Guideline for Alzheimer’s Disease Management California Workgroup on Guidelines for Alzheimer’s Disease Management Final RepoRt 2008 Supported by the State of California, Department of Public Health California Version © april 2008 Guideline for Alzheimer’s Disease Management California Workgroup on Guidelines for Alzheimer’s Disease Management Final RepoRt 2008 Supported by the State of California, Department of Public Health California Version © april 2008 Acknowledgments We gratefully acknowledge the members of the California Workgroup on Guidelines for Alzheimer’s Disease Management for their efforts in updating this guideline. This effort would not have been possible without their participation in the following work groups: Executive Committee Debra Cherry, PhD (Co-Director) James Howard, MS Brian Mittman, PhD Alzheimer’s Association, Calif. Southland California Department of Public Health VA Greater LA Healthcare System at West LA Freddi Segal-Gidan, PA, PhD (Co-Director) Kathony Jerauld, MPH Dodie Tyrrell, MA USC ADRC & USC/ Rancho Los Amigos ARCC California Department of Public Health California Department of Public Health Patrick Fox, MSW, PhD Neal Kohatsu, MD, MPH Barbara Vickrey, MD, MPH UCSF Institute for Health & Aging California Department of Public Health UCLA Alzheimer’s Center Carol Hahn, MSN, RN (Manager) Kit Lackey Alzheimer’s Association, Calif. Southland California Department of Public Health Assessment Treatment Patient and Caregiver Education and Support Josh Chodosh, MD (Co-Chair) Bradley Williams, PharmD (Chair) Linda Hewett, Psy.D (Chair) VA Greater LA Healthcare System/ USC School of Pharmacy UCSF- Fresno Alzheimer’s Research Center UCLA Division of Geriatrics Cynthia Barton, RN, MSN, GNP Cordula Dick-Muehlke, PhD Laura Mosqueda, MD (Co-Chair) UCSF ARCC CAADS & Alzheimer’s Family Services Center Program in Geriatrics, Jeffrey Cummings, MD Bunni Dybnis, MA, MFT, CMC UCI School of Medicine Mary S. Easton Center National Assoc. of Professional Geriatric Care Linda Aoyama, MD for AD Research at UCLA Managers & LivHome Healthcare Partners Medical Group Denise Feil, MD, MPH Elizabeth Edgerly, PhD Michael-Anne Browne, MD VA Greater LA Healthcare System Alzheimer’s Association, Northern Calif. Blue Shield of California at West LA & Northern Nevada Tony Kuo, MD, MSHS R. Ron Finely, BS Pharm, RPh. Dolores Gallagher-Thompson, PhD Office of Senior Health, UC School of Pharmacy, Dept. of Psychiatry & Behavioral Sciences, LA County Dept. of Public Health Dept. of Clinical Pharmacy Stanford University School of Medicine Verna Porter, MD James Hendrickson, MD Kathleen Kelly, MPA UCLA Department of Neurology SCAN Healthplan Family Caregiver Alliance Lisa Yarick, MSW Cheryl Phillips, MD Helene Martel, MA Kaiser Permanente On Lok Lifeways Care Management Institute, Kaiser Permanente Jennifer Serafin, RN, GNP Thomas A. Porter Natl Conference of Gerontological AARP Nurse Practitioners Reporting Requirements Ramón Valle, PhD Elizabeth Smalley, MD San Diego State University Fay Blix, JD (Chair) Healthcare Partners Medical Group National Academy of Elder Law Attorneys Roberto Velasquez, MSG Alex Sherriffs, MD Alzheimer’s Association, San Diego/Imperial Kit Lackey UCSF-Fresno California Department of Public Health Alzheimer’s Research Center Janet Morris, JD Bet Tzedek Legal Services Additional Acknowledgments We sincerely acknowledge the efforts of the Guideline Project’s Research Associate, Randi Jones, JD for her remarkable efforts compiling data for this review and drafting significant sections of the report. Thanks also go to Mira Byrd, PharmD candidate for her valuable assistance in the revision of the drug therapy tables. Final thanks to Amy Landers of the Alzheimer’s Association for the development of a dissemination plan for this guideline. pReFaCe This report updates and expands the Guidelines for Alzheimer’s Disease Management (California Workgroup on Guidelines for Alzheimer’s Disease Management, 2002), which itself was a revision of the California Workgroup’s original Guideline published in 1998. All of these documents were based upon work begun by the Ad Hoc Standards of Care Committee of the Alzheimer’s Disease Diagnostic and Treatment Centers (ADDTCs) of California (Hewett, Bass, Hart, & Butrum, 1995) and were supported in part by the State of California, Department of Health Services, and the Alzheimer‘s Association, California Southland Chapter. Purpose and Scope of This Report More than 5 million Americans now have Alzheimer’s Disease (Alzheimer’s Association, 2008), an increase of 25% since the previous version of this Guideline was published. Alzheimer’s Disease destroys brain cells, causing prob- lems with memory, thinking, and behavior severe enough to affect work, family and social relationships, and, eventually, the most basic activities of daily living. Alzheimer’s Disease gets worse over time, it is incurable, and it is fatal. Today it is the seventh leading cause of death in the United States, and the fifth leading cause for individuals 65 and older (Alzheimer’s Association). Since the 2002 revision was completed, there has been an explosion of re- search in the field, generating new insights into the progression, treatment, and management of Alzheimer’s Disease. The revised Guideline and this report are based in large part on a review of journal articles and meta-analyses published after 2001, incorporating the results of this tremendous body of new work. Most older adults—including those with Alzheimer’s Disease—receive their medical care from Primary Care Practitioners (PCPs) (Callahan et al., 2006), who may lack the information and other resources they need to treat this growing and demanding population (Reuben, Roth, Kamberg, & Wenger, 2003). Nevertheless, PCPs should be able to provide or recommend a wide vari- ety of services beyond medical management of Alzheimer’s Disease and comor- bid conditions, including recommendations regarding psychosocial issues, as- sistance to families and caregivers, and referral to legal and financial resources in the community. Many specialized services are available to help patients and families manage these aspects of AD, such as adult day services, respite care, and skilled nursing care, as well as helplines and outreach services operated by the Alzheimer’s Association, Area Agencies on Aging, Councils on Aging, and Caregiver Resource Centers. This Guideline is intended to provide assistance to PCPs in offering comprehensive care to patients with Alzheimer’s Disease and those who care for them over the course of their illness. Because the Guideline is intended for use by PCPs who will encounter Alzheimer’s Disease in the course of their work, we use the word “patients” throughout this report. However, it is important to recognize that the needs of people with Alzheimer’s Disease and their families extend far beyond the realm of medical treatment, and that PCPs will be called upon to provide a wide spec- trum of information and resources to assist them in dealing with this challeng- ing, sometimes overwhelming condition. New Information The 2002 Guideline was written prior to the development and testing of some new pharmacological agents, as well as numerous non-pharmacological interventions designed to improve disease management and quality of life for both Alzheimer’s Disease patients and their caregivers. Although some of these treatment methods were already in use, few were supported by evidence of effi- cacy from well-designed clinical trials. In many cases, this evidence now exists, and it is discussed in the current revision. A notable advance in pharmacological treatment of Alzheimer’s Disease was the introduction of memantine (Namenda) in October 2003, a year after release of the previous version of this Guideline. The first drug approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate to severe Alzheimer’s Disease, memantine has become an important component of treat- ment for many patients. The Treatment section includes two tables devoted to its use. In the ensuing 6 years, additional emphasis on other topics relevant to the treatment of Alzheimer’s Disease, along with the needs of patients and their families, has become apparent. These topics include, among others: • the importance of cultural and linguistic factors in Alzheimer’s Disease treatment; • the conduct of legal capacity evaluations; and • the special needs of early-stage and late-stage patients and their families The revised report includes much new material regarding these critically important subjects, as well as updated references for many points discussed in previous versions. New Format This version of the report also has been reformatted for convenience and ease of use, with appendices containing copies of many of the assessment instru- ments and forms cited in the text. Websites containing valuable resources for both PCPs and patients are included, and the online version of the report con- tains links to many of these resources. As with the previous versions, the Guideline’s recommendations them- selves were designed to fit on one page for handy reference and organized by major care issues (assessment, treatment, patient and family education and sup- port, and legal considerations). The revised and expanded report has been or- ganized to conform to this layout. Each section deals with one of the four care issues and provides an overview of the issue, followed by the care recommenda- tions and a review of the literature supporting them. The language used through- out the report reflects the strength of the supporting evidence, either “strong” (e.g., randomized clinical trial) or “moderate.” In some instances, recommenda- tions that are not evidence-based are nevertheless supported by expert opinion and Workgroup consensus, and are labeled as such. taBle oF ContentS page 7 Guideline Recommendations page 9 assessment page 19 treatment page 37 patient and Family education and Support page 45 legal Considerations page 49 References appendices Guideline for Alzheimer’s Disease Management Monitor Changes Reassess Frequently Assess Capacity Conduct and document an assessment reassessment should occur at assess the patient’s and monitor changes in: least every 6 months, and sudden decision-making capacity t n •Daily functioning, including feeding, bathing, dressing, mobility, changes in behavior or increase in and determine whether a E toileting, continence, and ability to manage finances and medications the rate of decline should trigger surrogate has been identified. M an urgent visit to the PCP. •Cognitive status using a reliable and valid instrument S Identify Culture & Values S •Comorbid medical conditions which may present with sudden Identify Support identify the patient’s and fam- E worsening in cognition, function, or as change in behavior S identify the primary caregiver and ily’s culture, values, primary S •Behavioral symptoms, psychotic symptoms, and depression assess the adequacy of family and language, literacy level, and A •Medications, both prescription and non-prescription (at every visit) other support systems, paying par- decision-making process. •Living arrangement, safety, care needs, and abuse and/or neglect ticular attention to the caregiver’s own mental and physical health. •Need for palliative and/or end-of-life care planning Develop Treatment Plan Treat Behavioral Symptoms Non-Pharmacological Treatment First Develop and implement an ongoing Treat behavioral symptoms and IF non-pharmacological approaches prove treatment plan with defined goals. mood disorders using: unsuccessful, THEN use medications, t Discuss with patient and family: •Non-pharmacologic approaches, such targeted to specific behaviors, if clinically n •Use of cholinesterase inhibitors, NMDA as environmental modification, task indicated. note that side effects may be E antagonist, and other medications, if simplification, appropriate activities, etc. serious and significant. M clinically indicated, to treat cognitive •Referral to social service agencies or At decline support organizations, including the Treat Co-Morbid Conditions E •Referral to early-stage groups or adult Alzheimer’s Association’s MedicAlert® + Provide appropriate treatment for r comorbid medical conditions. t day services for appropriate structured Safe Return® program for patients who activities, such as physical exercise and may wander Provide End-of-Life Care recreation Provide appropriate end-of-life care, including palliative care as needed. Integrate Medical Care & Support Discuss Diagnosis & Treatment Discuss Stages t integrate medical care with education Discuss the diagnosis, progression, Discuss the patient’s need to make care r t and support by connecting patient and treatment choices, and goals of choices at all stages of the disease or caregiver to support organizations for alzheimer’s Disease care with the through the use of advance directives ypo Lpp linguistically and culturally appropriate patient and family in a manner and identification of surrogates for Miup educational materials and referrals consistent with their values, medical and legal decision-making. t & FAn & Sn & Su tgcoor oncuospumsltm,a lteuiognnait ylo cnroe cusanorsueer clnienesge,, d srsue psappniodter ot cpatiroen, s, plerveefel,r aenndce tsh,e c pualttuieren,t ’es daubcilaittiieosn. al DDiissccuusss sth Een indt-eonfs-iLtyi foef cDaerec iasniod ns noo and financial resources. Involve Early-Stage Patients other end-of-life care decisions with tiEAtiAti O•rgAalnzihzeaitmionesr’ sin Aclsusdoec:iation Pneaey dpsa ortfi ceualarlry -astttaegneti opna ttioe nthtse, sinpveocliva-l tahned a inlzvhoelvimede rfa’sm Diliys emaesme bpeartise nwth ile Acc puu (800) 272-3900 www.alz.org ing them in care planning, heeding respecting their cultural preferences. D their opinions and wishes, and refer- D •Caregiver Resource Centers EE (800) 445-8106 www.caregiver.org ring them to community resources, including the alzheimer’s association. •or your own social service department S n Planning Capacity Evaluations Elder Abuse Driving o include a discussion of the Use a structured approach Monitor for evidence of and report report the diagnosis i L At importance of basic legal and to the assessment of patient all suspicions of abuse (physical, of alzheimer’s Disease Ar financial planning as part of capacity, being aware of the sexual, financial, neglect, isolation, in accordance with EGDE the treatment plan as soon as relevant criteria for particular abandonment, abduction) to adult Pro- California law. Li possible after the diagnosis of kinds of decisions. tective services, long Term Care S n alzheimer’s Disease. ombudsman, or the local police o department, as required by law. c California Version © april 2008 Guideline for Alzheimer’s Disease Management Alzheimer’s Disease This is the third edition of this Guideline for and Its Impact Alzheimer’s Disease Management. The alzheimer’s Disease (aD) currently afflicts over first was disseminated in 1998 and updated 5.2 million americans, including an estimated in 2002. in the current version there are four 200,000 patients under the age of 65. The substantive changes: number of those afflicted is increasing annually •The advent of a new class of medication as the population continues to age. following (NMDA Antagonists) for the management of the aging of the baby boomers, prevalence will moderate to advanced AD escalate rapidly and is expected to double by •Support for a team approach (medical 2020. The burden on families and the health and social support strategies) to quality care system will be substantial as one out of ev- management of AD ery eight baby boomers develops this disease. •Strong evidence linking positive patient About the Guideline outcomes to caregiver education and support This Guideline presents core care recommen- •New evidence on management of the dations for the management of alzheimer’s disease in the very early and end stages Disease. it assumes that a proper diagnosis (see the recommendations below) has been made using reliable and valid di- agnostic techniques. The main audience for Early-Stage Recommendations the Guideline is primary care practitioners. Patients in early-stage aD have unique con- However, many of the activities recommended cerns. aD may progress slowly in the early stage. in the Guideline do not require a physician and follow up two months after diagnosis and every can be done by other members of the treatment six months thereafter. Pay particular attention to team (care managers, nurses, community sup- the special needs of early-stage patients, involv- port organizations) working closely with the pa- ing them in care planning and referring them to tient and caregiving family. The recommended community resources. Discuss implications with activities do not have to be done in one visit. respect to work, driving, and other safety issues with the patient. initiate pharmacologic therapy The California Workgroup on Guidelines for Alzheimer’s early. recommend interventions to protect and Disease Management, which consists of health- promote continuing functioning, assist with in- care providers, consumers, academicians dependence, and maintain cognitive health in- and representatives of professional and vol- cluding physical exercise, cognitive stimulation unteer organizations, developed the Guideline and psychosocial support. through a review of scientific evidence supple- mented by expert opinion when research has been unavailable or inconsistent. an expanded Late Stage and End-of-Life companion document, providing more in-depth Recommendations background information, is available through as the patient’s dementia worsens and the the alzheimer’s association’s California web- ability to understand treatments and partici- site www.caalz.org. pate in medical decision-making declines, care shifts to focus on the relief of discomfort. The advisability of routine screening tests, hospital- ization, and invasive procedures, including ar- Prepared by the tificial nutrition and hydration, will depend upon California Workgroup on Guidelines previously discussed care plan and the sever- for alzheimer’s Disease Management april 2008 ity of the dementia. Predicting the end-of-life for a patient with severe aD is difficult. referral to hospice should be considered. California Version © april 2008 GuiDeline for AlzheiMer’s DiseAse MAnAGeMent aSSeSSMent Assessment: Daily Functioning Careful and competent functional assessment enables the PCP and family to determine how best to maximize pa- tients’ independence (Ensberg & Gerstenlauer, 2005; Holmes Overview & Adler, 2005; Kane, Ouslander, & Abrass, 1994). Functional Appropriate treatment goals and plans that meet all of the assessment includes evaluation of physical, psychological, patient’s needs can only be developed through compre- and socioeconomic domains. Physical functioning may fo- hensive assessment of the patient, the family, and the home cus on basic activities of daily living (ADLs) that include environment. This assessment should address the patient’s feeding, bathing, dressing, mobility, and toileting (Kane et comorbid medical conditions, functional status, cognitive al.; Katz, 1983). Assessment of instrumental (or intermediate) status, and behavioral symptoms, including possible psy- activities of daily living (IADLs) addresses more advanced chotic symptoms and depression. The assessment should also self-care activities, such as shopping, cooking, and managing address the patient’s support system and decision-making ca- finances and medications. Standardized assessment instru- pacity, and identify the primary caregiver who, in addition to ments such as the Barthel (Mahoney & Barthel, 1965) or Katz other family members, is a critically important source of in- (Katz, Down, Cash, & Grotz, 1970) indices (see Appendix A) formation. The Primary Care Practitioner (PCP) should so- can provide information on the patient’s capacity for self- licit and consider caregiver and family input in post-diagnos- care and independent living. Proxies or patient surrogates tic treatment planning. can complete a number of these instruments when necessary (Bucks, Ashworth, Wilcock, & Siegfried, 1996; Byrni, Wilson, Bucks, Hughes, & Wilcock, 2000). The cognitive changes commonly associated with Recommendations • Conduct and document an assessment Alzheimer’s Disease first impact both the instrumental and and monitor changes in: eventually, the basic activities of daily living (Fitz & Teri, • Daily functioning, including feeding, bathing, 1994; Monllau et al., 2007; Park, Pavlik, Rountree, Darby, & dressing, mobility, toileting, continence, and Doody, 2007). The initial assessment of functional abilities is ability to manage finances and medications; important to determine a baseline to which future functional • Cognitive status using a reliable deficits may be compared. Assessment of a patient’s living en- and valid instrument; vironment can identify environmental supports that may be • Comorbid medical conditions which may present with sudden worsening in cognition, needed to maximize function, ensure safety, and minimize function, or as change in behavior; caregiver stress. It will also provide realistic goal setting and • Behavioral symptoms, psychotic symptoms, treatment planning information and allow early supportive and depression; interventions to be initiated (Ham, 1997). • Medications, both prescription and Recommendation: Conduct and document an assess- non-prescription (at every visit); ment and monitor changes in daily functioning, including • Living arrangement, safety, care needs, feeding, bathing, dressing, mobility, toileting, continence, and abuse and/or neglect. • Need for palliative and/or end-of-life and ability to manage finances and medications. care planning Assessment: Cognitive Status • Reassessment should occur at least every 6 months, and sudden changes in behavior or Cognitive status should be reassessed periodically to increase in the rate of decline should trigger an identify sudden changes, as well as to monitor the potential urgent visit to the PCP. beneficial or harmful effects of environmental changes, spe- • Identify the primary caregiver and assess the cific medications, or other interventions. Proper assessment adequacy of family and other support systems, requires the use of a standardized, objective instrument that paying particular attention to the caregiver’s own is relatively easy to use, reliable (with less variability between mental and physical health. different assessors), and valid (results that would be similar • Assess the patient’s decision-making capacity to gold-standard evaluations). A number of brief assessment and determine whether a surrogate has been identified. instruments have been developed, enabling PCPs to adopt instruments that are appropriate to their practices and pa- • Identify the patient’s and family’s culture, values, primary language, literacy level, and decision- tient populations. making process. The Mini-Mental State Exam (MMSE) (Folstein, Folstein, & McHugh, 1975) has become the most common- ly used tool for cognitive assessment. However, it has been criticized for the influence of education and language on an individual’s performance (Escobar et al., 1986; Grigoletto, CaliFornia VerSion © april 2008 9