Video Training Supplementation to Reduce the Risk of Central Venous Catheter Infection in Patients Discharged on Home Parental Nutrition
Phase: NA
Conditions: Intestinal Failure
Sponsor: University of Chicago

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 2023.10.16 
 
Video training supplementation to reduce the risk of central venous catheter 
infection in patients discharged on home parental nutrition  
 
Principal Investigator:  Dejan Micic, M.D 
Co-Investigators: Yichun Fu, M.D., Neal Desai, PharmD 
 
 
Background 
 
Home parenteral nutrition (PN) is an alternative form of nutrition in patients in whom 
enteral nutrition is infeasible or insufficient in the long term.1,2 Home PN improves the 
quality of patients’ life and consequently also the course of the underlying disease, with 
optimization of nutrition status.2 A study conducted in Australia found that home PN had 
a positive impact on the daily living of patients.3 In recent years, more emphasis has 
been placed on delivering parenteral nutrition to patients at home, which may improve 
patient care and reduce costs.4 Thus, more patients rely on TPN for lifesaving nutrition 
support. There were an estimated 20,883 adult patients receiving home PN in 2013 
based on data from Medicare and Medicaid Services.5 The use of home PN has 
increased in recent years in adult patients.6–9 Although comprehensive data is lacking in 
the United States, there is a trend of increasing home PN use across many countries, 
including UK, Canada, and Spain.8,10 
 
Studies have shown that patients receiving total parenteral nutrition (TPN) are at higher 
risk for bloodstream infections compared to other patients with chronic infusion needs1–
14. Increased parenteral caloric intake is an independent risk factor for bloodstream 
infection in patients receiving TPN. A prospective study in 87 critically ill patients showed 
that patients who had catheter related bloodstream infection (CRBSI) received more 
parental calories (36 kcal/kg/day versus 31 kcal/kg/day, P = 0.003).11,12  Catheter-related 
bloodstream infection is a major cause of mortality and morbidity in patients receiving 
TPN.13,14 Therefore, it is important to maintain safe vascular access to prevent life-
threatening complications. 
 
Fortunately, there are interventions that reduce risk for bloodstream infection in home 
TPN. In a retrospective study, chlorhexidine gluconate transparent antimicrobial dressing 
reduced CRBSI from eight cases to zero case in 12 months.15 Another research study 
found that patients with parenteral nutrition who are managed by a dedicated nutrition 
support team are less likely to develop CRBSI at 24 months than a variety of physicians 
(1.3% vs 26.2%).1 More importantly, patient engagement and education program has 
been proven feasible and potentially effective. An oncology unit in Denmark developed 
an education program for 42 out of 82 randomized patients with tunneled central vein 
catheters. 88% of the 42 patients completed the training, and the 42 patients had 50% 
less CRBSI in a five-month period.16 A group in MD Anderson Cancer Center designed 
an in-person and video education program for central catheter care. After 1 year, 95% of 
the participating patients caring for the catheters at home, and 97% of them reported 
confidence and satisfaction in catheter care.17 
 
We developed an education video addressing the aseptic techniques to safely handle 
central catheters at home for TPN use. It will be hosted in a mobile app with a secure 
link. Our primary aim is to assess the effect of the video training supplementation prior to 
discharge on the rate of CRBSI over a 12-month period of time. Our secondary aims are 

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to assess the patient’s comfort level when handling catheters for patients newly initiated 
home TPN. 
 
Hypothesis 
 
We hypothesize that 1) the video will improve rates of CRBSI compared to a control 
group receiving written catheter instructions; 2) the video will improve patients’ comfort 
level with handing central catheters; 3) patients will find the video easy to use. 
 
Participants 
 
Inpatient adult patients who are discharged home for the first time on home TPN will be 
approached for consent and inclusion in this prospective study design. 
 
Study duration 
24 months 
 
Methodology 
Inclusion Criteria 
1. Patient will be discharged to start TPN at home. 
2. Age >18 yrs. 
3. Ability to understand and sign written consent form. 
4. English-speaking patients. 
5. Patients who are willing to self-administer TPN at home. 
 
Exclusion Criteria 
1. Patients without consent 
2. Patients who have been on home TPN prior to the index admission at any time in 
the past 
3. Non-English-speaking patients 
4. Patients who will not self-administer TPN. 
 
 
During initial screening and recruitment, it will be necessary to acquire potential 
participants’ names and medical record numbers. Medical record numbers will be used 
to confirm the patients’ diagnosis and home TPN usage by reviewing electronic medical 
records. Names are necessary to obtain permission to approach the patients from the 
patients’ physicians. This information will be stored electronically in a password-
protected file on a computer in room M-421. After screening and recruitment, patient 
names will be replaced anonymous study I.D. numbers. For patients choosing not to 
participate in the study, medical record numbers will also be deleted, and standard of 
care will be continued. 
 
Following consent, each subject will be asked to complete a “TPN Central Catheter Self-
Care Questionnaire” (Appendix 1). The primary role of the enrollment questionnaire is to 
assess for baseline comfort level to manipulate a central catheter at home. In addition, 
following enrollment, electronic chart review will be performed to assess for clinical and 
laboratory variables within three months of enrollment (complete blood count, renal 
function, liver function studies, type of catheter placement, extent and duration of 
disease and comorbid conditions [Charlson score]). 
 

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All enrolled patients will receive baseline in-person hands-on training for catheter use. 
Then the patients will be randomly assigned to the control group (written instructions) or 
the intervention group (provided video link).  
 
A baseline entry questionnaire will be administered to assess the patients’ comfort level 
for central catheter use and indications for PN. Each subject will use their study I.D. in 
lieu of their name. Then patients in the intervention group will be given a link to the 
educational video, which they can access as many times as they prefer.  
 
Six weeks following enrollment, study participants will be asked to complete a second 
“TPN Central Catheter Teaching and Self-Care Questionnaire” (Appendix 2) via an email 
or secure text link generated from patient.iq. to reassess participants’ comfort level of 
catheter self-care. 
 
Six months following enrollment, study participants will be asked to complete a 
“Conclusion of Study Questionnaire” (Appendix 3) via an email or secure text link 
generated from patient.iq. The role of the concluding questionnaire is to assess for 
subjective reports of their confidence and comfort level in central line self-care.  
 
If a subject fails to respond to these electronic questionnaires, the IRB-approved study 
staff will approach he/she during a standard GI Nutrition follow-up clinic visit to obtain 
answers for the questionnaire via a secure link on a tablet device. 
 
The follow-up period will not exceed one year beyond the inclusion date. At the end of 
one year, the IRB-approved study staff will gather clinical information from the electronic 
medical record to determine if each subject has had a CRBSI event. Per CDC, CRBSI is 
defined as a laboratory confirmed infection where a Central Venous Catheter (CVC) is in 
place for over 2 calendar days prior to a positive culture and is also in place the day of or 
day prior to culture. And not deemed as a result from contamination by the primary 
hospital team at the time of the treatment.  
 
The subjects will undergo weekly laboratory tests (complete blood count, electrolytes, 
liver function, and kidney function) as part of their routine standard of care to ensure the 
TPN formula is up to date and meets subjects’ nutritional and metabolic needs. If a 
subject seeks care outside of UChicago, subject’s UChicago care team members will 
obtain permission to have the health information released to UChicago, as part of the 
subject’s standard of care. If patient wishes to transfer care of their TPN and CVC 
permanently to another institution, then their participation in this study will be terminated. 
 
Additionally, subjects will be followed-up weekly via phone by their care team at 
UChicago as part of subjects’ routine standard of care to ensure safe use of CVC and 
TPN infusions. 
 
Study Schema 
Assessment/Procedure 
Visit 1  
Visit 2 
Visit 3 
Visit 4 
Informed consent 
X 
 
 
 
Data collection: 
Demography and medical 
history 
X 
 
 
 
Randomization 
X 
 
 
 

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Watch video/ follow written 
instructions 
X 
X 
X 
 
Complete questionnaire 
X 
X 
X 
 
Review medical, surgical, 
and hospitalization records 
for CRBI evaluation  
 
 
 
X 
 
Location 
 
Patients will be consented at the University of Chicago’s Center for Care and Discovery 
and Mitchell Hospital. All obtained data will be stored in a password protected computer 
or a locked drawer in the research office in M-421. 
 
Potential risks and benefits 
 
There is a minor risk of loss of confidentiality with participation in this study since subject 
identifiers will be collected.  However, all study data will be recorded in a database 
where names and medical record numbers will be removed and replaced with a study 
I.D.  Only the study staff will have access to the key which links the study code to the 
subject’s identity.  
 
Patients may receive no direct benefit from participation in this study, but it is anticipated 
they will benefit from improve catheter self-care techniques, and an improved physicians’ 
understanding of catheter associated bloodstream infections. 
 
Special Precautions 
 
No specimens will be collected during this study. Standard precautions will be provided 
during all patient encounters and clinical care. 
 
Special precautions will be taken by research staff to ensure confidentiality. All data 
review will be performed electronically on a password-protected computer in a locked 
and limited access area.   
 
Data will be coded in case the study team needs to go back and re-check data or look 
into abnormalities. Subjects are assigned a unique study code in place of their name and 
MRN. Only the study staff will be able to link data with subjects’ identifiable information. 
Upon termination of the study, the coding link will be destroyed, leaving only completely 
de-identified data.  
 
Experimental controls and use of placebos 
 
N/A 
 
Number of experimental subjects 
 
One hundred (100) subjects will be included in the study.  
 
Data Analysis 
 

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The rate of CRBSI will be determined. Risk factors for the CRBSI will be assessed in 
univariable and multivariable analysis based on pre-defined clinical and subjective risk 
factors.  
 
Statistical justification 
The rationale for the number of subjects is as follows. With 30% rate of bloodstream 
infection, and a 70% power and 95% confidence interval, the total sample size required 
would be 93 patients in order to see a reduction in the rate of bloodstream infection. 
Suppose a 10% rate for loss to follow-up, the total subjects will be 100 patients. 
 
At the end of the study, the rate of CRBSI will be calculated and compared between the 
TPN video group and the control group using an unpaired Student’s T test. The frequency 
of TPN video use will be reported as quantitative data based on discrete values. The 
comfort level of CVC handling will be aggregated, and the mean value will be compared 
between the video group and the control group using an unpaired Student’s T test. 
 
Informed Consent  
 
Written consent will be obtained in standard fashion using an IRB-approved consent 
form. The patient will be approached by the PI, Co-I, or a trained study staff member. All 
ethnic populations will be eligible and recruited. The study will be explained in detail 
during a standard-of-care inpatient GI nutrition consultation visit, all patient questions will 
be answered and sufficient time will be allowed for the subject to make a decision 
regarding participation. The original signed consent form will be stored in a locked 
drawer in M-421. 
 
Patients that do not agree to participate in the study will continue to receive standard-of-
care treatment. At the time of consent, patients will also be informed that they are free to 
withdraw from the study at any time they wish.  
 
Confidentiality  
 
During initial data collection, patient names will be used.  However, after entering the 
selected data values into our study database, the medical record numbers and names 
will be stripped from the information to insure confidentiality. Unique, study-specific 
identifiers will be assigned to individual subjects’ data. Manipulation of data and 
reporting results will be performed in aggregate fashion and in no way will identify 
individual subjects. In addition, all data and any information that has specific medical 
record numbers recorded will be maintained in a secure location (M-421) and locked 
cabinet or password protected database. Only the P.I., Co-I’s and IRB-approved study 
staff will have access to these identifiers. 
 
Recruiting methods 
 
Patients will be referred from all inpatient primary services at the University of Chicago 
for eligibility of home TPN, who will grant permission for us to approach their patients for 
recruitment to this study.  
 
A rationale for excluding women, minorities and/or children from participation 
 
N/A 

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Bibliographic References 
1. Bozzetti F, Arends J, Lundholm K, Micklewright A, Zurcher G, Muscaritoli M. ESPEN 
Guidelines on Parenteral Nutrition: Non-surgical oncology. Clinical Nutrition. 
2009;28(4):445-454. doi:10.1016/j.clnu.2009.04.011 
2. Fojtová A, Norek B, Gazdíková K. The importance of home parenteral nutrition in 
clinical practice – own experience from our workplace. Gastroenterol Hepatol. 
2022;76(1):60-66. doi:10.48095/ccgh202260 
3. Tsang PY, Carey S. Impact of home parenteral nutrition on daily life: A qualitative 
study of eight patients: Qualitative nutrition and HPN. Nutrition & Dietetics. 
2015;72(1):16-21. doi:10.1111/1747-0080.12091 
4. Ferguson TI, Emery S, Price-Davies R, Cosslett AG. A review of stability issues 
associated with vitamins in parenteral nutrition. e-SPEN Journal. 2014;9(2):e49-e53. 
doi:10.1016/j.clnme.2014.01.001 
5. Mundi MS, Pattinson A, McMahon MT, Davidson J, Hurt RT. Prevalence of Home 
Parenteral and Enteral Nutrition in the United States. Nutr Clin Pract. 2017;32(6):799-
805. doi:10.1177/0884533617718472 
6. Kovacevich DS, Corrigan M, Ross VM, McKeever L, Hall AM, Braunschweig C. 
American Society for Parenteral and Enteral Nutrition Guidelines for the Selection and 
Care of Central Venous Access Devices for Adult Home Parenteral Nutrition 
Administration. Journal of Parenteral and Enteral Nutrition. 2019;43(1):15-31. 
doi:10.1002/jpen.1455 
7. Russell MK, Wischmeyer PE. Supplemental Parenteral Nutrition: Review of the 
Literature and Current Nutrition Guidelines: Nutrition in Clinical Practice. Nutrition in 
Clinical Practice. 2018;33(3):359-369. doi:10.1002/ncp.10096 
8. Donaldson E, Taylor M, Abraham A, et al. Improving quality in a national intestinal 
failure unit: greater efficiency, improved access and reduced mortality. Frontline 
Gastroenterol. 2015;6(3):182-193. doi:10.1136/flgastro-2014-100482 
9. Bonnes SL, Salonen BR, Hurt RT, McMahon MT, Mundi MS. Parenteral and Enteral 
Nutrition—From Hospital to Home: Will It Be Covered? Nutr Clin Pract. 
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10. 
Tappenden KA. A Challenge to Providers of Clinical Nutrition Therapy. JPEN J 
Parenter Enteral Nutr. 2012;36(4):377-377. doi:10.1177/0148607112451740 
11. 
Dissanaike S, Shelton M, Warner K, O’Keefe GE. The risk for bloodstream 
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parenteral nutrition. Crit Care. 2007;11(5):R114. doi:10.1186/cc6167 
12. 
Ishizuka M, Nagata H, Takagi K, Kubota K. Total Parenteral Nutrition Is a Major 
Risk Factor for Central Venous Catheter-Related Bloodstream Infection in Colorectal 
Cancer Patients Receiving Postoperative Chemotherapy. Eur Surg Res. 
2008;41(4):341-345. doi:10.1159/000160181 

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13. 
Dibb M, Lal S. Home Parenteral Nutrition: Vascular Access and Related 
Complications. Nutr Clin Pract. 2017;32(6):769-776. doi:10.1177/0884533617734788 
14. 
Bond A, Chadwick P, Smith TR, Nightingale JMD, Lal S. Diagnosis and 
management of catheter-related bloodstream infections in patients on home 
parenteral nutrition. Frontline Gastroenterol. 2020;11(1):48-54. doi:10.1136/flgastro-
2018-101094 
15. 
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16. 
Møller T, Borregaard N, Tvede M, Adamsen L. Patient education—a strategy for 
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Appendix 1: Central Catheter Teaching and Self-Care Initial Questionnaire 
 
Name: ___________________________ 
  Subject ID: ____________________________ 
Date: ___________________  
 Email: ______________________________________ 
 
 
 
1) What type of central venous catheter do you have?  
 
 
PICC line 
 Tunneled catheter (Hickman) 
 
2) How many lumens (or “ports”) on your catheter? ______ 
 
3) What are the cycle hours of your PN (parenteral nutrition)?  ______ hours 
 
4) Do you use any other IV medications through the catheter (excluding heparin 
lock, etc for catheter maintenance only)?  
Yes 
 
No 
 
What IV medications?  
_____________________________________________________________________ 
 
 
 
Yes 
No 
Do you currently have an ostomy?         
 
 
 
Do you currently have a fistula anywhere in your body? 
      
 
 
Do you currently have a G tube?         
         
 
 
Have you ever worked with IVs in a home or employment 
setting? 
          
 
 
 
5) How comfortable do you feel about taking care of your central venous 
catheter? 
Very uncomfortable 
 
Somewhat uncomfortable 
 
Neutral 
  
Somewhat comfortable 
  
Very comfortable 
 

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Appendix 2: Central Catheter Teaching and Self-Care Follow-up Questionnaire 
 
Name: ___________________________ 
  Subject ID: ____________________________ 
Date: ___________________  
 Email: ______________________________________ 
 
1) What are the cycle hours of your PN (parenteral nutrition)?  ______ hours 
 
2)  
 
Yes 
No 
Do you currently have an ostomy?         
 
 
 
Do you currently have a fistula anywhere in your body? 
      
 
 
Do you use any other IV medications through the catheter? 
 
 
If yes, what IV medications?  
_____________________________________________________________________ 
 
 
3) How comfortable do you feel about using your central venous catheter? 
Very uncomfortable 
 
Somewhat uncomfortable 
 
Neutral 
  
Somewhat comfortable 
  
Very comfortable 
 
4) How do you find the TPN education material? 
Very confusing 
 
A little confusing and not as helpful 
 
 
The information is clear, but it had no effect on my self-care practice 
 
Somewhat helpful 
  
Very helpful 
 
5)  How often do you watch the TPN educational material on average? 
I have not watched the video since discharge 
 
Less than once a week 
 
 
1-2 times a week 
 
3-6 times a week  
  
Daily or more 
 
 
 
 
 
 
 

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Appendix 3: Central Catheter Teaching and Self-Care Conclusion 
Questionnaire 
 
Name: ___________________________ 
  Subject ID: ____________________________ 
Date: ___________________  
 Email: ______________________________________ 
 
1) What are the cycle hours of your PN (parenteral nutrition)?  ______ hours 
 
2)  
 
Yes 
No 
Do you currently have an ostomy?         
 
 
 
Do you currently have a fistula anywhere in your body? 
      
 
 
Do you use any other IV medications through the catheter? 
 
 
If yes, what IV medications?  
_____________________________________________________________________ 
 
 
3) How comfortable do you feel about using your central venous catheter? 
Very uncomfortable 
 
Somewhat uncomfortable 
 
Neutral 
  
Somewhat comfortable 
  
Very comfortable 
 
4) How do you find the TPN education material? 
Very confusing 
 
A little confusing and not as helpful 
 
 
The information is clear, but it had no effect on my self-care practice 
 
Somewhat helpful 
  
Very helpful 
 
5) How often do you watch the education material on average? 
I have not watched the video since discharge 
 
Less than once a week 
 
 
1-2 times a week 
 
3-6 times a week  
  
Daily or more