Agenda for March 30th Coordinator Call...Agenda for March 30th Coordinator Call • Welcome •...

Agenda for March 30th Coordinator Call

• Welcome

• MaRISS Update

• Participating Sites

• Enrollment

• Awards

• Protocol 2.0, FAQ

• MaRISS PMT update

• Roll Call

2

MaRISS: A first look (as of Feb 2016)

• Total: 110 in GWTG PMT

• Sex: 50% female

• Non-Hispanic 98%, White 87%, Black 19%

• NIHSS baseline available: 106

• tPA administered: 36.8% (37/102, 8 missing)

• Fluctuations documented pre-hospital: N=52

• Fluctuations documented in hospital: N=78

61 hospitals: 49 contracted, 12 contracting

• 52 IRB approvals

• 189 participants recruited

Hospital recruitment

• Ongoing

• Contracts required, IRB local or Chesapeake

• Eligibility: >300 discharges, >65% NIHSS completion

MaRISS Study Update as of 3/30

3/30/2016 ©2013, American Heart Association 4

MaRISS Participating Hospitals Nationwide


Our Participating Hospitals Baptist Health Lexington Lexington, KYBaylor Scott and White - Temple Temple, TXBoston Medical Center Boston, MACatholic Health - Mercy Hospital of Buffalo Buffalo, NYCarolinas Medical Center Charlotte, NC Chandler Regional Medical Center Chandler, AZCox Health Springfield, MOFaxton St. Luke's Healthcare Utica, NYFlorida Hospital Orlando Orlando, FLGreenville Memorial Hospital Greenville, SCINTEGRIS Baptist Medical Center Oklahoma City, OKJackson Memorial Miami, FL

Participating Hospitals Kaiser Permanente - Los Angeles Medical Center Los Angeles, CAKaiser Sunnyside Medical Center Clackamas, ORLee Memorial Health Fort Myers, FLLutheran Hospital Fort Wayne, INMercy Hospital of Buffalo Buffalo, NY Mercy Hospital Oklahoma City Comprehensive Stroke Center Oklahoma City, OKMercy Hospital St. Louis St. Louis, MOMethodist Hospital Merrilville, INMorton Plant Hospital Clearwater, FLMS Baptist Medical Center Jackson, MSNew York Methodist Hospital Brooklyn, NYNorthwestern Medicine- Central Dupage Hospital Winfield, ILNovant Health Forsyth Medical Center Winston-Salem, NC

Participating Hospitals Ochsner Medical Center - New Orleans New Orleans, LAOverlake Medical Center Bellevue, WAPenn State Hershey Medical Center Hershey, PAPomona Valley Hospital Medical Center Pomona, CAProvidence Holy Cross Mission Hills, CAProvidence Little Company of Mary Medical Center -Torrance Torrance, CARhode Island Hospital Providence, RISacred Heart Health System Pensacola, FLSaint Vincent Health System Erie, PASSM DePaul Health Center St. Louis, MOSt. Anthony's Medical Center St. Louis, MOSt. David's Medical Center Austin, TXSt. Mary Medical Center Langhorne, PA

Participating Hospitals The Medical Center Navicent Health Macon, GAThe Queen's Medical Center Honolulu, HIUniversity of Louisville Hospital Louisville, KYUniv of Rochester Medical Center, Strong Memorial Hospital Rochester, NYUPMC Hamot Erie, PAValley Hospital Ridgewood, NJWake Forest Baptist Medical Center Winston-Salem, NC

MaRISS Enrollment 189

MaRISS Recruitment Goals

Overall Goal: 2650 Recruits

6 Recruits per Quarter

2 recruits per Month

• 100 hospitals recruit from May 2015 to May 2017

• Each hospital recruits 6 patients every 3 months

• Each hospital recruits 2 patients per month

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Honorable Mention: Mercy Hospital St. Louis, St. Louis, MO

3rd Place: Saint Vincent Health System, Erie, PA

2nd Place: Rhode Island Hospital, Providence, RI

1st Place: Mercy Oklahoma City Comprehensive Stroke Center, Oklahoma City, OK

Saint Vincent Hospital’s Recruitment Strategies Presented by: Melanie Henderson BA, RN, SCRN

• Stroke Coordinator (Site Coordinator) involvement

– Receives initial page for all Stroke Alerts

– Reviews all stroke alerts

– Works with second coordinator to identify potential subjects

• Coordinators discuss the study with patient/family to enroll

• Strong collaborative effort by the study team

– Weekly meetings with coordinators and PI

• Great community support for the study

13

Rhode Island Hospital’s Barriers to Recruitment and Retention in Clinical Trials – Presented by Jo-Ann M. Sarafin, MS, FNP-BC, SCRN

1. Subject-related

~ Dislike the uncertainty of a trial

~ Prefer the provider to make the decision

~ Unrealistic expectations

~ Subject disease state

~ Age, level of education, social, cultural, and language

2. Investigator-related

~ Lack of time and underestimation of the workload

~ PI may have difficulty with roles as caregiver vs scientist

3. Protocol-related

~ Lengthy study periods and excessive visit schedules

4. Other

~Site and Investigator needs3/30/2016 Sullivan, J., Subject Recruitment and Retention Barriers to Success. Applied Clinical Trials. April 01, 2004 14

Rhode Island Hospital’s Recruitment Strategies Presented by Jo-Ann M. Sarafin, MS, FNP-BC, SCRN

3/30/2016

1. Collaborate with ED: Enlist support of ED providers as

Sub-investigators

2. 24/7 Screening

3. Attend all Code Strokes: Communicate with ED and

neurology. Verify LKW and stroke diagnosis. Enroll early

within 30-45 minutes.

4. Continuity of Care: Patient satisfaction is increased with

identification of study personnel who have the time to

explain the study, answer questions, and follow the

patient.

5. Provide Clinical Trial Updates: Recruitment numbers for

the month. Special recognition for exemplary performance.©2013, American Heart Association 15

It’ s all about the great partnerships, common goals, AND

well designed systems.

Mercy Oklahoma’s Recruitment Strategies: Business success is all about the 3 P's – Presented by Jeffrey Craig, MD

3/30/2016

1. People – A great team

2. Process – All team members are invested.

• Have team meetings to discuss study progress/issues.

• All patients admitted are screened.

• We admit TIAs (1/3 of clinical TIAs are actually mild strokes).

• Patients can be enrolled after admission as long as study criteria are met.

• We ask questions.

• Get multiple contact phone numbers

3. Product – An easy study seeking to answer an important question.

• Most of the data is already collected by GWTG.

• Only needs 2 phone calls.

4

©2013, American Heart Association 16

Thank you to our Guest Speakers from the Top Recruiting Sites!!


Dr. Jeffrey Craig, Mercy Oklahoma

JoAnne Sarafin, Rhole Island Hospital

Melanie Henderson, Saint Vincent Hospital;

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Protocol Amendments


• Arrival <4.5 h, consent by 24 hours.• Ischemic stroke is confirmed clinically, CT compatible, no need to await

MRI to enroll.• Consent beyond 24h if arrival <4.5 hours from symptom onset, and

NIHSS performed as standard of care at 24 h (certified practitioner), andNIHSS sub-scores recorded in the participant’s study record.

• Mild Stroke (NIHSS 0-5) and/or Rapid Improvement prior to treatment.• TOAST can be done by experienced practitioner designated by PI.• Incorporated into MaRISS Protocol 2.0.• Very important to try to get outcomes!

FAQ, Clarifications, Protocol Amendments


• Documents for IRB Submission• MaRISS Protocol version 2.0 January 18 2016• MaRISS Protocol version 1.1 July 14th2014_Tracked changes• MaRISS Protocol Modification_Rationale for the changes• CRF_MaRISS BASELINE NIHSS_AT HOSPITAL ARRIVAL_Protocv2.0• CRF_MaRISS BASELINE NIHSS_AT TIME OF ACUTE TREATMENT DECISION_Protocv2.0• CRF_MaRISS NIHSS_24hour or neuro worsening_Protocv2.0 • CRF_MaRISS NIHSS_DAY 3 or at discharge_Protocv2.0

• Patient-facing materials – Reminder letters

Protocol Amendment


MaRISS PMT Follow-up Tab Update – effective March 26, 2016


MaRISS PMT Follow-up Tab Update – effective March 26, 2016 Query PMT Annotations


• MaRISS Team, will be sending Query annotations to sites within the PMT. Your site will be able to communicate back within the PMT MaRISS Tab.

• You will be able to pull a query breakdown report of all annotations for your site.

• Annotations will be for errors in data, missing data elements and other data clarifications requested by the MaRISS Team.

• Stay tuned for more information on the training slides and 30 min webinar session.

Email: [email protected]

Phone: 214-706-1994

MaRISS Team contact information


mailto:[email protected]

Thank you!


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