these comparative effectiveness questions about how best to achieve - - PowerPoint PPT Presentation

Role of clinical trials to answer these comparative effectiveness questions about how best to achieve SDM

Megan E. Branda, MS Academy Health ARM 2019 Washington, DC

SDM in the context of care and research

Patient has a decision to be made Behavioral Intervention Patient facing Clinician facing Within the encounter Impact on discussion b/w clinician & patient How to make it part of practice How to identify patients How to get intervention to patient How to train clinician How to document use Has to be understood for trial Outcomes to Assess SDM – knowledge, conflict, quality Clinical – adherence, utilization Implementation

SDM in RCT’s

• Where have we been
• What is the current state
• Highlights
• What would be ideal (from a statisticians

perspective)?

The Past SDM Trials

• 87 studies (45,641 patients and 3113 healthcare professionals)^
• Target: 44 patients, 15 health professionals, 28 patients/health

professionals

• Conclusion: Uncertain whether any interventions is effective for

increasing SDM because the evidence is low or very low.

• 105 studies (31,043 patients)#
• 50 different decisions
• 89 have DA in preparation of visit, 16 within encounter
• Conclusion: Increase knowledge of options, better informed, and more

clear about what matters most to them (high quality evidence).

^Legare Cochrane review 2018/ # Stacey Cochrane review 2017

The Current SDM Trials

• Pull of all clinical trials considered ‘Active’ – Recruiting or Not

yet recruiting studies in clinicaltrials.gov

• Data pulled as of April 9, 2019
• Search terms (separate pulls): ‘Shared decision making’ and ‘Decision

Aid’

• 125 trials were found after removing duplicates
• 5 removed after review (Not SDM/DA or not a trial)

The Current SDM Trials

1 Phase III Trial (N=1) 2 Cross Over (N=1) 3 Implementation Trial/Hybrid Type III (N=1)

Type Count

What are we doing with RCT’s?

• For the review of Clinicaltrials.gov a variety of primary outcome

were noted of the 73 RCT’s there are

• Primary outcome (N=30 different topics)
• DCS (19), Knowledge (11), OPTION(5), Decision Quality (3), SDMQ-9 (3)
• Range of specialties
• Primarily Cancer (31 studies), Pregnancy related (5), behavioral health (5),

arthritis (4), etc.

To date where has the focus been?

Patient has a decision to be made Behavioral Intervention Patient facing Clinician facing Within the encounter Impact on discussion b/w clinician & patient How to make it part of practice How to identify patients How to get tool to patient How to train clinician How to document use Has to be understood for trial Outcomes to Assess SDM – knowledge, conflict, quality Clinical – adherence, utilization Implementation

To date where has the focus been?

Patient has a decision to be made Behavioral Intervention Patient facing Clinician facing Within the encounter Impact on discussion b/w clinician & patient Outcomes to Assess SDM – knowledge, conflict, quality Clinical – adherence, utilization

Trials of Interest

Trial I: BEFORE Decision Aid Implementation Study (PI – Baxter)

• Begin Exploring Fertility Options, Risks and Expectations

(BEFORE) decision aid for young breast cancer patients in Canada

• Stepped Wedge Cluster Randomized Clinical Trial
• Innovative: Sub-Study
• Leveraging the resources and work that have already been established
• Data collection includes obtaining secondary data collected as part of

the RUBY study from all patient participants who were enrolled in RUBY during the study period

Trial I: BEFORE DA (cont)

• Introduced after Main study was already established
• Not directly consenting patients but using patients already

consented to Main study

• Patients chosen that completed surveys during enrollment time and

analyzed according to site’s allocation at time of patient consent

• Google analytics on usage
• Patient surveys administered via the tool to those women who visit the

site and choose to complete survey

Trial I: BEFORE DA

• Leveraging existing trial
• Save time on start-up
• Save on personnel to recruit patients
• Leveraging technology to collect outcomes
• Allowing for DA users to provide feedback on use

Trial II: A Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (PI – Matlock)

• Type II effectiveness implementation hybrid trial
• 6-site stepped-wedge RCT
• RE-AIM Framework
• Normalization Process Theory (NPT)
• Implementing a suite of tools to help patients at each stage of

treatment

• Before implementation, After and at time of Removal
• Giving patients options of formats for reviewing the Decision Aid

that meets the patients needs

Trial II: DECIDE Trial (cont.)

• Training of staff at beginning of study
• Clinician champion at each site
• Ongoing implementation support by study team
• Plans to assist in barriers
• Qualitative assessment throughout trial

Trial II: DECIDE

• Mixed method
• Support on implementation
• Different tools to meet patients needs at each stage
• Qualitative assessment

An Ideal Assessment on SDM Trial Design

From a statistician perspective

What to assess before

• Existing infrastructure
• Umbrella trial
• PBRN
• Hub & Spoke System
• Why?
• Saving time – Information in intervention is time sensitive. Assess in

trial prior to needing to update the information in the intervention.

What to assess before

• Qualitative assessment
• Clinicians perspective on intervention and use
• Staff perspective on incorporating intervention into practice
• Patient assessment on intervention, impact on decision being made

and discussion with clinician

• Why?
• Regardless of tools effectiveness, the understanding of how to

incorporate the tool and its impact on practice is valuable knowledge

• If the intervention is not effective, an understanding of why could help the

researcher understand what needs to be changed to move forward.

What to assess before

• Are there others working in this area already?
• If research is being conducted in the decision of interest can there be a

joint effort?

• Feasible?
• Maybe, this does not necessarily mean a direct comparison of tools

from different research teams of which should be explored as well

• For example, if two teams are working in the area of Schizophrenia addressing

different questions of interest can they combine their research to one clinical trial assessment?

Conclusion

• The past/current state:
• Research in this area has primarily focused on the effectiveness of the

intervention on SDM outcomes

• Smaller trials, predominantly patient level RCT’s
• Moving forward:
• Expand the knowledge on how to make SDM part of practice through

qualitative research

• Leverage existing resources
• Collaborate with external researchers

Thank you!

Questions? megan.branda@cuanschutz.edu