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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

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

dick.sara@mayo.edu @srhdick @KERUnit

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

Research is work.

Minimally Disruptive Research

Research must impose the smallest possible

footprint on clinical care activities.

CAREFUL and KIND RESEARCH

Research Burden for Patients • Multiple Clinical Visits • Excessive Survey Lengths

MDR Considerations - Patient • Apply a single pre-scheduled visit • Utilize wait time effectively • Collect usable data • Conduct videographic analysis • Engage as stakeholders

Patient Participation

Pre-contacts

Clinical Appointment

Post Follow-up X X

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

Research Burden for Clinicians • Identify Patients • Review Inclusion and Exclusion Criteria • Consent Patients

MDR Considerations - Clinician • Utilize roles effectively • Clinicians as research participants • Develop a clinician champion • Engage as stakeholders

Clinician Participation

Patient Identified

Review Inclusion / Exclusion Criteria Pt

Consent X X X Clinician Champion /

Confirm Eligibility

MDR Value Added - Clinician • Delegating work to appropriate person • Increase capacity • Escalate excitement • Improve delivery of clinical care

Engage, Engage, Engage!!!

Minimally Disruptive Research

Research must impose the smallest possible

footprint on clinical care activities. CAREFUL and KIND RESEARCH

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

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)

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”

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)

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

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

On the complexity

of knowledge

The possible simplification of knowledge

vs.

Depression

Can be improved by Lifestyle changes, self-care practices

psychotherapy, pharmacotherapy

But of different efficacy, safety, cost, burden to the patient

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

Maximal impact of Intervention

delivery

Sustainability of the delivery

vs.

http://shareddecisions.mayoclinic.org

Taking expertise for granted

Building on lessons learned

vs.

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

the value of a measure

The unintended consequences

vs.

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

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

the value of the intervention

the temporary necessity of the trial burden

vs.

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

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

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

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

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

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

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

http://minimallydisruptivemedicine.org

http://shareddecisions.mayoclinic.org

dick.sara@mayo.edu annie.leblanc@fmed.ulaval.ca