Purpose of Review

To assess adverse events of antidepressants in the treatment of major depressive disorder in adults 65 years of age or older.

Key Messages

In people 65 years of age or older:

• Serotonin norepinephrine reuptake inhibitors (SNRIs) (duloxetine and venlafaxine) cause adverse events more often than placebo and most likely lead to discontinuation of therapy during treatment of up to 12 weeks.
• Selective serotonin reuptake inhibitors (SSRIs) (escitalopram and fluoxetine) most likely cause adverse events at a similar frequency to placebo therapy but still may lead to discontinuation of therapy during treatment of up to 12 weeks.
• Duloxetine most likely increases the risk of falls over longer treatment (<24 weeks)
• Adverse events contributing to discontinuation of therapy were rarely reported in a way that allowed clear characterization of what adverse events to expect.
• Few studies compared other antidepressants to placebo or to each other, or reported other outcomes. Trial data were sparse, and trials were short in duration, underpowered, and studied low doses of antidepressants. Observational studies had limitations related to their design. Long-term, rigorous comparative studies are needed.

The Immediate Jeopardy Update Training introduces surveyors and non-surveyors to the revised Appendix Q–Core Guidelines to Determining Immediate Jeopardy. The Core Appendix Q focuses on the key components necessary to establish immediate jeopardy (IJ) under the regulations. 

These key components are:

• Noncompliance.
• Serious harm, injury, impairment, or death that has occurred or is likely to occur. 
• Immediate need for action by the provider/supplier to address the noncompliance.

The Core Appendix Q also contains information about how surveyors should determine whether IJ exists, and it includes a template that surveyors must use to ensure that sufficient evidence exists for each key component of IJ.

Memorandum Summary

Core Appendix Q and Subparts - Appendix Q to the State Operations Manual (SOM), which provides guidance for identifying immediate jeopardy, has been revised. The revision creates a Core Appendix Q that will be used by surveyors of all provider and supplier types in determining when to cite immediate jeopardy. CMS has drafted subparts to Appendix Q that focus on immediate jeopardy concerns occurring in nursing homes and clinical laboratories since those provider types have specific policies related to immediate jeopardy. 

Key Components of Immediate Jeopardy – To cite immediate jeopardy, surveyors determine that (1) noncompliance (2) caused or created a likelihood that serious injury, harm, impairment or death to one or more recipients would occur or recur; and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to one or more recipients.

Immediate Jeopardy Template – A template has been developed to assist surveyors in documenting the information necessary to establish each of the key components of immediate jeopardy. Survey teams must use the immediate jeopardy template attached to Appendix Q to document evidence of each component of immediate jeopardy and use the template to convey information to the surveyed entity.

The April 2019 changes include revisions to the inspection process, enhancement of new staffing information, and implementation of new quality measures.

This includes a lifting of the ‘freeze’ on the health inspection ratings instituted in February 2018. CMS ‘froze’ the health inspection star ratings category after implementing a new survey process for Long-Term Care facilities. Because facilities receive surveys at different times, some facilities would have been surveyed under the old process and others under the new process. Without placing a ‘freeze’ on health inspection star ratings, the facilities would have been scored using two different evaluation processes making the outcomes misaligned and the data inaccurate. CMS ‘froze’ the health inspection star rating score until all nursing homes were surveyed at least once under the new survey process for Long Term Care facilities. Ending the freeze is critical for consumers. In April, they will be able to see the most up to date status of a facility’s compliance, which is a very strong reflection of a facility’s ability to improve and protect each resident’s health and safety.

Additionally, CMS is setting higher thresholds and evidence-based standards for nursing homes’ staffing levels. Nurse staffing has the greatest impact on the quality of care nursing homes deliver, which is why CMS analyzed the relationship between staffing levels and outcomes. CMS found that as staffing levels increase, quality increases and is therefore assigning an automatic one-star rating when a Nursing Home facility reports “no registered nurse is onsite.” Currently, facilities that report seven or more days in a quarter with no registered nurse onsite are automatically assigned a one-star staffing rating. In April 2019, the threshold for the number of days without an RN onsite in a quarter that triggers an automatic downgrade to one-star will be reduced from seven days to four days. CMS is also making changes to the quality component on Nursing Home Compare that would improve identifying differences in quality among nursing homes, raise expectations for quality, and incentivize continuous quality improvement.

To provide further value and remain consistent with CMS’s Meaningful Measures initiative the April 2019 Nursing Home Compare Update includes adding measures of long-stay hospitalizations and emergency room transfers, and removing duplicative and less meaningful measures. CMS is also establishing separate quality ratings for short-stay and long-stay residents and revising the rating thresholds to better identify the differences in quality among nursing homes making it easier for consumers to find the right information needed to make decisions.

The most recent AHRQ Nursing Home Survey on Patient Safety Culture Database Report presents data from 191 nursing homes and 10,499 nursing home respondents who completed the survey between January 2016 and July 2018 and submitted data to the Nursing Home SOPS database. The report presents statistics (averages, standard deviations, minimum and maximum scores, and percentiles) on the patient safety culture composite measures and items from the survey. Appendixes A and B present overall results by nursing home characteristics (bed size, ownership, census region, and urban/rural status) and respondent characteristics (job title, nursing home work area, interaction with residents, shift worked most often, and tenure in nursing home). The report contains data voluntarily submitted by participating nursing homes and is not representative of all U.S. nursing homes.

All Cause Harm Prevention in Nursing Homes Applying Strategies from the New CMS Change Package

Thursday, January 24, 2019, 3:00pm ET (1 hour) Recording Available.

One-third of SNF residents experience an adverse or temporary harm event, and the majority of those are preventable. As part of CMS’s focus on raising awareness of nursing home safety and to support safer nursing home care across the nation, CMS and the Quality Innovation Network National Coordinating Center released a new resource: a Change Package to prevent all cause harm in nursing homes. The Change Package is a compendium of successful practices of high-performing nursing homes, illustrating how they prevent harm while honoring each resident’s rights and preferences.

Nursing homes can have the most beautiful policies and procedures for infection prevention and control in the world, but if staff aren’t following through on them, they are a waste of paper, notes Deb Patterson Burdsall, PhD, RN-BC, CIC, FAPIC, an infection prevention and control consultant and faculty member at the Association for Professionals in Infection Control and Epidemiology (APIC) in Arlington, VA.

“So monitoring and auditing infection prevention processes in the facility is a critical component of quality care,” says Burdsall. “Unfortunately, the focus on infection prevention has not always been well-supported because infection surveillance, monitoring whether proper supplies are available and used correctly, and watching whether staff are performing hand hygiene and correctly using personal protective equipment all take time, which means the effort costs money.”