RE-POWER Practice Site Agreement
PROJECT TITLE: Obesity Treatment Options: Midwestern Collaborative for Treating Obesity
Prime Recipient [“KUMCRI”]
University of Kansas Medical Center
Research Institute, Inc.
3901 Rainbow Boulevard MSN 1039
Kansas City, Kansas 66103-2937
Practice/Institution/Organization (“Site”)
Prime Contract (Funder)
Patient-Centered Outcomes Research Institute (“PCORI”)
Washington, DC
Prime Contract No. PCORI#OB-1402-09413
EIN No.:
<Site legal name>
Address:
Terms and Conditions
1. KUMCRI hereby awards this Practice Site Agreement to Site, in accordance with the Statement of Work and Payment Schedule described
in Attachment 1, attached hereto and made a part of this agreement. Site shall perform all work under this Agreement in accordance with
Attachment 1. In its performance of its work, Site shall be an independent entity and not an employee or agent of KUMCRI.
2. KUMCRI shall reimburse Site not more often than monthly for allowable costs. Invoices shall be prepared by the KUMCRI research
team, and approved by the Site, before being submitted to KUMCRI for payment. See Attachment 1, Page 5, “Payments” for details. A final
invoice, marked as “FINAL,” must be submitted to KUMCRI’s Financial Contact not later than forty-five (45) days after Agreement end
date.
3. All payments shall be considered provisional and subject to adjustment in the event of over-or under-payment.
4. Matters concerning the technical performance of this Agreement should be directed to the Principal Investigator, as shown in
Attachment 2.
5. Site agrees to submit technical and/or progress reports as reasonably requested by the Principal Investigator as identified in Attachment 2
to assist in her preparation of any reports due to PCORI under the Prime Contract. Such reports might include updated certification of
appropriate education in the conduct of human subject research of any new key personnel or annual IRB update, if appropriate.
6. Matters concerning the request or negotiation of any changes in the terms, conditions, or amounts cited in this Agreement should be
directed to the appropriate party’s Administrative Contact, as shown in Attachment 2. Any such changes made to this Agreement will require
the written approval of each party’s Authorized Official, as shown in Attachment 2.
7. Each party shall be responsible for its negligent acts or omissions and the negligent acts or omissions of its employees, officers, agents, or
directors, to the extent allowed by law.
8. Either party may terminate this agreement with sixty (60) days written notice to the appropriate party’s Administrative Contact, as shown
in Attachment 2.
9. Site is relying on KUMC Institutional Review Board (IRB), therefore it will be the responsibility of the KUMCRI Principal Investigator or
her designee, to notify Site immediately of approvals and/or any changes to protocol. Site shall not commence participant recruitment until
IRB approval is obtained and Secondary Contact sends activation notice. If the Study is discontinued by KUMC's IRB, this Agreement will
immediately terminate. If the Protocol is amended, Site shall not implement any amended Protocol until it has received written notice of such
change.
10. This Agreement is also subject to the “Additional Terms and Conditions”, and the terms and conditions of the Prime Contract, both of
which are provided separately at www.kumc.edu/repower and incorporated by reference.
11. By signing below Site accepts award and makes the “Certifications” identified at www.kumc.edu/repower and incorporated by reference.
By an Authorized Official of Prime Recipient [KUMCRI]:
By an Authorized Official of Site:
_______________________________Date:________
_______________________________Date:_________
Name:
Name: Jamie Caldwell, MBA
Title: Associate Vice Chancellor for Research Administration Title:
Read and Understood by:
Read and Understood by:
______________________________ Date: ________
Christie Befort, PhD, Principal Investigator
______________________________ Date: ________
Practice Liaison Name/Title
______________________________ Date: ________
Lead Physician Name/Title
PCORI OB-1402-09413 BEFORT
Page 1
Attachment 1
Statement of Work and Payment Schedule
Site and its Site Investigator agree to conduct the study as set forth in the Protocol for “Obesity Treatment Options: Midwestern
Collaborative for Treating Obesity - RE-POWER”, PCORI# OB-1402-09413, and in keeping with any future protocol revisions supplied
by the Principal Investigator and approved by KUMC Institutional Review Board.
Specifically, the Site will:
1. Recruit patients.
2. Enroll and consent forty (40) eligible participants
3. Monitor participant progress and retention
4. Report to KUMCRI Secondary Contact or Principal Investigator as named in Attachment 3 “Contacts”, any Serious Adverse
Events (SAEs) for patients enrolled in the study within 24 hours of awareness if possibly study-related and otherwise within five
(5) days. SAEs include any medical events that result in hospitalization, are life-threatening, or results in significant disability.
5. Complete all required data collection forms in the on-line Research Electronic Data Capture (REDCap) system.
6. Provide additional required information and documentation to KUMCRI on a timely basis
7. Agree to be randomized to any one of the following three arms of the study and complete the required counseling visits
associated with that arm:
a. Fee-for-service (FFS): Primary Care Provider (PCP), nurse, or allied health professional under PCP supervision will
offer the enrolled patients 15 minute counseling sessions that will occur weekly for four weeks, then every other week
for 5 months, then monthly for 6 months and quarterly after that first year (modeled after Intensive Behavioral Therapy
for Obesity reimbursed by Medicare) for a total of 24 months.
b. Patient Centered Medical Home (PCMH): Counseling will be provided in group visits by a care coordinator (this
individual can be a clinician (PCP), nurse, allied health professional, dietician or weight counselor working under PCP
supervision) with visits occurring weekly for 12 weeks, bi-weekly for 12 weeks, and monthly after that for a total of 24
months. 14 visits will be in-person and the remainder will be offered via group conference call. Practices in the PCMH
arm will establish 2 or 3 groups of 13 to 20 participants in each group.
c. Disease Management (DM): Enrolled patients will receive group counseling sessions by phone following the same
frequency as the PCMH visits. Counselors will be trained weight loss dieticians located on site at KUMC. Patients in
this arm of the study will be monitored and their progress will be provided in quarterly reports to their PCP of record.
With respect to Preparation and Training, the Site agrees:
1.
To identify Site Lead Physician and a Practice Liaison.
2.
To enter into a reliance agreement with the KUMC Institutional Review Board (IRB).
3.
To complete Federal Wide Assurance related to human subjects protection. (The KUMCRI study team will assist with
completing the FWA).
4.
To complete Conflict of Interest reporting requirements for both the Lead Physician and the Practice Liaison.
5.
To ensure that the Lead Physician and Practice Liaison complete training in the study procedures during an in-person meeting
held by KUMCRI Study Team. KUMCRI will cover associated travel costs for this training. If randomized to PCMH, practice
agrees their designated care coordinator will complete an additional 1-day training on obesity treatment/group visits and that they
will attend regular tele-mentoring sessions (bi-weekly and then monthly) with other practices in this arm for the duration of the
intervention.
6.
That the Lead Physician and Practice Liaison will ensure other physicians and staff from the Site involved in the study will
review the KUMCRI Study team-provided training materials and protocols (available on-line, by DVD, and/or in hardcopy
manuals).
7.
All participating physicians, clinicians, study coordinators and staff obtaining informed consent, collecting data, or conducting
counseling visits with study participants will complete human subjects training and conflict of interest reporting.
8.
To ensure their personnel are trained by KUMCRI in the use of REDCap for data collection, retention tracking, and documenting
counseling visit notes.
9.
That the Practice Liaison will serve as the primary point of contact between the practice and study staff at KUMC. The
Practice Liaison will supervise (with KUMC Study Team support) the implementation of the study at the practice unless the Lead
Physician chooses to take on these responsibilities.
10. To ensure that the Subject’s/ third party payers only be billed for clinic visits and services that are standard of care. The payment
provided by the Study for all visits that fall outside standard of care will be accepted as sole reimbursement for these services,
PCORI OB-1402-09413 BEFORT
Page 2
and additional payment will not be sought from the Subject or Subject’s third party payer for any study visits. One exception to
these billing guidelines is practices randomized to FFS may elect to bill Medicare patients only for Intensive Behavioral Therapy
for Obesity counseling. Note there are no patient co-pays associated with this service.
11. To complete provider self-assessment surveys and participate in an approximately hour-long interview with the KUMC Study
Team at 6. 12 and 24 months to provide feedback on how the study is progressing (for a total of three interviews).
With respect to Patient Recruitment and Consent , the Site agrees:
12. To develop a patient list with at least 300 patients (preferably 400 patients) in target BMI range (27-48 kg/m2), with more as
needed to reach target enrollment of 40 patients.
13. To assist KUMCRI study staff in sending recruitment mailings from the Site (on Site letterhead). Patients will be screened for
interest and eligibility by KUMCRI study staff by phone.
14. To augment the recruitment process by referring interested patients to the study screening line during office visits following the
Standard Operating Procedures (KUMCRI Study Team 2 A 4 below).
15. To enroll 40 patients into the study over a 6-month period for the PCMH or DM arm or 9 months for the FFS arm.
16. To obtain written consent from all patients who enroll in the study. Once obtained, the signed consent forms will be uploaded
into REDCap or sent via secure fax and original hard copy mailed to KUMC following the Standard Operating Procedures.
With respect to Assessments, the Site agrees:
17. To collect and record (in REDCap) height, weight, waist circumference, and blood pressure for each enrolled patient at baseline,
6 months, 18 months and 24 months.
18. At baseline, 6 months, and 24 months, to obtain a blood draw from each enrolled patient and complete an analysis of lipids and
fasting glucose. Laboratory results will be recorded in REDCap.
19. Only if in the FFS or PCMH arms, to record participant attendance at counseling visits and complete brief counseling visit
checklists in REDCap.
20. Agrees to monitor patient retention to data collection visits at 6, 18, and 24 months. Agrees to work closely with the designated
KUMCRI study team member(s) to send appointment reminders and contact participants who miss a data collection visit.
21. Agrees to track participant progress with weight loss
d. In all arms, PCP/clinician agrees to review patient’s progress as noted in their health record and provide feedback and
encouragement during their routine medical visits.
e. If randomized to DM, agrees to facilitate incorporation of patient progress reports sent by KUMC counselors into
medical record
f. If randomized to PCMH, agrees care coordinator will inform PCP of patient progress.
22. Will participate in the study including data collection, scheduling visits, counseling and support for the entire 36 months of the
study.
23. Will permit KUMCRI study team to visit Site in person, observe workflow and document implementation of the study
periodically.
The KUMCRI Study Team will provide the following for the Site:
1.
Comprehensive, project-relevant training as follows:
a. For all arms:
i. An in-person, tailored and interactive day-long training that will include:
1. REDCap Database training
2. Human Subjects Protection training (will fulfill the requirement in Attachment 3, Terms and
Conditions, Item #1)
3. Study procedures training
4. Obesity treatment training
5. Introduction to patient communication strategies regarding weight loss
b. For PCMH only:
i. Day-long training workshop for care coordinator (training will occur within 1 month of starting the first
group session)
PCORI OB-1402-09413 BEFORT
Page 3
ii. Group telementoring training and quality control. Will occur bi-weekly until all patient groups are meeting
monthly, and then will occur monthly.
2.
Study materials:
a. For all arms:
i. E-learning modules and training resources for staff who cannot attend the in-person training
ii. Reference guide for common Questions &Answers
iii. Standard Operating Procedures manual
Note: all specialized materials provided to FFS and PCMH Sites will be publicly available at the end of the
study.
b. For FFS
i. Diet self-monitoring tool
ii. Guide to using 5 A’s in each visit
iii. Case study with sample schedule of session topics
iv. Patient handouts/educational materials
c. For PCMH
i. Session-by-session Care Coordinator manual
ii. Patient manuals with session-by-session hand-outs
3.
Contact and Liaison Support
a. Email and phone contact for a KUMCRI Practice Coordinator (to be named) who will serve in an assistance/facilitator
role for the duration of the study
b. Routine phone and in-person visits with Practice Coordinator
Payments and Invoicing Procedure
Participation fee payments, as described in Compensation Summary below, will be paid monthly if study protocol and data are being
collected as described in the above Statement of Work.
Invoices for Participation fees, Participant Counseling Visits and Assessment Visits will be prepared by the KUMC Research Team based
on the monthly entry of data into the REDCap system, designed for capturing data and tracking patient visits. The invoices with applicable
REDCap backup will be emailed to the “Site” identified in Attachment 2 for review and reconciliation. The Site will have three (5)
business days to approve the invoice. No response after those five days will constitute approval of invoice and it will be emailed to
KUMCRI Financial Contact to process for payment. In the event the Site discovers missing or incorrect data in REDCap related to their
delivery of services, they will notify the KUMCRI Secondary Contact, and if it affects the invoicing, issues will be resolved and a revised
invoice will be prepared and emailed to the KUMCRI Financial Contact to process for payment. Payments will be mailed to Site within 710 business days.
Compensation Summary
a.
For the FFS arm, the Site will receive a monthly participation fee for effort by their staff of $1,183/month, not to
exceed $42,600 over the 3 year performance period, in addition to $27 per counseling visit and $50 per assessment visit
completed. The Site will be reimbursed monthly based on the number of participants served and for whom
documentation in REDCap is completed.
b.
For the PCMH arm, the Site will receive a monthly participation fee for effort by their staff of $1,183/month, not to
exceed $42,600 over the 3 year performance period, in addition to $400 for each “in person” group visit, $200 per
phone based group visit, and an additional $50 for each assessment visit completed. The Site will be reimbursed
monthly based on the number of participants/group visits conducted and for whom documentation in REDCap is
completed. The Site will also receive $50 per tele-mentoring session attended by their designated care coordinator.
c.
For the DM arm, the Site will receive a monthly participation fee for effort by their staff of approximately $592/month,
not to exceed $21,300 over the 3 year performance period, and $50 for each assessment visit completed. The Site will
be reimbursed monthly based on the number of participants served and for whom documentation in REDCap is
completed.
Additional Compensation Issues
d.
The Lead Physician and/or Practice Liaison will also attend meetings, participate in conference calls as needed and
cooperate with the KUMC representative during site visits for no additional compensation.
e.
If less than 40 patients are recruited into the study, the annual participation fee may be reduced proportionally to the
number of patients enrolled.
f.
If a participant withdraws before the completion of the study, Site will be paid for that subject’s completed visits, after
data has been completely and entered into REDCap.
PCORI OB-1402-09413 BEFORT
Page 4
Attachment 2 - Points of Contact
KUMCRI
Principal Investigator
Site
Site Investigator (Lead Clinician):
Christie Befort, Ph.D.
Associate Professor, Preventive Medicine and Public Health
University of Kansas Medical Center
3901 Rainbow Boulevard MS 1008
Kansas City, Kansas 66160-7702
Telephone: 913-588-3338
Email: cbefort@kumc.edu
Secondary Contact:
Danielle Christifano, Ph.D.
Project Director
Telephone: (913) 945-7890
Email: dchristifano@kumc.edu
Administrative Contact
Secondary Contact (Site Liaison):
Administrative Contact
Pam Hansen, Grant & Contract Specialist
Sponsored Program Administration
KUMC Research Institute, Inc.
3901 Rainbow Boulevard MSN 1039
Kansas City, Kansas 66103-2937
Telephone: 913-588-5370
Email: phansen3@kumc.edu or spa@kumc.edu
Financial Contact
Financial Contact
Doug Harris, Post Award Accounting
KUMC Research Institute, Inc.
Sponsored Program Administration
3901 Rainbow Boulevard MSN 1039
Kansas City, Kansas 66103-2937
Telephone: 913-588-1260 or 913-588-1261
Email: dharris@kumc.edu or spa@kumc.edu
Authorized Official
Authorized Official
Jamie Caldwell, MBA
Assoc. Vice Chancellor for Research Admin.
KUMC Research Institute, Inc.
3901 Rainbow Boulevard MSN 1039
Kansas City, Kansas 66103-2937
Telephone: 913-588-1261
Email: spa@kumc.edu
PCORI OB-1402-09413 BEFORT
Page 5