During the past 8 years, federal legislation has transformed nursing homes into one of the most highly regulated environments for health care delivery in the United States. Major changes in the federal oversight of nursing home care were approved by Congress and became law as the Nursing Home Reform Amendments of the Omnibus Budget Reconciliation Act of 1987 (OBRA 87). l To implement this law, Congress directed the Health Care Financing Administration (HCFA) to develop a set of regulations that affects all aspects of nursing home operation, including the mental health care of nursing home residents.2 This article identifies relevant factors that led to these federal regulations, provides an overview of the provisions that govern psychiatric assessment and treatment, describes practical implications for psychiatric practice in the nursing home setting, and discusses the effects of these regulations on the psychiatric care of nursing home residents.
IMPETUS FOR NURSING HOME REFORM
Several factors prompted Congress to pass the reform provisions in OBRA 87. These included concerns about incentives for states to shift fiscal responsibility to the federal government for the residential care of mentally ill older adults; inadequate detection, evaluation, and treatment of mental health problems; and widespread inappropriate and even inhumane treatment of nursing home residents, including the misuse of psychotropic drugs and physical restraints.
Medicaid legislation enacted in the mid1960s provided part of the incentive that contributed to the closing of state psychiatric hospitals, a trend that continued through the 1970s and 1980s. With Medicaid available to cover the cost of their care in community nursing facilities, older adults with chronic mental illness who required residential care could now be discharged from state hospitals and admitted instead to nursing homes. In 1987, the House Committee on the Budget and the General Accounting Office cited concerns that patients with chronic and severe psychiatric problems were being inappropriately placed in nursing homes at Medicaid expense, thereby denying them access to the active psychiatric treatment they needed, and shifting a substantial portion of the costs of their care from the state to the federal government. These were major factors compelling Congress to enact OBRA 87. As a result, OBRA includes specific provisions for preadmission screening for all nursing home applicants.
Another major focus of concern was the need to improve quality of care, including mental health care. Despite the high prevalence of mental disorders among nursing home residents,3"6 most nursing facilities traditionally have lacked the design, staff, programs, services, and funding to care for patients with psychiatric symptoms and behavioral disturbances. The serious mismatch between residents' mental health needs and facility resources has been associated with a long history of inadequate treatment and neglect.7 Many problems have gone unrecognized and undiagnosed, and it has been estimated that as many as two thirds of nursing home residents with psychiatric disorders are misdiagnosedA9
The 1984 National Nursing Home Survey pretest revealed that, even for those with known psychiatric illness, access to mental health services was limited to less than 5% of affected residents.10 A 1986 report of the Institute of Medicine highlighted the underuse of antidepressant medication for treatment of affective disorders as an important problem to be overcome in improving the quality of nursing home care.11 Similarly, epidemiologie studies of patients with dementia demonstrate a pattern of unrecognized psychiatric symptoms or undiagnosed syndromes and disorders,3*8 including depression and psychosis, which remain untreated. Underuse of psychotropic medications in these patients deprives them of opportunities for relief of reversible symptoms and improvement in function and quality of life.7'12 In an attempt to address these deficiencies, OBRA. 87 mandated assessment and appropriate treatment of mental health problems in nursing home residents.
In addition to identifying the problem of undertreatment, there has been even more widespread concern among consumers, health care providers, and legislators regarding the overuse of psychotropic drugs and physical restraints in the nursing home. Studies have reported that psychotropic drugs are often prescribed without documented assessment of patients' mental status13 or without established psychiatric diagnoses.10 Thus, many patients are treated without clear indications or target symptoms that are likely to respond to psychotropic drugs.
The use of neuroleptic drugs for the control of behavioral symptoms may present the greatest potential for inappropriate use. Unfortunately, our knowledge in this area is limited by the paucity of quality research conducted specifically in nursing home populations. Most of the relevant studies suffer from significant design problems and do not provide an optimal scientific foundation on which to base professional practice guidelines - or governmental regulations. Nevertheless, when considered together, these studies suggest that neuroleptics can be effective in managing agitation and related symptoms in nursing home residents with dementia, although clinical benefits are often not substantial or may reflect placebo responses.14 Although controlled outcome studies are lacking, it has been suggested that other medications, as well as behavioral interventions, social/interpersonal strategies, or environmental modifications may have a lower risk of adverse effects while offering comparable therapeutic effects. Moreover, evidence for the efficacy of neuroleptic medications comes from short-term studies but, in the nursing home setting, these agents are often prescribed for long-term treatment.
Although we do not know what rate of neuroleptic use should be expected with optimal psychiatric care in the nursing home setting, we do know that 20% to 40% of nursing home residents are treated with neuroleptics. One classic, double-blind neuroleptic withdrawal study showed that only 16% of patients who had been receiving medications on a chronic basis exhibited significant deterioration when they were withdrawn.15 A more recent small-scale withdrawal study in patients who had been receiving neuroleptics for several months found that 22%' exhibited increased agitation upon drug discontinuation, 22% were unchanged, and 55% improved.16 These studies have been criticized for failing to allow sufficient time to observe all cases of relapse after complete clearance of drug in these elderly patients. Nevertheless, the results suggest that while a substantial proportion of patients do need to be treated and benefit from neuroleptics, an even larger proportion are treated unnecessarily.
Consumer advocacy groups such as the National Citizens' Coalition for Nursing Home Reform and the Alzheimer's Association have emphasized concerns that these medications, originally intended as therapeutic agents, are frequently being misused in long-term care facilities as "chemical restraints," often resulting in toxicity and decreased function. The enactment of OBRA 87 was, in part, a response to these concerns, and the OBRA regulations include a mandate for periodic révaluation of the need for and benefit from neuroleptic treatment.
Misuse of physical restraints also appears to be related to the mismatch between patients' needs and the resources available in most nursing facilities.7 Although disruptive behavior is a frequent reason for the use of restraints, it has been demonstrated that restraints do not actually decrease behavioral disturbances.17 Furthermore, restraint use is associated with such potential adverse effects as falls and injuries, skin breakdown, physiologic effects of immobilization stress, disorganized behavior and increased agitation, functional decline, and emotional distress.18 Several investigators have suggested that patients with behavioral disturbances can be managed effectively, more kindly, and perhaps more safely, without physical restraints.18,19 Nevertheless, surveys have reported physical restraint use in 25% to 85% of nursing home residents,18 and the resultant public outrage provided further impetus for federal regulation of nursing home care.
The legislation enacted by Congress (OBRA 87) mandated that HCFA issue regulations20 were designed to operationalize the laws. This, in turn, required that HCFA develop interpretive guidelines21 to assist federal and state surveyors in determining whether individual nursing facilities are in compliance with the regulations. The federal regulations cover nearly all aspects of nursing home operation, including administration (e.g., licensure, staff qualifications, recordkeeping, quality assurance), physical environment (e.g., space, equipment, safety, infection control), and specialized services (e.g., nursing, dietary, dental, rehabilitation, pharmacy). Mental health screening, evaluation, care planning, and treatment are addressed under sections of the regulations that pertain to resident assessment, resident rights and facility practices, and quality of care.
FEDERAL REGULATIONS AND PSYCHIATRIC ASSESSMENT
The OBRA regulations include provisions for Preadmission Screening and Annual Resident Review (PASARR) that require assessment of all applicants for admission to nursing facilities that receive federal funds.22 When a first-stage screening reveals that serious mental illness (other than dementia) may be present, a second-stage assessment requires a psychiatric evaluation to ascertain whether the patient has a mental disorder, to make a specific psychiatric diagnosis, and to determine whether there is a need for acute psychiatric care that precludes adequate treatment in a nursing home.
Thus, preadmission screening is intended to prevent inappropriate nursing home admission of patients with severe psychiatric disorders, as well as to ensure that patients with treatable psychiatric disorders are not placed in long-term care facilities before receiving the benefits of adequate psychiatric treatment. Patients who have a primary diagnosis of dementia, however, are exempt from the second-stage evaluation, presumably because they are categorically considered appropriate for nursing home placement. While this provision might make it less likely that a patient with dementia will be subject to discrimination and excluded from nursing home placement, it may also increase the chances that serious, potentially treatable psychiatric complications of dementia (such as delirium, depression, psychotic symptoms, and disruptive behaviors) will go untreated if the patient is admitted to a nursing facility without access to adequate psychiatric resources.7
Regulations requiring periodic comprehensive standardized assessment for all residents20 have led to guidelines for the completion of the Minimum Data Set (MDS) or an equivalent instrument on a regular basis, usually by nursing staff and other members of the interdisciplinary health care team.23 Areas of assessment on the MDS relevant to mental illness include mood, cognition, communication, behavior patterns, activities, functional status, psychosocial well-being, oral/nutritional status, comorbid disease, medications, and other treatments. Responses on the MDS that indicate deficits or changes in the patient's health status serve as triggers for Resident Assessment Protocols (RAPs), which are second-stage assessment tools designed to help nursing home staff recognize common signs and symptoms clusters that are indicators of clinically significant problems; to move beyond the MDS to algorithms that direct a more in-depth assessment for preventable or treatable factors that contribute to these problems; and evaluate care practices and treatments to determine those that will help the resident achieve the highest possible level of physical, mental, and psychosocial function.
To assist with these tasks, the RAPs provide specific information on medical conditions, psychiatric disorders, adverse treatment effects, functional impairments, and disabilities that are common among nursing home residents; list differential diagnoses and potential causal and aggravating factors; outline suggested approaches to evaluation; and identify key elements of management to be considered in treatment decisions and care planning.23 RAP problem areas related to mental disorders and behavior include delirium, cognitive loss/dementia, psychosocial well-being, mood state, behavior problems, psychotropic drug use, and physical restraints.
The regulations hold facilities responsible for ensuring that RAPs are followed appropriately. Although physicians have no mandated role in this process, physician involvement is clearly necessary for proper diagnosis and treatment of conditions covered by the RAPs.2 Psychiatrists may be involved in this process either if they are delegated by the facility to coordinate RAPs relevant to mental disorders and behavior problems, or if they are consulted regarding patients for whom the MDS or RAPs indicate a need for further evaluation.12
FEDERAL REGULATIONS AND PSYCHIATRIC TREATMENT
The sections of the OBRA regulations on resident rights, facility practices, and quality of care address pharmacologie and behavioral management, and thus directly affect psychiatric treatment in the nursing home. These sections of the regulations prohibit the use of physical restraints and psychotropic drugs when they are "administered for purposes of discipline or convenience and not required to treat the resident's medical symptoms."20
Neuroleptics are specifically targeted, with the requirement that facilities ensure that (1) residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record, and (2) residents who use antipsychotic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. Syndromes such as delirium and dementia, when accompanied by agitated or psychotic features, are listed among the accepted indications for the use of these agents. The nature and frequency of agitated behaviors must be charted; it must be shown that there are no preventable causes of psychosis or agitation; and they must be documented to cause (1) danger to the patient or others; (2) continuous crying, screaming, yelling, or pacing; or (3) resident distress or impairment in functional capacity.
Regulations related to quality of care further require that each resident's drug regimen be free from unnecessary drugs. An unnecessary drug is defined as any drug when used in excessive dose (including duplicate therapy); for excessive duration; without adequate monitoring; without adequate indications for its use; in the presence of adverse consequences indicating that it should be reduced or discontinued; or any combination of the reasons listed above.20 The interpretive guidelines that accompany these regulations are extensive and specifically limit the use of antipsychotic drugs, antianxiety agents, sedative-hypnotics, and related drugs.21 For each of these classes of medication, the guidelines provide a list of acceptable indications as well as specific agents that may not be used, maximum limits for daily doses, requirements for monitoring treatment and adverse effects, and time frames for attempting dose reductions and discontinuation. Although the regulations on unnecessary drugs apply to all classes of drugs, critics note that the accompanying guidelines focus on psychotropic drugs and do not specifically address the use of drugs for non-psychiatric conditions, despite the fact that inappropriate use of antibiotics, steroids, diuretics, analgesics, and other classes of drugs similarly represents a significant problem in the nursing home.
To minimize concerns that these explicit federal restrictions on medication use might interfere with medical practice, qualifying statements were added to the current guidelines to take into consideration the physician's judgment and input from medical or psychiatric consultants, including those specializing in geriatrics. Geriatric psychiatrists played a key role in persuading HCFA to amend the initial guidelines to reflect the fact that many nursing home residents have psychiatric symptoms and disorders that are likely to respond positively to psychotropic medications. For these residents, pharmacotherapy is often an appropriate first-line treatment, and in such cases, the goal should not be to limit the use of medication, but rather to ensure that patients receive medication in adequate doses and for sufficient duration to relieve their distress and promote optimal function, safety, and quality of life. Although the regulations still emphasize limits on the use of psychotropic drugs, the guidelines now acknowledge that appropriate medical treatment can entail psychotropic medication regimens that depart from these limits when necessary to maintain or improve symptom control and the resident's functional status. For example, the guidelines recognize the possibility of a situation in which dose reduction or discontinuation is associated with recurrence of symptoms, in which case further attempts at dose reduction or discontinuation are considered "clinically contraindicated."
The guidelines instruct surveyors to allow nursing facilities the opportunity to present a rationale for the use of a drug that deviates from the guidelines, and to explain why this serves the best interest of the resident, before finding that the facility is not in compliance with the regulations. Thus, physicians' prescribing options for treating nursing home patients are not strictly constrained by the federal regulations, as long as there is documentation of the clinical reasoning process by which the physician determined that the benefits to the patient (measured by symptom relief, improved health status, or increased level of function) outweigh the risks of treatment as prescribed.7 Although the facility, not the physician, is accountable for compliance with the regulations, the physician's clinical reasoning and judgment still play a critical role in the process of ensuring quality care.
The regulations also emphasize the resident's right to be free from physical restraints unless they are required to treat medical symptoms or promote function.20 According to the interpretive guidelines, restraints may not be used unless there have been documented efforts to identify and correct preventable or treatable factors that cause or contribute to the problem, prior attempts to use less restrictive measures have failed, and the restraints enable the resident to achieve or maintain the highest practicable level of function.21 When restraints are indicated to enhance body positioning or mobility, physical or occupational therapists must be consulted and must document the medical need and benefit to the patient. The use of physical restraints further requires the consent of the patient or responsible family member or guardian.
The unique and complex problems of geriatric patients, together with the federal mandate to ensure quality of care in long-term care facilities, define a need for geriatric mental health services in the nursing home. The section of the regulations on quality of care requires the facility to provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being. Nursing facilities "must ensure that a resident who displays mental or psychosocial adjustment difficulty receives appropriate services to correct the assessed problem."20
Despite the attempt to promote casefinding through resident screening and assessment, and the provisions for mental health services under quality of care requirements, OBRA legislation and regulations have not addressed deficiencies in access to mental health services for nursing home residents or limitations due to inadequate funding for such services.7
IMPACT OF OBRA 87
Several studies have demonstrated significant changes in the use of psychotropic drugs and physical restraints after the implementation of the OBRA 87 regulations. Rovner et al24 evaluated changes in psychotropic prescribing for 2707 residents in 17 nursing homes after a pharmacy service provided educational materials about the OBRA regulations and medication use to medical directors, primary care physicians, and directors of nursing. From 3 months before until 3 months after the implementation of the regulations, there was a 37.4% reduction in neuroleptic use and a 53.3% reduction in prescriptions for physical restraints with no increase in sedative/ hypnotic use. A slight increase in prescriptions of antidepressants from 19.4% to 21.9% was not sustained at 1-year follow up.
Semla et al25 conducted a 12-month retrospective review of prescriptions for antipsychotic drugs in a 485-bed nursing home after the regulations went into effect. Discontinuation or dose reduction was attempted in 75% of all 107 patients studied; antipsychotic drugs were stopped in 45% of residents with a dementia-only diagnosis and in 25% of residents with a psychiatric diagnosis. Of those residents whose antipsychotic medication was either tapered or discontinued, 20% subsequently had the agent restarted or its dose increased.
Shorr et al26 conducted a longitudinal study of 9432 elderly Medicaid enrollees in Tennessee nursing homes during a 30-month period surrounding the implementation of OBRA 87 regulations. They found a 26.7% decline in antipsychotic drug use without a concomitant increase in the use of other psychotropic drugs. Greater reductions in antipsychotic use were associated with higher baseline rates of antipsychotic use and higher third-shift staffing levels.
Several other investigators have developed educational interventions that complement the process of reform initiated by the federal regulations. Avorn et al27 evaluated the efficacy of an educational program in geriatric psychopharmacology aimed at physicians, nurses, and aides. Scores on an index measuring the magnitude and probable inappropriateness of medication use declined significantly more in nursing facilities where staff participated in the program, in comparison to control nursing homes.
Ray et al28 evaluated an educational intervention directed at physicians and nursing staff that emphasized evaluations of patients for reversible medical or psychosocial causes of behavior disorders, nonpharmacologic techniques for prevention and management, use of low-dose antipsychotics for serious behavior disorders, and gradual withdrawal of antipsychotics when possible. In facilities receiving the intervention, antipsychotic use was reduced by 72%, compared to only 13% in control nursing homes.
Similarly, Schnelle et al29 evaluated the effectiveness of a simple procedure that provided cues to staff, and found an increased rate of compliance with federal regulations regarding the use of physical restraints.
These studies demonstrate that historic patterns of overuse of psychotropic drugs and physical restraints may be reduced effectively through educational and regulatory efforts. Although these reductions are consistent with an improvement in the quality of nursing home care,26 it is not known how these changes affect residents' symptoms, levels of distress, functional status, or quality of life. It is also not known whether problems of inadequate recognition and undertreatment of mental disorders will be remedied by these reform measures. Geriatric practitioners and researchers have urged that the federal regulations, with their emphasis on avoidance and discontinuation of unnecessary drugs, not be applied without regard to individual clinical circumstances such that they have the undesirable effect of discouraging the initiation and continuation of appropriate and necessary treatment.30 Although the federal regulations do require that mental health treatment be made available to nursing home residents who would benefit from it, OBRA does not address problems of access to care and has been criticized as an underfunded mandate. No studies have been done to determine whether the regulations have actually resulted in improved casefinding and provision of mental health care. Furthermore, Elon and Pawlson note that this regulatory model creates an adversarial relationship between the regulators and the providers of service, with heavy penalties to enforce compliance instead of helpful educational strategies to promote continuous quality improvement.2 Use of educational approaches by governmental regulatory agencies is more common outside the United States, and their utility is supported by the educational outcome studies cited.
Despite all their theoretical and actual limitations, the OBRA 87 regulations constitute a substantial public policy initiative intended to improve the care of nursing home residents by explicitly recognizing the importance of psychological and social domains of their lives; restricting the inappropriate use of psychotropic drugs and physical restraints; and requiring the provision of activities and services that are necessary for patients to attain and maintain the "highest practicable physical, mental, and psychosocial wellbeing." Quality of care is likely to be enhanced by increasing the emphasis on education of providers, rather than penalties for noncompliance. Although the actual impact of OBRA 87 on many important resident outcomes, including quality of life, is unknown, the federal regulations are a significant landmark in the reform movement with major ramifications for psychiatric care in the nursing home.
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