Minimally Disruptive SDM Trials - WordPress.com · Minimally Disruptive SDM Trials Small Breakout...
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©2014 MFMER | slide-1
Minimally Disruptive SDM Trials Small Breakout 1
Annie LeBlanc, PhD Health Services Researcher Department of Family and Emergency Medicine Faculty of Medicine, Laval University Institute of Primary Healthcare and Social Services KER unit, Mayo Clinic, Rochester, MN Strategy for Patient-Oriented Research Support Unit
Sara Dick, MSc, CCRP Cardiovascular Research Unit Mayo Clinic
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Introduction • Name • What is your most recent learning experience that
took you out of your comfort zone
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Plan • Objectives • A respectful approach to conducting clinical studies • Group discussion • A case in point – The KER experience • How can we help you ? • Wrap up
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Objectives (what are you hoping to take away from this workshop)
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Disclosures
No financial conflict of interest
We do not receive funding from any for-profit pharmaceutical or manufacturer, nor do we receive any royalties or monetary benefits,
directly or indirectly, from the use of the decision aids
Decision aids are available free of charge
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Minimally Disruptive Research a respectful approach to conducting clinical studies
[email protected] @srhdick @KERUnit
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Jill 36 year old female Chronic disease
Clinical appointment Phone call
Present Early Consent Confused Concerned
Coerced Randomization
Appointment
Distracted
A1c
job medication
caretaker
Survey Stressed
Frustrated Withdraws
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Research is work.
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Minimally Disruptive Research
Research must impose the smallest possible
footprint on clinical care activities.
CAREFUL and KIND RESEARCH
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Research Burden for Patients • Multiple Clinical Visits • Excessive Survey Lengths
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MDR Considerations - Patient • Apply a single pre-scheduled visit • Utilize wait time effectively • Collect usable data • Conduct videographic analysis • Engage as stakeholders
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Patient Participation
Pre-contacts
Clinical Appointment
Post Follow-up X X
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MDR Value Added - Patient • Subjects become participants • Amplified empathy • Effective use of scheduled time • Increase capacity • Escalate excitement • Reduce lost to follow-up data • Stronger completion rates
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Research Burden for Clinicians • Identify Patients • Review Inclusion and Exclusion Criteria • Consent Patients
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MDR Considerations - Clinician • Utilize roles effectively • Clinicians as research participants • Develop a clinician champion • Engage as stakeholders
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Clinician Participation
Patient Identified
Review Inclusion / Exclusion Criteria Pt
Consent X X X Clinician Champion /
Confirm Eligibility
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MDR Value Added - Clinician • Delegating work to appropriate person • Increase capacity • Escalate excitement • Improve delivery of clinical care
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Engage, Engage, Engage!!!
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Minimally Disruptive Research
Research must impose the smallest possible
footprint on clinical care activities. CAREFUL and KIND RESEARCH
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Jill 36 year old female Chronic disease
Clinical appointment Phone call
Present Early Consent Confused Concerned
Coerced Randomization
Appointment
Distracted
A1c
job medication
caretaker
Survey Parking Ticket
Frustrated Withdraws
Increased capacity
Less overwhelmed
Sense of empathy
excited
efficient
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Activity • Generate a list of all the Do’s and don’ts that we
should pay attention to in order to achieve MDR (participant focus researched, minimize work)
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Activity • Reduce the Max Specs list to the absolute
minimum needed to achieve the purpose-
“If we broke or ignored this rule, could we still achieve our purpose?”
• Goal: 2-5 Min specs
“What must we do to make progress”
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The Case of the Depression Choice Trial Minimally Disruptive Research
LeBlanc et al. Trials 2013 LeBlanc et al. JAMA Inter Med 2015
AHRQ Funded (iADAPT-1 R18 HS019214)
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Summary 10 primary care practices, 107 clinicians, 300 patients
Patients & clinicians more comfortable with the decision made (>20% ↑) more satisfied with the decision process (>30% ↑)
Patients more knowledgeable (14% ↑)
more involved in the decision making process (50% ↑) Voiced preferences (92%) and issues of importance (63%)
Clinicians able to use DMC with no/little training
use of DMC did not add to the length of encounter
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Clinical Studies
Systematic Reviews
Clinical Research
Aware Accepted Applicable Able Acted on Agreed to Adhered to
Research Synthesis
Evidence-based medicine Clinical decision making
Clinical quality improvement
Health services research
Clinical care research
Glasziou et al. 2005
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On the complexity
of knowledge
The possible simplification of knowledge
vs.
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Depression
Can be improved by Lifestyle changes, self-care practices
psychotherapy, pharmacotherapy
But of different efficacy, safety, cost, burden to the patient
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Conversation not information Design to support the interaction of people not the transfer of information
Designed for context
How that is done depends on the challenges of the medical and personal situation
Development is a partnership
The voice and experience of clinicians, patients and caregivers is the impetus of development
feasible and sustainable
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Maximal impact of Intervention
delivery
Sustainability of the delivery
vs.
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http://shareddecisions.mayoclinic.org
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Taking expertise for granted
Building on lessons learned
vs.
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Previous 6 decision aids RCTs
The depression decision aid RCT Vs.
•Recruiting practices rather than clinicians alone •Clinical champion and sufficient eligible patients •Involving practices, clinicians, patients and staff in the development of the intervention
•Engaging clinicians and patients as collaborators of the study rather than as ‘subjects’ of the study
•Opt-out approach while recruiting clinicians •Using study coordinators •Minimizing burden of the trial procedures
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the value of a measure
The unintended consequences
vs.
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Initial proposal End users engagement Outcomes
Screening for depression/ PHQ-9 Approach to participate in a depression study
key words used to describe/mask real reasons for visit Approach to participate in a study about communication/ decision making
New vs recurrent depression Reached target on time (300 pts/13 mo) 74% participation rate
Identification & recruitment of patients
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Patients and Clinicians Outcomes
Initial proposal End users engagement Outcomes
Patient Stigmatization
Patient = no Clinicians = no No stigmatization measure
Reduced the likelihood of unintended consequences
Clinician Satisfaction Usage
Comfort with decision
>30% improvement
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the value of the intervention
the temporary necessity of the trial burden
vs.
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The diabetes decision aid RCT
The depression decision aid RCT Vs.
How much time will it take me?
Can someone else deliver it?
How long the study?
We need to think about it
Focus entirely on
The trial and its burden
What do we get to play with?
Can I use it?
See what I did with the DA !
Engaged, excited
Focused entirely on the intervention
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The diabetes decision aid RCT
The depression decision aid RCT Vs.
22/20 practices
103 clinicians
350/620 patients
5 years
Already available DA
High rate of missing data
10/8 practices
107 clinicians
300/300 patients
2 years
Co-construction of DA
Low rate of missing data
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Megan Branda Kathy Shepel Maggie Breslin Kari Ruud Joanne Nordeen Azra Thakur
Victor Montori Nilay Shah Mark Williams Kathy Yost Jeph Herrin Jonathan Inselman
Laurie Pencille Angela Sivly Kim Hurley Emma Heim Sara Dick Sara Poplau
Mayo Clinic Patient Advisory Groups Hennepin County Medical Center (Linzer, Boehm)
Entira Family Clinics (Conboy) Mayo Clinic Rochester (Williams, DeJesus, Matthews)
Mayo Clinic Health System La Crosse (Lerberg) Institute of Clinical Systems Improvement
Stakeholders Groups (24 individuals from 12 organizations)
The Study Team
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Normalization Process Theory
Coherence Distinguishing the intervention from ways of working
Cognitive participation Agree on the purpose of the intervention
Collective action Identify the “work” required of them
Reflexive monitoring Each individual evaluates the value of the intervention
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Development/ Evaluation
Development/ Optimization Intervention
Intervention worth evaluating? (likely to be sustained)
NPT analysis
Development/ Optimization Trial design
NPT analysis
Trial design feasible? (likely to be sustained)
no no Trial killer (do not proceed to trial!)
Yes Yes Proceed to trial
Murray et al. 2009
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Take Home Message Decision aids for use during clinical encounters
Design for use (and reuse) in planned visits Efficacious, free, and accessible Embed into the workflow of care
Considers patients, team and setting Add SDM to quality-of-care dashboard
Empower (and train) clinicians and patients Path to high quality healthcare
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Softest research footprint as possible Real life setting and context
Engage patients, clinicians, staff Don’t go against the flow – work with it! Minimalized steps/work for all parties
Minimize options to say no Clinicians as participants not recruiters
Minimize contact point – workload Invest in study coordination
Take Home Message
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http://minimallydisruptivemedicine.org
http://shareddecisions.mayoclinic.org