Do antipsychotic dose reduction trials result in worsening behavior among nursing home residents with dementia: a systematic review of the literature

Background: While federal regulations require gradual dose reduction trials of antipsychotics prescribed for behavior management in nursing home (NH) residents with dementia, widespread concern about precipitating behavioral disturbances limits implementation. We conducted a systematic review of clinical trials reducing antipsychotic drug use in NH residents to determine best dose reduction practices and risk of behavior escalation. Methods: A comprehensive literature search was conducted in MEDLINE, EMBASE, and International Pharmaceutical Abstracts between January 1970 and October 2011 using the terms “antipsychotic agent or neuroleptic agent,” “dementia,” “nursing homes,” and “withdrawal.” One investigator reviewed abstracts for inclusion based on: English-language, human subjects, clinical trial, nursing home site, and ≥5 participants, and reported reduction in medications due to an intervention. We excluded review articles and commentaries and secondary analysis of main trial results. The remaining articles were reviewed by 2 investigators for final inclusion, resulting in 9 articles. Results: The nine articles meeting inclusion criteria included randomized controlled trials of both typical and atypical antipsychotics. Study populations ranged in size from 55 to 183 NH residents with dementia and typically targeted patients who were not psychotic and did not have a history of violent behavior. Gradual dose reduction protocols typically followed a strategy of 50% dose reduction per week for 2-3 sequential weeks. Outcomes measured included behavioral problems, cognitive function, and resumption of antipsychotic medications. All 9 studies reported that the majority of residents randomized to gradual dose reductions of antipsychotics had no overall detrimental effect on functional and cognitive status, or exacerbation of behavioral symptoms. Conclusions: Clinical trials evaluating the withdrawal of antipsychotic medications from NH residents with dementia do not show evidence of rebound behavioral escalation after gradual dose reductions

Dissemination of Evidence-based Atypical Antipsychotic Information to Nursing Homes

Background: Accumulating evidence demonstrates minimal benefit and increased risk of off-label use of atypical antipsychotic medications for dementia-related behaviors. Optimal strategy for disseminating evidence-based guides to nursing home (NH) stakeholders is unclear. Our objective is to describe the impact of differing dissemination efforts in Connecticut NHs. Methods: Forty-three Connecticut NHs were randomized to one of 3 arms receiving incrementally intensive dissemination strategies of the Agency for Healthcare Research and Quality Comparative Effectiveness Review Summary Guide on the off-label use of atypical antipsychotic drugs, which was included in a toolkit informed by a needs assessment of NHs. All NHs received the paper-based toolkit and notifications regarding the online toolkit. Additionally, Arm 2 received individualized quarterly audit and feedback reports with atypical antipsychotic prescribing rates; Arm 3 received in-person educational visits and audit and feedback reports. Toolkit reach was assessed using interviews with NH leadership and staff. Online toolkit use was assessed using Google analytics. Results: Eighty leaders and 222 direct care staff were interviewed. Leadership and direct care staff in Arm 3 NHs were more likely to be familiar with the toolkit that those in Arm 1 (p=0.008) and Arm 2 (p Conclusions: Intensive dissemination, using multi-pronged approach including academic detailing and direct care staff trainings, appeared to be associated with higher familiarity with paper-based toolkit, but not Internet-based use of the toolkit in the NH setting

Technological Resources and Personnel Costs Required to Implement an Automated Alert System for Primary Care Physicians When Patients Transition from Hospitals to Home

Background With the adoption of electronic medical records by medical group practices, there are opportunities to improve the quality of care for patients discharged from hospitals. However, there is little guidance for medical groups outside of integrated hospital systems to automate the flow of patient information during transitions in care. Objective To describe the technological resources, expertise and time needed to develop an automated system providing information to primary care physicians when their patients transition from hospitals to home. Development Within a medical group practice, we developed an automated alert system that provides notification of discharges, reminders of the need for follow-up visits, drugs added during in-patient stays, and recommendations for laboratory monitoring of high risk drugs. We tracked components of the information system required and the time spent by team members. We used US national averages of hourly wages to estimate personnel costs. Application Critical components of the information system are notifications of hospital discharges through an admission, discharge and transfer registration (ADT) interface, linkage to the practice’s scheduling system, access to information on pharmacy dispensing and lab tests, and an interface engine. Total personnel cost was $76,314. Nearly half (47%) was for 614 hours by physicians who developed content, provided overall project management, and reviewed alerts to ensure that only “actionable” alerts would be sent. Conclusion Implementing a system to provide information about patient transitions requires strong internal informatics expertise, cooperation between facilities and ambulatory providers, development of electronic linkages, and extensive commitment of physician time

Knowledge of and perceived need for evidence-based educational materials about antipsychotic medication safety by nursing home staff

Background: Given the widespread overuse of antipsychotic medications among US nursing home (NH) residents, we sought to identify knowledge of and perceived need for the AHRQ Comparative Effectiveness Research Summary Guide (CERSG) “Off-Label Use of Atypical Antipsychotic Drugs”. Methods: We conducted a baseline needs assessment with 12 NHs participating in a randomized controlled trail evaluating evidence dissemination strategies. Using a mixed method approach, we conducted in-depth assessments of knowledge, attitudes, and practice behavior using telephone interviews with NH leadership (administrators, directors of nursing [DON], and medical directors), and questionnaires with NH leadership, consultant pharmacists and direct care staff. Interviews were transcribed, verbatim responses were coded independently by 2 project staff. The coding scheme was revised after each round until substantial agreement (85%) was reached. Results: Interviews revealed that 70% of medical directors and 46% of DON and administrators believed that antipsychotics decreased agitation and controlled harmful behavior; 50% of medical directors and 7% of DONs & administrators reported knowledge of the increased risk of morbidity and mortality due to atypical antipsychotics. Half of administrators and DONs expressed interest in receiving information for NH staff pertaining to understanding dementia and dementia-related behaviors, 42% believed families would benefit from information about antipsychotic use for dementia-related behaviors. Questionnaire results were similar. When leaders were asked to list any risks associated with antipsychotic use for residents with dementia, only 17% reported death as a possible adverse event; licensed nursing staff (RN and LPNs) reported death 5% of the time. Over half of consultant pharmacists identified that their biggest barrier to improving medication use in challenging NHs was physician resistance to accepting recommendations. Conclusions: The responses of the NH leaders, staff and consultant pharmacists suggest widespread knowledge gaps regarding antipsychotic benefits and risks, and suggest a need for increase evidence dissemination and broad organizational change

Intervention to Reduce Adverse Outcomes among Older Adults Discharged from Skilled Nursing Facilities to Home

Background: Older adults may be at risk for adverse outcomes after discharge from skilled nursing facilities (SNF), but little research has focused on this transition. Objective: To assess the impact of an alert system on the rates of adverse outcomes among older adults discharged from SNFs to home. Methods: Within a multispecialty group practice, we tracked 30-day re-hospitalizations after SNF discharges during an intervention that provided discharge alerts to primary care physicians. We compared them to discharges from the pre-intervention period matched on age, gender and SNF. For the first 100 intervention discharges and their matches, we performed chart reviews to identify adverse drug events (ADEs). Multivariate analyses controlled for age, gender and intervention status. Results: We matched 313 intervention SNF discharges to 313 previous discharges. There was a slight reduction in the rate of 30-day re-hospitalization (30% vs. 31%) adjusted. Within the ADE study, 30% of the discharges during the intervention period and 30% of matched discharges had ADEs within 45 days. Among the 83 ADEs identified, 28% were deemed preventable; 69% resulted in symptom duration more than one day; 69% occurred within the first 14 days after discharge. This was a highly vulnerable population: mean age 82.5 (standard deviation (SD) 6.7); mean number of prescribed medications 11.9 (SD 8); 17% had Charlson Comorbidity Scores of ≥4. Common clinical conditions included myocardial infarction (24%), heart failure (22%), COPD (23%), and major depression (28%). Patients with scores of ≥4 were more likely to experience an ADE than those with lower scores (adjusted OR 2.5 (CI 1.2, 5.5), RD 0.21). Conclusion: Simply providing alerts when these vulnerable patients are discharged from SNFs is not sufficient to lower rates of adverse outcomes. Further research is required to track trajectories and identify additional points for interventions

Reducing Rehospitalizations through Automated Alerts to Primary Care Providers and Staff When Older Patients are Discharged from the Hospital: A Randomized Trial

Background: Inadequate continuity of care places older patients at very high risk during transitions from the hospital to ambulatory setting. Methods: We conducted a randomized controlled trial of an HIT-based transitional care intervention in patients aged 65 and older discharged from hospital to home. All patients were senior plan members of a Massachusetts-based health plan, and cared for by a multispecialty medical group using the EpicCare Ambulatory Medical Record. In addition to notifying providers about the patient’s recent transition, the system provided information about new drugs added during the inpatient stay, warnings about drug-drug interactions, recommendations for dose changes and laboratory monitoring of high-risk medications, and reminded the primary care provider’s support staff to schedule a post-hospitalization office visit. Randomization occurred at the time of hospital discharge during a one-year intervention period beginning in August 2010. Alerts were automatically delivered to the provider and staff in-basket within the EMR. The primary outcomes were: 1) having an outpatient office visit with the primary care provider within 30 days following discharge; and 2) having a rehospitalization within 30 days following discharge. Results: The study included 3667 discharges of which 1877 discharges were randomly assigned to the intervention arm. Forty-nine percent of discharges in the intervention arm were followed by office visits with the primary care provider within 30 days, compared to 51% in the comparison arm (RR 0.96, 95% CI 0.90, 1.03). Eighteen percent of discharges in the intervention arm were followed by a rehospitalization within 30 days compared to 20% in the comparison arm (RR 0.92, 95% CI 0.80, 1.05). Conclusions: This HIT-based intervention was not effective in increasing the percentage of hospital discharges of older patients that were followed by timely office visits to primary care providers or reducing the percentage with rehospitalization

Adverse Drug Events Post-Hospital Discharge in Older Patients: Types, Severity, and Involvement of Beers Criteria Medications

Objective: To characterize adverse drug events (ADEs) occurring within the high-risk 45-day period post-hospitalization in older adults. Design: Clinical pharmacists reviewed the ambulatory records of 1000 consecutive discharges. Setting: A large multispecialty group practice closely aligned with a Massachusetts-based health plan. Participants: Hospitalized patients aged 65 years and older who were discharged to home. Measurements: Possible drug-related incidents occurring during the 45-day period post-hospitalization were identified and presented to a pair of physician-reviewers who classified incidents as to whether an ADE was present, whether the event was preventable, and the severity of the event. Medications implicated in ADEs were further characterized according to their inclusion in the 2012 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Results: At least one ADE was identified during the 45-day period in 18.7% (187) of the 1000 discharges. Of the 242 ADEs identified, 35% (n=84) were deemed preventable, of which 32% (n=27) were characterized as serious, and 5% (n=4) as life threatening. Over half of all ADEs occurred within the first 14 days post-hospitalization. The percentage of ADEs in which Beers Criteria medications were implicated was 16.5% (n=40). Beers Criteria medications with both a high quality of evidence and strong strength of recommendation were implicated in 6.6% (n=16) of the ADEs. Conclusion: ADEs are common and often preventable among older adults following hospital discharge, underscoring the need to address medication safety during this high-risk period in this vulnerable population. Beers Criteria medications played a small role in these events suggesting that efforts to improve the quality and safety of medication use during this critical transition period must extend beyond a singular focus on Beers criteria medications

Technological resources and personnel costs required to implement an automated alert system for ambulatory physicians when patients are discharged from hospitals to home

Background With the adoption of electronic medical records by medical group practices, there are opportunities to improve the quality of care for patients discharged from hospitals. However, there is little guidance for medical groups outside integrated hospital systems to automate the flow of patient information during transitions in care.Objective To describe the technological resources, expertise and time needed to develop an automated system providing information to ambulatory physicians when their patients are discharged from hospitals to home.Development Within a medical group practice, we developed an automated alert system that provides notification of discharges, reminders of the need for follow-up visits, drugs added during inpatient stays, and recommendations for laboratory monitoring of high-risk drugs. We tracked components of the information system required and the time spent by team members. We used USA national averages of hourly wages to estimate personnel costs.Application Critical components of the information system are notifications of hospital discharges through an admission, discharge and transfer registration (ADT) interface, linkage to the group’s scheduling system, access to information on pharmacy dispensing and lab tests, and an interface engine. Total personnel cost was $76,314. Nearly half (47%) was for 614 hours by physicians who developed content, provided overall project management, and reviewed alerts to ensure that only ‘actionable’ alerts would be sent.Conclusion Implementing a system to provide information about hospital discharges requires strong internal informatics expertise, cooperation between facilities and ambulatory providers, development of electronic linkages, and extensive commitment of physician time

A Mixed-Methods Study To Characterize Pharmaceutical Marketing in the Nursing Home Setting: Off-Label Use of Atypical Antipsychotics

Background: Despite FDA warnings that atypical antipsychotic medications are associated with an increased risk of death when used to treat behavioral disorders in older adults with dementia, they are prescribed to nearly one-third of older U.S. nursing home (NH) residents. Reasons for their high use in NHs are poorly understood, but may include pharmaceutical marketing efforts in the NH setting. Methods: This study is nested within an ongoing cluster randomized trial to improve the use of atypical antipsychotics in NHs. We analyzed semistructured interviews (n = 36) and surveys (n = 139) of administrators, directors of nursing and medical directors from 62 NHs in Connecticut. Using prescription drug claims from a national long-term care pharmacy, we arrayed study NHs into lowest to highest tertile of atypical antipsychotic use. We tested for differences in the receipt of information or clinical tools from pharmaceutical company representatives (PCRs) to manage dementia-related behaviors by medication use tertiles, adjusting for NH profit status, size, quality (overall, health inspections, staffing) and staffing measures (daily nurse hours per resident). Results: Average baseline use of atypical antipsychotics ranged from 6.6 to 44.3 percent of all residents in the facility. Approximately one-quarter of NH leaders presently receive information on dementia-related behavioral management strategies from PCRs through detailing, in-service training, written or Web-based material or sponsorship as speakers. However, we did not detect statistically significant differences in the receipt of information by level of atypical antipsychotic use, NH characteristics, quality and staffing measures. Conclusions: This first attempt to characterize pharmaceutical marketing within the NH setting did not find differences among reports of marketing efforts with respect to medication use and facility-level characteristics. However, studies across a wider geographic area should continue investigating the possible role of marketing efforts on overall use and choice of atypical antipsychotics in the NH setting