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Long Term Follow-Up Core

The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center Long Term Follow-up (LTFU) Core consists of a Manager (Carrie Pidro), 4 full-time equivalent research interviewers (2 full-time, 4 part-time), and part-time administrative staff to assist with duties such as data entry and mass mailings. The LTFU Core is based within the CRISMA Center, Department of Critical Care Medicine, a clinical, translational and health services research group focused on critical illness.

The CRISMA LTFU Core has over 10 years of experience in conducting long-term outcomes (LTO) studies, and has developed data management procedures to incorporate LTO assessment in several trials of acute respiratory distress syndrome (ARDS) and critical illness. We have collaborated with many Coordinating Centers and hundreds of sites, and have well-trained staff with extensive experience in assessing LTO. We can reach study participants in all time zones, evenings and weekends, as all interviewers work a flexible schedule to accommodate participant schedules and requests, thereby consistently achieving high follow-up rates.

Key Personnel

David T. Huang, MD, MPH and Sachin Yende, MD, MS are the Co-Directors of the CRISMA Long Term Follow-up Core (LTFU Core), with Dr. Huang handling day-to-day staff supervision and project execution, and Dr. Yende responsible for academic expertise.

Drs. Huang and Yende have complementary skills. Dr. Huang is an emergency and critical care physician and a NIH-funded clinical trialist. He is PI of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter trial testing use of procalcitonin in Emergency Department patients with respiratory infection (R01GM101197), and served as Medical Monitor for the Protocolized Care for Early Septic Shock trial (ProCESS, P50GM076659). Dr. Huang is also Director of MACRO (Multidisciplinary Acute Care Research Organization), a multi-department University of Pittsburgh CTSA cost center that provides 24/7 clinical research coordinator infrastructure for 29 PIs in 10 Departments.

Dr. Yende is a pulmonary and critical care physician and a NIH-funded translational scientist, focusing on epidemiology of pneumonia and sepsis. He leads ConsequenceS, a multicenter observational study of severe sepsis patients (R01GM097471). ConsequenceS is conducting home visits in survivors of severe sepsis over 1 year to collect blood and urine samples to understand mechanisms underlying poor LTO after sepsis. Dr. Yende is also Director of the Clinical Epidemiology Program within the CRISMA Center, and Vice President, Critical Care, Veterans Affairs Pittsburgh Healthcare System.

Caroline Pidro, BS has served as CRISMA LTFU Core Manager since 2010, and has 12 years of phone call interview experience. She has extensive experience in not only performing and training staff in the proper conduct of follow-up calls, but also crafting informed consent language to facilitate follow-up, selection of instruments, protocol writing, and document preparation. She has created a ‘Hard To Reach Participant’ checklist that provides a multi-strategy approach to maximize follow-up. Ms. Pidro closely works with Drs. Huang and Yende to guide her Core, and on the LTFU aspects of their individual studies.

 

Experience

Experience in obtaining long-term outcomes in patients with ARDS and critical illness:

  • We have successfully incorporated LTFU into multicenter clinical trials (e.g., Economic Analysis of Pulmonary Artery Catheter use1 [EA-PAC] and Adult Respiratory Distress Syndrome Cognitive Study2 [ACOS] in NHLBI ARDS Network trials) and are conducting multicenter studies to understand mechanisms underlying poor LTO (e.g., Cardiovascular consequences of sepsis [ConsequenceS]). We have successfully worked with several Coordinating Centers and over 250 national and international sites for LTO studies (Table 1).
  • We have conducted over 9,000 patient interviews after hospital discharge, with follow-up exceeding 80% at 6 months and 60% at 1 yr.

Table 1. Recent and current CRISMA Long Term Follow-up Core studies

Study and sample size

No. of sites

Population

Follow-up (telephone vs. in-home visit)

Instruments or key measures

Eligible participants contacted at primary time points

EA-PACa,d (n=655)

41

Adults with ARDS

Telephone

Health Utilities Index-2, ADL/IADL, post-hospitalization resource use

84% at 1 yr

ACCESSb,d,e (n=1,984)

197

Adults with severe sepsis

Telephone

EQ5D, living status

78% at 6 months and 62% at 1 yr

ACOSa,d (n=213)

14

Adults with ARDS

Telephone

Beck Anxiety inventory, Zung depression scale, Post-traumatic Stress Syndrome 10-Q. Inventory, Wechsler Adult Intelligence Scale-III, Wechsler Memory Scale-III, Controlled Oral Word Association test, Hayling’s sentence completion test

57% at 1 yr

ProACTa, c (ongoing, 157 to date)

14

Adults with respiratory tract infection

Telephone

Airway Questionnaire-20, antibiotic and resource use

87% at 30 days

PARTNERS-1a,c (ongoing, 735 to date)

5

Surrogate decision makers of ICU patients

Telephone

Impact of Event Scale, Hospital Anxiety and Depression, post-hospitalization resource use, quality of physician communication

81% at 6 months

PrONOxa,d (n=652)

16

Premature newborns with respiratory failure

Telephone

Post-hospitalization resource use

94% at 1 yr (at least 1 interview)

ConsequenceSa,c (ongoing, 350 to date)

10

Adults with severe sepsis

In-home visit

Causes for re-hospitalization and blood/urine samples for biomarkers

48% at 3 months had home visits

a - NIH-funded; b - industry-funded; c - primarily designed to assess LTO; d - incorporated LTO; e - international study with sites in the Americas, Europe, and Asia.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Experience in analyzing long-term outcomes:

We have conducted studies to examine LTO of critically ill patients for over a decade. We have extensive experience in longitudinal data analyses (e.g., trajectory analyses and joint modeling) and using competing risk models, and will assist the Clinical Coordinating Center (CCC) for analyses that include LTO.

  • We showed that sepsis survivors have increased long-term mortality compared to multiple controls in over 1.5 million Medicare beneficiaries. This study and our prior work suggest that the high long-term mortality cannot be solely attributed to poor health prior to sepsis hospitalization.
  • We showed that sepsis accelerates several health conditions, including cognitive dysfunction, dementia, and cardiovascular disease.
  • We assessed quality of life using EQ5D. For example, in the ‘A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis’ (ACCESS) trial, we showed that at 1 year, almost a third of participants reported problems with mobility (31.7%) and usual activities (32.3%), and 14.7% reported problems with self-care (manuscript in preparation).