Research proposal: Leveraging Clinical Audit to Promote the Delivery of Value-Based Stroke Care

1. Introduction

Stroke is a major global health issue, causing approximately 5.5 million deaths annually and leaving up to 50% of survivors chronically disabled (Donkor 2018). The burden of stroke is increasingly shifting to developing countries, where there are currently 4.85 million stroke deaths and 91.4 million DALYs annually, compared to 1.6 million deaths and 21.5 million DALYs in high-income countries (Donkor 2018). The World Health Organisation (WHO) reports that a stroke occurs approximately every 5 seconds, highlighting the urgency of addressing this medical condition characterized by rapid onset of cerebral functions impairment (Grysiewicz et al. 2008; Warlow 1998).

 

The quality of care received by stroke patients significantly impacts their health-related quality of life, which can be affected by physical disability, cognitive impairment, depression, and social isolation (Donkor 2018). Specialized stroke units have been shown to improve patient outcomes, including survival rates and quality of life, through a multidisciplinary approach to care (Langhorne & Pollock 2002; Lannon et al. 2011).

 

In this context, clinical audits serve as a critical tool for enhancing healthcare quality (Chung 2003; Hopkins 1996). Defined as a systematic evaluation of patient care against specific standards, clinical audits identify areas for improvement and implement changes at various levels of healthcare delivery (Burgess & Moorhead 2011; Johnston et al. 2000; Tsaloglidou 2009).

 

Value-based healthcare aims to optimize health outcomes relative to costs, serving as the framework for improving patient care (Porter 2010). Clinical audits are integral to this model,

 

providing data-driven insights that align healthcare practices with the goal of maximizing value (Nanni et al. 2022). Through rigorous data collection, performance feedback, and accountability, clinical audits facilitate the transition to a healthcare model that prioritizes value for patients (Nanni et al., 2022; Porter 2010).

 

2. Research question aim/objectives

 

The primary aim of this research is to investigate how the pilot national clinical audit on stroke in Saudi Arabia can be leveraged to promote the delivery of value-based stroke care. The objectives include assessing the impact of the clinical audit on patient outcomes and the quality of care in selected Ministry of Health (MoH) hospitals, including King Saud Medical City, King Fahad Medical City, Prince Mohammed Bin Abdulaziz Hospital, Damman Medical Complex, and Al Qatif Central Hospital. The research seeks to identify areas of improvement and recommend strategies for enhancing stroke care, thereby contributing to the broader goal of value-based healthcare.

 

3. Research design

 

a. Methodology

 

This research will employ a mixed-methods approach, integrating both quantitative and qualitative data analysis to offer a comprehensive understanding of the impact of the pilot national clinical audit on stroke care in Saudi Arabia.

 

I. Quantitative Methods

 

The quantitative aspect of the study will focus on selected Ministry of Health (MoH) hospitals in Saudi Arabia, namely King Saud Medical City, King Fahad Medical City, Prince Mohammed Bin Abdulaziz Hospital, Damman Medical Complex, and Al Qatif Central

 

Hospital. Data for this research will be sourced from the pilot national clinical audit on stroke, which was initiated through a collaborative effort involving the Health Holding Company, the Clinical Excellence Department in the Ministry of Health, and other technical support entities.

 

II. Qualitative Methods

 

For the qualitative component, semi-structured interviews will be conducted with 15- 25 key stakeholders involved in the pilot national clinical audit. This will include doctors who worked on the audit, managerial leaders in the participating hospitals, and other relevant stakeholders. The interviews aim to capture insights into the experiences, challenges, and perceived impacts of the audit on stroke care delivery.

 

The mixed-methods approach is particularly suited for healthcare research as it allows for a comprehensive understanding of complex issues, combining the ‘what’ from quantitative data with the ‘why’ from qualitative data (Carpenter 2008). While the mixed-methods design offers a more holistic view of healthcare quality, it is important to note that the complexity of managing and integrating data types could pose challenges (Carpenter 2008).

 

b. Data sources

 

Data for this research will be sourced from the pilot national clinical audit on stroke in Saudi Arabia. The initial data collection aimed to include a sample of 50 consecutive stroke patients admitted to each participating MoH hospital starting from 16 May 2021. However, some hospitals reported not having 50 stroke patients between 16 May and 30 September, and they submitted data for fewer cases. The follow-up data collection was based on a sample of 50 consecutive patients admitted for a stroke from 1 April to 31 May 2022.

 

I. Population Sampling

 

Any patient who experienced a stroke was eligible to be included in the audit if the patient was admitted to the hospital because of the stroke. It was estimated by the Stroke Clinical Expert Group that the hospitals participating in the pilot admit 25 to 30 stroke patients a month.

 

II. Data Validation

 

A 10 percent sample of the patient records that were included in the audit was selected for reliability testing. The level of agreement in the data collected for the audit ranged from 57.0% to 99.1% on the initial reliability test, and after consultation on differences, from 97.3% to 99.9%.

 

c. Data analysis

 

I. Quantitative Analysis

 

For the quantitative component, descriptive statistics will be used to characterize the sample in terms of demographic variables, clinical outcomes, and healthcare utilization. The study will involve comparing two groups: the initial group based on data collected from 16 May to 30 September 2021, and the follow-up group based on data collected from 1 April to 31 May 2022. The primary outcome being compared will be patientfocused compliance with quality-of-care measures and goals for the patient’s recovery, serving as proxies for Patient-Reported Outcomes (PROs). Given that the outcome is continuous and involves two groups, statistical techniques such as t-tests or Analysis of Variance (ANOVA) will be used for the comparison. Regression analysis may also be employed to control for confounding variables.

 

II. Qualitative Analysis

 

For the qualitative component, semi-structured interviews with key stakeholders will be transcribed and analyzed using thematic analysis. This involves coding the data, identifying themes, and interpreting the findings to understand the experiences, challenges, and perceived impacts of the clinical audit on stroke care. Alternative qualitative analysis techniques such as grounded theory or content analysis could also be considered based on the richness and complexity of the data collected. The qualitative findings will be triangulated with the quantitative results to provide a more comprehensive understanding of the impact of the clinical audit on stroke care.

 

By employing a mixed-methods approach, this study aims to not only quantify the impact of the clinical audit but also to understand the contextual factors that may influence its effectiveness.

 

d. Justification of the Design

 

This study’s mixed-methods approach provides a comprehensive framework for studying clinical audits, patient outcomes, and healthcare quality. The study analyses a targeted healthcare setting at selected MoH hospitals that participated in the pilot national clinical audit on stroke to improve specificity and relevance. Quantitative and qualitative data can be used to understand clinical audits’ effects, including statistical trends and contextual factors that may affect patient care. Comparing initial and follow-up data sets assesses clinical audits’ temporal impact on stroke care. Last, the study uses patient-focused compliance with qualityof-care measures as proxies for Patient-Reported Outcomes (PROs) to focus on patientcentred and clinically relevant metrics.

 

e. Limitations

 

I. Generalizability to the Saudi Setting

 

One of the primary limitations of this research is its generalizability to the broader Saudi healthcare system. The study focuses on selected MoH hospitals, which may not be representative of all healthcare facilities in Saudi Arabia. Therefore, the findings may have limited applicability beyond the scope of these specific hospitals.

 

II. Health Systems Similarity

 

The study’s findings may also have limited generalizability to other countries or regions with health systems that differ significantly from Saudi Arabia’s. While the research aims to provide insights that could be applicable to similar health systems, variations in healthcare delivery, policy, and patient demographics could limit the transferability of the results.

 

III. Data Limitations

 

The research relies on data from a pilot national clinical audit, which may have its own limitations such as sample size and the period of data collection. These factors could potentially impact the robustness of the study’s findings.

 

IV. Outcome Measures

 

The study uses patient-focused compliance with quality-of-care measures and goals for the patient’s recovery as proxies for Patient-Reported Outcomes (PROs). The absence of direct PROs could limit the comprehensiveness of the study’s outcome assessment.

 

f. Ethical Considerations

 

I. Risks vs Benefits

 

The National Statement on Ethical Conduct in Human Research (2023) requires a thorough risk-benefit analysis. Misuse of sensitive patient data is the main risk in this study. However, strict data protection measures will reduce this risk. The study aims to improve stroke care in Saudi Arabia, reducing morbidity and mortality. The insights gained could shape healthcare policies and clinical practises, benefiting providers and patients long-term (NHMRC 2023). The research will follow the National Statement on Ethical Conduct in Human Research (2023) guidelines for informed consent, privacy and confidentiality, and risk management.

 

II. Justification for Waiver of Consent

 

The original data collection process involved obtaining informed consent from participants for the primary study. However, this research will be utilizing secondary data, and the data will be anonymized and aggregated, ensuring that individual participants cannot be identified. Given these safeguards and the retrospective nature of the study, a waiver of consent is being sought for this research. This is in line with the guidelines provided by the NHMRC (2023), which state that a waiver can be considered when the research involves no more than low risk and it is impracticable to obtain consent.

 

III. Ethical Approvals

 

Approval to use the data for this project has been submitted to the Custodian in Saudi Arabia. Additionally, an application for ethical approval will be submitted to the University of Wollongong (UOW) ethics committee to ensure that the study adheres to international ethical standards.

 

Expected Findings/Results:

 

1. Impact on Patient Outcomes:

 

The research is likely to reveal a significant impact of clinical audits on patient outcomes, particularly in the areas of survival rates, quality of life, and patient satisfaction.

 

2. Quality of Care:

 

The audits may show varying levels of adherence to clinical guidelines across the selected MoH hospitals. This could lead to targeted interventions for improvement.

 

3. Cost-Effectiveness:

 

The study might find that the implementation of clinical audits and the subsequent improvements in care are cost-effective, aligning with the principles of value-based healthcare.

 

4. Stakeholder Perspectives:

 

Qualitative data from interviews could reveal insights into the challenges and opportunities perceived by healthcare providers in implementing and sustaining clinical audits.

 

5. Areas for Improvement:

 

The research is expected to identify specific areas where stroke care can be improved, offering actionable recommendations for healthcare policy and practice.

 

6. Generalizability:

 

While the study focuses on selected hospitals, the findings could offer insights that are generalizable to other similar healthcare settings, at least within Saudi Arabia.

 

7. Data Reliability:

 

The research might validate the reliability of the data collected during the clinical audits, thereby strengthening the case for their broader implementation.

 

Research dataset

 

Part one: Quantitative dataset

 

• From the Clinical audit project:

 

A. Patient related data:

 

1. Patient ID (National ID for Saudi, Iqama or passport No. for non-Saudi)

 

2. Hospital name

 

3. Age

 

4. Gender

 

5. Nationality

 

6. Admission date

 

7. Discharge date

 

8. Patient died?

 

a. Date of death

 

b. Time of death

 

9. LOS in stroke unit

 

10. LOS other

 

B. Care related data:

 

1. Way of transport to hospital

 

2. Onset

 

a. Onset date

 

b. Onset time

 

3. EMS alert?

 

4. Blood glucose test?

 

a. Time

 

5. NIHSS assessment?

 

a. Time

 

6. Thrombolysis?

 

a. Time

 

b. Contraindications to thrombolysis?

 

7. NCCT/MRI?

 

a. Time

 

8. Thrombectomy?

 

a. Time

 

b. Contraindications to Thrombectomy?

 

9. CTA/MRA?

 

a. Time

 

10. Brain scan?

 

a. Time

 

11. Swallow screen?

 

a. Time

 

b. If no, Explanation?

 

c. Time

 

12. Admitted to stroke unit?

 

a. Date

 

b. Time

 

13. Stroke unit Name

 

a. Date

 

b. Time

 

14. Blood glucose measured?

 

a. Within 60 mins?

 

b. 4 times on Day 1?

 

c. Day 1 time 1

 

d. Day 1 time 2

 

e. Day 1 time 3

 

f. Day 1 time 4

 

g. 4 times on Day 2?

 

h. Day 2 time 1

 

i. Day 2 time 2

 

j. Day 2 time 3

 

k. Day 2 time 4

 

l. Result >10 mmol/L

 

m. Date

 

n. Time

 

15. Insulin?

 

a. Date

 

b. Time

 

16. Temp?

 

a. Within 60 mins?

 

b. 4 times on Day 1?

 

c. Day 1 time 1

 

d. Day 1 time 2

 

e. Day 1 time 3

 

f. Day 1 time 4

 

g. 4 times on Day 2?

 

h. Day 2 time 1

 

i. Day 2 time 2

 

j. Day 2 time 3

 

k. Day 2 time 4

 

l. 4 times on Day 3?

 

m. Day 3 time 1

 

n. Day 3 time 2

 

o. Day 3 time 3

 

p. Day 3 time 4

 

q. Temp >37.5?

 

i. Date

 

ii. Time

 

r. Paracetamol?

 

i. Date

 

ii. Time

 

17. NIHSS?

 

18. VTE risk?

 

a. Date

 

b. Time

 

19. CR surgery?

 

a. Date

 

b. Contraindication?

 

20. Rehabilitation assess within 24 hours?

 

21. Rehab plan?

 

a. Date

 

b. Time

 

c. PT

 

d. OT

 

e. SLT

 

f. PMRS

 

g. PT mins D5

 

h. PT mins D6

 

i. PT mins D7

 

j. PT mins D8

 

k. PT mins D9

 

l. OT mins D5

 

m. OT mins D6

 

n. OT mins D7

 

o. OT mins D8

 

p. OT mins D9

 

q. SLT mins D5

 

r. SLT mins D6

 

s. SLT mins D7

 

t.SLT mins D8

 

u. SLT mins D9

 

v.PMRS mins D5

 

w. PMRS mins D6

 

x. PMRS mins D7

 

y. PMRS mins D8

 

z. PMRS mins D9

 

22. Education?

 

a. Family?

 

23. Aspirin?

 

a. Date

 

b. Time

 

c. Contraindication

 

24. Asp/Clop?

 

25. LMWH?

 

a. Contraindication

 

b. Date

 

c. Time

 

26. Discharge NIHSS?

 

• From the MoH patient experience program:

 

In-patient data from the selected hospitals which reflects the concerned departments:

 

I. Emergency department

 

II. Internal medicine department/Neurology department

 

III. Stroke unit

 

IV. Rehabilitation department

 

Qualitative dataset:

 

Interview survey with leaders involved in the project.

 

Here are some sample questions that could be included in the interviews with key stakeholders:

 

Introduction

 

1. Could you please introduce yourself and describe your role in the pilot national clinical audit on stroke care?

 

Experiences with the Clinical Audit

 

2. Can you describe your initial expectations when you first became involved in the clinical audit?

 

3. What were some of the most memorable experiences you had while participating in the audit?

 

4. Can you share any success stories or positive outcomes that you observed as a result of the audit?

 

Challenges and Barriers

 

5. What challenges did you encounter during the implementation of the clinical audit?

 

6. Were there any barriers to collecting or using the data effectively?

 

7. How were these challenges addressed, if at all?

 

Perceived Impacts

 

8. In your opinion, what impact has the clinical audit had on the quality of stroke care in the participating hospitals?

 

9. Do you think the audit has influenced the approach to value-based healthcare in these settings?

 

10. Can you discuss any changes in patient outcomes that you attribute to the audit?

 

Stakeholder Involvement

 

11. How were various stakeholders (e.g., healthcare providers, administrators, patients) involved in the audit process?

 

12. What was the level of engagement and cooperation among different stakeholders?

 

Future Directions

 

13. What areas do you think still need improvement in the audit process or in stroke care more generally?

 

14. Are there plans to expand or continue the audit? If so, what would you like to see in future iterations?

 

Methodological Considerations

 

15. Do you have any suggestions for improving the methodology of the audit, such as data collection or analysis techniques?

 

Closing

 

16. Is there anything else you would like to add that we haven’t covered?

 

References:

 

Burgess, R & Moorhead, J 2011, New Principles of Best Practice in Clinical Audit, Taylor & Francis Group, Milton, UNITED KINGDOM.

 

Carpenter, C 2008, John W. Creswell and Vicki L. Plano Clark. Designing and conducting mixed methods research, 1403-8196.

 

Chung, C 2003, ‘Clinical audit in emergency medicine’, Hong Kong Journal of Emergency Medicine, vol. 10, no. 3, pp. 181-7.

 

Donkor, ES 2018, ‘Stroke in the 21(st) Century: A Snapshot of the Burden, Epidemiology, and Quality of Life’, Stroke Res Treat, vol. 2018, p. 3238165.

 

Grysiewicz, RA, Thomas, K & Pandey, DK 2008, ‘Epidemiology of Ischemic and Hemorrhagic Stroke: Incidence, Prevalence, Mortality, and Risk Factors’, Neurologic Clinics, vol. 26, no. 4, pp. 871-95.

 

Hopkins, A 1996, ‘Clinical audit: time for a reappraisal’, Journal of the Royal College of Physicians of London, vol. 30, no. 5, p. 415.

 

Johnston, G, Crombie, I, Alder, E, Davies, H & Millard, A 2000, ‘Reviewing audit: barriers and facilitating factors for effective clinical audit’, BMJ Quality & Safety, vol. 9, no. 1, pp. 23-36.

 

Langhorne, P & Pollock, A 2002, ‘What Are the Components of Effective Stroke Unit Care?’, Age and Ageing.

 

Lannon, R, Smyth, A & Mulkerrin, EC 2011, ‘An audit of the impact of a stroke unit in an acute teaching hospital’, Irish Journal of Medical Science, vol. 180, no. 1, pp. 37-40.

 

Nanni, O, Montroni, I, Garulli, G, Catena, F, Lucchi, A, Ansaloni, L, Gentili, N, Danesi, V, Montella, MT & Altini, M 2022, ‘Emilia-Romagna Surgical Colorectal Cancer Audit (ESCA): A Value-Based Healthcare Retro-Prospective Study to Measure and Improve the Quality of Surgical Care in Colorectal Cancer’, International Journal of Colorectal Disease.

 

NHMRC 2023, ‘National Statement Ethical Conduct Human Research 2023’.

 

Porter, ME 2010, ‘What Is Value in Health Care?’, New England Journal of Medicine, vol. 363, no. 26, pp. 2477-81.

 

Tsaloglidou, A 2009, ‘Does audit improve the quality of care’, Int J Caring Sci, vol. 2, no. 2, p. 65.

 

Warlow, CP 1998, ‘Epidemiology of stroke’, The lancet, vol. 352, pp. S1-S4.