Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia.

OBJECTIVES: To evaluate whether a community-based, telephone-delivered, brief patient/caregiver-centered collaborative dementia care management intervention is associated with improved caregiver and care recipient (CR) outcomes. DESIGN: Longitudinal program evaluation of a clinical intervention; assessments at baseline and 3- and 6-month follow-up. SETTING: General community. PARTICIPANTS: Caregivers (N = 440) of older, community-dwelling, low-income CRs prescribed a psychotropic medication by a primary care provider who met criteria for dementia and were enrolled in the SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program for older adults. INTERVENTION: Dementia care management versus clinical evaluation only. MEASUREMENTS: Perceived caregiving burden and caregiver general health (primary outcomes); CR neuropsychiatric symptoms and caregiver distress in response to CRs' challenging dementia-related behaviors (secondary outcomes). RESULTS: Caregivers were, on average, 64.0 (SD: 11.8) years old and 62.6% provided care for the CR for 20 or more hours per week. The majority of the sample was female (73.2%), non-Hispanic White (90.2%), and spousal caregivers (72.5%). Adjusted longitudinal models of baseline and 3- and 6-month data suggest that compared with caregivers receiving clinical evaluation only, caregivers receiving care management reported greater reductions in burden over time. Subgroup analyses also showed statistically significant reductions in caregiver-reported frequency of CR dementia-related behaviors and caregiver distress in response to those symptoms at 3-month follow-up. CONCLUSIONS: A community-based, telephone-delivered care management program for caregivers of individuals with dementia is associated with favorable caregiver and CR-related outcomes. Findings support replication and further research in the impact of tailored, collaborative dementia care management programs that address barriers to access and engagement.

Older adults recently started on psychotropic medication: where are the symptoms?

OBJECTIVE: The objective of this study is to understand the characteristics of older adults on newly prescribed psychotropic medication with minimal psychiatric symptoms. METHODS: Naturalistic cohort study of non-institutionalized older adults in Pennsylvania participating in the Pharmaceutical Assistance Contract for the Elderly. Persons newly prescribed antidepressant or anxiolytic monotherapy or combination therapy were contacted for clinical assessment by a telephone-based behavioral health service. The initial assessment included standardized mental health screening instruments and scales including the Blessed Orientation-Memory-Concentration test, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Medical Outcomes Survey (SF-12). In addition, patients were asked for their understanding of the prescription indication. RESULTS: Of the 254 participants who met minimal symptom criteria (Patient Health Questionnaire-9 < 5 and Generalized Anxiety Disorder-7 < 5), women comprised slightly more of the anxiolytic compared with antidepressant monotherapy group (88.9% vs. 76.7%, p = 0.04). The most common self-reported reason for prescription of an antidepressant or anxiolytic was depression or anxiety, respectively, despite near-absence of these symptoms on clinical assessment. Comparing monotherapy to combination therapy groups, those with combination therapy were more likely to report a history of depression (12.6% vs. 1.8%, p < 0.001) and also report depression as the reason for the prescription (40.2% vs. 21.0%, p < 0.01). CONCLUSIONS: In this sample of older adults on new psychotropic medication with minimal psychiatric symptoms, there are few patient characteristics that distinguish those on antidepressant versus anxiolytic monotherapy or those on monotherapy versus combination therapy. While quality of care in late-life mental health has focused on improving detection and treatment, there should be further attention to low-symptom patients potentially receiving inappropriate pharmacotherapy.

Telephone-based care management for older adults initiated on psychotropic medication.

OBJECTIVE: This study aimed to explore the longitudinal, 6-month symptom course of older adults newly started on an antidepressant or anxiolytic by non-psychiatrist physicians and enrolled in a care management program. METHOD: This is a naturalistic cohort study of older adults (age ≥65 years) receiving pharmacotherapy and telephone-based care management. Participants are non-institutionalized adults participating in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly who completed telephone-based clinical assessments including demographic data, self-report on history of psychiatric treatment and adherence, and standardized symptom scales. RESULTS: A total of 162 participants with an average age of 77.2 years (SD 6.8) were followed and, for analysis, split into two groups by PHQ-9 score: 75 (46.3%) scoring 0-4 (minimally symptomatic group, MSG) and 87 (53.7%) scoring ≥5 (symptomatic group, SG). Over 6 months, the SG improved with PHQ-9 scores beginning on average at 10.0 (SD 4.6) and falling to 5.4 (SD 4.2) (F(1, 86) = 29.53, p < 0.0001). The MSG had no significant change in depressive symptoms. Emotional health as measured by SF-12 Mental Composite Score mirrored the PHQ-9 change and lack thereof in the SG and MSG, respectively. No clinical or demographic features were associated with symptom improvement in the SG although they were more likely to report medication adherence (66.7% vs. 44.0%, χ(2) (1) = 8.4, p = 0.0037) compared with the MSG. CONCLUSIONS: Participation of symptomatic older adults initiated on psychotropic medication in a telephone-based care management program was associated with improvement in depressive symptoms and overall emotional well-being, notable findings given participants' advanced age, state-wide distribution, and history of limited utilization of mental health care.

A randomized controlled trial of a close monitoring program for minor depression and distress.

BACKGROUND: Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress. OBJECTIVES: The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress. DESIGN: Subjects were randomly assigned to either the control arm (usual care; UC) or the intervention arm (close monitoring; CM). We hypothesized that those randomized to CM would exhibit less depression and be less likely to have symptoms progress to the point of meeting diagnostic criteria. SUBJECTS: Overall, 223 PC subjects with minor depression or distress consented to participation in this trial. MEASUREMENTS: At baseline, subjects completed a telephone-based evaluation comprised of validated diagnostic assessments of depression and other MH disorders. Outcomes were assessed at six months utilizing this same battery. Chart reviews were conducted to track care received, such as prescribed antidepressants and MH and primary care visits. RESULTS: Subjects in the CM arm exhibited fewer psychiatric diagnoses than those in the UC arm (chi(2) = 4.04, 1 df, p = 0.04). In addition, the intervention group showed improved overall physical health (SF-12 PCS scores) (M = 45.1, SD = 11.8 versus M = 41.5, SD = 12.4) (chi(2) = 5.90, 1 df, p = .02). CONCLUSIONS: Those randomized to CM exhibited less MH problems at the conclusion of the trial, indicating that the close monitoring program is effective, feasible and valuable. The findings of this study will allow us to enhance clinical care and support the integration of mental health services and primary care.

Correlates of Caregiver Participation in a Brief, Community-Based Dementia Care Management Program.

Purpose of the Study: The evidence base for dementia care management interventions for informal caregivers (CGs) is strong, yet enrollment and sustained engagement in academic and community-based research trials is low. This study sought to examine rates and correlates of participation in a community-based, telephone-delivered dementia care management program designed to address logistic and practical barriers to participation in CG trials and services. Design and Methods: Participants included 290 CGs of older, community-dwelling, low-income care recipients (CRs) who met criteria for enrollment in a collaborative dementia care management program that provides assessment, psychosocial support and education, and connection to community resources via telephone. Cross-sectional analyses examined the association between CG-related (e.g., financial status, relationship to CR, caregiving burden) and CR-related (e.g., functional limitations, symptom severity) factors and CG enrollment and engagement. Results: The majority of CGs were non-Hispanic White, female, financially stable, and adult children of the CRs. Over half of CGs lived with the CR and provided 20 or more hours of care per week. Roughly half of CGs refused care management services. Adjusted logistic regression models revealed that perceived caregiving burden and financial status were related to initial enrollment and engagement in services once enrolled, respectively. Implications: A significant proportion of CGs refuse free, convenient, evidence-based dementia care management services, underscoring the need for further examination of correlates of program acceptance. Nonetheless, community-based programs that address barriers may improve enrollment and engagement rates among CGs, including those who are especially vulnerable to negative CG and CR outcomes.

Simvastatin causes changes in affective processes in elderly volunteers.

OBJECTIVES: To test for simvastatin-induced changes in affect and affective processes in elderly volunteers. DESIGN: Randomized, clinical trial. SETTING: The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania. PARTICIPANTS: Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol. INTERVENTION: Simvastatin up to 20 mg/d or placebo for 15 weeks. MEASUREMENTS: Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events. RESULTS: Thirty-one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication-by-time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication-by-event, and medication-by-event-by-time interactions, reflecting a time-limited increase in the apparent effect of negative events. CONCLUSION: Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.

Probing for affective side effects of drugs used in geriatric practice: use of daily diaries to test for effects of metoclopramide and naproxen.

The aim of this study was to develop the use of daily diaries of affects and events as measures of pharmacological effects on affective processes and to apply them to evaluate the possible affective toxicity of metoclopramide and naproxen, two medications commonly used in geriatric practice. In all, 105 adults aged 65 years or older were randomized to receive metoclopramide (up to 40 mg/day), naproxen (up to 1000 mg/day), or placebo under double-blind conditions for a period of 5 weeks. Patients were seen weekly for evaluations of affective and cognitive outcomes as well as safety. In addition, patients kept diaries with daily records of positive and negative affect and reports of significant daily events. Findings included mixed model analyses of drug assignment, time, events, and interactions for both positive affect and days with significant negative affect. Subjects exhibited high levels of adherence in completing daily diaries. Neither the pattern of dropouts nor the weekly assessments demonstrated significant drug effects on mood or affect. However, diary data demonstrated that metoclopramide increased the apparent impact of negative events on both positive and negative affect relative to placebo, and that naproxen increased the apparent impact of positive events on positive affect and, possibly, of negative events on negative affect relative to placebo. The findings confirm the utility of diary methods for studying drug effects on affective processes in normal elderly subjects. They suggest that both metoclopramide and naproxen can affect the associations between daily events and affects. If replicated, they would demonstrate that drug effects can extend beyond the intensity of affect and/or the emergence of full-fledged psychiatric disorders to include moderation of the interactions between daily events and affect.

A Telephone-Based Program to Provide Symptom Monitoring Alone vs Symptom Monitoring Plus Care Management for Late-Life Depression and Anxiety: A Randomized Clinical Trial.

IMPORTANCE: Mental health (MH) conditions are undertreated in late life. It is important to identify treatment strategies that address variability in treatment content and delivery and take individual-specific symptoms into account, particularly among low-income, community-dwelling older adults. OBJECTIVE: To evaluate program feasibility and MH outcomes among community-dwelling older adults randomized to 1 of 2 treatment arms of varying intensity of evidence-based, collaborative MH care management services (ie, the Supporting Seniors Receiving Treatment and Intervention [SUSTAIN] program) that provide standardized, measurement-based, software-aided MH assessment and symptom monitoring and connection to community resources via telephone. DESIGN, SETTING, AND PARTICIPANTS: Trial participants were 1018 older, community-dwelling, low-income adults prescribed an antidepressant or anxiolytic by a primary care or non-MH professional and experiencing clinically significant MH symptoms at intake. The participant subsample was drawn from a larger parent sample of older adults enrolled in the SUSTAIN program. Individuals were randomized to receive MH symptom monitoring alone (hereafter monitoring alone) or MH symptom monitoring plus care management (hereafter care management) provided by an MH professional. Baseline characteristics were examined, and changes in clinical MH outcomes were evaluated at 3-month and 6-month follow-up. The study dates were August 5, 2010, to May 5, 2014. INTERVENTIONS: Monitoring alone or care management delivered by an MH professional. MAIN OUTCOMES AND MEASURES: Overall MH functioning (primary) and depressive and anxiety symptoms. RESULTS: A total of 509 participants were randomized to the monitoring alone group and 509 to the care management group; 377 and 401 completed ≥2 research assessments in the monitoring alone and case management groups, respectively. Compared with those randomized to monitoring alone, individuals randomized to care management showed greater improvements in the 3 domains of MH functioning (ß [SE], 0.36 [0.12]; 95% CI, 0.12 to 0.60; P = .004), depressive symptoms (ß [SE], -0.20 [0.06]; 95% CI, -0.32 to -0.09; P < .001), and anxiety symptoms (ß [SE], -0.23 [0.05]; 95% CI, -0.33 to -0.14; P < .001) over time. CONCLUSIONS AND RELEVANCE: The SUSTAIN program, which provides assessment, monitoring, care management, and brief therapies for MH symptoms and needs in primary care settings, is feasible and scalable. A more intense level of care (ie, symptom monitoring plus care management) is associated with more favorable individual outcomes for low-income, community-dwelling older adults experiencing clinically significant MH symptoms. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02440594.

Probing the safety of medications in the frail elderly: evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents.

BACKGROUND: In nursing home residents and other frail elderly patients, old age and potential drug-drug and drug-disease interactions may affect the relative safety and efficacy of medications. The purpose of this study was to examine the efficacy and tolerability of venlafaxine and sertraline for the treatment of depression among nursing home residents. METHOD: The study was a 10-week randomized, double-blind, controlled trial of venlafaxine (doses up to 150 mg/day) versus sertraline (doses up to 100 mg/day) among 52 elderly nursing home residents with a DSM-IV depressive disorder and, at most, moderate dementia. The primary measure of outcome was the Hamilton Rating Scale for Depression (HAM-D). Adverse events were monitored and recorded systematically during the trial. RESULTS: Twelve subjects were discontinued due to serious adverse events (SAE), 5 were discontinued due to other significant side effects, and 2 withdrew consent. Tolerability estimated by the time to termination was lower for venlafaxine than sertraline for serious adverse events (log rank statistic = 5.28, p =.022), for serious adverse events or side effects (log rank statistic = 8.08, p =.005), or for serious adverse events, side effects, or withdrawal of consent (log rank statistic = 10.04, p =.002). Mean (SD) HAM-D scores at baseline were 20.2 (3.4) for sertraline and 20.3 (3.7) for venlafaxine; intent-to-treat endpoint HAM-D scores were 12.2 (5.1) and 15.7 (6.2) (F = 3.45; p =.069). There were no differences in categorical responses for the intent-to-treat sample or completers. CONCLUSION: In this frail elderly population, venlafaxine was less well tolerated and, possibly, less safe than sertraline without evidence for an increase in efficacy. This unexpected finding demonstrates the need for systematic research on the safety of drugs in the frail elderly.

Use of Prediction Intervals to Characterize Electroencephalographic Changes Caused by Diphenhydramine.

The authors report on progress in the use of a two-channel, microprocessor-based electroencephalographic (EEG) device and the statistical strategy of prediction intervals for characterizing the normal limits of variability in cerebral state in older subjects and recognition of excessive change caused by mildly toxic medications. Prediction intervals for relative delta, theta, alpha, and beta power were calculated from repeated EEG measures on 54 medically stable elderly subjects. The authors subsequently evaluated the effects of diphenhydramine (25-75 mg) administered to 10 additional subjects. Significant drug-induced changes at the group level were apparent only in relative theta power. Significant change in relative theta power at the individual level was observed in five of nine subjects for whom data at 50 mg were available.

Use of the Hamilton and Montgomery-Asberg Depression Scales in Institutionalized Elderly Patients.

In screening for a study of drug treatment of major depression, the authors obtained data on depressive symptoms in elderly residential care patients (N = 116; average age 84 years; 81% women). Principal-components analysis (with varimax rotation) of the Hamilton Rating Scale for Depression yielded a four-factor solution (accounting for 47.2% of variance): core depression, anxiety, insomnia-hypochondriasis, and cognitive-ideational symptoms. The Montgomery-Asberg Depression Scale yielded two factors (54% of variance)-core depression and anxiety. Core depression factor scores from both scales (but not other factor scores) predicted mortality. The association of core depression with mortality (in subsets of patients for which data on these covariates were available) remained significant after measures of illness burden and disability were controlled.

Effect of increasing the dose and duration of sertraline trial in the treatment of depressed nursing home residents.

There has been limited research into defining what constitutes an adequate first-line antidepressant trial in elderly patients. The authors report the outcome of extended, high-dosage sertraline treatment in a sample of nursing home residents experiencing residual significant depressive symptoms after 10 weeks of treatment with sertraline at a final dosage of 100 mg/day. Subjects who had a Hamilton Depression Rating Scale score > or = 12 after 10 weeks of treatment with sertraline were eligible for the 8-week open-label extension phase, which involved titrating the sertraline dosage to 200 mg/day. The cumulative response rate was 52% for the extension phase, compared with 37% for the acute phase. Examining acute phase nonresponders, 39% responded during the extension phase. Rates of discontinuation due to adverse events were comparable in the 2 phases. Our findings suggest that an extended trial or high dosages of sertraline may benefit some depressed elderly patients with persistent depression after acute treatment.

Pharmacologic treatment of depression in nursing home residents: a mental health services perspective.

Over the past 10 to 15 years, there has been marked progress in clinical research on depression in nursing home residents. There have also been significant changes in federal regulations designed to improve the quality of care. In 1987, only 10% of nursing home residents diagnosed with depression were receiving treatment, but by 1999,25% of all residents were receiving antidepressants. We report on two studies: one demonstrating that treatment for depression has a substantial, ecologically relevant impact in the nursing home and another demonstrating that profound changes have occurred in the clinical epidemiology of depression and its treatment in the nursing home. Although the numbers of nursing home residents receiving antidepressants have increased dramatically, there are now second-generation problems that must be addressed to ensure the delivery of effective treatment. Developing models to ensure quality of care will require focused mental health services research.

A comparison of xylazine and medetomidine in an anesthetic combination in New Zealand White Rabbits.

A comparison was made of two anesthetic protocols for cardiothoracic surgery in rabbits. Eight male New Zealand White rabbits (2.8 to 3.2 kg) were used in a double crossover study. Each rabbit received intramuscular ketamine (35 mg/kg), xylazine (5 mg/kg), and buprenorphine (0.03 mg/kg) or ketamine (35 mg/kg), medetomidine (0.5 mg/kg), and buprenorphine (0.03 mg/kg) on alternate weeks. After intramuscular injection, each rabbit was intubated and placed on 0.75% isoflurane in 1 L O2/min. Palpebral, pedal, and righting reflexes and cardiopulmonary parameters were measured every minute for the first 10 min and every 5 min thereafter. Rabbits were monitored for 20 min of spontaneous ventilation followed by 60 min of intermittent positive pressure ventilation. Intermittent positive pressure ventilation and isoflurane then were discontinued and recovery monitored. Systolic, mean, and diastolic blood pressures were higher in the medetomidine-treated rabbits. Return of the palpebral, pedal, and righting reflexes was prolonged in the medetomidine-treated rabbits. There were no differences in heart rate, respiratory rate, return to spontaneous breathing, and time to extubation between the two groups. These results indicate medetomidine can be safely used in rabbit anesthesia, provides acceptable cardiovascular parameters, and induces a longer anesthetic period than that of xylazine.

Testing the PHQ-9 interview and observational versions (PHQ-9 OV) for MDS 3.0.

OBJECTIVES: To test the feasibility and validity of the Patient Health Questionnaire-9 item interview (PHQ-9) and the newly developed Patient Health Questionnaire Observational Version (PHQ-9 OV) for screening for mood disorder in nursing home populations. METHODS: The PHQ-9 was tested as part of the national Minimum Data Set 3.0 (MDS 3.0) evaluation study among 3822 residents scheduled for MDS 2.0 assessments. Residents from 71 community nursing homes (NHs) in eight states were randomly included in a feasibility sample (n = 3258) and a validation sample (n = 418). Each resident's ability to communicate determined whether the PHQ-9 interview or the PHQ-9 OV was initially attempted. In the validation sample, trained research nurses administered the instruments. For residents in the validation sample without severe cognitive impairment (3 MS ≥30) agreement between PHQ-9 and the modified Schedule for Affective Disorders and Schizophrenia (m-SADS) was measured with weighted kappas (κ). For residents with severe cognitive impairment (3MS <30), agreement between PHQ-9 interview or PHQ-9 OV and the Cornell Scale for Depression in Dementia (Cornell Scale) was measured using correlation coefficients. Staff impressions were obtained from an anonymous survey mailed to all MDS assessors. RESULTS: The PHQ-9 was completed in 86% of the 3258 residents in the feasibility sample. In the validation sample, the agreement between PHQ-9 and m-SADS was very good (weighted κ = 0.69, 95% CI = 0.61-0.76), whereas agreement between MDS 2.0 and m-SADS was poor (weighted κ = 0.15, 95% CI = 0.06-0.25). Likewise, in residents with severe cognitive impairment, PHQ correlations with the criterion standard Cornell Scale were superior to the MDS 2.0 for both the PHQ-9 (0.63 vs 0.34) and the PHQ-9 OV (0.84 vs 0.28). Eighty-six percent of survey respondents reported that the PHQ-9 provided new insight into residents' mood. The average time for completing the PHQ-9 interview was 4 minutes. DISCUSSION: Compared with the MDS 2.0 observational items, the PHQ-9 interview had greater agreement with criterion standard diagnostic assessments. For residents who could not complete the interview, the PHQ-9 OV also had greater agreement with a criterion measure for depression than did the MDS 2.0 observational items. Moreover, the majority of NH residents were able to complete the PHQ-9, and most surveyed staff reported improved assessments with the new approach.