Transcript Slide 1

SUCCESS STRATEGIES FOR
REDUCING OFF-LABEL USE OF
ANTIPSYCHOTIC MEDICATIONS
DAVID GIFFORD, MD MPH
Senior VP Quality & Regulatory Affairs
RUTA KADONOFF, MA, MHS
VP, Quality & Regulatory Affairs
New Mexico Health Care Association
Albuquerque, NM
July 11, 2013
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Outline of today
• Interactive approach
• Evidence based practices to safely reduce antipsychotic
medications
• Strategies to successfully implement new practices
• At the end of each segment, jot down reflections on your
worksheet to build a take-home plan
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Learning Objectives
Participants in this session will:
• Re-frame common understanding of behavioral responses in
•
•
•
•
persons with dementia.
Understand evidence base on effectiveness of antipsychotic
medications in persons with dementia.
Discuss practical strategies to engage physicians as critical
partners in reduction of antipsychotic use.
Explore CMS approach to assessing compliance with requirements
to improve care for persons with dementia and reduce
antipsychotic use.
Review practical, effective strategies and tools facilities can use
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Polling Technology
• We will be asking you to answer questions using an
online polling technology.
• Respond by sending standard text messages –
please have your cell phone handy
• If you have unlimited text messaging, this will be free
• If not, it may have a small cost per message
• Your information is private - we cannot see your
phone numbers, and you’ll never receive follow-up
text messages outside this presentation
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How To Vote via Texting
1. Standard texting rates only (worst case US $0.20)
2. We have no access to your phone number
3. Capitalization doesn’t matter, but spaces and spelling do
Poll: Who is in the audience?
Poll: What brings you here today?
Technical vs. Adaptive Change
• Balance technical vs. adaptive changes
• Classic technical change = new form
• Requires adaptive change (e.g. workflow
redesign) to address how staff will complete
and use the new form
Technical changes rarely work because the
adaptive changes needed to make them
workable in practice have not been addressed.
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SAFELY REDUCING THE USE OF
ANTIPSYCHOTIC MEDICATIONS
AHCA Quality Initiative Goal:
Safely reduce the off-label use of
antipsychotics by 15% by the end of 2013
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What’s the Fuss?
Why is the use of antipsychotic
medication in older adults with
dementia a problem?
What Drugs are We Talking About?
Conventional
•
•
•
•
•
•
•
•
•
•
•
Compazine
Haldol
Loxitane
Mellaril
Moban
Navane
Orap
Prolixin
Stelazine
Thorazine
Trilafon
Atypical
• Aripiprazole (Abilify)
• Asenapine
• Clozapine
• Iloperidon
• Olanzapine (Zyprexa)
• Paliperidone
• Quetiapine (Seroquel)
• Risperidone (Risperdal)
• Ziprasidone
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FDA-Approved Diagnoses
• Schizophrenia
• Bi-polar Disorder
• Irritability associated with Autistic Disorder (Abilify &
Risperdal)
• Treatment Resistant Depression (Zyprexa)
• Major Depressive Disorder (Seroquel)
• Tourettes (Zyprexa)
When prescribed for a patient without an FDA
approved diagnosis; the prescription is considered as
an “off-label use”, which is allowed by the FDA and
Medical Boards
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Common Off-Label Uses
• Dementia with “behaviors”
• Agitation
• Aggression
• Walking about
• Acute Delirium
• Obsessive-compulsive disorder
• Psychotic symptoms (e.g. hallucinations, delusions) with
neurological diseases
• Parkinson’s disease
• Stroke
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National Use of Antipsychotic Meds
30
25
0
LA
TX
TN
UT
VT
AR
MS
ME
MO
NH
AL
GA
IL
OH
OK
MA
KY
FL
CT
NE
ID
VA
KS
WA
AZ
NV
IN
PA
NM
DE
WV
SD
MT
IA
DC
NY
CO
RI
OR
SC
ND
MD
NC
WI
WY
CA
NJ
MN
MI
AK
HI
% Antipshotic Use (State Avg)
State Rank in Antipsychotic Use
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New Mexico = 21.2%
National Avg = 22.0%
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15
10
5
NM Facilities’ Use of Antipsychotics
18
16
16
NM Average: 21.2%
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Number of Nursing Facilities
14
12
10
10
8
6
6
4
4
4
2
1
1
1
1
1
35-40%
40-45%
45-50%
50-55%
0
0-5%
5-10%
10-15%
15-20%
20-25%
25-30%
30-35%
Percentage of Off-label Antipsychotic Usage among Long-Stay Residents in ALL Nursing Facilities, 2012 Q4, NM
Source: CMS Nursing Home Compare Quality Measures, 2012.
Change in Antipsychotic Use ‘11 to ‘12
HI NE WV TX MT NJ IL OH LA MI VA AR MO WI FL OK PA VT MN SD NM NV WAMD KS IA IN UT MS CO OR DE NH WYMA ME TN AK DC NY ND AZ KY AL CT SC NC CA ID RI GA
2.0%
0.0%
% Change in Antitipsychotic Use
-2.0%
-4.0%
-6.0%
-8.0%
-10.0%
New Mexico: 4.9% decrease
-12.0%
-14.0%
-16.0%
-18.0%
Change in Antipsychotic Use from 2011 to 2012
NM Facilities’ Change in Antipsychotics
10
8
8
Number of Nursing Facilities
6
4
4
3
3
3
2
2
0
-2
-4
-6
-8
-2
-3
-5
-8
-8
-8
-10
Percentage Reduce (-) or Increase (+) of Off-label Antipsychotic Usage among Long-Stay Residents in All NM
Nursing Facilities - Comparing Baseline Score (2011 Q4) and Average Score in 2012 Q4
Source: CMS Nursing Home Compare Quality Measures, 2012.
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DEMENTIA RE-EXAMINED
Poll: Which statement best represents your bel...
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Exercise – “Speed Dating”
• Stand up and form two lines, facing each other, so that
each person has a partner to talk to
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What would you do if…?
• Make sense of the situation – what’s going on here?
• How do you feel?
• What do you do?
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How Do We Understand Behavior?
• What are “behaviors”?
• Medical symptoms?
• Predictable human responses to the perceived situation?
• Attempts to communicate an unmet need?
• Our answer to above question shapes our response
• Identifying and prescribing pharmacologic or non-pharmacologic
“treatment”?
• Focus on stopping the behavior? Or identifying the need?
• Seeking empathy and understanding?
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Biomedical vs. Experiential
Model of Dementia
Biomedical Model
Experiential Model
View of
behavior
Confused, purposeless,
driven by disease &
neurochemistry
Attempts to cope & problemsolve, communicate needs
Response to
behavior
Problem to be managed;
medication, restraint
Care environment inadequate;
conform environment to person
Behavioral
goals
“Normalize” behavior; meet
needs of staff & families
Satisfy unmet needs; focus on
individual perspective
NonFocus on discrete
pharmacologic interventions
approaches
Focus on transforming the care
environment
Overall result
Rare use of meds, attention to
spiritual needs, improved wellbeing
High use of meds,
continued suffering,
decreased well-being
A. Power, Dementia Beyond Drugs (2010)
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“Behaviors” vs.
“Behavioral Communication”
Agitation (Self-Referred)
• Clapping
• Yelling/Screaming
• Slapping thighs
Aggression (Other-Referred)
• Hitting/Kicking
• Pinching
• Biting
• Threatening/Swearing
Message:
• Something is wrong with me!
• Do something!
Message:
• Stop! Leave me alone!
• At its core = FEAR
Response:
• Curiosity
• Identify the need
• Precipitating factor(s)
Response:
• De-escalate – back off, come back
later
• Identify fear triggers
• Foster sense of safety & security
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Maslow’s Hierarchy of Needs
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A Person-Centered Approach
A continuous, relationship-based process…
• Listening
• Paying attention
• Trying things
• Seeing how they work
• Changing as needed
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Questions to ask before Rxing
• What did you do to try and figure out why the resident was
doing <fill in the blank>?
• What could the resident be trying to communicate to us
about their <fill in blank>?
• What do you think might be the reason(s) for resident
doing <fill in blank>?
• Unacceptable answer (Dementia or sun-downing)
• What did you try before requesting medications?
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Primary Challenge is Changing Beliefs
• Most health care professionals and families believe
(1) “Dementia behaviors” are abnormal & need to be treated.
(2) Antipsychotics medications are effective.
• Without addressing these underlying beliefs, attempts at
practice change are unlikely to succeed due to fear and
resistance
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Déjà Vu All Over Again?
• When else have we been successful at changing beliefs,
resulting in changed practice?
• Use of seat belts in cars
• Use of physical restraints in nursing facilities
• Others?
• What worked well in changing staff and family beliefs that
restraints are helpful? What did not work?
• What have you seen outside of healthcare work to change
people’s beliefs or attitudes?
Beginning with Staff Beliefs
• Exercise content:
• Scenarios
• Tip sheet
• Staff education module – PowerPoint slides with notes
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Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
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WHAT IS THE EVIDENCE
ON EFFECTIVENESS OF
ANTIPSYCHOTICS IN
PERSONS WITH DEMENTIA?
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#1 Challenge is Changing Beliefs
• Most health care professionals and families believe
(1) “Behaviors” are abnormal & need to be treated.
(2) Antipsychotics medications are effective.
Without addressing these underlying
beliefs, attempts at practice change are
unlikely to succeed due to fear and
resistance
Are Antipsychotic Medications Effective?
Conventional
•
•
•
•
•
•
•
•
•
•
•
Compazine
Haldol
Loxitane
Mellaril
Moban
Navane
Orap
Prolixin
Stelazine
Thorazine
Trilafon
Atypical
• Aripiprazole (Abilify)
• Asenapine
• Clozapine
• Iloperidon
• Olanzapine (Zyprexa)
• Paliperidone
• Quetiapine (Seroquel)
• Risperidone (Risperdal)
• Ziprasidone
Poll: What is the drug you most commonly use i...
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Effectiveness in Dementia
• Antipsychotic effect takes 3-7 days to start working –
acute response is due to sedating side effect
• Randomized controlled trial (RCTs) - gold standard
method to determine effectiveness of medication
• Persons randomized to receive a drug or a placebo
• Clinicians also blinded to who gets the meds when rating outcomes
• Meta-analysis is method that combines the results from
multiple RCTs
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Scales to assess Behavior in Dementia
• NeuroPsychitatric Inventory (NPI)
• Assesses12 behaviors on a 4-point scale: delusions,
hallucinations, agitation/aggression, depression, anxiety,
euphoria, apathy, disinhibition, irritability, aberrant motor
behavior, sleep, eating disorders
• Higher score = worse symptoms
• Cohen-Mansfield Agitation Inventory (CMAI) scale
• Behavior Pathology in Alzheimer’s Disease Rating Scale
(BEHAVE-AD)
• Clinical Global Impression of Change (CGI-C)
Poll: Compared to placebo, what percentage of ...
Effectiveness in Dementia is weak
Meta-Analysis (JAMA 2011)
• Zyprexa, Risperdal, and Abilify- small but statistically
significant effect (12 – 20%) compared to placebo
• Seroquel – no statistically significant effect
• Antipsychotics led to an average change on the NPI of:
• 35% from a patient’s baseline
• 3.41 point difference from placebo group
• 30% change or 4.0 difference = minimum clinically meaningful
• No conclusive evidence found on comparative
effectiveness of different antipsychotics
Source: JAMA 306:1359-69 2011; Meta-analysis 38 RCTs in dementia
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Net Effectiveness
“For every 100 patients with dementia
treated with an antipsychotic medication,
only 9 to 25 will benefit”
Drs Avorn, Choudhry & Fishcher
Harvard Medical School
Dr Scheurer
Medical University of South Carolina
Source: Independent Drug Information Service (IDIS) Restrained Use
of antipsychotic medications: rational management of irrationality. 2012
Dose for Antipsychotics Used in Dementia
Medication
Low Dose
Normal Dose
Aripiprazole (Abilify)
<2 mg/d
2-15 mg/d
Olanzapine (Zyprexa)
<5 mg/d
5-10 mg/d
Quetiapine (Seroquel)
<50 mg/d
50-100 mg/d
Risperidone (Risperdal)
<1 mg/d
1-2 mg/d
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Effectiveness with Low Dose
• Low dose Risperdal <1 mg/d):
• small positive effect
• increased risk of adverse events
• Low dose Zyprexa (5 mg/d):
• no positive effect
• increased risk of adverse events
• Low dose Abilify and Seroquel effectiveness unknown, but
Seroquel at normal dose is ineffective
Source: Cochrane Review 2012; Meta-analysis 16 RCTs in dementia
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Adverse outcomes
• Off-label use of antipsychotics in nursing facility residents
are associated with an increase in:
• Death
• Hospitalization
• Falls & fractures
• Venothrombolic events
• Conventional antipsychotics are worse than atypical
antipsychotics
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Odds of having an adverse event after receiving
Risperidone 1 mg/d compared to placebo
Adverse Event
Odds
Ratio
95% Confidence Interval
Mortality
1.25
0.73 to 2.16
Somnolence
2.40
1.70 to 3.20
Falls
0.84
0.63 to 1.14
Extrapyramidal disorder
1.78
1.00 to 3.17
UTI
1.40
0.92 to 2.13
Edema
2.75
1.51 to 5.03
Abnormal Gait
5.31
2.24 to 12.62
Urinary Incontinence
13.6
1.81 to 101
CVA
3.64
1.72 to 7.69
Drop out (had to stop
meds)
1.43
1.01 to 2.03
Source: Cochrane Review 2012; Meta-analysis 4 RCTs in dementia
Poll: If individuals with dementia on low dose...
Evidence for Discontinuing Meds
• RCTs comparing withdrawal of medication to
continuing antipsychotics will show the medication:
• to be effective,
• if more people randomized to stop the medication get worse than
those randomized to continue on the medication
• to be ineffective,
• if the same percentage of people randomized to stop the
medication as continue the medication get worse or do not change
• to be harmful,
• if more people randomized to stop the medication get better
compared to those who continue the medication
RCT to withdraw antipsychotics2
100 w/
dementia on
antipsychotics
Outcomes
assessed
over 3
months
Outcomes
- 76% no change in behaviors
- NPI total worse
- Agitation worse
- QOL worse
- 9% stopped due to behaviors
2Ballard
46 stopped
med
54 continue
med
C et al J Clin Psychiatry 2004: 65:114-119
Statistical
Difference
None
None
None
None
None
Outcomes
- 67% no change behaviors
- NPI total worse
- Agitation worse
- QOL better
- 13% stopped due to behaviors
Meds
stopped
abruptly
and given a
placebo
RCT to withdraw antipsychotics3
165 w/
dementia on
antipsychotics
Outcomes
assessed after
6 months
83 continue
med
Outcomes (N=51)
- Cognitive Fxn worse
- NPI total worse
- Verbal fluency worse
- ADLs worse
- Agitation 32%
3Ballard
82 stopped
med
Statistical
Difference
None
None
YES
None
None
C et al Plos Medicine 2008; 5:e76: 587-599
Meds stopped
abruptly and
given a placebo
Outcomes (N=51)
- Cognitive Fxn worse
- NPI total worse
- Verbal Fluency better
- ADLs worse
- Agitation 34%
RCT to withdraw antipsychotics4
110 w/ Dementia with
psychosis who responded to
antipsychotics
Outcomes
assessed @
4 & 8 months
32 continue
med
Outcomes
- 33% Relapse (n=14)
- Adverse events worse
- Completed trial (N=10)
4Devandand
40 stopped
med
Statistical
Difference
YES
None
None
Outcomes
- 60% Relapse (n= 23)
- Adverse events worse
- Completed trial (n=10)
DP et al NEJM 2012; 367:1497-1507
Third group not shown here: continued med for 4 moths then discontinued meds
Meds tapered
over 1 week to
placebo
51
Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
52
BREAK
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ENGAGING
PHYSICIANS
AS PARTNERS
5 Strategies to Engage Physicians
1. Understand actions performed by
2.
3.
4.
5.
physicians
Provide information needed to make a
decision
Enlist patient or family members
Provide feedback on their performance
Utilize Medical Director to communicate
with physicians
#1 Actions Performed only by Physicians
There are several actions that can only be performed
by physicians, NPs or PAs.
•
•
•
•
•
Diagnose
Prescribe medications
Prescribe treatments (e.g. PT) or equipment
Order tests
Perform procedures
Physicians assume when a nurse calls, they are
asking for one of these actions since the nurse can do
all other actions without physician order.
Preventing MDs from giving an order
• Physicians respond to nurse’s requests
• Most calls are requests for an order
• “If you do not respond, nurses will keep calling you”
• When calling to ask a physician for an opinion or
to “make physician aware” say so, otherwise the
physician will assume the nurse wants an order
• When physician gives an order you don’t want or need,
its OK to tell them you don’t think the order is necessary
Preventing MDs from giving an order
• Nurses often ask for the very things we are trying
to prevent (e.g. antipsychotics)
• Your Medical Director & DON need to support
physicians when they say “no” to nurse’s
requests for:
• Antipsychotics for “behaviors”
• Chair alarms
• Antibiotics for bacteria in urine
• Feeding tube for end stage dementia
Implications for Antipsychotic Prescribing
• When staff call about a resident with dementia
who is having “behaviors” the physician is
thinking:
• Is this acute delirium?
• What tests should I order to rule out medical causes?
• Staff must have already tried non-pharmacological
strategies; so nursing must want a medication.
• If I do not give an order, they will keep calling me
• Tell the physician that you do NOT want medication but want to
run the patient’s changes by them to make sure you are not
missing any medical reasons for the behavior.
#2 Provide Information Needed to Make
Decision
• Provide information needed to make a decision
• Vital signs (BP, Pulse, Resp & Temp as well as pulse ox)
• Duration of symptoms and change from baseline
• Medications and recent administration times
• Recent labs (eg. last INR was on <date> and was <insert value>)
• Other medical diagnoses (e.g. Diabetes, CHF, etc)
• Not having key information available during the call
makes the caller sound stupid
How You Communicate is Important
• Introductory sentence is key
• Do NOT apologize for calling/interrupting them
• Apologies generally are done when you have done something wrong.
MDs often interpret an apology as you saying “I’m not sure I needed to
call you”
• You are calling about a patient that needs his/her attention. No apology
is necessary.
• First sentence should be:
• “I am calling you about <name> because of <XXX> to ask you if we
should <yyy>
• Then provide information needed to make a decision
SBAR: An Communication Tool
• Structured format to assemble key
relevant information that
physicians need to make a
decision
• Complete SBAR prior to calling
physician
Tips on SBAR implementation
• Start with 1 nurse on 1 unit
• Announce to all staff that your using SBAR but piloting with <insert
nurse’s name>
• Review nurse’s experience with SBAR daily
• Modify SBAR protocol based on each day’s feedback
• Engage Medical Director
• Seek feedback from attending and covering MDs
• Try pilot testing for 1 condition on 1 unit, for example:
• INR calls to physicians
• Elevated blood glucose
• Falls
4-6 months to successfully roll out SBAR
Successful Implementation Strategies
• Rely on staff to design & test new strategies
• Learn from Peers
• Learning collaboratives
• Visit other facilities
• Get at the adaptive change that is needed
• Ask “what is the problem/issue we are trying to solve?”
• How will what we/you propose help us solve the
problem?
• Avoid “1 and Done” approach to implementation
• Utilize short “huddles” to review implementation
#3 Enlist Patients or Families
• Physician usually respond to patient or family requests
• Families often have relationship with physician prior to nursing
home admission
• Many of the treatments at admission were started after family physician discussion
• Physician will be concerned family will be upset if meds are stopped that
were started prior to admission
• Get families to make request for changes to treatments
• Let physician know that families are ok with requested order (to start or
stop a treatment)
#4 Compare Performance to Peers
• Physicians respond to data comparing them to
peers
• Compare to respected peers or “top performers”
• List all MD names & performance (e.g.
prescribing rates)
• List all the physician’s residents who are
triggering the performance measure
• Acknowledge
• Residents who have a reason for being on the list;
• Small sample size
Example Physician Report about
Antipsychotic Use
Provide rate compared to other physicians:
Physician
# patients
# on
antipsychotic
% on antipsychotic
Dr Ralston
10
5
50%
Dr Snow
2
1
50%
List his/her patients with info about prescribing:
Patient
Antipsycho
tic
Sallie Smith Risperdal
John Davis
Dose &
Freq
Notes
5 mg 2x day Alzheimer's Family Request
None
Mary Myers Seroquel
Dementia
None
10 mg QHS
dementia
Started for
agitation
#5 Utilize Medical Director
• Meet with medical director to determine:
• Attitude and knowledge about antipsychotic
medication for individuals with dementia
• Willingness to send letter to attending
physicians
• Willingness to call attending physicians about:
• Their practices (e.g antipsychotic prescribing)
• Their response to pharmacist's recommendations for
GDR
• Their methods of interacting with nursing (e.g. SBAR)
Medical Director Contacts other MDs
• Announce new policies, new protocols, by
• Letter from med director to attending physicians
• Sample letter provided
• Phone calls from medical director
• Need to provide feedback on attending and
coverage physician behavior and practices
• Medical director needs to follow up on these
issues
Ask Your Medical Director To…
• Share data with each physician on the practice that you
are focusing on
• Sample feedback report included in letter template
• Share feedback during monthly QA meeting that he/she
has received from attending physicians he/she has called
• Conduct in-service for nurses:
• On using SBAR
• On dementia and antipsychotics
Share Evidence-based Information
• Information best received from a trusted colleague –
physician to physician
• Should be another physician, ideally an expert in the field
• Provide summary of literature with references from trusted sources
(NEJM, JAMA, etc)
• Share reference list and PPT slides on evidence
• Think about subscribing to UP TO DATE for Medical Director and
make available to physicians during their visits.
71
Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
72
LUNCH
73
CHANGING PRACTICE:
TRIAL WITHDRAWAL
Poll: Residents who are started on an APM in t...
75
Trial Withdrawal: Recap - the Evidence
• Antipsychotic effect takes 3-7 days
• Low dose - limited effectiveness, no difference when
meds withdrawn:
• Risperidone [Risperdal) (<1 mg/d)
• small positive effect, but increased risk of adverse events
• No difference when meds withdrawn and given a placebo;
• Olanzapine [Zyprexa] (<5 mg/d)
• no positive effect, increased risk of adverse events
• Quetiapine [Seroquel] (<50 mg/d) or Aripiprazole [Abilify] (<2 mg/d)
• effectiveness at low dose never tested but at normal dose RCTs do not
show meds to be effective
76
Acting on the Evidence: Initial Steps
• No role for PRN only antipsychotic medications
• Discontinue or gradual dose reduction for residents on
medications for greater than 12 weeks (3 months)
• Evaluate need for antipsychotics started during the
evening/night shift or over the weekend
• Evaluate the need for continuing antipsychotics started
while in the hospital
77
Exercise – Step 1
• Call your facility and identify a nurse to speak with who
can tell you about a case that meets “low-dose or PRN”
criteria
• Someone with dementia on an off-label use of antipsychotic med
• PRN-only order or
• Low dose of common antipsychotic medications
Aripiprazole (Abilify)
<2 mg/d
Olanzapine (Zyprexa)
<5 mg/d
Quetiapine (Seroquel)
<50 mg/d
Risperidone (Risperdal)<1 mg/d
2-15 mg/d
5-10 mg/d
50-100 mg/d
1-2 mg/d
78
Exercise – Step 2
• Gather the information needed to complete the SBAR
form as if you were preparing to have a discussion with
the physician about GDR or withdrawal of the drug
• If there is information about the person needed on the
form that is not readily available, mark “N/A”
79
Exercise – Step 3
• With the group at your table, discuss the information you
have gathered about the cases you reviewed:
• What might your next steps be in moving toward a trial GDR or
withdrawal for this person?
• What challenges or barriers can you foresee?
• What could you do to address them?
• What information was difficult to obtain and why? How could you
make it easier going forward?
80
Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
CMS EXPECTATIONS –
UNDERSTANDING &
COMPLYING WITH NEW
SURVEYOR GUIDANCE
Overview: CMS Surveyor Guidance
• New guidance for F309 & F329 about care for persons
with dementia and use of antipsychotics
• Three surveyor training videos
• Details and links: see S&C 13-35-NH
• They are looking for
• A “good” assessment
• A “good” care plan
• Staff awareness of resident and tracking effectiveness
• Staff training and demonstrated competency
• Involvement of Physician, Medical Director, & QA committee
• Involvement of the family
Guiding Principles for Dementia Care*
• Assess nature, frequency, severity & duration of symptoms
• Identify risks of behaviors to the person and others
• Discuss potential causes & triggers with family & all care staff
• Exclude potentially remedial causes (e.g. medical)
• Try interventions that address behavior as a form of
communication of an unmet need
• Assess effects of all interventions and adjust
• When using antipsychotics, use lowest dose for shortest
duration possible; taper when symptoms have been stable
*CMS training video:
http://surveyortraining.cms.hhs.gov/pubs/AntiPsychoticMedHome.aspx
Surveyors Are Being Instructed to…
• Ask staff about their knowledge of the resident's:
• Usual behaviors in different situations
• Personal likes and dislikes
• Individualized care plan
• Behaviors on other shifts
• Observe staff to see if they:
• Follow resident’s care plan
• Demonstrate competency in skills and techniques to care for
individuals with dementia
Family Involvement & Input is Key
• Family involvement mentioned throughout surveyor
training, including:
• Personal interests, likes & dislikes of resident
• What “sets off” the resident
• What activities help improve resident’s well-being
• Care plan development
• Informed of medications: reason, risks vs benefits
• Interventions being implemented and resident response
Conducting a “Good Assessment”
What is CMS looking for?
• A “good assessment” of individuals with dementia
includes:
• Description of the behavior – what is person doing?
• Supporting diagnoses
• Consideration of possible medical or pharmacologic causes for
observed “behaviors”
• What is the person trying to communicate?
• Is the behavior a risk to the person or others safety?
“KEY is to KNOW the PERSON”
How to Avoid Deficiencies #1
• Describe behavior in enough detail so others can
understand the following:
• Onset, duration, intensity, severity and frequency
• Is this a change from baseline?
• Situation – possible precipitating events
• How does resident typically communicate a need (hunger, thirst,
discomfort, frustration)?
• What is person trying to communicate?
• Is the person or other’s safety at risk?
“KEY is to KNOW the PERSON”
How to Avoid Deficiencies #2
Rule Out Medical Causes
• Does behavior represent an acute change or worsening
from the baseline?
• Was a clinician contacted and medical evaluation done to
exclude underlying medical or physical causes?
• Such as pain, constipation, delirium or infection
• Did physician and care team consider whether current
medications could be causing or contributing to the
observed behavior?
“KEY is to KNOW the PERSON”
Assessing root causes of distress
• Did staff use knowledge about the person to understand
possible causes of behavior?
• Use information from family members
• Use information from prior care givers
• Use information from other staff in facility
• Did staff consider causes such as
• Boredom
• Anxiety related to changes in routines
• Care routines (e.g. bathing) inconsistent with preferences
• Environmental factors (e.g. contributing to sensory overload)
“KEY is to KNOW the PERSON”
Developing a “Good Care Plan”
What is CMS Looking For?
• Plan that flows from comprehensive assessment
• Interdisciplinary team (IDT) involvement, including
physician and family
• Individualized, person-centered interventions:
• Non-pharmacological approaches first
• Individualized strategies to understand and respond to behavior as
communication
• Monitoring for effectiveness
How to Avoid Deficiencies #1
• Ensure reasonable efforts made to engage family in care
•
•
•
•
planning process
Pursue non-pharmacologic strategies
Monitor effectiveness for all interventions
Be specific in descriptions – “yelling” vs. “agitation”
Individualize, individualize, individualize
How to Avoid Deficiencies #2
• For persons on antipsychotic medications
provide:
• Specific indications and rationale - dementia
diagnosis alone insufficient
• Specific target behaviors & expected outcomes
• Dosage, duration
• Documentation of efficacy & adverse effects
• Plans for Gradual Dose Reduction (GDR)
Staff Knowledge of Residents &
Care Plans
What is CMS Looking For?
• Does staff working with the resident KNOW the person?
• Likes/dislikes
• Typical ways of communicating, responses to different situations
• Care plan
• Is information communicated to all staff who need it?
• Is there a process for timely communication about
changes?
• What attempts were made to understand and meet
needs?
• If antipsychotic meds are being used – can staff describe
indications, target symptoms, goals of treatment?
How to Avoid Deficiencies
• Documentation is necessary, but not sufficient to
demonstrate this aspect of compliance
• How will your direct care staff respond to surveyor
questions?
• “I don’t know, let me check her care plan…”
• “Sure, let me tell you about her… she used to… she likes… she
doesn’t like… so what we do is…”
Tracking Effectiveness of Interventions
What is CMS Looking For?
Evidence that staff is:
• Attempting various approaches to interaction and care to
prevent or reduce distress
• Evaluating their effectiveness
• Communicating information about what works and what
doesn’t to staff on all shifts
How to Avoid Deficiencies #1
• Response to interventions:
• “We tried X for Y in this manner, for this time period, with these staff
members and found these results.”
• If positive – benefits, frequency and whether being continued.
• If negative – what is plan B?
• How much is enough for non-pharmacological
interventions?
• Remember – if behavior communicates an unmet need, medication
is inappropriate response!
• No magic number
• Reasonable attempts as long as no danger to resident or others
• Demonstrate a systematic process based in knowing the resident
How to Avoid Deficiencies #2
For persons on antipsychotic drugs:
• Monitor for side effects - therapeutic benefit with respect
to specific target symptoms.
• Inadequate documentation:
• “Behavior improved.”
• “Less agitated.”
• “No longer asking to go home.”
• Include specifics: why the behaviors were
harmful/dangerous; what the person is now able to do
(positive) as a result of the intervention
Staffing & Staff Training
What is CMS Looking For?
• Sufficient staff to consistently implement care plan
• Initial and annual training for all nursing assistants in care
for persons with dementia
• CARES training by Alzheimer's Association provides a certificate
for participants
• Competency to care for resident’s needs – based on
observation of staff interactions with residents
• Annual performance reviews & in-service based on
outcomes of those reviews
Physician & Medical Director
Involvement
What is CMS Looking For ?
• Physicians
• Involved and part of care team
• Communication with staff about resident’s behaviors
• Has considered (“ruled out”) medical or medication causes
• Provides a documented rationale for use of medications to “treat”
behaviors in dementia
• Diagnosis of dementia, psychoses, agitation, unacceptable
• Provide a rationale if they do not follow pharmacist
recommendations
What CMS is looking for ?
• Medical Director
• Involved and part of
• Care team
• QA team
• Staff contact medical director when attending
physicians do not follow pharmacist
recommendations
• Communication with other physicians when they do
not:
• Provide rationale for use of antipsychotics
• Provide rationale for not following pharmacist
recommendations
Quality Assurance Committee
Responsibilities
What is CMS looking for?
• QA committee is tracking antipsychotic use,
appropriateness and efforts to lower their use
• Is the QA committee looking at:
• Policies and procedures about dementia care
• Compliance with those policies
• Do care policies reflect the development of individualized
•
•
•
•
care
How individualized care policies are implemented
Do staff receive annual dementia care training
Level of staff sufficient to carry out policies
Physician’s response to pharmacist's recommendations
NOT looking for QA committee data, notes or minutes
Documentation Needed
• SSA will interview the staff person responsible for QA
committee
• Facilities do NOT have to share QA committee
• Minutes
• Notes
• Data analysis
• Recommend that a facility consult its lawyer before
sharing QA committee information with SSA
NOT looking for QA committee data, notes or
minutes
Documentation Needed
• You do have to show SSA how you are making changes
to address certain issues* for example,
• How did you address physicians not following pharmacist’s
recommendations?
• How are you tracking staff training and ability to apply content of
training?
* Note: You do NOT have to use QA committee material but SSA will
expect to see in other areas some type of response by the facility to
how it is making changes (e.g. personal folders, medical record, etc)
How to avoid a deficiency
• When asked by the SSA you can say:
“Yes the QA committee tracks the following <insert what you
track> and as a result we have made the following changes
<list changes> that have resulted in a <fill in change in
antipsychotic use or changes in practice>.
NOT looking for QA committee data, notes or
minutes
Key Take-Aways: Providing Good Care &
Avoiding Deficiencies
• Know the person
• Ensure quality processes in place for assessment & care
•
•
•
•
•
•
planning
Make sure staff is competent in dementia care
Involve the family
Involve the clinicians
Involve all staff
Practice consistent assignment
Ensure QA&A committee is looking at antipsychotic use
113
Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
114
BREAK
STRATEGIES FOR
RESPONDING TO
BEHAVIORAL
COMMUNICATION
Exercise – What Would it Take?
• Imagine that you are upset, frustrated, anxious, scared,
lonely, or just having a really bad day…
• How do these emotions show up for you?
• What are 2-3 things you might do to help improve your well-being?
• Discuss with the person next to you
• If you could not make these things happen yourself, what would
someone need to know about you to tailor these “interventions” to
make them most successful?
• If you couldn’t speak for yourself, who could tell others this
important information about you?
• Report out
All Behavior Has Meaning
Understanding Potential Factors that can
Trigger Behavioral Responses
• Internal:
• Pain
• Fear
• Unmet needs – physical or emotional
• External
• Environmental factors
• Caregiver interactions
Questions to Ask
• What did the person do?
• When did it happen?
• What happened right before?
• Where did it happen?
All provide possible clues that can point to the “why”?
Assessment –
What could the problem be?
Does the person have a balance of sensory
stimulating and sensory calming activities?
• Are there periods of sustained
“up” or “down” activity in the
person’s day?
• Most people don’t tolerate > 1.5
hours sustained “up” or “down”
time.
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
Does the person have regular, meaningful
human interaction?
• Everyone needs
meaningful human
interaction – it provides
feelings of comfort and
safety.
• If necessary, order 10
minutes of 1:1 time two
times/day as a nursing
order.
Kovach, C. Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
How stressful is the person’s environment?
• When environmental
stressors exceed the
person’s stress threshold,
the result is stress. This
may  agitation.
Kovach, C. , Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
What are environmental stressors?
Noise
• TV on all day
• Pounding pill crushers
• Background
conversations
• Phones turned too loud
• Echoes in bathrooms or
other tiled areas
• Public address systems
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
What are environmental stressors?
Tactile
• Itchy skin conditions
• Rough handling
• Room temperature too cold or too warm
• Vinyl furniture
• Hard, unpadded chairs
• Wrinkled bed linens or clothing
• Poorly fitted shoes or clothing
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
What are environmental stressors?
Visual
• Glare from lights
• Shiny floors
• Clutter
• Spaces that are too big or
too small
• Unfamiliar environments
or people
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
Are there any psychosocial factors that may be
affecting a person’s behavior?
BOREDOM
GRIEF/LOSS
LONELINESS
ANXIETY
FEAR
HELPLESSNESS
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
Remember -- Maslow’s Hierarchy
Think Beyond the Basic Levels…
Pain: Inadequately Assessed and
Under-Treated
Behaviors Associated with
Dementia
Behaviors Associated with Pain
• Agitation
• Combative/Angry
• Aggression
• Agitation
• Wandering
• Restless Body
• Activity Disturbances
Movement
• Change in Behavior
• Moaning
• Withdrawn Behavior
• Crying/Tears
• Depressed Affect
• Withdrawn Behavior
• Crying
Kovach, C., Managing Challenging Behaviors: Non-Pharmacological Interventions
July 11, 2012
What clues can research give us:
When does aggression occur?
Study of 124 cognitively impaired residents:
• 86.3% - some aggression in 7-day period.
• 72.3% of events involved response to touch or “invasion
of personal space” during caregiving.
• Movement, dressing and toileting = almost 50% of
incidents.
M. Ryden, et. al, Aggressive Behavior in Cognitively Impaired
Nursing Home Residents, Research in Nursing & Health, April 1991
What clues can research give us:
Why is she screaming??
Studied 7 “triads” in NH - person with dementia, family
caregiver, and 1-2 formal caregivers.
Findings:
• Screaming related to vulnerability, suffering, loss of
meaning.
• Meanings influenced by organizational factors and
reciprocal effects between persons who scream and
others.
• Each person's screams are a unique language. It
can be learned.
Bourbonnais, A. & Ducharme, F., The Meanings of Screams in Older People Living with
Dementia in a Nursing Home, International Psychogeriatrics, November 2010.
Response –
What Should We Do?
Begin with the End in Mind:
What is the goal?
Stopping the behavior?
OR
Helping the person achieve the best
possible well-being?
A Non-Drug Approach Requires…
• Knowing the person – hinges on consistency of staff
assignments
• Seeking to understand root cause(s)
• Finding ways to identify and address unmet needs
Strategies to Consider - Domains
• Activities
• Caregiver education
• Communication
• Simplify Environment
• Simplify Tasks
Source: Gitlin, L., et. al., Nonpharmacologic Management of Behavioral
Symptoms in Dementia, JAMA, November 2012
Activities
• Tap into preserved abilities and prior interests
• Introduce activities involving repetitive motions
• Set up activity and help initiate participation to extent
needed based on person’s abilities
Caregiver Education
• Understanding that behavior is not intentional
• Relaxing “rules” – no right or wrong in performing
•
•
•
•
activities or tasks
Understanding disease process & changing needs with
initiation, sequencing, organizing and completing tasks
Avoid arguing or trying to reason
Positive physical and caregiving approaches
Resources:
• CMS Hand-in-Hand curriculum
• CARES online training (Alzheimer’s Association)
• Bathing Without a Battle
• Mouth Care Without a Battle
Communication
• Allow sufficient time for responses
• Provide simple, 1-2 step, verbal instructions
• Use calm, reassuring tone
• Offer simple choices – no more than 1-2 at a time
• Avoid negative words or tone
• Use light touch to reassure, calm or redirect
• Identify self & others if person does not remember names
• Help person find words as needed for self-expression
Simplify Tasks
• Break each task into simple steps
• Use verbal or tactile prompts for each step
• Provide structured, predictable daily routines
Simplify Environment
• Remove clutter and unnecessary objects
• Use labeling or other visual cues
• Reduce or eliminate noise and distractions
• Use simple visual reminders
Exercise – Table Discussions
Noise:
1. Brainstorm – list as many sources of noise in your
facilities as possible
2. Review your lists – how might a person with sensory
deficits and impaired cognition interpret each of these
noises?
3. Review top items and discuss - what is one possible step
you could take tomorrow to reduce or eliminate this source
of noise?
Follow-up step: Noise Reduction & Bathing Exercises
Noise Reduction –
Where is it coming from?
• Listen to the sounds in
your setting.
• What do you hear?
Sorting it out
• Strategies for tracking noise
• Stop & Listen Tickets
• Overhead paging Count
• Smartphone Apps“Decibel 10th”
• Meters – “Yakker Tracker”
144
Sample Results from Pilot Facilities
• Decreased the incidents of combative events
• 81-4
• Saved money on medication
• $75k
• Hired activity staff person for 4-9 PM (with the savings)
• Decreased staff absentee rate
• 41%
• Increased activity
Other Areas to Look for Opportunity
• Bathing
• Sleeping & Waking
• Dining
• Shift change
Put yourself in the resident’s shoes – how would you
experience these processes and what would make them
better?
Other Potential Strategies to Explore
• Familiar or comfort foods or beverages
• Essential oils/aromatherapy – lavender, rose, rosemary
• Favorite scents – cologne, aftershave, lotions
• Lighting – outside sunlight; ensure lighting is not causing
•
•
•
•
unpleasant visual disturbances
Interaction with children and/or pets
Exercise
Massage
Music
One Size Does Not Fit All –
Individualized approach is critical
A continuous, relationship-based process…
• Listen – to the person and those who know him/her best
• Notice – what supports well-being & what triggers
negative reactions
• Try things – take your best guess
• See how they work – what helps and what doesn’t?
• Change as needed – and try again!
• Communicate – what works for whom
Creating Conditions for Success
• ENABLE – staff to develop knowing relationships with
people – use consistent assignment
• ENGAGE – the staff who know each person best in
finding options that work
• EMPOWER – them to act on what they know and to
experiment to find winning solutions
149
Questions, Reflections
• Any questions?
• Take a moment to reflect on this segment and make some
notes on your worksheet.
150
NEXT STEPS –
ACTION PLANNING
151
A To-Do List…
• Review your data – where do you stand?
• Take the temperature – what are the current beliefs in
your facility about antipsychotic use?
• Administrator?
• DON/DNS?
• Nurses?
• CNAs?
• Medical Director?
• Attending Physicians?
• Families?
152
A To-Do List…
• Address beliefs:
• Conduct “What would you do if…” exercise
• Share evidence – with staff, with physicians
• Identify candidates for GDR/discontinuation
• Discuss with family
• Discuss with physicians
• Review surveyor training video
• Evaluate your facility processes relative to CMS
requirements
153
A To-Do List…
• Begin filling identified gaps:
• Assessment
• Care Planning
• Staffing & Consistent Assignment
• Staff Training
• Family Involvement
• Physician Involvement
• QA&A
What Can I Do on Monday?
155
Action Planning
• Take a moment to complete the remaining questions on
the reverse side of your worksheet:
• 3 concrete action steps you can take in the next week to begin
implementing something you learned here today
• Potential barriers you anticipate and at least one action step you
might try to prevent or overcome each
• Key people in your organization that you will need to engage to be
successful
156
The Challenge of Practice Change
“I did then what I knew how to do.
Now that I know better, I do better.”
― Maya Angelou
157
Contact Information
American Health Care
Association
1201 L St. NW
Washington DC 20005
www.ahcancal.org
AHCA Quality Initiative
Web: qualityinitiative.ahcancal.org
E-mail: [email protected]
David Gifford, MD, MPH,
SR VP for Quality & Regulatory Affairs
[email protected]
202-898-3161
Ruta Kadonoff, MA, MHS,
VP for Quality & Regulatory Affairs
[email protected]
202-454-1282