challenges in end-stage heart failure: compliance fabienne dobbels, phd
TRANSCRIPT
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Challenges in end-stage heart failure: Compliance
Fabienne Dobbels, PhD
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Heart failure: A chronic disease
• Requires ongoing management over a period of years
• Cannot be cured
• May lead to disability, or the short- or long-term reduction of a person’s activity
• Goal of treatment:
= to improve patients’ ability to live a productive and pain free life
to get rid of the disease!!!
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Treatment of heart failure:A complex therapeutic regimen
Management of heart failure
Prescription of multiple drugs
- fluid restrictions- diet (< salt)- weighing +exercise- …
Optimal treatment of co-morbidities
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Management of patient with heart failure:
PsychologicalDimension
PhysicalDimension
Goal = to optimize outcomes!
BehavioralDimension
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Non-adherence: the Achilles heel of heart failure treatment
Peter Paul Rubens 1630
Definition
Prevalence
Consequences
Risk factors
Interventions
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Eve and the Apple in the Garden of Eden....
...the first case of nonadherence?
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Compliance = adherence = concordance
= “The extent to which a person’s behavior corresponds with the agreed recommendations from a
health care provider”(Sabate. WHO report 2003)
= “Is a behavioral process, strongly influenced by theenvironment in which the patient lives, including thehealthcare practices and system. Adherence assumes that a patient has the knowledge,motivation, skills and resources required to follow therecommendations of a healthcare professional.
(AHA expert panel. Miller et al. 1997)
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MEDICATION ADHERENCE
TAKING
DOSING
TIMING
DRUG HOLIDAYS
Age 65 - 74 years: 8.5 medications dailyAge 75 – 84 years: 7.9 medications dailyAge > 84 years: 7.0 medications daily
(Soumerai et al. Arch Int Med 2006; 166: 1829)
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Prevalence of non-adherence (NA) in elderly with heart failure
• Medication taking: 1 - 90%
• Fluid restrictions: 27 - 77%
• Sodium restrictions: 27 – 87%
• Daily weighing: 21 – 88%
Large variation depending on operational definition and measurement method used
(van der Wal et al. Int J Cardiol 2008; 125: 203)
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Prevalence of adherence
Disease Mean (%) adherence
Random effects 95% CI
HIV 88.3 (78.9; 95.2)
Arthritis 81.2 (71.9; 89.0)
Cancer 79.1 (75.9; 84.2)
Cardiovascular disease* 76.6 (73.4; 79.8)
End-stage renal disease 70.0 (56.8; 81.6)
Pulmonary disease 68.8 (61.1; 76.2)
Diabetes 67.5 (58.5; 75.8)
(DiMatteo MR. Med Care 2004; 42(3): 200-209)
* Numbers for hypertension similar to other cardiovascular diseases
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Estimated NA of elderly patients with heart disease in Belgium
Estimations (2004):- 10 318 000 inhabitants
- 1 754 060 (17%) > 65 years
- 261 355 (14.9%) serious heart disease or heart attack in past 12 months
- 23.4% non-adherent
61 680 PATIENTS WITH HEART DISEASE NONADHERENT!!!
(Belgian Health Interview Survey 2004, www.iph.fgov.be)(DiMatteo MR. Med Care 2004; 2: 200)
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NA is a prevalent problem: so what???
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Clinical consequences
Economic consequences
“Drugs don’t work in patients who don’t take them”
(C Everett Koop M.D.)
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NA associated with poor clinical outcomes in heart failure
• Absence of the intended effect of the drugs
• Higher number of hospitalizations
• More visits to the emergency department
• Adverse effects (rebound effect)
(Hope et al. Am J Health-Syst Pharm 2004; 61: 2043)(Vinson et al. Am J Geriatr Soc 1990; 38: 1290)
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NA and outcome of medical treatment: A meta-analysis (63 studies)
(DiMatteo et al. Med Care 2002; 40: 794)
-1
-0,8
-0,6
-0,4
-0,2
0
0,2
0,4
0,6
0,8
1
Ris
k di
ffer
ence
Risk difference(%) OR (95% CI)
Overall 0.26 [0.20 – 0.32] 2.88 [2.23 – 3.73]
Hypercholesterolemia 0.25 [0.13 – 0.35] 2.81 [1.67 – 4.71]
Hypertension 0.30 [0.12 – 0.46] 3.44 [1.70 – 7.37]
Heart disease 0.10 [-0.02 – 0.22] 1.49 [0.91 – 2.42]
OV
ER
AL
L
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Good adherence reduces mortality riskin chronic illness populations
10.50.2 2 5
TOTAL
(Simpson et al. 2006; 333: e-pub June 21)
OR= 0.56 [0.50 – 0.63]
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Impact of NA assessed by MEMS on event-free survival (N= 137)
% of prescribed doses taken
% of days the correctnumber of prescribed doses were taken
% of doses taken on schedule (within 25% of prescribed time interval)
Median= 95.4% Median= 90.3% Median= 76.0%
(Wu et al. J Cardiac Fail 2008; 14: 203)
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Economic consequences
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Economic consequences of NA
Direct costs
cost of non-taken medication cost for treatment of morbidity cost of avoidable hospitalizations
Indirect costs• Missed work days• Cost for transportation, household, home care quality of life cost of evolving more potent medications
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Non-drug medical costs within 1 year
Adherent
( 80% taking)
Non-adherent
(< 80% taking)
Diabetes $ 6377 $ 9363 - $ 15 186
Hypertension $ 6570 $ 7658 - $ 10 286
Hypercholesterolemia $ 4780 $ 5509 - $ $ 9849
(Muzbek et al. Int J Clin Pract 2008; 62: 338)
One study in heart failure: No difference in costs
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Noncompliance: a major and important problem
Or will we expel patients from Paradise?
Can / will health care provider do something...
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Randomized controlled
trials
What can be done to improve adherence ?
Determinantsof NA
Identifying patients
at risk for NA
Implementationof interventions
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Measurement of nonadherence
A. Direct methods- observation- assay- objective tests
B. Indirect methods– pill count– prescription refill– clinical judgement– electronic monitoring– self-report
Clinical nonadherence
Sub-clinical nonadherence
No gold standard: combine measures to increase accuracy
(Osterberg et al. N Engl J Med 2005;353)
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5 interrelated categories of determinants
Socio-economic factors
Condition related factors
Health professional and setting-related
Treatment related factors
Patient related factors
(Sabate E. WHO report 2003)
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Determinants in patients with HF
Socio-economic
Poor socioeconomic status
Low education/illiterate
Cost of medication
Poor social support
Living alone
Condition related
Depression
Cognitive dysfunction
Higher co-morbidity
Poor social support
Treatment related
Complex regimen
Side effects
Lifelong duration of treatment
Frequent changes
Patient related
Poor knowledge
Lack of motivation
Health beliefs/ attitudes
Interference with socialization
(van der Wal et al. Int J Cardiol 2008; 125: 203)
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Impact of the health care providerand setting related factors
Macro levelPolicy
Meso levelHealth care
organizations and community
Micro levelpatient-provider
interaction
- Poor knowledge about adherence- lack of trust- poor communication style
- Short consultations- Lack of follow-up / cooperation with community services- Uni-disciplinary treatment
- reimbursement and insurance policy- no funding for chronic disease management programs or prevention
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Interventions…
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0 20 40 60 80 100
Education + behavior
Affective
Behavior
Education
randomintervention
control
Absolute difference (%)
ES= .20
ES= .35
ES= .20
ES= .22
(Roter et al. Med Care 1998; 36: 1138-1161)
Effectiveness of adherence-enhancing interventions: RCT’s
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Typical reaction if treatment is not working: the radar syndrome
The patient appears…
Find the problem and fix it, by:- increasing the dose- switching to another drug- adding another drug
But nonadherence frequently ignored!
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Disease management programs in heart failure populations
• Integrated programs with focus on
- detailed assessment of the patient
- patient education about treatment regimen
- optimizing medications
- regular monitoring by health
professionals
DISEASE MANAGEMENT
Education Monitoring
(Health and health care 2010 – The Forecast – the ChallengeInstitute of the future 2003)
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Efficacy of disease management programs: a meta-analysis
Re-hospitalization *Mode Personal
Phone
-10.5 [-14.7; -6.2]
-3.6 [-6.8; -0.3] **
team Single group
2-3 disciplines
multidisciplinary
-7.5 [-10.7; -4.4]
-2.5 [-8.7; -3.8] **
-18.1 [-23.4; -12.9] **
Transition Yes
No
-8.6 [-12.7; -4.4]
-6.1 [-9.8; -2.5]
Follow-up 3 months
3-9 months
> 12 months
-10.9 [-17; -4.9]
-6.2 [-12; -0.4]
-9.0 [-13.9; -4]
* Risk Difference; negative value in favor of program** significant difference with reference value; pooled relative risk 0.84 [0.77; 0.92]
(Göhler et al. J Cardiac Fail 2006; 12: 554)
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Cost-effectiveness of disease management programs
• Mean age at onset 67 years (35% female)
– Quality adjusted life expectancy:2.64 years for standard care2.83 years for disease management program
– Additional lifetime cost for 84 days difference:1700 Euro(i.e. 9800 Euro per QALY gained)
(Göhler et al. Eur J Heart Failure 2008; e-pub)
Beneficial impact on clinical outcomes but expensive…
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Problem of disease management problems
1o
3o
2o
Patient preferencesReadiness for treatment
ComplianceSymptom management
…
20% Providing professional patient care
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The majority of care is taking place outside the hospital setting
1o
3o
2o
Patient preferencesReadiness for treatment
ComplianceSymptom management
…
20% Providing professional patient care
80%Fostering patient self-management
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“The most effective approaches have been shown to be
multidimensional and multilevel – targeting more than one factor with
more than one intervention”
(Haynes et al. Cochrane Reviews 2008)
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Tackling Nonadherence: A Multidimensional and Multilevel Approach
Healthsystem/
HCT-factors
Social/economic
factors
Condition-relatedfactors
Therapy-relatedfactors
Patient-related factors
Patient
Micro
Meso
Macro
+
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Multilevel interventions
Macro levelPolicy
Meso levelHealth care
organizations and community
Micro levelpatient-provider
interaction
- development of adherence counseling toolkit- Training in fostering self-management- training in motivational interviewing
- Multi-disciplinary treatment- follow-up organized with focus on chronic illness- Engagement of community resources
- Health care system changes allowing self-management support and chronic care
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From disease management to self-management programs
= A set of things patients can do for themselves to follow the prescribed therapy, to avoid health deterioration and preserve function
SELF-MANAGEMENT
PROBLEMSOLVING
DECISION MAKING
RESOURCE UTILIZATION
BUILDINGPATIENT/ PROVIDERRELATION
TAKING ACTION
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Remember the definition???
= “Is a behavioral process, strongly influenced by the
environment in which the patient lives, including the
healthcare practices and system.
Adherence assumes that a patient has the knowledge,
motivation, skills and resources required to follow the
recommendations of a healthcare professional.
(AHA expert panel. Miller et al. 1997)
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Efficacy and cost of HF self-management programs
Odds ratio [95% CI]
All-cause readmission in 1 year (5 studies) 0.59 [0.44; 0.80]
Readmissions due to HF (3 studies) 0.44 [0.27; 0.71]
Mortality (3 studies) 0.95 [0.57; 1.51](NS)
Adherence (2 studies) Both significant
(Jovicic et al. BMC Cardiovascular Disorders 2006; 6: 43)
Cost saving (3 studies) after subtracting the intervention cost:
$ 1300 - $ 7515 saved per patient annually
ONLY POSSIBLE IF YOU HAVE A TRAINED TEAM!!!
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Conclusion
• HF is a chronic disease requiring a complex management
• Nonadherence is a prevalent problem, resulting in poor clinical and economical outcomes
• Risk factors are multi-factorial
• Interventions should be multidimensional, targeting more than 1 risk factor with more than 1 intervention
• A multilevel approach is mandatory, integrating interventions at the patient, health care professional, team and policy level
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“Changing systems of care and applying
multidimensional + multilevel adherence-
enhancing interventions to improve self-
management may have a far greater impact
on the health of heart failure patients than any
improvement in specific medical treatments”
Take home message
(Haynes et al. Cochrane review 2008)
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HET IS NOOIT TE LAAT!
Increasing adherence with heart failure treatment...
IT IS NEVER TOO EARLY!
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IT IS NEVER TOO LATE!
KEEP ON BELIEVING THAT PEOPLE CAN CHANGE!
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Some numbers…
• 3.7% of the Belgian population reported with a serious heart problem or heart attack in the last 12 months (2004)
• 21.9% treated by GP alone• 38.9% treated by specialist alone• 25.7% treated by both GP and specialist
• 89.3% of these patients use medicines for this problem• Use of cholesterol reducing agents: 6.4%• Use of cardiac glycosides: 0.7% • Use of anti-arrhytmics: 0.8%• Use of ace-inhibitors: 3.8%• Use of diuretics: 4%• Use of beta-blocking agents: 8.7%
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• > 65 years: 3.4 drugs on average• 14.9% of > 65 years serious cardiac
disease or heart attack in past 12 months– 22.3% cholesterol reducing agent– 3.9% cardiac glycosides– 4.2% anti-arrhytmics– 14.1% ace-inhibitor– 18.7% diuretics– 26.2% beta-blocking agents
Belgian Health Interview Survey 2004, Scientific Institute for Public Healthwww.iph.fgov.be
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Percentage of nonadherence for different therapeutic aspects
20,6
27,3
28
30,3
34,1
40,7
0 10 20 30 40 50
medication
screening
exercise
health behavior
appointment
diet
(DiMatteo MR. Med Care 2004; 42(3): 200-209)