Consent2Share

Linking Cohort Discovery to

Consent

David R Nelson MDAssistant Vice President for ResearchProfessor of MedicineDirector, Clinical and Translational Science

InstituteUniversity of FloridaGainesville, USA

Americans are Interested in

Clinical Trials

• I am interested in finding out more about taking part in clinical trialso 62% agree

• I would take part in a clinical trial if I was asked by someone I trusto 63% agree

• Taking part in a clinical trial is as valuable to our health care system as giving bloodo 67% agree

• 72% likely to participate in clinical trial if their doctor recommended it to themo 70% of doctors do not talk to patient about medical research

opportunities

Research!America poll conducted in partnership with Zogby Analytics from May 2013

UF Learning Health SystemCreate, strengthen and integrate the infrastructure required to accelerate discoveries toward better health

• Link patients with samples and medical/research datao EMR (EPIC) + Integrated Data Repository

• Biorepository: institutional and centralized, CAP certified• Genomics and metabolomics

• Link researchers to patients and datao Consent2Share (universal consent)o i2b2 cohort discovery

• Link participants to researcherso StudyConnect (web-based trials portal)o HealthStreet (community engagement)

• Link populations and community clinicians to researcherso One Florida Clinical Research Consortium

• UF + UMiami + FSU state-wide network (13.5M lives)

StudyConnect• StudyConnect: Web site with > 400 active studies for

potential research participants to find opportunities

Consent2Share• An effort by UF Health to offer patients the

opportunity to consent to be contacted sometime in the future about being part of new research studies at UF Health for which they might qualify

Consent2Share - Process1. Consent form printed from EPIC, includes patient specific bar code2. Admission folks hand 2 copies of the consent form to the patient, briefly describe

what it entails, provides flier describing program3. Any straight forward questions are addressed, if someone has more questions,

they are referred to either their doctor or the Consent2Share Hotline4. Patients are given time to review5. If they return the documents and have checked boxes, initialed and signed;

Admission staff then record the patient’s answers in EPIC6. The signed consent forms are scanned into OnBase, linked to EPIC7. All newly enrolled subjects information is checked to confirm

o That the consent form is “valid”o That the consent form is attached to the correct patiento That the choices made were recorded correctly.

8. Each verified record will be so marked by the individual conducting the QA before that information can be sent to the IDR.

This is the main section, describes what we are asking to collect.

Re-contact

Hotline

The IRB has to review and approve any research being done with their data

Can stop at any time

Risks

Reminds them what they are agreeing to.

Check for signature

Recruitment Language

Consent2Share Contacts

Dear <potential subject name>,

My name is <name> and I <title or study staff relationship> from <UF or Shands>. I am contacting you to see if you are interested in participating in a research study <describe the topic briefly [eg. On diabetes]> . During a past clinic visit, you signed a consent form telling us you were interested in being contacted for future research that you might qualify for.

Would you like to hear more about this study?

Consent2Share

• To Date: ~20,000 subjects have been approached

• 84% “yes’ rate• Research support to date:

• 4,157 patient names have been released to clinical research projects• Tracking outcomes of these contacts and

ongoing IRB QA process

UF Integrated Data Repository (IDR)

i2b2 DataMart

(Limited Data Set)

Research Extract(PHI removed)

Cohort Discovery

Privacy Wall

Outpatient EMR

Inpatient EMR

Billing

Claims

Labs

IntegratedData

repository

HealthcareData

Extr

act-

Tra

nsf

orm

-Load

Pharmacy

UF Consent2Share –

Next Steps

• Implement electronic form with electronic signature• Expand to all clinics• Expand to patients under 18 who will require a

parent or guardian signature• Expand to OneFlorida network

o UF, UMiami, and FSU statewide network• Cover 13.5M lives

Consent2Share: Conclusion

• An effort by UF Health to offer patients the opportunity to consent to be contacted sometime in the future about being part of new research studies at UF Health for which they might qualify

• Identifying potential research participants is a key part to a successful research enterprise and patient engagement

• More than 20,000 patients enrolled to date:• 84% of patients approached agreed to be re-

contacted• 4,157 patient names linked (with IRB approval)

to researchers • Enterprise-wide implementation at UF Health

underway with electronic consent