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A pilot randomised controlled trial evaluating the feasibility of a patient-held difficult intravenous access (DIVA) card for adults with difficult intravenous access at Sir Charles Gairdner Hospital, Western Australia.

Feasibility of a patient-held difficult intravenous access card: a pilot randomised controlled trial with embedded qualitative interviews.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000856314
Enrollment
250
Registered
2026-07-14
Start date
2026-11-02
Completion date
2027-11-02
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some patients are difficult to insert an intravenous cannula into. These patients may experience multiple cannulation attempts, pain, anxiety, delayed treatment, and the need for more experienced clinicians or ultrasound-guided cannulation. This study will test whether it is feasible to use a patient-held Difficult Intravenous Access (DIVA) card for adults who are identified as having difficult intravenous access at Sir Charles Gairdner Hospital. Participants will be randomly allocated to either receive a DIVA card in addition to standard care, or to receive standard care without a DIVA card. The DIVA card is designed to help patients communicate their difficult intravenous access history to healthcare staff during future cannulation episodes. The study will assess whether patients can be recruited, whether they use the DIVA card, whether follow-up information can be collected by text message surveys, and whether the study procedures are practical for a larger future trial. The study will also collect early information about cannulation outcomes, such as first-attempt success, number of attempts, pain, escalation to senior clinicians or vascular access staff, and use of ultrasound-guided cannulation. Patient interviews will also be used to explore participant experiences of difficult cannulation and their views on the DIVA card.

Interventions

Intervention: Participants allocated to the intervention group will receive a patient-held difficult intravenous access card, approximately the same size as a credit card. The card is intended to alert healthcare staff that the participant has a history of difficult peripheral intravenous access and may require early escalation to an experienced cannulator and/or vascular access support, such as ultrasound-guided cannulation. The card will be provided to eligible adult patients identified as hav

Intervention: Participants allocated to the intervention group will receive a patient-held difficult intravenous access card, approximately the same size as a credit card. The card is intended to alert healthcare staff that the participant has a history of difficult peripheral intravenous access and may require early escalation to an experienced cannulator and/or vascular access support, such as ultrasound-guided cannulation. The card will be provided to eligible adult patients identified as having difficult intravenous access during their hospital admission. Participants will be advised to present the card to healthcare staff at any Western Australian hospital if they require future peripheral intravenous cannulation during the 12-month study follow-up period. Who delivers it: The intervention will be delivered by members of the vascular access team, or by delegated research or clinical staff employed in the emergency department who have been trained in the study protocol. These staff will have relevant clinical expertise in peripheral intravenous cannulation, identification of difficult intravenous access, and escalation pathways for patients requiring vascular access support. How is it delivered: The intervention will be delivered face to face and individually to eligible participants. Participants randomised to the intervention group will be given the patient-held DIVA card during their hospital admission. The card will be explained verbally, including its purpose and how the participant should use it. Participants will be advised to show the card to healthcare staff if they require future peripheral intravenous cannulation during the 12-month study follow-up period. How often is it delivered: The DIVA card will be provided once following randomisation. The brief explanation of the card is expected to take approximately 5 minutes. Participants will keep the card and may use it for any subsequent peripheral intravenous cannulation episodes during the 12-month study follow-up period. Where is it delivered: The intervention will be delivered in the hospital setting, such as the participant’s ward, emergency department, or other clinical area where the participant is identified as eligible and enrolled in the study. The participating site is Sir Charles Gairdner Hospital. Adherence: Participants allocated to the intervention group will receive brief verbal and written instructions advising them to keep the DIVA card with them and present it to healthcare staff during future peripheral intravenous cannulation episodes over the 12-month study follow-up period. Intervention adherence will be monitored using participant-reported follow-up surveys delivered via SMS, which will ask whether the participant retained the card, had it available, and presented it during subsequent cannulation episodes. Reported non-use, loss of the card, or failure to present the card will be recorded as feasibility outcomes. Adherence to study follow-up procedures will also be assessed through SMS survey response rates, survey completion rates, and data completeness. The overall study duration will be 24 months, comprising a 12-month intervention/recruitment period and a 12-month participant follow-up period. Participants allocated to the intervention group will be advised to use and present the DIVA card for any future peripheral intravenous cannulation episodes occurring during their 12-month follow-up period.

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults aged 18 years or older who are receiving care at Sir Charles Gairdner Hospital and are identified as having difficult intravenous access by a vascular access clinician or emergency department clinician. Difficult intravenous access may be identified by patient-reported history of difficult cannulation, previous documentation of difficult intravenous access, poor vein visibility or palpability, two or more failed peripheral intravenous cannulation attempts, requirement for ultrasound-guided cannulation, or referral/escalation to a vascular access clinician or more experienced inserter. Participants must be able to provide informed consent and complete electronic enrolment and follow-up procedures, either independently or with assistance where appropriate

Exclusion criteria

1) Patient in critical/emergency situation (such as CODE BLUE), immediate life-threatening situation, palliative care not requiring IV procedures or other similar clinical scenario and requiring vascular access*1b. This scenario is left to the discretion of the VAT or ED staff member, and they can determine whether recruitment is appropriate or not. *1b Emergency Department: Adults classified by Australasian Triage Scale and determined as Category 1 or 2 2) Patient requiring primary vascular access, that is not peripheral IV (such as PICC line or port). 3) Paediatric patients (<18 years old).

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026