increase the number of prescribers involved in treatment. This study examined whether patients with SMI (depression and schizophrenia) and comorbid CMCs experience greater discontinuity of prescribing than patients with CMCs alone. METHODS: 2009 Medicaid data were used to compare number and types of prescribers (primary care, cardiometabolic, psychiatric, other) in individuals with 1-3 CMCs (diabetes, hypertension, dyslipidemia) alone (n=76.451); with CMC and schizophrenia (n=6507); and with CMC and depression (n=23.510) and the degree of prescribing within a provider's area of specialty. RESULTS: 44%, 61%, and 71% of individuals with CMCs only, with CMCs and schizophrenia, and with CMCs and depression had medications from these classes prescribed by 5 or more providers respectively. >35% of patients with CMCs alone or CMCs and schizophrenia had prescriptions provided by 3 or more PCP providers, which increased to 49.1% for patients with CMCs and depression. In the schizophrenia cohort, 29% of antipsychotics were PCP-prescribed while psychiatrists prescribed 10%, 9%, and 9% of antihypertensive, antihyperlipidemic, and antidiabetic medications respectively. CONCLUSIONS: The presence of SMI increases the number of prescribers treating individuals with CMCs. The impact of this fragmentation in medication management on health outcomes is unknown.

Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.

IMPORTANCE: Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders. The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed. OBJECTIVE: To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate. DESIGN, SETTING, AND PARTICIPANTS: Multisite, double-blind, randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites. Randomized patients (n = 311) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic. INTERVENTIONS: Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months. MAIN OUTCOME MEASURES: Efficacy failure, defined as a psychiatric hospitalization, a need for crisis stabilization, a substantial increase in frequency of outpatient visits, a clinician's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics, or a clinician's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit. Key secondary outcomes were common adverse effects of antipsychotic medications. RESULTS: There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate (adjusted hazard ratio, 0.98; 95% CI, 0.65-1.47). The number of participants who experienced efficacy failure was 49 (33.8%) in the paliperidone palmitate group and 47 (32.4%) in the haloperidol decanoate group. On average, participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight; after 6 months, the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg (95% CI, 1.25-3.09) and was decreased for those taking haloperidol decanoate (-0.96 kg; 95% CI, -1.88 to -0.04). Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin (men, 34.56 µg/L [95% CI, 29.75-39.37] vs 15.41 µg/L [95% CI, 10.73-20.08]; P <.001, and for women, 75.19 [95% CI, 63.03-87.36] vs 26.84 [95% CI, 13.29-40.40]; P<.001). Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia (0.73 [95% CI, 0.59-0.87] vs 0.45 [95% CI, 0.31-0.59]; P=.006). CONCLUSIONS AND RELEVANCE: In adults with schizophrenia or schizoaffective disorder, use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure, but was associated with more weight gain and greater increases in serum prolactin, whereas haloperidol decanoate was associated with more akathisia. However, the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01136772.

Metformin for weight loss and metabolic control in overweight outpatients with schizophrenia and schizoaffective disorder.

OBJECTIVE: The purpose of this study was to determine whether metformin promotes weight loss in overweight outpatients with chronic schizophrenia or schizoaffective disorder. METHOD: In a double-blind study, 148 clinically stable, overweight (body mass index [BMI] ≥27) outpatients with chronic schizophrenia or schizoaffective disorder were randomly assigned to receive 16 weeks of metformin or placebo. Metformin was titrated up to 1,000 mg twice daily, as tolerated. All patients continued to receive their prestudy medications, and all received weekly diet and exercise counseling. The primary outcome measure was change in body weight from baseline to week 16. RESULTS: Fifty-eight (77.3%) patients who received metformin and 58 (81.7%) who received placebo completed 16 weeks of treatment. Mean change in body weight was -3.0 kg (95% CI=-4.0 to -2.0) for the metformin group and -1.0 kg (95% CI=-2.0 to 0.0) for the placebo group, with a between-group difference of -2.0 kg (95% CI=-3.4 to -0.6). Metformin also demonstrated a significant between-group advantage for BMI (-0.7; 95% CI=-1.1 to -0.2), triglyceride level (-20.2 mg/dL; 95% CI=-39.2 to -1.3), and hemoglobin A1c level (-0.07%; 95% CI=-0.14 to -0.004). Metformin-associated side effects were mostly gastrointestinal and generally transient, and they rarely led to treatment discontinuation. CONCLUSIONS: Metformin was modestly effective in reducing weight and other risk factors for cardiovascular disease in clinically stable, overweight outpatients with chronic schizophrenia or schizoaffective disorder over 16 weeks. A significant time-by-treatment interaction suggests that benefits of metformin may continue to accrue with longer treatment. Metformin may have an important role in diminishing the adverse consequences of obesity and metabolic impairments in patients with schizophrenia.

Effects of switching from olanzapine, quetiapine, and risperidone to aripiprazole on 10-year coronary heart disease risk and metabolic syndrome status: results from a randomized controlled trial.

PURPOSE: This study examined the clinical significance of switching from olanzapine, quetiapine, or risperidone to aripiprazole by examining changes in predicted risk of cardiovascular disease (CVD) according to the Framingham Risk Score (FRS) and metabolic syndrome status. FRS estimates 10-year risk of "hard" coronary heart disease (CHD) outcomes (myocardial infarction and coronary death) while metabolic syndrome is associated with increased risk of CVD, stroke, and diabetes mellitus. METHOD: Changes in FRS and metabolic syndrome status were compared between patients with BMI ≥ 27 and non-HDL-C ≥ 130 mg/dL randomly assigned to stay on stable current treatment (olanzapine, quetiapine, or risperidone) or switch to treatment with aripiprazole with 24 weeks of follow-up. All study participants were enrolled in a behavioral program that promoted healthy diet and exercise. RESULTS: The pre-specified analyses included 89 switchers and 98 stayers who had post-baseline measurements needed to assess changes. Least squares mean estimates of 10-year CHD risk decreased more for the switch (from 7.0% to 5.2%) than the stay group (from 7.4% to 6.4%) (p = 0.0429). The odds ratio for having metabolic syndrome (stay vs. switch) at the last observation was 1.748 (95% CI 0.919, 3.324, p = 0.0885). CONCLUSION: Switching from olanzapine, quetiapine, or risperidone to aripiprazole was associated with larger reductions in predicted 10-year risk of CHD than the behavioral program alone. The advantage of switching on metabolic syndrome was not statistically significant. The benefits of switching must be balanced against its risks, which in this study included more discontinuations of the study treatment but no significant increase in symptoms or hospitalizations.

Physical and sexual assault of women with disabilities.

North Carolina women were surveyed to examine whether women's disability status was associated with their risk of being assaulted within the past year. Women's violence experiences were classified into three groups: no violence, physical assault only (without sexual assault), and sexual assault (with or without physical assault). Multivariable analysis revealed that women with disabilities were not significantly more likely than women without disabilities to have experienced physical assault alone within the past year (odds ratio [OR] = 1.18, 95% Confidence Interval [CI] = 0.62 to 2.27); however, women with disabilities had more than 4 times the odds of experiencing sexual assault in the past year compared to women without disabilities (OR = 4.89, 95% CI = 2.21 to 10.83).

The changing nature of women's sexual health concerns through the midlife years.

OBJECTIVE: Information about the sexual health care needs for midlife women is limited. This study compares and contrasts the nature and prevalence of sexual concerns for women as they progress through life and into menopause and the interest and experience these women have in discussing sexual concerns with their physicians. METHODS: Questionnaires were mailed to 2073 eligible women at military medical clinics in the early 1990s. Main outcome measures are self-reported sexual concerns and interest and experience in discussing these concerns with their physicians. RESULTS: Over 98% of women reported one or more sexual concerns. Type and intensity of sexual concerns changed as women aged. Most women had not had the topic of sexual health ever raised by their physicians. CONCLUSIONS: The sexual health concerns of women change as they age. Women desire to address their sexual health care needs with their physicians. Physicians should be aware of the common sexual concerns of women, and be comfortable in initiating discussion to address them.

Retinal thickness measurement after phacoemulsification.

PURPOSE: To measure macular thickness using the Retinal Thickness Analyzer (RTA) (Talia Technologies, Ltd.) before and after routine phacoemulsification. SETTING: Ophthalmology Clinic, Ambulatory Care Center, University of North Carolina at Chapel Hill, School of Medicine, and the University of North Carolina Hospitals, Chapel Hill, North Carolina, USA. METHODS: Thirty-five nonconsecutive patients scheduled for phacoemulsification and posterior chamber intraocular lens implantation were recruited. The best corrected visual acuity (BCVA) and macular thickness in the surgical and nonsurgical eyes were measured with the RTA prior to surgery and 1 and 6 weeks after surgery. Wilcoxon signed rank tests were used to evaluate each index of macular thickness--the mean posterior pole, perifoveal, and foveal thicknesses--over the 3 time periods and to compare the indices before surgery in surgical and nonsurgical eyes. Spearman correlations were computed for each index and the BCVA. Significance was assessed at the 5% level. RESULTS: Preoperatively, all indices were higher in surgical [corrected] eyes than in nonsurgical [corrected] eyes. In surgical eyes, all indices decreased from preoperatively to 6 weeks after surgery. In nonsurgical eyes, there was no change. The BCVA in surgical eyes improved from before surgery to 1 week and 6 weeks after surgery. In surgical eyes, there were nonsignificant negative correlations between each index and the BCVA before surgery and 1 and 6 weeks after surgery. In nonsurgical eyes, there were nonsignificant negative correlations between each index and the BCVA preoperatively and 6 weeks after surgery, except for a significant negative correlation for the foveal index at 6 weeks. CONCLUSIONS: Measurements by the RTA indicate that the decrease in macular thickness indices in surgical eyes from before surgery to 6 weeks after routine phacoemulsification is an artifact of imaging the retina through hazy media. Therefore, the results must be interpreted in the context of the clinical situation.