Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study) (iPIVAP)

Implementing Ipsilateral Peripheral Intravenous Access Procedures for Routine Scanning in Patients With a History of Surgical Axillary Procedures (The iPIVAP Study)

This pilot study will examine facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection in a single radiology center.

Study Overview

• Status: Completed
• Conditions: Melanoma; Breast Cancer; Lymphedema of Upper Arm; Thoracic Cancer
• Intervention / Treatment: Other: Ipsilateral peripheral IV insertion

Detailed Description

This prospective single arm study will be conducted within DUH Department of Radiology CT Imaging. The study team will enroll 50 patients with a history of axillary SLNP presenting for routine radiographic scan to undergo ipsilateral IV insertion. Patients will complete baseline bilateral arm volumetric measurements and self-reported symptom assessments. Patients will be followed every 3 months for 1-year duration for development of lymphedema. Patient acceptance or reluctance to ipsilateral IV access will be categorized at time of screening. Staff uptake on practice change will be assessed through medical record documentation for number, location, and factors affecting IV attempts and their perceptions of practice change and acceptance at the end of one year.

All participants will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Per DUH policy, participants will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt. At the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt.

Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur within 2 weeks; findings will be discussed with their physician. Participants will undergo bilateral volumetric measurements, symptom assessments, and perceptions of the ipsilateral IV access protocol at the end of one year.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Allen, PhD RN; Phone Number: 919 6814719; Email: hutch.allen@duke.edu
• Study Contact Backup: Name: Britt H Meyer, PhD RN; Phone Number: 919 6849420; Email: britt.meyer@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. History of bilateral or unilateral axillary SLNP (sentinel biopsy, lymphadenectomy or dissection) and a previous or current failed contralateral IV attempt or at the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt
2. Scheduled to undergo routine imaging scan with contrast
3. 18 years of age and older
4. Read, reviewed and signed study-specific consent

Exclusion Criteria:

1. Active swelling, rash, or injury in bilateral upper extremities
2. Subjects with diabetes, sickle cell disease, and/or peripheral vascular insufficiency as vascular inflammatory processes pose a lymphedema risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single arm study; Patients with a history of axillary surgical lymph node procedures (SLNP) presenting for routine radiographic scan will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Patients will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt.

Other: Ipsilateral peripheral IV insertion; Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.	Perceptions of barriers and facilitators by staff will be collected at study end using a qualitative format. Modeled after Melnyk, Fineout-Overholt, and Mays (2008) EBP surveys, open-ended questions will be asked during a focus group to ascertain their perceptions of the impact of the ipsilateral IV access protocol. Staff will be asked what worked well, what barriers did they experience, and what do they recommend for protocol adoption. Constant comparative analysis will be used to categorize themes from their responses	Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric measurements	Volumetric measurements will be obtained using a tape measure to assess limb girth circumference at five anatomic points. A difference of 2 centimeters or more in arm circumference at a corresponding point between ipsilateral and contralateral arms is considered a common criterion for a diagnosis of lymphedema.(Armer et al 2003)	Baseline and at 12 months post ipsilateral IV insertion
Lymphedema symptoms; patient reported outcomes (PRO)	The Lymphedema Breast Cancer Questionnaire (LBCQ) uses 3 items to assess 19 symptoms most commonly associated with lymphedema (Radina et al., 2007). The LBCQ shows an acceptable measure of internal consistency (r=.785) for all 19 items. Test-retest reliability was evaluated using a sample of healthy women without breast cancer or lymphedema (n=35) over a 2-hour test-retest interval. The findings show a high degree of reliability (r =.98).	Baseline, every 3 months after intervention for 12 months
Self reported lymphedema changes :patient reported outcomes (PRO)	The Lymphedema Scale uses 2 items for self-reported changes in wrist, elbow, and upper arm sizes. Scale sensitivity ranged from 0.86-0.92 in women with circumferential arm differences >2 cm indicating presence of moderate lymphedema (Norman et al., 2001).	Baseline, every 3 months after intervention for 12 months
Study participation acceptance	Potential participants who decline to enroll at time of phone screening: the study team will ask if they would be willing to share a reason for their reluctance. The reasons will be categorized as qualitative responses at the end of study, for example: "I must ask my oncologist permission, I've been told to never allow a procedure in my affected arm". b) For those enrolled: their perceptions regarding the ipsilateral access will be ascertained at the time of quarterly phone follow-up and at the end of study. Qualitative data will be analysed thematically. Patient perceptions of acceptance will be assessed in those who opt to or not to participate in thestudy:	Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Deborah H Allen, PhD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: Pro00106186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No