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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
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