PROSPECTIVE STUDY OF THE ACCUCATH® INTRAVENOUS CATHETER SYSTEM WITH NITINOL GUIDEWIRE COMPARED TO PUBLISHED LITERATURE FOR CONVENTIONAL IV CATHETERS

NORMAN R. ANDERSON, RN, CRNI, VA -BC

EVANGELICAL COMMUNITY HOSPITAL, LEWISBURG, PA

Patient satisfaction continues to be an important driver in today’s ever changing health care environment. The ability to influence patient satisfaction through improving infusion delivery makes it an important responsibility in the field of intravenous therapy. Currently peripheral intravenous (PIV) outcomes are multi-challenged:

• Patient satisfaction averages 42% overall.

• First attempt success averages only 40% in adults and 44-46% in pediatrics.

• Complications occur 47% of the time.

• Average PIV dwell time is 44 hours.

• 50% of PIV lines require replacement before completion of therapy.

• Unsuccessful PIV access is escalated to midline or central line therapy increasing CLABSI risk and cost.

• This sub-optimal care results in poor clinician satisfaction, inefficiencies and unnecessary costs.

• A new peripheral IV catheter technology that uses a proprietary coiled tip guidewire design is now available and has been shown in a previous study to improve PIV performance when used by general nursing staff in a university hospital.

• This prospective study will collect catheter performance data with a Vascular Access Team to validate improvement opportunities offered with guidewire technology compared to published literature for conventional catheter outcomes.

• Outcomes evaluated included: first attempt success, complication rates, dwell times, completion of therapy, patient satisfaction and overall costs of therapy.

• The long range goal being to validate a new technology that can significantly improve patient satisfaction at a time when it now impacts overall hospital reimbursement.

• Hospital and IRB approval were obtained prior to beginning the study.

• Adult medical-surgical patients who required a non-emergent IV catheter were enrolled and consented.

• Data was collected using a standardized instrument by Vascular Access Team RNs with greater than 7 years of experience.

• The study enrolled 95 total patients using the study IV from insertion to removal.

• Outcomes were assessed using parametric and non-parametric tests.

With INS (Infusion Nursing Society) standards now stating IVs can dwell until complication, there is significant opportunity to improve patient outcomes with guidewire technology that offers greater first attempt success, longer dwell time and improved patient satisfaction as seen with the study IV.

Overa l l Pa t ien t

Sa t is fac t ion N

Number

Sa t is f i ed

Percen

t

95%

Conf idence

In te rva l

p -va lue

At Insertion 95 95 100% 96.2% - 100% < 0.001

At Discharge 95 93 97.9% 92.6% - 99.7% < 0.001

Patient satisfaction using a 5 point Likert Scale (Score 3-5 defined satisfaction):

F i rs t A t tempt Success

N First Attempt

Success Percent 95% Confidence Interval p-value*

95 81 85.3% 76.5% - 91.7% < 0.001

*Compared to 47% average complications in published literature for conventional

catheters.

1.2 catheters were required per IV start compared to 2.18 for conventional catheters. *Compared to 40% average first attempt success in published literature for conventional catheters.

• This novel, proprietary guidewire technology offers an opportunity for significant

improvement in patient satisfaction and clinical outcomes by increasing first attempt

success, lowering complications, improving dwell time and completion of therapy.

• All of these are reasonable IV therapy objectives in today’s health care environment

with patient satisfaction playing a key role as it’s now linked to reimbursement and

highly influenced by the patient’s overall IV experience.

• Change can be accomplished by nursing action to impact review and adoption of new

technologies, especially those that are evidenced based.

Compl ica t ions

N Complications Percent 95% Confidence Interval p-value*

95 17 17.9% 10.8& - 27.1% < 0.001

Comple t ion o f Therapy

N First Attempt

Success Percent 95% Confidence Interval p-value*

95 78 82% 70.5% - 87.5% < 0.001

Dw el l T ime

N Av. Dwell Time

Hrs.**

Av. Dwell Time Hrs. Without

Complications

Av. Dwell Time Hrs. With Complications

p-value*

95 58 59.1 (78) 52.6 (17) < 0.002

*Compared to 47% average completion of therapy in published literature for

conventional catheters. Defined as original IV in place as long as needed.

*Compared to 44 hrs. average dwell in published literature for conventional catheters.

**Hospital av. LOS was 2.98 days during study.

BACKGROUND

PURPOSE

METHODS

ACCUCATH® INTRAVENOUS

CATHETER

PATIENT SATISFACTION RESULTS

ACKNOWLEDGEMENTS: • AccuCath ® Inventor, Dr. Amir Belson

• Sponsor, Vascular Pathways, Inc .

• Evangel ica l IV Team Nurses, Nurs ing Management ,

ICU/SDU and Medica l Surgica l Nurs ing Depar tments

2015 INFUSION NURSES SOCIETY ( INS) ANNUAL

CONVENTION

CLINICAL RESULTS

CONCLUSIONS *Compared to 42% average satisfaction rate in published literature for conventional catheters.

Patient satisfaction continues to be an important driver in today’s ever changing health care environment. The ability to influence patient satisfaction through improving infusion delivery makes it an important responsibility in the field of intravenous therapy. Currently peripheral intravenous (PIV) outcomes are multi-challenged:

• Patient satisfaction averages 42% overall.

• First attempt success averages only 40% in adults and 44-46% in pediatrics.

• Complications occur 47% of the time.

• Average PIV dwell time is 44 hours.

• 50% of PIV lines require replacement before completion of therapy.

• Unsuccessful PIV access is escalated to midline or central line therapy increasing CLABSI risk and cost.

• This sub-optimal care results in poor clinician satisfaction, inefficiencies and unnecessary costs.

•A new peripheral IV catheter technology that uses a proprietary coiled tip

guidewire design is now available and has been shown in a previous study to

improve PIV performance when used by general nursing staff in a university

hospital.

•This prospective study will collect catheter performance data with a Vascular

Access Team to validate improvement opportunities offered with guidewire

technology compared to published literature for conventional catheter outcomes.

•Outcomes evaluated included: first attempt success, complication rates, dwell

times, completion of therapy, patient satisfaction and overall costs of therapy.

•The long range goal being to validate a new technology that can significantly

improve patient satisfaction at a time when it now impacts overall hospital

reimbursement.

•Hospital and IRB approval were obtained prior to beginning the study.

•Adult medical-surgical patients who required a non-emergent IV catheter were

enrolled and consented.

•Data was collected using a standardized instrument by Vascular Access Team RNs

with greater than 7 years of experience.

•The study enrolled 95 total patients using the study IV from insertion to removal.

•Outcomes were assessed using parametric and non-parametric tests.

BACKGROUND

PURPOSE METHODS

With INS (Infusion Nursing Society) standards now stating IVs can dwell until complication, there is significant opportunity to improve patient outcomes with guidewire technology that offers greater first attempt success, longer dwell time and improved satisfaction as seen with the study IV.

OVER-NEEDLE Versus GUIDEWIRE DELIVERY

AccuCath® Intravenous Catheter System

Overal l Pat ient

Sat isfact ion N Number

Sat isf ied Percent

95%

Confidence

Interval

p-value

At Insertion 95 95 100% 96.2% - 100% < 0.001

At Discharge 95 93 97.9% 92.6% - 99.7% < 0.001

First Attempt Success

N First Attempt

Success Percent 95% Confidence Interval p-value*

95 81 85.3% 76.5% - 91.7% < 0.001

*Compared to 40% average first attempt success in published literature for conventional catheters.

1.2 catheters were required per IV start compared to 2.18 for conventional

catheters.

Complicat ions

N Complications Percent 95% Confidence Interval p-value*

95 17 17.9% 10.8& - 27.1% < 0.001

*Compared to 47% average complications in published literature for conventional catheters.

Dwell Time

N Av. Dwell Time

Hrs.**

Av. Dwell Time Hrs. Without

Complications

Av. Dwell Time Hrs. With Complications

p-value*

95 58 59.1 (78) 52.6 (17) < 0.002

*Compared to 44 hrs. average dwell in published literature for conventional catheters.

**Hospital av. LOS was 2.98 days during study.

Complet ion of Therapy

N First Attempt

Success Percent 95% Confidence Interval p-value*

95 78 82% 70.5% - 87.5% < 0.001

*Compared to 47% average completion of therapy in published literature for conventional

catheters. Defined as original IV in place as long as needed.

STUDY RESULTS

OVERALL PATIENT SATISFACTION COMPLICATION RATES

Patient satisfaction using a 5 point Likert Scale (Score 3-5 defined satisfaction):

FIRST ATTEMPT SUCCESS

DWELL TIME

COMPLETION OF THERAPY

*Compared to 42% average satisfaction rate in published literature for conventional catheters.

• This novel, proprietary guidewire technology offers an opportunity for significant improvement in

patient satisfaction and clinical outcomes by increasing first attempt success, lowering

complications, improving dwell time and completion of therapy.

• All of these are reasonable IV therapy objectives in today’s health care environment with patient

satisfaction playing a key role as it’s now linked to reimbursement and highly influenced by the

patient’s overall IV experience.

• Change can be accomplished by nursing action to impact review and adoption of new technologies,

especially those that are evidenced based.

CONCLUSIONS

STUDY BIBLIOGRAPHY

1. HCAPCA Web site. http://www.hcahps.com. Accessed January 12, 2015.

2. Keogh S. New research: change peripheral intravenous catheters as clinically indicated, not routinely. J Assoc Vasc Access. 2013; 18 (3): 153-154.

3. Zingg W, Pittet D. Peripheral venous catheters: an under-evaluated problem. Int. J Antimicrobial Agents. 2009; 34 Suppl 4: S38-42.

4. Kokotis K. Cost containment and infusion services. J of Infusion Nurs. 2005; 28 (3 Suppl):S22-S32.

5. Sebbane M. Pierre-Geraud C, Lefebvre S, et al. Predicting peripheral venous access difficulty in the emergency department using body mass index and a clinical evaluation of venous accessibility. J Emergency Med. 2013; 44(2): 299-305.

6. Frey AM, Schears GJ. Why are we stuck on tape and suture? J Infus Nurs. 2006; 29 (1):34-38.

7. Schears GJ. Summary of product trials for 10, 164 patients. J Infus Nurs. 2006; 29 (1):34-38.

8. Wolosin RJ. Largest study of patient satisfaction ever conducted. The Press Ganey Satisfaction Report. 2003; VII: 2-4.

9. Kokotis K. The role of the IV therapist. J Vasc Access Device. 1999; Winter: 22-27.

10. Infusion Nursing Society. Infusion nursing standards of practice. J Infus Nurs. 2011; 34 (1 Suppl):S57.

11. Centers for Disease Control and Prevention. Guidelines for prevention of intravascular catheter-related infections. MMWR. 2011: 7-8

12. Centers for Disease Control and Prevention. www.cdc.gov/nchs/fastats/hospital.htm. Accessed 1/12/2015.

13. Powell J, Tarnow K, Perucca R. The relationshop between peripheral intravenous catheter indwell time and the incidence of phlebitis. J of Infusion Nurs. 2008; 31 (1) 39-45.

14. Dychter S, Gold D, Carson D, et. al. M. Complications and economic considerations of peripheral access. J of Infusion Nursing. 2012; 35 (2): 84-91.

15. Idemoto BK, Rowbottom J, Reynold J, et.al. The AccuCath intravenous catheter system with retractable coiled tip guidewire and conventional peripheral intravenous catheters: a prospective, randomized, controlled comparison. J of the Assoc

for Vasc. Access. 2014; Vol. 19 No. 2: 94-102.

16. Vascular Pathways Web site. http://vascularpathways.com/accucath. Accessed January 12, 2015.

17. Cosentino F. I can start that IV with one attempt. NITA 1984; 7:377-378.

18. Jacobson A, Winslow E. Variables influencing intravenous catheter insertion difficulty and failure: An analysis of 339 intravenous catheter insertions. Heart and Lung. 2005; 34 (5): 345-359.

19. Hadaway L. Escalation of vascular access devices. Presented at: Association for Vascular Access Annual Scientific Meeting; October 3-6, 2011 San Jose, CA. http://www.avainfo.org/website/download.asp?id=280462. Accessed January 12, 2015.

20. Barton A, Danek G, Johns P, Coons M. Improving patient outcomes through CQI: vascular access planning. J Nurs Care Quality 1198; 13 (2)77-85).

21. Palefski S, Stoddard G. The infusion nurse and patient complication rates of peripheral–short catheters: a prospective evaluation. J Intraven Nurs. 2001; 24(2):113-123.

22. Hadaway L. Short peripheral intravenous catheters and infections. J of Infusion Nurs. 2012; 35 (4):230-240.

23. Gallant P, Schultz A. Evaluation of a visual infusion phlebitis scale for determining appropriate discontinuation of peripheral intravenous catheters. J of Infusion Nurs. 2006; 29 (6): 338-345.

24. Abolfotouh M, Salam M, Bani-Mustafa A, et.al. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Therapeutics and Clinical Risk Manag. 2014; 10:993-1001.

25. Webster J, Osborne S, Rickard CM, et.al. Clinically-indicated replacement versus routine replacement of peripheral venous catheters. Cochrane Database Syst. Rev. 2013 Apr 30; 4: CD007798.

26. Danek G, Kilroy R. IV CQI Study: impact of a vascular access planning algorithm on patient outcomes. Friday’s Focus Hospital Newsletter at Shands (University of Florida). April 1998:1-5.

27. Santolucito JB. A retrospective evaluation of the timeliness of physician initiated PICC referrals. J Vasc Access Devices. 2001:20-26