Applying Treatment Guidelines to the Older Adult with Multiple Co-Morbidities Nicole J. Brandt, PharmD, MBA, CGP, BCPP, FASCP Professor, Geriatric Pharmacotherapy, Pharmacy Practice and Science UMB School of Pharmacy Director, Clinical and Educational Programs of Peter Lamy Center Drug Therapy and Aging Email: nbrandt@rx.umaryland.edu Financial Disclosure During the past 12 months, I have had financial relationships with the following organizations: Research/Grants: Econometrica, US Department of Health and Human Services Health Resources & Services Administration(HRSA), and the Research Retirement Foundation. Speakers Bureau: none Consultant: Centers for Medicare and Medicaid Services University of Pittsburgh Medical School Stockholder: none Other Financial Interest: Advisory Board: Pharmacy and Therapeutics Committee for Omnicare Editorial Boards: Section Editor for Gerontological Nursing Importance of Multimorbidity Over 50% of older adults have 3+ chronic conditions Increased risk of: Death Institutionalization Increased utilization of healthcare resources Decreased quality of life Higher rates of adverse effects of treatment or interventions Brendan Smialowski (NYTimes) Almost all existing guidelines have single disease focus Best approaches to decision-making and clinical management of older adults with multimorbidity remain unclear 1
Inquire about the patient s primary concern (and that of family and/or friends, if applicable) and any additional objectives for visit. Conduct a complete review of care plan for person with multimorbidity. OR Focus on specific aspect of care for person with multimorbidity. Current medical conditions and interventions Is there adherence/comfort with treatment plan? Patient preferences Is relevant evidence available regarding important outcomes? Consider prognosis. Consider interactions within and among treatments and conditions. Weigh benefits and harms of components of the treatment plan. Communicate and decide for or against implementation or continuation of intervention/ treatment. Reassess at selected interval (benefit, feasibility, adherence, alignment with preferences). Case Example An 87 year-old man complains of fatigue and taking too many medications. He is being referred for a MTM Comprehensive Review Lives in the community and is accompanied by his daughter, who is his Health Care Agent. Family is concerned about his safety and ability to live alone. High financial burden of medications with Medicare Part D His Current Care Plan Condition Probable Alzheimer s Disease Congestive Heart Failure Osteoarthritis Osteoporosis Insomnia Type 2 Diabetes Mellitus Benign Prostatic Hyperplasia Medical Treatment donepezil, memantine furosemide, metoprolol, lisinopril acetaminophen, tramadol calcium, D, alendronate zolpidem metformin, glyburide Tamsulosin, dutasteride Additional medications: aspirin, rosuvastatin 2
His Current Care Plan Current data: MMSE 23/30 today (25/30 6 months ago) Sitting BP: 110/70 pulse 54; standing: 100/60 pulse 56 HbA1c 6.8% (3 months ago 7%) Lipid panel: total 180, LDL 70, HDL 50, triglycerides 300 Echo 1 year ago: EF 30% Labs today: BUN/Cr: 40/1.7, glucose 100 Guiding Principles: Patient Preferences Interpreting the Evidence Prognosis Treatment Complexity and Feasibility Optimizing Therapies and Care Plans GUIDING PRINCIPLES: PATIENT PREFERENCES 3
Patient Preferences: Role of Family and Social Supports by using the term patient preferences, we aim to keep the patient central to the decision-making process, but fully recognize that family and social supports play a vital role in the management and decision-making process Not just for people with cognitive impairment that affects decision-making capacity Patient Preferences Justification: Older adults with MM can evaluate choices and prioritize preferences for care Most decisions are preference sensitive more than one reasonable treatment option possible lifelong implications for chronic disease management choices about treatments or interventions with important risks or uncertain benefits Patient Preferences Recognize when older adult with MM faces a preference sensitive decision Ensure that older adult with MM are adequately informed about the expected benefits and harms of different treatment options Elicit patient preferences after the older adult with MM is sufficiently informed Evidence base may be insufficient 4
Patient Preferences Eliciting Preferences is not the same as making a treatment decision Patients may want family, friends and caregivers to be included in decision-making Preferences may change over time Case: Patient Preferences The patient and his daughter express the following priorities: To stay alive To optimize quality of life To reduce out-of-pocket expenses To remain safely in his home GUIDING PRINCIPLES: INTERPRETING THE EVIDENCE 5
Interpreting the Evidence Justification: Evidence-based medicine provides tools to evaluate the applicability of findings in literature to each patient Gaps about interactions of conditions and treatments in older adults with MM Evaluation of medical literature is essential Interpreting the Evidence 1) Applicability and quality of evidence 2) Outcomes 3) Harms and Burdens 4) Absolute Risk Reduction 5) Time horizon to benefit Interpreting the Evidence Applicability and quality of evidence Study(ies) included and enrolled older adults with MM? Effect modification? Adverse events 6
Interpreting the Evidence Outcomes Surrogate (intermediate) vs. patientimportant outcomes What are the expected outcomes? Interpreting the Evidence Harms and Burdens Short-term efficacy trials Burden rarely reported Interactions Interpreting the Evidence Absolute Risk Reduction (ARR) Relative Risk Reduction (RRR) can be misleading Baseline risk of outcome in question (control group of RCTs, observational studies, prognostic indices) RRR and baseline risk can be used to calculate ARR 7
Interpreting the Evidence Time horizon to benefit Often not reported Length of time needed to accrue an observable and clinical meaningful risk reduction for a specific outcome Often imperfect information Dementia 36% (13-63%) decreased risk of NH placement for max use vs. min use of donepezil Time to NHP was different, but not significantly significant Geldmacher DS et al. JAm Geriatr Soc 51:937 944, 2003. Diabetes Mellitus Less stringent control reasonable in those with a long history of diabetes, limited life expectancy, or comorbid conditions Drug withdrawal study in 17 nursing homes in patients with HbA1c <6: safe to discontinue all oral meds, and stop or reduce insulin ADA Standards of Medical Care in Diabetes 2012. Sjoblom P. Diabetes Res Clin Prac 2008; 82:197-202. 8
Statin Use atorvastatin % event-free placebo Time until the statin is beneficial: approx 1-2 years for MI, >3 years for stroke PROSPER: 15% relative reduction, 2.1% ARR for primary endpoint Median life expectancy: 2.7-4.7 years Prevention of heart attack and stroke (PREFERENCES?) TIME 87 year old man with dementia: benefits with statins? PROSPER. Lancet 2002; 360: 1623 30. Time to Benefit How to Extrapolate from the Evidence H1 Proportion in the PROSPER Trial with CHD Death, Non-Fatal MI, or Stroke PROSPER. Lancet 2002; 360: 1623 30. Case: Evidence Diabetes Tight glycemic control may result in more harm than benefit Prolonged time until benefit for secondary endpoints Dementia Donepezil has had modest success in delaying institutionalization and maintaining functional status Osteoporosis Bisphosphonates for osteoporosis effective, with a modest absolute risk reduction 9
Slide 26 H1 Cynthia and Matt: This could go in Cynthia's section. The point is that we show a framework for how to understand time until benefit (as before in slide 72) but studies don't always report evidence in that way. Time until benefit would have to be extrapolated from PROSPER using these kinds of figures, which is how they report the time to event data. HMHolmes, 4/26/2012
GUIDING PRINCIPLES: PROGNOSIS Prognosis Justification: Necessary to assess risks, burdens and benefits Informs, does not dictate, clinical management decisions within context of preferences Not just mortality Prognosis Frame focused clinical question Determine outcome being predicted Select a prognosis measure (recognizing strengths and weaknesses) Estimate prognosis Integrate information into decision-making process 10
Case: Prognosis 87 year old man Median life expectancy between 3.2-4.7 years With Alzheimer s disease Median life expectancy between 2.7-3.3 years Walter and CovinskyJAMA 2001 Larson et al. Ann Int Med 2004 GUIDING PRINCIPLES: TREATMENT COMPLEXITY AND FEASIBILITY Treatment Complexity and Feasibility Justification: Treatment complexity and burden inform guideline recommendations and individual decisions Affect adherence and safety 11
Treatment Complexity and Feasibility Tools to assess medication management capacity Assessing adherence and preferences are essential Concordance between clinician and patient Care transitions are key opportunities Case: Complexity and Feasibility Adherence issues with evening meds Cost problems, with Part D coverage Treatment Plan Time Medications Non-pharmacologic Therapy 7AM Alendronate 70mg weekly Sit upright 30 min once per week All Day Exercise walk 1 mile per day Periodic Pneumonia vaccine, Yearly influenza vaccine 8 AM Eat Breakfast Check blood sugar three Metformin 500 mg, glyburide 10mg times per week ECASA 325mg, donepezil 10mg memantine 10mg, furosemide 40mg, metoprolol 100mg, lisinopril 20mg acetaminophen 325mg; 2 pills tramadol 50mg, calcium and vitamin D DASH DIET 12 PM Eat Lunch Diet as above 5 PM Eat Dinner Diet as above Eat Metformin 500 mg, glyburide 10mg Dinner Memantine 10mg, furosemide 40mg, metoprolol 100mg, lisinopril 20mg, acetaminophen 325mg; 2 pills, tramadol 50mg calcium and vitamin D 7 PM tamsulosin 0.4mg simvastatin 40mg 11 PM zolpidem (10mg; 1 pill at bedtime) Tramadol PRN All provider visits: Evaluate Selfmonitoring blood glucose, foot exam and BP Quarterly HbA1c, biannual LFTs Yearly creatinine, electrolytes, microalbuminuria, cholesterol Referrals: DEXA scan every 2 years Yearly eye exam Medical nutrition therapy Patient Education: High-risk foot conditions, foot care, foot wear Diabetes Mellitus 12
GUIDING PRINCIPLES: OPTIMIZING THERAPIES AND CARE PLANS Optimizing Therapies and Care Plans Justification: Potential harms of polypharmacy prioritize treatments and interventions with the goal of optimizing adherence to the most essential pharmacologic and nonpharmacologic therapies Avoid therapeutic omissions as well as reduce potentially harmful or non-beneficial treatments Optimizing Therapies and Care Plans Tools to identify potentially inappropriate medications Consider non-pharmacologic interventions in this category Stopping and Not Starting Multiple issues identified in care plan Optimum rate of intervention is 1 to 2 changes at a time 13
Time Medications Non-pharmacologic Therapy 7AM Alendronate 70mg weekly Sit upright 30 min once per week 8 AM Eat Breakfast Adherence Problems with Treatment Plan Metformin 500 mg, glyburide 10mg ECASA 325mg, donepezil 10mg memantine 10mg, furosemide 40mg, metoprolol 100mg, lisinopril 20mg acetaminophen 325mg; 2 pills tramadol 50mg, calcium and vitamin D Check blood sugar three times per week DASH DIET All Day Exercise walk 1 mile per day Tramadol PRN Periodic Pneumonia vaccine, Yearly influenza vaccine All provider visits: Evaluate Selfmonitoring blood glucose, foot exam and BP Quarterly HbA1c, biannual LFTs Yearly creatinine, electrolytes, microalbuminuria, cholesterol Referrals: DEXA scan every 2 years 12 PM Eat Lunch Diet as above Yearly eye exam 5 PM Eat Dinner Diet ashe aboveforgets evening medications Medical nutrition therapy Eat Metformin 500 mg, glyburide 10mg Patient Education: High-risk foot Dinner Memantine 10mg, conditions, foot care, foot wear furosemide 40mg, metoprolol 100mg, lisinopril 20mg, acetaminophen 325mg; 2 pills, tramadol 50mg calcium and vitamin D 7 PM tamsulosin 0.4mg simvastatin 40mg 11 PM zolpidem (10mg; 1 pill at bedtime) because he is tired. Diabetes Mellitus He does not check blood sugar regularly because the finger stick hurts. WHAT WOULD BE YOUR RECOMMENDATIONS? TAKE 5 MINUTES AND WRITE DOWN WHAT YOU WOULD DO 41 Possible Revisions to the Treatment Plan REDUCE STOP SIMPLIFY/MODIFY 14
Emerging Clinical Tools Life Expectancy Sample Clinical Decision Guidelines Short-term (<2 yr) < 6 months Discontinuation of Statins None Mid-term (2-3yr) <2-3 yr Lowering Blood pressure to <140/80 mmhg unlikely to improve cardiovascular outcomes <5yr Long-term (> 3yr) Limited benefit to lowering HgA1C therapeutic target to <8% None California Healthcare Foundation and AGS Adapted from: Yourman, L. C. et al. JAMA 2012;307:182-192 Coordinated Medication Management Patient Patient understands his/her medications and participates in a care plan to improve health Optimal therapeutic recommendations are based on the experience/needs of the patient Clinical Pharmacist Appropriate, Effective, Safe and Adherent Medication Use! Physicians/PA s/anp s Nurses/Social Workers Family members/aides Gaps in clinical goals are determined, drug therapy problems identified, and therapeutic recommendations made Clinical goals of therapy are determined and medication recommendations are considered Questions??? Nicole J. Brandt, PharmD, MBA, CGP, BCPP,FASCP Email: nbrandt@rx.umaryland.edu 45 15