Condition category
Not Applicable
Date applied
02/08/2019
Date assigned
09/08/2019
Last edited
15/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The retention of blood donors is an important challenge for both developed and developing countries. The demand for blood will increase within the next few years due to changes in demographics and ageing populations. The experience of blood donors is particularly important for blood collection services not only because of the duty of care, but because repeat donation is critical for the blood supply. Donor fear is associated with increased risk for procedural issues, donor distress, and some adverse reactions. In turn, these reactions may be disincentives for donor return. Several studies have reported on strategies to assess and possibly address donation related fears, though it remains unclear how these insights can be best incorporated into standard operating procedures. This study aims to examine whether assessing and addressing donor fears may help staff to recommend the most relevant interventions and information in order to increase donor self-efficacy, improve the donation experience, reduce adverse events, and increase subsequent return. Additional study benefits include improving donor health, and improving session flow by avoiding disruptive and costly adverse reactions.

Who can participate?
Any eligible whole blood or plasma donor who has had 3 or less previous completed donations (plasma and/or whole-blood), presenting in participating Red Cross donor centres in Sydney, Australia.

What does the study involve?
Eligible donors are invited to participate while at a donor centre. Participants are randomly allocated to one of four groups. Those in the first group will donate as usual. Those in the second group are asked to complete a fear assessment. Participants in the third group will be offered an instructional brochure in addition to the fear assessment; this brochure includes a summary of a variety of ways to manage fear and stress while donating. Following the fear assessment and receiving the brochure, participants in the fourth group will participate in a brief discussion with the research assistant to review the contents of the brochure. All participants will complete post-donation questionnaires.

What are the possible benefits and risks of participating?
There will be no anticipated risks of participating. We expect some donors to benefit from participation by a reduced risk for adverse events, increased self-efficacy, and an increased desire to return.

Where is the study run from?
The study is being run by Macquarie University in collaboration with the Australian Red Cross Blood Service.

When is the study starting and how long is it expected to run for?
August 2019 to June 2020

Who is funding the study?
Australian Red Cross Blood Service and Macquarie University

Who is the main contact?
Dr. Philippe Gilchrist, philippe.gilchrist@mq.edu.au

Trial website

Contact information

Type

Public

Primary contact

Dr Philippe Gilchrist

ORCID ID

http://orcid.org/0000-0001-5036-3369

Contact details

Macquarie University
Department of Psychology
Macquarie Park
2109
Australia
+61 2 9850 2340
philippe.gilchrist@mq.edu.au

Type

Scientific

Additional contact

Dr Philippe Gilchrist

ORCID ID

http://orcid.org/0000-0001-5036-3369

Contact details

Macquarie University
Department of Psychology
Macquarie Park
2109
Australia
+61 2 9850 2340
philippe.gilchrist@mq.edu.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Improving donor experiences by assessing and responding to the fears of the individual donor

Acronym

N/A

Study hypothesis

1. Fear of the blood draw will be significantly positively related to higher anxiety, higher self-reported venipuncture pain, and the self-report and official record of more vasovagal reactions.
2. Assessing fear will not lead to (prime) more donor fear, anxiety, venipuncture pain, self-reported vasovagal reactions, or the official record of more vasovagal reactions.
3. Among fearful donors, providing an instructional brochure will be more effective than no provision of donor information in terms of increasing self-efficacy.
4. Among fearful donors, engaging with a donor to advise relevant strategies, including an instructional brochure following a fear assessment, is expected to result in increased self-efficacy, an improved donation experience, increased donor return, a greater reduction in fear (pre vs. post), and less venipuncture pain, post-donation anxiety, and vasovagal reactions when compared to donation as usual, fear assessment only, or fear assessment combined with an information brochure alone.

Ethics approval

Approved 11/06/2019, the Australian Red Cross Blood Service Ethics Committee (17 O'Riordan Street
Alexandria, NSW, 2015, Australia; 02 9234 2368; ethics@redcrossblood.org.au), ref: 2019#11.

Study design

Multi-centre, pragmatic, parallel group, individually randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Blood donor health and management

Intervention

Condition A: control group. Donation as usual.

Condition B: fear assessment only. Donors will be asked to respond to an e-tablet-based question, prior to donating, relating to their fear of donation.

Condition C: fear assessment and an instructional brochure. Condition C will be identical to Condition B, though the research assistant will also provide all donors with an instructional brochure. This brochure will include a summary of a variety of evidence-based strategies to manage fear and stress-related adverse reactions among donors, including distraction, breathing techniques, and a muscle tensing technique to prevent vasovagal symptoms.

Condition D: fear assessment, with an instructional brochure, and follow-up questions from the Research Assistant. This condition is identical to Condition C, but participants who indicate fear will be asked about the nature of the fear, and the research assistant will discuss and point to appropriate strategies outlined in the accompanying instructional brochure. This condition is designed to demonstrate whether engaging with the donor in follow-up questioning and recommendation of relevant strategies provides additional benefit beyond simply providing information.

Randomisation will include individual randomisation, determined by a computerised randomisation process for each participant following consent.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Donor fear is measured using a self-report (France et al., 2013) at pre- and post-donation.
2. Donor anxiety is measured using the Blood Donor Anxiety Scale (Chell, Waller, & Masser, 2016; France et al., 2013) at post-donation.
3. Donor return at 6- and 12-month follow-up is measured using Australian Red Cross Blood Service records.

Secondary outcome measures

1. Self-reported vasovagal symptoms are measured using the Blood Donation Reactions Inventory (France, Ditto, France, & Himawan, 2008; Meade, France, & Peterson, 1996) at post-donation.
2 Staff recorded vasovagal reactions are measured using Australian Red Cross Blood Service standard procedures at any point at the donation centre.
3. Venipuncture pain is measured using a self-report at post-donation.
4. Donor self-efficacy is measured using a self-efficacy scale (France, Montalva, France & Trost, 2008) at post-donation.
5. Donor experience/satisfaction is measured using a self-report including Positive Support Scale (Brown et al., 2003; Hanson & France, 2009) at post-donation.

Overall trial start date

03/12/2018

Overall trial end date

11/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age ≥18 years and fulfilling Blood Service criteria for blood donation
2. 3 or less prior completed donations (plasma and/or whole-blood)
3. Willing and able to provide informed consent
4. Has a plasma or whole blood appointment (appointment made as a walk-in donor or previous appointment)

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

1,200 participants in total

Participant exclusion criteria

1. Unwilling or unable to provide informed consent.
2. Lack of understanding of the English language necessary to complete questionnaires.
3. Contacted for a research study in the last 6 months as per Blood Service contact policy.
4. Donors with therapeutic, autologous, sample or platelet donation appointments.

Recruitment start date

14/08/2019

Recruitment end date

16/11/2019

Locations

Countries of recruitment

Australia

Trial participating centre

Australian Red Cross Blood Service Parramatta Donor Centre
22 Oak St, Rosehill NSW 2142
Sydney
2142
Australia

Trial participating centre

Australian Red Cross Blood Service Chatswood Donor Centre
62/436 Victoria Ave, Chatswood
Sydney
2067
Australia

Sponsor information

Organisation

Australian Red Cross Blood Service

Sponsor details

417 St Kilda Road
Melbourne
3004
Australia
03 9863 1600
tdavison@redcrossblood.org.au

Sponsor type

Other

Website

https://www.donateblood.com.au/

Funders

Funder type

University/education

Funder name

Australian Red Cross Blood Service

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Macquarie University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

Results and Publications

Publication and dissemination plan

We plan to publish the results of this research in academic journals and Blood Service internal reports by end of year 2020.

IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available due to IP/confidentiality issues.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/08/2019: The intention to publish date was added. 06/08/2019: Trial's existence confirmed by the Australian Red Cross Blood Service Ethics Committee.