Improving Patient Safety in Long-Term Care Facilities: An Overview of AHRQ Funded Projects

Janice Feinberg, PharmD, lawyer, and a research manager for the American Society of Consultant Pharmacists Research and Education Foundation, reviewed her research proposal, which was submitted in response to the Agency for Healthcare Research and Quality (AHRQ) RFP for clinical informatics and patient safety. The aims of this study were to test the effectiveness of a software tool called the Geriatric Risk Assessment Med Guide™ (GRAM™) in reducing serious and preventable adverse drug effects, and focused on reducing falls and delirium. “What we hope to do with this study,” Dr. Feinberg explained, “is improve daily monitoring of potential adverse drug effects for early recognition, so the problems can be avoided, managed, or reversed.

The specific aims of the study are to find out the extent to which the use of the GRAM™ software increases incorporation of monitoring recommendations to detect adverse medication effects into the resident care plan.” The hypothesis is that the use of the software will reduce the incidence of falls and delirium, reduce the incidence of hospitalizations due to potential adverse drug effects, and reduce the number of residents who trigger the falls and delirium RAP (Resident Assessment Protocol). The pharmacy staff and the nursing facility staff were also surveyed to determine the impact on efficiency, productivity, workload, and satisfaction. GRAM™ is a unique clinical software tool that was developed based on the federally mandated resident assessment instrument. It identifies medications that have the potential to cause, aggravate, or contribute to 15 common geriatric problems that correspond to the RAP problems. It also correlates medication effects with signs, symptoms, syndromes, and indicators that describe mood, behavior, cognition, psycho-social well-being, and involvement activities that correspond to Minimum Data Set (MDS) items. It can be used to help inform the resident assessment and care-planning process; promote the integration of medication monitoring information into the patient’s care plan; identify medications that have the potential to cause, aggravate, or contribute to geriatric problems; and promote the incorporation of assessment data into the pharmaceutical care plan.

The first rationale for the project is that medication-related problems persist in nursing facilities despite the requirement that all residents’ drug regimens be reviewed at least monthly by the consultant pharmacist. The other part of the rationale is that most patient safety initiatives focus on reducing medication errors through targeting prescribing, dispensing, or administration errors. This research project is unique in that it is focusing on the monitoring stage of the medication use process. Dr. Feinberg and her team chose to focus on delirium because one-third of preventable adverse drug effects are neuropsychiatric in origin. Delirium is associated with severe outcomes, and drugs are one of the most common precipitating factors for delirium. The treatment of delirium is based on the treatment of precipitating factors, and prevention plays the most important role. The rationale for the focus on falls is that 20% of preventable adverse drug effects involve falls; therefore, prevention targets medications as a major risk factor. “It is a randomized trial,” Dr. Feinberg explained. “We enrolled 26 nursing facilities, 13 that receive the intervention, and 13 that receive the usual standard of care. Facilities had to be Medicare/Medicaid-certified with more than 50 beds, and be used primarily for geriatrics. They also had to have stable contracts with the long-term care pharmacies that we are working with.” For all new admissions, the nursing facility receives a GRAM™ RAP-Med report, which identifies the medications the patient is receiving that may cause, aggravate, or contribute to 15 of the RAP problems. The nurses can also request this report for their quarterly and annual assessments.

In addition to the RAP-Med report, new patients who are receiving medications that can cause, aggravate, or contribute to falls and/or delirium get a medication monitoring care plan and flow record, which specify specific MDS items that are signs, symptoms, and indicators of potential adverse medication effects that should be observed for. “It has been our experience,” explained Dr. Feinberg, “that for about 5 months into the intervention phase virtually every nursing home admission is on at least one medication that can cause, aggravate, or contribute to either falls or delirium. The medication monitoring care plan and flow record are implemented upon admission. They do not need to wait for a complete care plan after the initial assessment is done. Many adverse medication effects occur within the first week to 10 days after admission, so we are looking at early recognition of potential problems.” In most of the intervention facilities, the nursing assistants are observing for and documenting the potential adverse medication effects. The study was not intended to be an all-encompassing fall prevention program, but rather to target adverse medication effects that may contribute to the risk for falls.

Specific MDS items monitored and observed for in the falls flow record include dizziness or vertigo, periods of lethargy, blurred or impaired vision, unsteady gait, dehydration, urination urgency, urination frequency, and nocturia. While not all-encompassing in terms of risk factors for falls, the researchers wanted to focus on items that are included in the resident assessment instrument, which can be easily observed by the nursing assistant. “This observation and documentation is done until the admission assessment is complete. Nursing, in conjunction with the consultant pharmacist, will determine whether or not any of these items should be carried forward into the current care plan,” said Dr. Feinberg. The consultant pharmacists become involved in this study when a resident triggers the falls and/or delirium RAP. The pharmacist receives a GRAM™ triggered RAP-Med report for all residents who have triggered the falls and/or delirium RAP since the pharmacist’s last facility visit. The report lists the medications that the patient is receiving that may cause, aggravate, or contribute to falls and/or delirium. The consultant pharmacist provides a targeted drug regimen review, evaluating the patient’s medications for the potential to cause, aggravate, or contribute to falls and/or delirium. In addition, they observe and/or assess the patient on each visit; make recommendations directly to the prescriber based on their evaluation; review the medication monitoring care plan and flow record, as well as the recommendations to the physician, with the MDS Coordinator; and make decisions on what to continue in the care plan, and whether or not to continue observations on the flow record.

Dr. Feinberg and her team also developed nursing in-service programs and related materials, for both nurses and nurse assistants, that focus on medication effects and how they relate to the risk for falls and delirium; the inservices are conducted by the consultant pharmacist. “The evaluation of the study will rely on MDS data, which will be obtained from the Centers for Medicare & Medicaid Services (CMS), as well as pharmacy claims data and pharmacist intervention data, which will be obtained from the pharmacies. We are doing primary data collection through a survey of the pharmacy staff and nursing facility staff, and also have nursing facility demographic information.” Dr. Feinberg explained that the pre-implementation tasks included development of the medication monitoring care plans and flow records, which was done with nurses with experience in long-term care; integration of the GRAM™ software into the pharmacies’ computer systems; recruitment of nursing facilities; and development and administration of the staff survey.

The team conducted orientations for all the facility staff and the pharmacy staff and provided special training to the consultant pharmacists on the resident assessment process, GRAM™ software, and on drug effects contributing to the risk for falls and delirium. “We were delayed in implementation for at least 5 or 6 months because of the new HIPAA regulations. We were scheduled to start the study before HIPAA went into effect,” said Dr. Feinberg, “and basically we had to wait until it went into effect last March because no one knew how to evaluate a research study for compliance with the regulations. Eventually we used an independent HIPAA Review Board. The implementation started in January of this year, and we will be doing our data collection through December. I have several anecdotal reports on how the study is progressing. In some facilities, the nursing assistants who have been given the responsibility for doing this observation and charting take this responsibility seriously and have risen to the task of doing this work. The nurses, in general, like having this information to help inform the initial assessment. They can review the RAP-Med report and see which RAP problems the patient’s drug regimen puts them at greatest risk for.”

Pain Management

Dr. Ginette Pepper, a Professor and the Colby Presidential Endowed Chair in Gerontological Nursing at the University of Utah College of Nursing, focused on patient safety in the context of improving resident pain management in nursing homes. The presentation explored pain management as a safety issue as informed by the AHRQ Funded Study directed by Dr. Katherine Jones from Yale University. “In this study,” Dr. Pepper explained, “we had 12 nursing homes that were matched and then randomly assigned to the experimental or control condition. Eight of the nursing homes were in rural areas, some in northeast Colorado and some in southwest Colorado, as well as four in urban areas. Facilities were selected to have a high representation of Hispanic residents.

The intervention was based upon Rogers’ Diffusion of Innovations Model and consisted of intensive staff education, short in-services given several times in a 24-hour period, the implementation of a pain team within the nursing home, posters containing “factoids” about pain management, consultation by a pain expert doing pain rounds with the staff, and the provision of a large number of resources in pain management. There was also education through academic detailing and resources provided to physicians and mid-level providers (ie, nurse practitioners, physician assistants) who were prescribing in the nursing homes, as well as to the consulting pharmacists. Finally, a family and patient video was developed to inform consumers that pain can be managed without serious side effects. Outcomes were assessed four times per year, in both the experimental and control homes, using a direct resident assessment, as well as chart review and collection of some MDS data.

A Staff Knowledge and Attitudes Scale measured the effects of the intervention at baseline at the end of one year of intensive intervention. There were also focus groups leveled by education, with nursing assistants interviewed separately from licensed personnel (ie, registered nurses, liscensed practical nurses, therapists).” Pain is a major problem in nursing homes. The literature indicates that between 40% and 83% of individuals in a nursing home have persistent pain. The Institute of Medicine’s “To Err is Human” report defined patient safety as freedom from accidental harm, and error as being when the patient is harmed by the care that is supposed to help them.  “If we think about pain,” Dr. Pepper explained, “the majority of the pain that we see in nursing homes is related to the disease process and not to the care that is meant to help people, so it is not obvious that pain is a safety issue. In acute-care settings, pain usually results from procedural and operative pain, clearly a patient safety issue because the medical care caused the pain. In contrast, pain in the nursing home can be conceptualized in terms of errors that occur in managing pain or not managing pain.

Starck et al¹ defined three types of errors: skill-based errors (slips and lapses), rule-based errors (misapplication of good rules or the application of bad rules), and knowledge-based errors (incomplete or incorrect knowledge). All three types of errors occur in pain management. The belief that if the resident does not complain of pain, then he or she is not having pain is an example of a skill-based error due to a lapse in assessment. Another lapse would be prescribing or administering the wrong dose of medication unintentionally. A common rule-based error found in the study was that if a resident was on pain medication that is ordered every 3-4 hours, then he or she must wait 4 hours for medication regardless of the level of pain. A knowledge-based error might be giving nonsteroidal anti-inflammatory drugs around the clock routinely to older adults, as opposed to using these agents that can have multiple adverse events only on a short-term or as-needed basis. “Much of the conceptualization around patient safety comes out of the theory of James Reason,” explained Dr. Pepper. “This includes the concept of the blunt end or latent failure, which are those errors that are lurking in our health care systems, waiting to be triggered by the active failure of the direct care provider at the sharp end. These latent failures might be the policies, budgetary distribution, and regulations of an organization which determine the resources and constraints at the sharp end. The knowledge, goals, and mindset of the care provider at the sharp end interact to produce error (poor pain management or adverse drug events) or expertise (controlled pain with minimal side effects). When looking at pain management errors that occurred in our study, our goal is to fix the error and not to fix blame. We are looking at ways to make sure that people get the best pain management possible, so it is necessary to look at the system that promoted the error or failed to prevent human error from harming the resident. Blaming and punishing individuals does not prevent the next triggering of latent error.”

Dr. Pepper and colleagues found that the independent risk factors for patients who were likely to be receiving no analgesia were those over age 85 and those who were cognitively-impaired. Risk factors for moderate-to-severe pain were being male or having Hispanic ethnicity. A common finding was failure to document the effectiveness of medications. So even when people were getting medication, it was unclear from the record whether the medication was effective or not. Staff reported in the focus groups that they used non-drug treatments like repositioning, massage, or exercise, but this was not evident in the record. One of the general rules for geriatric prescribing is “start low and go slow,” beginning with the lowest dose possible and very gradually increasing the dose, which applies to most medications other than analgesics. “Too many staff, residents, and families believe we should save pain medication for when the pain gets worse,” said Dr. Pepper. “Pain management experts would tell us that to postpone pain medication or to start low and go slow is not necessarily the best approach to pain management.” Treating pain before it becomes severe will reduce suffering and can even decrease the total amount of medicine required.

Another lack of knowledge area was about the dangers of using bulk laxatives like psyllium for individuals taking opioids (narcotics) for pain management, because this can cause serious side effects. There was common use of propoxyphene-containing products for nursing home residents, particularly propoxyphene with acetaminophen, despite the fact that propoxyphene has poor analgesic effectiveness combined with side effects as serious a those for strong narcotics. These products are listed as drugs to avoid on the Beers Criteria and American Medical Director’s Association (AMDA) pain management guideline, two sets of standards for prescribing compiled by panels of experts in geriatrics. Staff tended to think that nonpharmacologic treatments like repositioning and massage should be used for mild pain, but there was no recognition of the role of nonpharmacologic interventions for moderate-to-severe pain as an adjuvant to medications.” In terms of errors in resident education, Dr. Pepper and colleagues found that the residents and the family members tended to have great fear of side effects, fear of tolerance, fear of dependence, and fear of addiction. They were not educated about how rare these problems actually are. The residents largely were satisfied with their pain management even though they may have had pain in the range of 6 or more (on a 10-point scale). This reflected very low expectations. Some of the residents considered pain a normal part of aging.  They often do not want to bother the nurses and do not like taking so many pills. “Some of the system changes indicated were the implementation of routine pain assessments in long-term care,” said Dr. Pepper.

Many of the nursing assistants had cultural, language or educational barriers that needed to be considered. Many of the strategies to improve pain management may be simple tools. “We need to translate our scientific knowledge of optimal pain management into the tools that people are used to using in the clinical area, such as standardized assessment forms and routine procedures, recognizing that some of the smaller nursing homes may have limited resources. Some effective translation strategies are the interactive education processes, using role-playing, participative discussions, or interactive workbooks, “We provided feedback on our quarterly audits of pain to the staff, so that they knew how many of the residents were stating they were having pain on a daily basis, which made what we were teaching and modeling real and immediate. Also effective was having staff rounds with a pain consultant who role-modeled assessment and communication with prescribers,” said Dr. Pepper.

One of the problems that Dr. Pepper and co-workers encountered was the constant turnover at all levels. Some of their study sites had staff turnover of more than 100% in a one-year period, so that in some sites few of the staff at the end of the project had received the original educational intervention. “This complicates knowledge utilization, so you have to make sure ongoing education is built into the structure of the long-term care,” said Dr. Pepper. “We had a video that was shown to each new staff member, supplemented by an interactive workbook. We often found that even when there wasn’t high turnover, there was a lack of continuity in assignments. The nursing assistants would have a different group of patients each day rather than having consistency that might benefit staff and residents.” Absenteeism was also very high, and the researchers frequently found that when they went into the nursing homes to provide in-service, personnel might be working so short-staffed that they couldn’t get people off the unit to do the 30-minute in-services.

Communication issues are another set of latent failures in the system, particularly the hierarchy in long-term care. A relevant patient safety conceptual is the hierarchical gradient-retiscence of people who were junior to others to speak out, such as a nursing assistant not wanting to challenge a nurse, or a nurse not wanting to question a physician. The senior individuals often were not encouraging feedback and/or collecting information that the junior had about the resident. The residents felt vulnerable and often had a lack of trust in the nursing home personnel. Nursing assistants were usually excluded from meetings and reports, so they did not have the information about managing pain. There was often a lack of physician presence and physician trust, and the physician often felt like an outsider. Among all of the staff, there were knowledge gaps, biases, and stereotyping that have been commonly found to be barriers to the management of pain. “What were the implications of pain as a safety issue?” Dr. Pepper asked. “There is unnecessary pain and suffering without adequate management of pain.” Documented in the pain literature are the negative physiologic, medical, and financial consequences of pain, such as impairment of sleep, decreased quality of life, poor healing, and excess anxiety. This could translate into delayed participation or lack of participation in activities within the facility, which results in poor functional status and deconditioning. “Pain management is an area in which science is known and the evidence regarding the best practices is clear,” according to Dr. Pepper. “The problem lies in the knowledge about and the adherence to those guidelines. However, there are effective ways to promote translation of the science into practice to improve the safety and well-being of nursing home residents.”