Transcript Chronic anxiety in ICD patients: A multi

CoRPS
E-health for implantable cardioverter defibrillator patients to improve
secondary prevention: New kid on the block for a selected few?
Susanne S. Pedersen, Professor of Cardiac Psychology
Center of Research
on Psychology
in Somatic diseases
CoRPS
Affiliations
Prof.dr. Susanne S. Pedersen
• CoRPS - Center of Research on
Psychology in Somatic diseases, Tilburg
University, The Netherlands
• Thoraxcenter, Erasmus Medical Center,
Rotterdam, The Netherlands
• Department of Cardiology, Odense
University Hospital, Denmark
Phone: + 31 (0) 13 466 2503
E-mail: [email protected]
www.tilburguniversity.nl/corps
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Project participants
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• Susanne S. Pedersen (PI; PhD)
• Johan Denollet (PhD)
• Mirela Habibovic (MSc; PhD candidate)
Free University, Amsterdam
• Pim Cuijpers (PhD)
Amphia Hospital, Breda
• Marco Alings (MD, PhD)
Erasmus Medical Center, Rotterdam
• Luc Jordaens (MD, PhD)
• Dominic Theuns (PhD)
Onze Lieve Vrouwe Gasthuis, Amsterdam
• Jean Paul Herrman (MD, PhD)
Vlietland Hospital, Schiedam
• Suzanne Valk (MD)
Canisius Hospital, Nijmegen
• Leon Bouwels (MD, PhD)
STIN (Stichting ICD dragers Nederland)
• Peter Zaadstra (Projectadvisor)
Catharina Hospital, Eindhoven
• Pepijn van der Voort (MD)
Funding
• ZonMw/Dutch Heart Foundation (grant
no. 300020002) and ZonMW (VIDI grant
91710393) to Dr. SS Pedersen
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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ICD units per million inhabitants
800,000 heart patients
in Europe and 1 mill in
North America have a
cardiovascular implantable
electronic device
2009 Eucomed data (based on reports from major manufacturers)
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The implantable cardioverter defibrillator (ICD)
TRANSVENOUS ICD:
Leads in or on the
heart
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Used as primary and secondary prevention of sudden cardiac death
ICD is superior to anti-arrhythmic drugs in saving lives
The ICD can shock with up to 700-800 volts
“It’s like getting kicked in the chest by a big horse!”
Ahmad et al. PACE 2000;23:931-3
Crespo et al. Am J Med Sci 2005;329:238-46
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ICD therapy: Benefits and side effects
Epstein, J Am Coll Cardiol 2008;52:1122-7
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ICD therapy: Benefits and side effects
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Complications (lead fractures, dislodgement, and infection)
Shocks that are inappropriate  mortality risk ?
Potential malfunctioning, as notified with a device recall
Significant anxiety and depression in 20-30% of patients
Patient´s psychological reaction to the device may increase
the risk of arrhythmias
Risk that patients will refuse this potentially
life-saving treatment
Tung et al. J Am Coll Cardiol 2008;52:1111-21
Pedersen et al. Pacing Clin Electrophyiol 2009;32:1006-11
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Prevalence
of
anxiety
and
depression
in
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patients stratified by Type D and shocks
80
70
60
(N = 182)
%
72
67
61
57
50
40
Type D - shocks
Type D - no shocks
Non Type D - shocks
Non Type D - no shocks
32
30
20
13
19
14
10
0
Anxiety
Depression
Pedersen et al. Psychosom Med 2004;66:714-719
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Distress (depression) and arrhythmias
Adjusted analysis:
•HR: 3.2 – time to first shock
for VT/VF
•HR: 3.2 – all shocks for VT/VF
including recurrent episodes
Whang, Sears et al. J Am Coll Cardiol 2005;45:1090-5
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Posttraumatic stress symptoms and mortality
N = 147
Ladwig et al. Arch Gen Psychiatry 2008;65:1325-30
Type D personality / high ICD pre
implantation concerns and mortality
N = 371
HR: 3.65; 95%CI: 1.57-8.45; p = .003
20
18
16
2-year mortality (%)
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18.2%
14
12
10
8
6
4
2
0
Type D and concerns
Pedersen et al. Europace 2010;12:1446-52
5.2%
None or one risk marker
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ICD shock - the paradox
Safety?
Danger?
Braunschweig, Boriani, ... Pedersen et al., Europace 2010;12:1673-90
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Psychological intervention trials in ICD patients
N = 12-246; 15 trials
Authors
N (design)
Duration
Crössman et al. (2011)
Dunbar et al. (2009)
Irvine et al. (2011)
Kuhl et al. (2009)
Lewin et al. (2009)
Sears et al. (2007)
119 (RCT)
246 (RCT)
193 (RCT)
30 (RCT)
192 (RCT)
30 (RCT)
6
12 mths
12 mths
1 mth
6 mths
4 mths
Pedersen et al. Pacing Clin Electrophysiol 2007;30:1546-1554
Salmoraga-Blotcher et al. BMC Cardiovasc Disorders 2009;9:56
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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OBJECTIVES
Primary:
• To investigate whether the web-based intervention is
superior to usual care in terms of reducing anxiety,
depression, and ICD concerns as well as improving ICD
acceptance and QoL
• To investigate the cost-effectiveness of the web-based
intervention and whether the web-based intervention is
associated with reduced health-care utilization
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Secondary:
• To examine whether psychological (i.e., Type D personality
and positive affect) and clinical factors (i.e., cardiac
resynchronization therapy (CRT)) moderate the effect of
the intervention, with a view to developing risk profiles of
patients who are less likely to benefit from the intervention
Explorative:
• To explore whether the web-based intervention influences
physiological parameters (i.e., ventricular arrhythmias and
the cortisol awakening response (CAR))
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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Patient population
Consecutive first-time ICD patients recruited from:
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Amphia Hospital, Breda
Canisius Hospital, Nijmegen
Catharina Hospital, Eindhoven
Erasmus Medical Center, Rotterdam
Onze Lieve Vrouwe Gasthuis, Amsterdam
Vlietland Hospital, Schiedam
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Inclusion criteria
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Patients implanted with an ICD
18-75 years of age
Speaking and understanding Dutch
With access to and ability to use the internet
Providing written informed consent
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Exclusion criteria
• A life expectancy less than 1 year
• A history of psychiatric illness other than
affective/anxiety disorders
• On the waiting list for heart transplantation
• With insufficient knowledge of the Dutch
language
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Study design
5-10 days post implantation:
completion of baseline
questionnaire
-T1
T0
Follow-up
Intervention
T1
T2
T3
14
26
52
Usual care
Weeks
0
Hospitalisation
for ICD
implantation
2
Randomisation
to intervention
or usual care
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Patient reported measures
Construct
Anxiety
Questionnaire
GAD-7
FSAS
Florida Shock Anxiety Scale
STAI-S
Stait-Trait Anxiety Inventory
PDS
Depressive symptoms
Quality of life
Generalized Anxiety Disorder Scale
Posttraumatic Stress Disorder Scale
HADS
Hospital Anxiety and Depression Scale
PHQ-9
Patient Health Questionnaire
SF-12
Short Form Health Survey 12
EQ-5D
EuroQol 5D
MLWHFQ
Minnesota Living With Heart Failure Questionnaire
ICD concerns
ICDC
ICD Patient Concerns Questionnaire
ICD acceptance
FPAS
Florida Patient Acceptance Survey
Health care utilization and costeffectiveness
TiC-P
Trimbos/iMTA questionnaire for Costs associated with
Psychiatric Illness
Type D personality
DS14
Type D Scale
Expectations
EXP
Patient expectations about the ICD treatment
Optimism
LOT
Life Orientation Test
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Physiological measures
• Salivary cortisol, using the Salivette, assessed at 3
out of the 4 time points (i.e., T0 = 5 to 10 days after
ICD implantation; T1 = 14 weeks post-implantation;
T3 = 52 weeks post-implantation)
• Four samples will be taken at each time point and
on the consecutive day, that is (a) when waking up,
(b) ½ hour later, (c) 11.00 a.m., and (d) 3.00 p.m.
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Other measures
• Clinical: ICD indication, etiology, LVEF, CRT, comorbidity, type of ICD therapy (ATP vs. shock;
appropriate vs. inappropriate), QRS-complex,
cardiac medication, etc.
• Demographic: Sex, age, marital status, education,
working status
• Other: Smoking status, participation in cardiac
rehabilitation since ICD implantation, the use of
psychotropic medication, help-seeking from a
psychologist/psychiatrist
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Study endpoints
Primary:
• Anxiety; depression; ICD concerns; ICD acceptance;
quality of life; health care utilization; costeffectiveness of the intervention
Secondary:
• Ventricular arrhythmias; cortisol awakening response
Long-term:
• Mortality
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Intervention – web application
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Intervention (fixed, 3-month duration)
COMPONENTS
 Psycho-education about the ICD
 Problem-solving skills
 Cognitive restructuring
 Relaxation training
 Personalized feedback by a
therapist via the computer
TOPICS DEALT WITH
 Emotional reactions to ICD therapy
 Which aspects of ICD therapy may
lead to distress
 How to deal with shocks
 Disease-specific issues and fears
 How to prevent the avoidance of
activities
 Interpretation of bodily symptoms
 How to cope with uncertainty
 Help-seeking behavior
 How to cope with stress
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WEBCARE
Pedersen et al. Trials 2009;10:120
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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Patient inclusion (total) – status
50%
↓
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Patient inclusion stratified by center
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Intervention completion rate
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Reasons for refusal and quitting prematurely
Reason for initial refusal of participation:
• Too much work
• No interest in participating in a study
• Participating in other studies
Reason for quitting prematurely:
• Too confronting / too personal
• Too time consuming / too much work
• Have a lot of other things to deal with
• Feeling fine, no need for extra support
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• Background
• Objectives - WEBCARE
• Methods – WEBCARE
• Preliminary results – WEBCARE
• Pros and cons of e-health in ICD patients
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E-health in ICD patients for a selected few
• 50% of patients are excluded  reasons:
Lack of internet
o Age > 75 years
o Language
o
• 59% response rate  reasons:
o
o
o
o
o
o
o
Inclusion at participating centers needs to be optimized
Other study participation (competing with clinical studies)
Timing of intervention (too soon)
Including patients irrrespective of distress (no screening)
Type of intervention (patient preferences)
Too work intensive
Too confronting
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Advantages of web-based approach
• Low-threshold accessibility
• Less stigma – no face-to-face meetings with
therapists
• Obtain treatment at any time and place, work at
own pace and review material as often as
desired
• No extra hospital visits – reminded less of illness
as the context of the intervention is different
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Clinical and societal relevance
• Immediate applicability in health care
• Identification of high-risk patients  screening
• Personalized care  optimization of clinical
management of device patients
• Reduced health-care utilization
• Increased cost-effectiveness
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Research group
Susanne S. Pedersen (PhD)
Professor of Cardiac Psychology
Center of Research on Psychology in Somatic diseases, Tilburg University, The Netherlands
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Device Conference, 3-4 November 2011,
Tilburg, the Netherlands
Living in a Device World: Focus on Recent Challenges and Tools to Improve
Clinical Care for Patients with an Implantable Cardioverter Defibrillator
Themes
Selection of invited faculty
• OVERCOMING THE SHOCK OF THE ICD
• Nico Blom (MD, PhD), Leiden University Medical Center, NL
• ICD REGISTRIES AND THE INCLUSION OF THE
PATIENT PERSPECTIVE
• Matthew Burg (PhD), Yale School of Medicine, USA
• DEACTIVATION OF THE ICD AND END OF LIFE
ISSUES
• NEGLECTED SUBGROUPS
• Dorothy Frizelle (PhD), University of Hull, UK
• Jens Brock Johansen, (MD, PhD), Odense University Hospital, DK
• Karl-Heinz Ladwig (MD, PhD), Helmholtz Institute, Munich, GE
• Trudie Lobban,
More information available
on: The Arryhthmia Alliance, UK
• Mathias Meine (MD, PhD), University Medical Center Utrecht, NL
•www.tilburguniversity.edu/device2011
THE DO’S AND DON’TS OF PATIENT
• Susanne S. Pedersen (PhD), CoRPS, Tilburg University, NL
COMMUNICATION
• CRT SELECTION AND RESPONSE
• SEXUALITY IN ICD PATIENTS
• Samuel Sears (PhD), East Carolina University, USA
• BEHAVIORAL INTERVENTIONS
• Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK
• LOOKING INTO THE FUTURE
• Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL