Titelfolie

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Workshop D4 Shared Decision Making from
scientific experiences to routine health care
Part 3 Design and issues in DSTs
evaluationProf. Dr. Dr. Martin
HärterUniversity Medical Center Freiburg
Section Clinical Epidemiology and Health
Services ResearchInternational Forum on
Quality and Safety in Health Care22.04 -
25.04.08, Paris
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Aims

• To learn more about
• State of knowledge about DST evaluation
• Key evalution dimensions for DSTs
• Formulating a valuable evaluation design
• Key issues running RCTs in real life
  circumstances
• Future evaluation agendas

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Evaluation of DSTs
Cochrane Review, OConnor et al., 2008 Decision
aids for people facing health treatment or
screening decisions

• Use leads to
• greater knowledge
• more realistic expectations about
  outcomes/course of disease
• lower decisional conflict related to feeling
  informed
• increased proportion of people active in
  decision-making
• reduced proportion of people remaining undecided
  
• greater agreement between values and actual
  choice

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Patient dialogue

• Aims
• development of patient competencies
• encouragement of positive health behaviour
• patients acceptance towards evidence-based
  effective therapies

• Format
• web-based interactive DST (modules acute low
  back pain, depression)
• information individually tailored to users
  interests and needs

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Quality standards

• International Patient Decision Aid Standards
  (IPDAS)
• HON
• DISCERN

• Topics, e.g.
• 1) Systematic development process
• 2) Adherence to legal conditions
• 3) Quality and presentation of content
• User-friendlyness
• Further information (authors, contacts,
  cooperating partners)
• 6)

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Pilot system test depression
experts
patients
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Patient dialogue

• Aims
• development of patient competencies
• encouragement of constructive health behaviour
• patients acceptance towards evidence-based
  effective therapies

• Format
• web-based interactive DST (modules acute low
  back pain, depression)
• information individually tailored to users
  interests and needs

• Evaluation
• RCT patient dialogue (IG) vs. patient
  information only (CG)
• online survey among TK-members

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Questions for you ?

• Your questions / hypotheses to DSTs?
• What kind of dimensions would you suggest ?
• What kind of scales would you suggest ?
• Design of the study ?

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Hypotheses
Patients using the patient dialogue

• experience less decisional conflict (primary
  outcome)
• 2) know more about evidence-based options
  (secondary outcomes)
• 3) are better prepared for decision-making with
  their physician
• 4) have a stronger preference for participation
  in decision-making
• 5) experience a stronger participation in
  decision-making
• 6) have less decision regret
• 7) report better treatment adherence

than patients using patient information only.
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Study design
Currently suffering from low back pain or
depression?
Yes
Randomisation
No
IG
CG
50 each
Survey T0 adapted
Survey T0
Survey T0
Patient dialogue
Patient information
Survey T1 adapted
N (T1) 500
Survey T1
3 months
N (T2) 250
Survey T2
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Questions for you ?

• Your questions / hypotheses to DSTs?
• What kind of dimensions would you suggest ?
• What kind of scales would you suggest ?
• Design of the study ?

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Data collection and assessment

• T0 (prior to system use)
• Control Preference Scale (Degner Sloan,1992)
• Shared decision-making questionnaire (Simon et
  al., 2006)
• Perceived Involvement in Care Scale (Lerman et
  al., 1990)
• T1 (immediately after system use)
• Decisional Conflict Scale (OConnor, 1995)
• Preparation for Decision Making Scale (Graham
  OConnor, 2005)
• Condition specific knowledge questions (new
  development)
• System acceptance (new development)
• T2 (3 months after system use)
• Shared decision-making questionnaire (Simon et
  al., 2006)
• Perceived Involvement in Care Scale (Lerman et
  al., 1990)
• Decision regret Scale (Brehaut et al., 2003)
• Question on treatment adherence

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Problems you will face ?

• Participation rates ?
• Drop-outs ?
• Quality of data ?

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New users per month (2007-2008)
TK-aktuell 01.11.07
TK-aktuell 01.09.07
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Frequency of using patient dialogue
June - September 2007

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Length of stay (in minutes)

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Drop-outs during evaluation
Transfer from TK-website to patient dialogue
- 65
Information on trial and informed consent
Question on back pain and depression
Randomization
T0 -Survey
- 20 (no entry)
Intervention
- 20 (no entry)
- 60 (no evaluation)
T1 -Survey
T2 -Survey
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Conclusions

• Insurants interest in patient dialogue
  
• (about 60 spend more than 45 minutes in the
  system)
• High drop-out rates ? cautious interpretation of
  results
• Different aims health insurance fund
  researchers
• RCT results expected for June 2008
• Contribution to state of knowledge about DST
  evaluation

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Cooperating partners

• Universitätsklinikum Freiburg
• Prof. Dr. Dr. Martin Härter
• Dr. Andreas Loh, Dipl. Psych.
• Dipl. Psych. Daniela Simon
• Prof. Dr. Wilhelm B. Niebling
• Dr. Klaus Böhme

Techniker Krankenkasse Christine Vietor Dr.
Torsten Hecke u.v.a.
Patienten-dialog
GAIA AG Dr. Mario Weiss, MBA Dr. Matthias Zenker
Dr. Lars Mühlenhoff Dr. Kai Grimme Dr. Anne
Runde, Dipl. Psych. Björn Meyer, Ph.D., M.S.,
B.A. Dr. Michael Hanik Dr. Bernhard Wellhöfer,
Dipl. Math. Hamoud Gahl Steffan Schiewe, B. Sc.
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Evaluation of DSTs (II)

• Unclear effects (to be investigated in future
  studies)
• acceptance in diverse patient populations
• influence on physician-patient-communication
• lasting effects on decisions / decision regret
• relation between values and outcomes
• resource use (health economy)
• evaluation of web-based applications

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Thank you for your attention!
Prof. Dr. Dr. Martin Härter Sektion Klinische
Epidemiologie und Versorgungsforschung Abteilung
für Psychiatrie und Psychotherapie Universitätskli
nikum Freiburg
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Potential and actual users
TK 6.300.000 insurants 4.284.000 with
preference for participation 515.000 with
current access to members-only portal
Prevalences (lifetime) 80 acute low back pain
? 411.250 insurants 18 depression ? 25.200
insurants
Potential/year 9.150 acute low back pain, 2.050
depression 11.200 total

• User
• 12.250 Logins
• 3.326 symptom free
• 8.916 total (80 real. potential)

Drop-out
35 accepted study
44
35
27
LBP
Depr
no symptoms
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Study participants
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Aims

• To learn more about
• State of knowledge about DST evaluation
• Key evalution dimensions for DSTs
• Formulating a valuable evaluation design
• Key issues running RCTs in real life
  circumstances
• Future evaluation agendas