Overcoming Barriers to Early Phase Clinical Trials: The Community Navigator Model

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Overcoming Barriers to Early Phase Clinical
Trials The Community Navigator Model

• November 30, 2005
• Bruce Chabner MD and Lisa Weissmann MD, co-PIs
• Speakers
• Karen Donelan, ScD (Evaluation)
• Karin Hobrecker (Trainer and Interpreter,
  Certified US Courts)

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Community Navigator Model

• Objective Increase minority enrollment in
  clinical trials across DF/HCC
• Create partnership between Boston-based DF/HCC
  and community-based oncology practice in
  Cambridge MA
• Hire and train navigator to work in community
  practice (RN, MS)
• Equip MD and RN with access to clinical trials
  database to screen eligibility
• Create systems at academic centers for easy
  contact with MDs
• Navigator performs patient education, assistance
  with overcoming structural barriers to referral
  (financial, travel, linguistic, informational)

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Patient PathwayOvercoming Barriers to Clinical
Trials
Patient identified as potential candidate for
Phase I/Phase II
NAVIGATOR ENGAGED
Eligible N19
Enter N80
Enrolled N13
Refer Cancer Center Consult Determine
eligibility N38
MD presents options Introduce Navigator Select/con
tact site Patient teaching N65
Referred back to CHA for care
NO PROTOCOLS N15
NOT ELIGIBLE N19 No protocols (3) Perf Stat
(5) Std Treat (5) Other (4)
PATIENT NOT REFERRED N27 Pt Declined
(8) Hospice (2) MD consult (8) Pending (3) Other
(6)
NOT ENROLLED N6 Pt Declined (2) Health
(2) Other (2)
4
Race of Patients All Patients, Eligible, Enrolled
5
Ethnicity of Patients All Patients, Eligible,
Enrolled
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Patient Survey Referred Population

• Key Outcome Measures
• Patient experience with navigator program
• Patient satisfaction with care (Press Ganey
  baseline)
• Patient understanding of eligibility, enrollment
• Patient attitudes about clinical trials
• Respondent
• Patient, family member, health proxy
• Mode
• Advance letter, mail, telephone, in-person
• Eligible
• All patients referred for consultation (n38)
• Progress
• IRB approved from primary care site
• Data collection ongoing
• 24/38 patients or proxies available for interview
• Interpreter services collaborate (5 languages
  currently)
• Target n40 completes for publication

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Preliminary Findings

• Diverse population of patients gains access to
  clinical trial option
• Proportion of uninsured, minority, LEP patients
  substantially higher than DF/HCC population
• Community MD would not refer without assistance
• Once referred, rate of enrollment similar to
  DF/HCC population despite prior screening for
  eligibility
• Navigator with professional skills and
  credibility essential
• System learning helps all patients, not just
  navigated patients
• Physician relationships
• Referral pathway (DF/HCC initiative)
• Research (Multilingual, DF/HCC, Disparities
  Solutions)
• Interpretation/translation

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Medical Interpreter Training

• Goal / Objective
• Improve accuracy of communication with Limited
  English Proficient patients
• Increase interpreter knowledge of cancer clinical
  terms interpreting skills
• Delivery Cancer, Cancer Clinical Trials
  Interpreting Skills and Standards
• 6 half day workshops
• 2 presentations at National interpreter
  conference
• Participants
• 230 /- medical interpreters
• 20 languages
• 5 tertiary hospitals, 2 community hospitals, 1
  community health center
• local regional participants MA CT, NH, NJ, NY,
  MD (Bethesda)
• Participant profile
• 59 had previous training, 38 had none
• 76 of attendees had interpreted for cancer
  patients
• Reported discomfort with prior experience
• 50 sometimes had trouble understanding the
  disease
• 30 sometimes found it hard to interpret
  physicians explanations

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Cancer Basics Pre Post TestOn Cancer
Terminology (n97)

• Pre / Post Test Format
• 15 items
• match term with definition given
• leave blank if you do not know
• Range for Item Accuracy
• Pre Test min/item 22, max/item 69
• Post Test 54, 85
• Improvement
• Average change 21 pts
• of people who could match each term to its
  definition correctly

• Sample Results
• Benign
• Pre test 55 correct
• Post test 75
• Malignant
• Pre test 55
• Post test 70
• Metastasis
• Pre test 69
• Post test 85
• Adjuvant therapy
• Pre test 29
• Post test 81

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Clinical Trials Pre and Post Test (n43) who
correctly labeled each item as true or false

• 100 of attendees reported they
• learned new material
• would use the information interpreting with
  cancer patients
• would attend other sessions

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Train the Trainer WorkshopBoston, October 26-27,
2005

• Objective
• Share experience developing implementing
  workshops
• Share medical interpreter skills training used at
  MGH
• Brainstorm on challenges for interpreting in
  medical specialties
• Participants
• 13 lead interpreters/ interpreter trainers from 8
  hospitals CA, CO, FLA, MA, MO, PA,
• 3 observers from NCI
• Model Presented
• Curriculum Components
• Clinical Content taught by clinicians
• Interpreting Standards of Practice led by
  Interpreter Trainer
• Interpreting Skills led by Interpreter Trainer
• Evaluation Components
• Pre and Post Test for Key Concepts
• Measure Overall Program Experience
• Response
• Positive request for follow up programs
  training on interpreting skills standards
  ethics

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Train the Trainer WorkshopBoston, October 26-27,
2005

• Key Elements
• Partnership
• Topic Experts
• Skilled Interpreter Trainers
• Clinicians Fellows time commitment
• Administration
• Funding and logistical support
• Endorsement for interpreter staff participation
• Local Regional Hospitals Medical Interpreter
  Associations
• Publicize endorse for staff interpreter
  contract interpreter participation
• Customization in response to variations by
  institution, region of the country
• Organizational Culture varied definition of
  interpreter role
• Participant Characteristics variety of
  skills, training experience
• Materials NCI materials adapted to medical
  interpreting needs
• Research Evaluation for validation to seek
  funding and support
• Next Steps
• Follow Up Conference Calls to Collaborate and
  Support Local Programming
• Follow Up Meeting identification of regional
  experts
• Replication of Train the Trainer workshop

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Concluding Remarks