Office of Clinical Research

DCI’s Office of Clinical Research was established in 2007 to review all studies (industry or investigator-initiated) being proposed to be conducted in DCI patients to ensure the research is scientifically rigorous and valid and that the appropriate procedures for human protections are being followed. We have expert knowledge in Federal Regulations, HIPAA, Medicare Clinical Trial Policy, Good Clinical Practice, and Federal Wide Assurances.

 

The Office of Clinical Research now plays a major role in facilitating multisite projects through identifying and confirming participation from the clinics and investigators that are best suited to a particular project, preparing budgets and IRB documents, orchestrating data transfers from the Medical Information System (MIS) and serving as a liaison between study Sponsors, individual investigators/research sites, and the dialysis staff.

 

We have access to approximately 2500 potential study patients. Our research sites have on average over 12 years of research experience.

 

DCI has an extensive MIS. All DCI clinics use the system. Information is entered on the patient at initiation to a DCI clinic and updated as events occur (medication changes, hospitalizations).  The MIS provides current information about demographics, oral and IV medications, hospitalization dates and the primary diagnosis, and comorbidities.  The MIS is problem-based.  Problems are created from patient histories, 2728 forms, hospital discharge summaries, and physician correspondence.  Problem descriptions come from the ICD-9-CM manual.  All orders (medication, treatment, lab, procedures, and consultation) must have an assigned problem in order to enter them into the medical information system.  Multi-disciplinary progress notes may also be entered in the MIS. This type of system allows for very extensive precise data collection.

 

DCI’s Site Management Organization Services

  • Teamwork approach between the Sponsor, DCI, the research sites, and the dialysis staff.
  • MIS: this robust system allows for a centralized approach to identify research sites as well as eligible patients.
  • Dedicated and experienced research staff.
  • Template contracts between DCI and research sites to ensure a fast study start up.
  • Project Management services to oversee and aid each site with IRB submissions, screening and recruitment, identify and troubleshoot potential problems, as well as provide DCI staff in-services.
  • Sites are efficient in recruiting due to the fact they have multiple clinics in a geographical area.
  • Dedicated staff to ensure correct invoicing and reconciling of accounts.

 

Recent Studies:

 

For more information regarding the DCI Office of Clinical Research and/or in participating in clinical trials, please contact:

Karen Majchrzak, MS, CCRP

Director of Clinical Research
Dialysis Clinic, Inc
1633 Church Street
Suite 500
Nashville, TN 37203
615-342-0483

Karen.Majchrzak@dciinc.org

 

Upcoming Events:

ASN Kidney Week 2017 – New Orleans, LA

  • Wednesday, November 1, 2017 Presentations

    • Eduardo Lacson, Jr.: Wednesday, November 1, 2017 – 7 am – 5:45 pm
      NTDS Event: Early Program: The Dialysis Infection Crisis in the United States: A Call to Action
      Location: Room 288 Convention Center
  • Thursday, November 2, 2017 Presentations
    (Posters on display from 10am – 12:30 pm)

    • M Diamond: Poster Board # TH-PO685
      Abstract Title: Dialysis modality and complications in PD patients undergoing CABG
    • Eduardo Lacson, Jr.: Lecture 10:30 am – 12:30 pm
      Lecture Title: Should the UFR be incentivized?
      Session Title: Fluid Management in Hemodialysis
    • Eduardo Lacson, Jr.: Thursday, November 2, 2017 – 12:30 pm – 1:45 pm
      NTDS Event: Focus group Session (Luncheon)
      Location: Room 297 Convention Center
    • Harold J. Manley: Poster Board # TH-PO904
      Abstract Title: High Dose and Quadrivalent Influenza Vaccine Safety and Efficacy in Dialysis Patients: Interim 2016-17 Flu Season Analysis
    • Rita L. McGill: Poster Board # TH-OR001
      Abstract Title: Comorbid Disease Trends in Hemodialysis and Peritoneal Dialysis Patients
    • Rita L. McGill: Poster Board # TH-PO762
      Abstract Title: The Significance of a Maturing Fistula or Graft at HD Initiation
    • Richard Muther: Poster Board # TH-PO1043
      Abstract Title: Four Times Daily Versus Three Times Daily Dosing of Phosphorus Binders Does Not Improve Serum Phosphorus in Dialysis Patients.
      Session Title: 1201-PO01 Mineral Disease: Ca/Mg/PO4
    • E Weathers: Poster Board # TH-PO897
      Abstract Title: Incidence, risk factors, and distribution of syphilis in the end-stage renal disease population in the United States
    • Robert H. Weiss: Lecture 12 pm – 12:30 pm
      Lecture Title: Renal Cell Cancer and AKI – CKD: Preventable or Inevitable?Session Title: Cancer and the Kidney: Examining the Connection
  • Friday, November 3, 2017 Presentations
    (Posters on display from 10am – 12 pm)

    • Ching-Hsien Chen: Poster Board # FR-PO240         Abstract # 2788415
      Abstract Title: Loss of methylthioadenosine phosphorylase confers malignant potential in renal cell carcinoma
      Session Title: 202-PO01 Apoptosis, Proliferation, Autophagy, Cell Senescence, Cell Transformation
    • David Charytan: Poster Board # FR-PO1078         Abstract # 2831020
      Abstract Title: Safety and Cardiovascular Efficacy of Spironolactone (SPL) in Dialysis-Dependent ESRD (SPin-D): A Pilot Trial of the NIDDK Hemodialysis Novel Therapies Consortium
      Session Title: Late-Breaking Clinical Trial Posters
    • Taimur Dad: Poster Board # FR-PO804          Abstract # 2786519
      Abstract Title: In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey Non-Responder and Responder Characteristics
      Session Title: 601-PO02 Standard Hemodialysis for ESRD – II
    • Ambreen Gul: Poster Board # FR-PO816         Abstract # 2775282
      Abstract Title: Measured Versus Prescribed Dialysate Sodium Using Dialysis Machines from Different Manufacturers
      Session Title: 601-PO02 Standard Hemodialysis for ESRD – II
    • Antonia Harford: Poster Board # FR-PO812       Abstract # 2769878
      Abstract Title: Use of Poisson Regression Analysis with Restricted Cubic Splines Facilitates Cross Sectional Comparisons of Mortality in a Large Provider
      Session Title: 601-PO02 Standard Hemodialysis for ESRD – II
    • Antonia Harford: Poster Board # FR-PO1034       Abstract # 2780778
      Abstract Title: Referral Rates for Renal Transplant in Dialysis Clinic, Inc.
      Session Title: 1702-PO05 Transplantation: DonorCandidate Assessment and Predictors of Outcome
    • Doug Johnson: Lecture 4:30 pm – 6:30 pm
      Lecture Title: ESRD Seamless Care Organizations: An Overview
      Session Title: International Models of Dialysis: Process of Care and Payment
    • Doug Johnson: Friday, November 3, 2017 – 2:00 pm – 4:00 pm
      NTDS Event: Annual Session: Infection Prevention: Are You Prepared for the Next “Ebola”?
      Location: Room 395 Convention Center
    • Rita L. McGill: Poster Board # FR-PO858
      Abstract Title: Long-Term Trends in the Co-Morbid Disease Burden of Incident Hemodialysis Patients
    • Dana Miskulin: Poster Board # FR-PO848         Abstract # 2785010
      Abstract Title: Differences between Home and In-Center BP Readings in Dialysis Patients
      Session Title: 606-PO02 Dialysis: Epidemiology, Outcomes, Clinical Trials – Cardiovascular – II
    • Manisha Singh: Poster Board # FR-PO960
      Abstract Title: Prevention of Medication Reconciliation Errors: Results of a QI Study
  • Saturday, November 4, 2017 Presentations
    (Posters on display from 10am – 12 pm)

    • J Cho: Poster Board # SA-PO691
      Abstract Title: Dialysis modality in PD patients undergoing laparoscopic surgery
    • Taimur Dad: Poster Board # SA-PO779          Abstract # 2786579
      Abstract Title: Patient Characteristics Associated with the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) scores
      Session Title: 601-PO01 Standard Hemodialysis for ESRD – I
    • Dana Miskulin: Poster Board # SA-PO848         Abstract # 2785010
      Abstract Title: Differences between Home and In-Center BP Readings in Dialysis Patients
      Session Title: 606-PO02 Dialysis: Epidemiology, Outcomes, Clinical Trials – Cardiovascular – II
    • Youli Wang: Poster Board # SA-PO472
      Abstract Title: Altered kynurinine 3-monooxidase may mediate rejection and tubular cell injury in pig kidney transplants.
  • Publications
    • Harold J. Manley: PUB366
      Title of Publication: Influenza Vaccine Safety and Efficacy in Dialysis Patients in the 2015-16 Flu Season