PURPOSE:We developed and evaluated an explicit procedure for obtaining self-report pain data from nursing home residents across a broad range of cognitive status, and we evaluated the consistency, stability, and concurrent validity of resident responses. DESIGN AND METHODS:Using a modification of the Geriatric Pain Measure (GPM-M2), we interviewed 61 residents from two nursing homes (Mini-Mental State Examination score, M = 15 +/- 7) once a week for 4 consecutive weeks. We collected additional data by means of chart review, cognitive status assessments, and surveys of certified nursing assistants. We used descriptive and correlational analyses to address our primary aims. RESULTS:Eighty-nine percent of residents completed all four scheduled interviews. Cognitive status was not significantly correlated with number of nonresponses and prompts for yes-no questions, but it was significantly correlated with nonresponses and prompts for Likert-scale questions (r = -.48, p <.001 and r = -.59, p <.001, respectively). Completion time for the 17-item pain measure (M = 13 min) was not predicted by cognitive status. Residents' scores on the GPM-M2 were significantly correlated with number of chronic pain-associated diagnoses, r =.37, p <.01, and internal consistency was excellent, alpha = 0.87 - 0.91. Residents' GPM-M2 scores were stable over time, r =.74-.80, p <.0001, for all comparisons. IMPLICATIONS:Using explicit protocols and reporting procedural data allows researchers and clinicians to better understand and apply results of self-report studies with cognitively impaired elders. Results suggest that many nursing home residents can provide consistent and reliable self-report pain data, given appropriate time and assistance.

Background Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials. Purpose This paper summarizes how issues associated with safety monitoring and adverse event reporting were handled in the Resources for Enhancing Alzheimer's Caregiver Health (REACH II) program, a multi-site randomized clinical trial, funded by the National Institutes on Aging (NIA) and the National Institutes of Nursing Research (NINR), that tested the efficacy of a multicomponent social/behavioral intervention for caregivers of persons with Alzheimer's disease. Methods A task force was formed to define adverse events for the trial and protocols for reporting and resolving events that occurred. The task force conducted a review of existing polices and protocols for data and safety monitoring and adverse event reporting and identified potential risks particular to the study population. An informal survey regarding data and safety monitoring procedures with investigators on psychosocial intervention trials was also conducted. Results Two categories of events were defined for both caregivers and patients; adverse events and safety alerts. A distinction was also made between events detected at baseline assessment and those detected post-randomization. Standardized protocols were also developed for the reporting and resolution of events that occurred and training of study personnel. Results from the informal survey indicated wide variability in practices for data safety and monitoring across psychosocial intervention trials. Conclusions Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining “resolution” of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed.

PURPOSE:The purpose of this study was to examine group differences in verbal agitation, verbal interaction, bed restraint, pain, analgesic and neuroleptic medication use, and medical comorbidity among agitated nursing home residents who died during a 6-month clinical trial compared with residents of the same gender and similar initial cognitive status who did not die during the trial. DESIGN AND METHODS:We conducted a two-group secondary data analysis of prospective observational data from 10 nursing homes in Birmingham, Alabama. By means of chart review, resident assessments, surveys of certified nursing assistants, and direct observation of residents' daily behaviors and environment, 32 residents (87.34 +/- 7.29 years) with a Mini-Mental State Examination (MMSE) score = 4.31 (+/-5.54) who died were compared with 32 residents (84 +/- 6.96 years) with a mean MMSE score = 4.28 (+/-5.49) who did not die during the clinical trial. RESULTS:Residents who died displayed more verbal agitation, less time in verbal interaction with staff, and almost twice as much time restrained in bed during observation time in comparison with residents who did not die during the clinical trial. However, groups did not differ significantly in severity of comorbid illness, functional status, number of painful diagnoses, certified nursing assistants' reports of residents' pain, or opioid or nonopioid analgesic prescription or dosage. Surviving residents were more likely to receive neuroleptic medication than residents who died. IMPLICATIONS:Results suggest that agitated nursing home residents may exhibit a heightened level of verbal agitation, decreased verbal interaction with staff, and increased bed restraint up to 3 months prior to death. Prospective observational studies are needed to identify markers for imminent mortality among nursing home residents.

To evaluate psychometric properties and response patterns of the Care-giver Assessment of Function and Upset (CAFU), a 15-item multidimensional measure of dependence in dementia patients and caregiver reaction. Method: 640 families were administered the CAFU (53% White, 43% African American, and 4% mixed race and ethnicity). We created a random split of the sample and conducted exploratory factor analyses on Sample 1 and confirmatory factor analyses on Sample 2. Convergent and discriminant validity were evaluated using Spearman rank correlation coefficients. Results: A two-factor structure for functional items was derived, and excellent factorial validity was obtained. Convergent and discriminant validity were obtained for function and upset measures. Differential response patterns for dependence and caregiver upset were found for caregiver race, relationship, and care recipient gender but not for caregiver gender. Discussion: The CAFU is easily administered, reliable, and valid for evaluating appraisals of dependencies and upsetting care areas.

We examined differences in positive aspects of caregiving (PAC) among 275 African American and 343 Caucasian caregivers of individuals with Alzheimer's disease from the National Institutes of Health Resources for Enhancing Alzheimer's Care Health (REACH) study sites in Birmingham, Memphis, and Philadelphia. African Americans reported higher scores on PAC than did Caucasians. African Americans' higher religiosity partially mediated the relationship between race and PAC. Additional variables that contributed to their higher PAC scores were African Americans' lower anxiety, lower feelings of bother by the care recipient's behavior, and lower socioeconomic status.

PURPOSEThe purpose of this study was to compare a variety of resident and staff outcomes across two types of staffing patterns, permanent and rotating assignment, and work shift. Although studies have examined these staffing patterns as part of multicomponent intervention packages, few studies have examined the isolated effects of staffing pattern by using an experimental design.DESIGN AND METHODSA between-groups comparison design was used to compare residents and certified nursing assistants (CNAs) from four nursing homes; two self-identified as using permanent assignment (PA) staffing and two as using rotating assignment (RA) staffing. Measures yielded data on verbal interaction among residents and staff, resident disruptive behavior, and specific aspects of resident-staff behavior during care routines. Other assessments included resident personal appearance and hygiene, expressed affect, and CNAs' job satisfaction, burnout, absenteeism, and turnover rates. A treatment fidelity check was conducted to confirm PA and RA staffing patterns.RESULTSStaffing patterns were significantly different between self-identified PA and RA nursing homes. Residents in PA nursing homes and on morning shifts received significantly higher ratings of personal appearance and hygiene. Rates of expressed sadness and interest among residents differed by staffing patterns and shift. However, these differences do not appear to be clinically significant. Although absenteeism was higher in PA nursing homes, these CNAs reported greater job satisfaction than CNAs from RA nursing homes. As expected, evening shifts across nursing homes had significantly higher turnover rates and significantly more resident disruptive behavior.IMPLICATIONSQuality-of-care outcomes were similar among the two types of nursing homes, despite significantly different staffing patterns. Though staff permanency rates in PA nursing homes (50%) were twice that of RA nursing homes (26%), more research is needed to determine feasibility of higher rates of staff permanency (i.e., > 50%) and effects on resident and CNA outcomes.

PURPOSE:The identification of nursing home residents who can continue to participate in advance care planning about end-of-life care is a critical clinical and bioethical issue. This study uses high quality observational research to identify correlates of advance care planning in nursing homes, including objective measurement of capacity.DESIGN AND METHODS:The authors used cross-sectional, cohort study between 1997 and 1999. Seventy-eight residents (M age = 83.97, SD = 8.2) and their proxies (M age = 59.23, SD = 11.77) were included across five nursing homes. The authors obtained data via chart review, proxy interviews, resident assessments, survey completion by certified nursing assistants, and direct observation of residents' daily behaviors.RESULTS:Capacity assessments revealed that most residents could state a simple treatment preference (82.4%), but a sizable number did not retain capacity to understand treatment alternatives or appreciate the consequences of their choice. Global cognitive ability (Mini-Mental State Examination score) was related to understanding and appreciation. When the authors removed the effects of global cognitive ability, understanding and appreciation were related to time spent by residents in verbal interaction with others. Residents were more likely to possess advance directives when proxies possessed advance directives, proxies were less religious, and residents were socially engaged.IMPLICATIONS:Assessment of proxy beliefs and direct determination of residents' decisional capacity and social engagement may help nursing home staff identify families who may participate in advance planning for end-of-life medical care. Measures of global cognitive ability offer limited information about resident capacity for decision making. Decisional capacity assessments should enhance the verbal ability of individuals with dementia by reducing reliance on memory in the assessment process. Interventions to engage residents and families in structured discussions for end-of-life planning are needed.

The Resources for Enhancing Alzheimer's Cargiver Health (REACH) project was designed to test promising interventions for enhancing family caregiving for persons with dementia. The purpose of this article is to describe the research design, interventions, and outcome measures used in REACH and to characterize the sample recruited for the study. Nine interventions and 2 control conditions were implemented at 6 sites; 1,222 dyads were randomly assigned to an intervention or a control condition. The caregiver sample was 18.6% male with an average age of 62.3 years (56% Caucasian, 24% Black, and 19% Hispanic). Caregivers reported high levels of depressive symptoms and moderate burden. Care recipients were older, with a mean age of 79, and were moderately to severely impaired with mean Mini-Mental State Exam scores of 13/30.

Meta-analysis was used to examine pooled parameter estimates of 9 active compared with 6 control conditions of the Resources for Enhancing Alzheimer's Caregiver Health (REACH) project at 6 months on caregiver burden and depressive symptoms. Associations of caregiver characteristics and outcomes were examined. For burden, active interventions were superior to control conditions (p = .022). Also, active interventions were superior to control conditions for women versus men and for caregivers with lower education versus those with higher education. For depressive symptoms, a statistically significant association of group assignment was found for Miami's family therapy and computer technology intervention (p = .034). Also, active interventions were superior to control conditions for Hispanics, nonspouses, and caregivers with lower education. Results suggest interventions should be multicomponent and tailored.

A modified version of the Revised Memory and Behavior Problems Checklist (RMBPC; L. Teri et al., 1992) was administered across 6 different sites to 1,229 family caregivers of community-dwelling adults with dementia. The total sample was divided randomly into 2 subsamples. Principal components analyses on occurrence responses and reaction ratings from the first subsample resulted in a 3-factor solution that closely resembled the originally proposed dimensions (memory-related problems, disruptive behaviors, and depression). Confirmatory factor analyses on data from the second subsample indicated adequate fit for the 3-factor model. Correlations with other caregiver and care-recipient measures supported the convergent and discriminant validity of the RMBPC measures. In addition, female caregivers and White caregivers reported more problems, on average, than male caregivers and African American caregivers, respectively.

Confirmatory factor analysis of the Revised Memory and Behavior Problems Checklist--Nursing Home (RMBPC) replicated the factor structure of the community-based RMBPC (L. Teri et al., 1992). The reliability of the total score was high as indexed by estimates of internal consistency (alpha = .95), test-retest reliability (r = .86), and interrater reliability between 2 interviewers (r = .88). Notably, the interrater reliability between 2 independent certified nursing assistants (CNAs) regarding residents' behavior problem frequency was more modest (r = .46), possibly reflecting the degree to which resident behaviors capture individual CNA's attention. This may have implications for the interpretation of data from the Minimum Data Set. CNAs reported moderately severe burden associated with behavior problems in 47% of residents under their care.

Researchers have examined numerous psychosocial and behavioral interventions intended to alleviate distress among family caregivers of persons with dementia. Many of these interventions are complex, combining numerous treatment components. Although some multicomponent interventions have been successful in reducing caregiver distress, the impact of specific elements of these interventions on outcomes is not known. The article presents results of an analytic approach that allows researchers to describe the individual elements of multicomponent interventions and to examine the relationships between those components and outcomes. This approach is successfully applied to interventions being evaluated in the Resources for Enhancing Alzheimer's Caregiver Health (REACH) program. The results indicate that actively targeting caregiver behavior is effective in achieving positive outcomes with respect to care giver depression.

OBJECTIVES: To examine correlates of analgesic medication prescription and administration in communicative, cognitively impaired nursing home residents. Residents' behaviors were assessed using computer-assisted real-time observations as potential adjunctive indicators of pain.DESIGN: Cross-sectional study over a 4-week period.SETTING: Five nursing homes in the greater Birmingham, Alabama, area.PARTICIPANTS: Ninety-two residents (mean age +/- standard deviation = 83.86 +/- 8.55) with a mean Mini-Mental State Examination (MMSE) score of 13.81 +/- 6.34.MEASUREMENTS: Data were obtained via chart review, resident assessments, questionnaire completion by certified nursing assistants familiar with residents' care, and direct observation of residents' daily behaviors.RESULTS: Receipt of analgesic medication was related to self-report of pain (F (2,89) = 9.89, P = .0001), MMSE (F (2,88) = 3.98, P = .022), and time spent inactive (F (2,89) = 3.04, P = .053). Residents who received analgesic medication reported greater intensity of pain than other residents. Residents who received analgesics had higher MMSE scores than those who did not receive analgesics. Residents who received analgesics spent less time being inactive than those not prescribed analgesics. Receipt of higher dosage of opioid analgesic medication was associated with more time spent with others in verbal interaction (r = .22, P = .03).CONCLUSION: This study refines the methodology of measuring analgesic medication dosage and its effect on resident behavior. Analgesic prescription and administration patterns are related to time residents spend being inactive. Results suggest that opioid analgesics may hold particular promise in alleviating pain, as indicated by resident behaviors.