Challenges in end-stage heart failure: Compliance

Fabienne Dobbels, PhD

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!!!

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

Management of patient with heart failure:

PsychologicalDimension

PhysicalDimension

Goal = to optimize outcomes!

BehavioralDimension

Non-adherence: the Achilles heel of heart failure treatment

Peter Paul Rubens 1630

Definition

Prevalence

Consequences

Risk factors

Interventions

Eve and the Apple in the Garden of Eden....

...the first case of nonadherence?

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)

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)

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)

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

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)

NA is a prevalent problem: so what???

Clinical consequences

Economic consequences

“Drugs don’t work in patients who don’t take them”

(C Everett Koop M.D.)

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)

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

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]

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)

Economic consequences

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

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

Noncompliance: a major and important problem

Or will we expel patients from Paradise?

Can / will health care provider do something...

Randomized controlled

trials

What can be done to improve adherence ?

Determinantsof NA

Identifying patients

at risk for NA

Implementationof interventions

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)

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)

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)

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

Interventions…

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

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!

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)

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)

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…

Problem of disease management problems

1o

3o

2o

Patient preferencesReadiness for treatment

ComplianceSymptom management

…

20% Providing professional patient care

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

“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)

Tackling Nonadherence: A Multidimensional and Multilevel Approach

Healthsystem/

HCT-factors

Social/economic

factors

Condition-relatedfactors

Therapy-relatedfactors

Patient-related factors

Patient

Micro

Meso

Macro

+

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

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

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)

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!!!

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

“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)

HET IS NOOIT TE LAAT!

Increasing adherence with heart failure treatment...

IT IS NEVER TOO EARLY!

IT IS NEVER TOO LATE!

KEEP ON BELIEVING THAT PEOPLE CAN CHANGE!

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%

• > 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

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)