Apr 27, 2024

Public workspaceWhole blood viscosity test implementation: Community based participatory approach study protocol

DOI
dx.doi.org/10.17504/protocols.io.rm7vzj39rlx1/v1
Whole blood viscosity test implementation: Community based participatory approach study protocol
  • Ezekiel U Nwose1,
  • Phillip Bwititi2,
  • Lexin Wang1,
  • Rasheda Khanam3,
  • Hayder Al-Aubaidy4,
  • San Low5,
  • Simon Tawasu6,
  • Chukwudiebube Ajaero7
  • 1School of Health and Medical Sciences, University Of Southern Queensland Toowoomba Australia;
  • 2School of Dentistry and Medical Sciences, Charles Sturt University Wagga Wagga, Australia;
  • 3Health Economics, School of Business, University Of Southern Queensland Toowoomba Australia;
  • 4MAPP department, and Diabetes Development & Prevention (DDP) Group, La Trobe University Melbourne Australia;
  • 5Queensland Health, Toowoomba Australia;
  • 6Western Australia Health, Perth Australia;
  • 7African-Australian Heart Health Initiative, Adelaide Australia
Ezekiel U Nwose
Open access
DOI: dx.doi.org/10.17504/protocols.io.rm7vzj39rlx1/v1
Protocol Citation: Ezekiel U Nwose, Phillip Bwititi, Lexin Wang, Rasheda Khanam, Hayder Al-Aubaidy, San Low, Simon Tawasu, Chukwudiebube Ajaero 2024. Whole blood viscosity test implementation: Community based participatory approach study protocol. protocols.io https://dx.doi.org/10.17504/protocols.io.rm7vzj39rlx1/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: April 27, 2024
Last Modified: April 27, 2024
Protocol Integer ID: 98898
Keywords: cardiovascular medicine, clinical management, evidence base, laboratory test, therapeutic monitoring
Funders Acknowledgement:
None to declare
Grant ID: not applicable
Abstract
This study would employ a Community-Based Participatory Research (CBPR) approach, and mapped with implementation strategies, to engage healthcare providers in initiating change. Participants would include cardiologists, general practitioners, and psychiatrists as well as medical laboratory scientists. Expected primary outcome measures include attendance (knowledge impartation) and change in perception regarding the clinical laboratory test tool. Secondary outcome measures will include quantitative analysis of eWBV from workshop.
Image Attribution
Nwose EU, Bwititi PT, Wang L, Khanam R, AL-Aubaidy H, Low S, Tawasu S, Ajaero C.
Guidelines
This proposal meant to advance existing guidelines
1. for monitoring 'at risk hyperviscosity'
2. to predict bleeding risk
Materials
Clinical laboratory test records
Clinical laboratory facility
Medical records to match pathology
eWBV algorithm (electronic and/or hardcopy chart)

Safety warnings
Attention
Achievability must be established in terms of the clinicians and medical scientists as well as healthcare facilities.
Ethics statement
Relevant ethics approval should be obtained from at least of the health facility sites, before performing this study
Before start
Knowledge of the eWBV method as well as how to use the electronic and hardcopy chart tools are basic imperatives.
Introduction in brief
Introduction in brief
Monitoring of whole blood viscosity (WBV) is critical in patients at risk of hyperviscosity (The Royal College of Pathologies of Australia, 2019). Prothrombin Time Test (PT/INR), which is currently used is insufficient to predict bleeding risk (Cao et al., 2024). There is a test for blood viscosity, which is cheaper than currently recommended plethora of tests, but clinicians are unaware that haematocrit and serum protein, can be used in an algorithm to obtain eWBV that is specific for the cardiovascular phenomenon (Nwose & Bwititi, 2022).
The protocol
The protocol
Study design: This study employs a Community-Based Participatory Research (CBPR) approach (Holkup et al., 2004; Sanders & Baisch, 2008; Wynn et al., 2011). This is also designed to be observational cohort and pilot studies, hence the methods’ section of STROBE checklist (Kang & Foster, 2022), is adopted in this protocol layout. The cohort component would involve eWBV analysis of deidentified patients’ data, while pilot component is on participant healthcare personnel.
Participants: The participants would comprise Australian-based general practitioners (GPs) and clinicians specialising in diabetes and cardiovascular management. This includes GPs, registrars, cardiology and mental health registrars, nurses. Participants will provide informed consent and receive detailed written information about the study. Inability to provide de-identified necessary clinical and laboratory data and/or be available at seminar, workshop and survey constitute exclusion criteria.
Variables: This will include the numbers of seminars and workshops organised, attendance at the events, number of clinicians and health facilities reached. There would be results of ‘perception and uptake’ survey, and publications. Summary of metrics matching study objectives is presented in table 1. Further, data variables for the workshop would include:
  • Clinical data of patients’ diagnosis and treatment in-between serial laboratory tests.
  • Laboratory data including series of routine haematology and liver function test – at least two sets per patients, with known clinical intervention between tests’ dates. Also, serial INR results done on the same blood collection with routine haematology and liver function test.
  • Survey dataset: Likert scale data on perception and uptake
Table 1: The objectives of the current study and the measurable metrics.
Objective/goal Metrics
Engage with Public Health Network (PHN) to recruit participants No. of health facilities and individual recruited
Propagate the developed digital and manual algorithm No of viewers of the digital and manual algorithm
Organise seminars to promote agenda (intervention step1 of 2) No. of seminars and attendances
Organise workshops among participants (the intervention step 2 of 2) No. of workshops and attendances
Assess uptake and user-friendliness of the tools Qualitative and quantitative analysis of perception

The process

Download Dynamic flow chart protocol. CBPA for laboratory test implementation study - draft2.jpgDynamic flow chart protocol. CBPA for laboratory test implementation study - draft2.jpg77KB Fig 1: Dynamic flow chart
Seminars and workshops would be convened in at least one facility in the 6 states/territory. Primary outcome measures include attendance, survey analysis. Secondary outcome measures include quantitative analysis of eWBV from workshop (Fig 2).

Fig 2: Further details on stages in workflow
Fig 2: Further details on stages in workflow


Conclusion statement
Conclusion statement
Based on the participants’ capacities, survey of ability and willingness to adopt/integrate the laboratory method into practice would be conducted. Analysis of the perception survey will inform next direction in the implementation research.
References
References
Cao, C., Xu, Y., Jiang, W., Wu, S., Shen, Y., Xia, X., Wang, L., Zhang, H., Jiang, H., Li, X., Li, X., & Ye, Y. (2024). Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study. Health Sci Rep, 7(1), e1792. https://doi.org/10.1002/hsr2.1792
Holkup, P. A., Tripp-Reimer, T., Salois, E. M., & Weinert, C. (2004). Community-based participatory research: an approach to intervention research with a Native American community. ANS Adv Nurs Sci, 27(3), 162-175. https://doi.org/10.1097/00012272-200407000-00002
Kang, E., & Foster, E. R. (2022). Use of implementation mapping with community-based participatory research: Development of implementation strategies of a new goal setting and goal management intervention system. Front Public Health, 10, 834473. https://doi.org/10.3389/fpubh.2022.834473
Nwose, E. U., & Bwititi, P. T. (2022). Whole blood viscosity: Affordances and re-evaluation of sensitivity and specificity for clinical use. Int J Bio Lab Sci, 11(2), 96 - 103. https://www.ijbls.org/index.php/current-issue/101-articles-2022/187-research-article-whole-blood-viscosity-affordances-and-re-evaluation-of-sensitivity-and-specificity-for-clinical-use
Sanders, J., & Baisch, M. J. (2008). Community-based participatory action: impact on a neighborhood level community health improvement process. Prog Community Health Partnersh, 2(1), 5, 7-15. https://doi.org/10.1353/cpr.2008.0000
The Royal College of Pathologies of Australia. (2019). Viscosity. Retrieved 22nd Aug 2022 from https://www.rcpa.edu.au/Manuals/RCPA-Manual/Pathology-Tests/V/Viscosity
Wynn, T. A., Taylor-Jones, M. M., Johnson, R. E., Bostick, P. B., & Fouad, M. (2011). Using community-based participatory approaches to mobilize communities for policy change. Fam Community Health, 34 Suppl 1, S102-114. https://doi.org/10.1097/FCH.0b013e318202ee72
Protocol references
Cao, C., Xu, Y., Jiang, W., Wu, S., Shen, Y., Xia, X., Wang, L., Zhang, H., Jiang, H., Li, X., Li, X., & Ye, Y. (2024). Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study. Health Sci Rep, 7(1), e1792. https://doi.org/10.1002/hsr2.1792

Holkup, P. A., Tripp-Reimer, T., Salois, E. M., & Weinert, C. (2004). Community-based participatory research: an approach to intervention research with a Native American community. ANS Adv Nurs Sci, 27(3), 162-175. https://doi.org/10.1097/00012272-200407000-00002

Kang, E., & Foster, E. R. (2022). Use of implementation mapping with community-based participatory research: Development of implementation strategies of a new goal setting and goal management intervention system. Front Public Health, 10, 834473. https://doi.org/10.3389/fpubh.2022.834473

Nwose, E. U., & Bwititi, P. T. (2022). Whole blood viscosity: Affordances and re-evaluation of sensitivity and specificity for clinical use. Int J Bio Lab Sci, 11(2), 96 - 103. https://www.ijbls.org/index.php/current-issue/101-articles-2022/187-research-article-whole-blood-viscosity-affordances-and-re-evaluation-of-sensitivity-and-specificity-for-clinical-use

Sanders, J., & Baisch, M. J. (2008). Community-based participatory action: impact on a neighborhood level community health improvement process. Prog Community Health Partnersh, 2(1), 5, 7-15. ttps://doi.org/10.1353/cpr.2008.0000

The Royal College of Pathologies of Australia. (2019). Viscosity. Retrieved 22nd Aug 2022 from https://www.rcpa.edu.au/Manuals/RCPA-Manual/Pathology-Tests/V/Viscosity

Wynn, T. A., Taylor-Jones, M. M., Johnson, R. E., Bostick, P. B., & Fouad, M. (2011). Using community-based participatory approaches to mobilize communities for policy change. Fam Community Health, 34 Suppl 1, S102-114. https://doi.org/10.1097/FCH.0b013e318202ee72