Compliance with current VTE prophylaxis guidelines and associated factors among admitted medical inpatients in Mehal Meda General Hospital, North Shewa Zone, Ethiopia: a cross-sectional study

Abstract

Objectives

Venous thromboembolism (VTE) remains highly prevalent among medically ill patients and often leads to increased mortality. Therefore, this study aimed to assess compliance with VTE prophylaxis guidelines and associated factors among admitted medical inpatients at Mehal Meda General Hospital, North Shewa Zone, Ethiopia, in 2024.

Design

An institution-based cross-sectional study was conducted. Data were collected via medical chart review and interview-administered questionnaires, entered into EPI Data V.4.6, and exported to SPSS V.26 for analysis. Data were presented using frequency tables and graphs. Binary logistic regression was used to identify factors associated with compliance with VTE prophylaxis. Variables from the bivariable logistic regression analysis with a value of p<0.3 were included in the multivariable logistic regression model. A value of p<0.05 and an adjusted OR (AOR) with a 95% CI were used to identify factors associated with compliance with VTE prophylaxis. Model fitness was assessed using the Hosmer and Lemeshow goodness-of-fit test.

Setting

The study was conducted at Mehal Meda General Hospital.

Participants

The study was conducted among 365 admitted medical inpatients. The study participants were selected using a systematic random sampling technique.

Results

The overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was 24.2% (95% CI 19.9% to 28.8%). In this study, being a patient with heart failure (AOR = 6.8, 95% CI 3.7 to 12.54) and being a patient with diabetes (AOR = 3.98, 95% CI 2.2 to 7.2) were positively associated with compliance with VTE prophylaxis.

Conclusion

The overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was low compared with previous studies. Heart failure and diabetes were positively associated with compliance with VTE prophylaxis guidelines. Therefore, greater attention should be given to both, patients with diabetes and patients with heart failure.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Data collection involved a dual-method approach using both medical chart reviews and interviewer-administered questionnaires.

• To ensure tool reliability, a pretest was conducted on 5% of the total sample size at a separate comprehensive specialised hospital.

• The study was done in a single centre that has very limited medical resources; the generalisability of the study is very limited.

• As an institution-based cross-sectional study, the design is limited in its ability to establish definitive causal relationships between the variables and compliance outcomes.

• The reliance on participant interviews for certain data points introduced the potential for recall bias, which may affect the accuracy of reported behaviours.

Introduction

Venous thromboembolism (VTE) is a disease that encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE); it is a major healthcare problem resulting in significant mortality, morbidity and the expenditure of healthcare resources.¹ VTE is a medical condition addressed in many clinical practice guidelines and affects individuals of all age groups, races, ethnicities and genders.² The prevention of VTE among hospitalised patients is of paramount importance to avoid preventable deaths, chronic illnesses, long-term complications, extended hospital stays and increased healthcare costs.³

VTE is a leading cause of morbidity and mortality in hospitalised patients and is the third most common cause of vascular mortality worldwide.4,6 In clinical practice, approximately two-thirds of VTE episodes manifest as DVT, while a third manifest as PE, with or without the presence of DVT. Less frequently, thrombosis affects other veins, including those in the upper extremities, cerebral venous sinuses and the mesenteric, renal and hepatic veins.^{5 6}

It is estimated that 100 000 people die each year from VTE. Almost half of VTE cases occur during or after hospitalisation, with PE accounting for 10% of inpatient mortality.⁵ Between 10% and 20% of patients are expected to develop VTE during their hospitalisation,⁷ and hospital-acquired VTE accounts for an estimated 25 000 preventable deaths.⁸

Many factors are known to increase the risk of VTE. Of these, the main ones are hospitalisation, hypercoagulable disorders, cancer and a greater risk of developing adverse events from the drugs.^{9 10} Several strategies are being investigated in an attempt to improve compliance with the guidelines for VTE prophylaxis. For example, the investigators developed strategies or interventions to improve the use and uptake of clinical practice guidelines for VTE prophylaxis.¹⁰

Clinical practice guidelines are evidence-based recommendations that support clinicians in making decisions about patient care within specific conditions. Patients with cancer are at greater risk for VTE compared with the general population, resulting in considerable morbidity, mortality and costs, with a prevalence ranging from 5% to 20%.^{2 11} VTE is a major preventable disease that affects hospitalised inpatients. Risk stratification and prophylactic measures have strong evidence supporting their use, but various factors hinder their full adoption, compliance and effectiveness, which may contribute to the continued prevalence of VTE over the past several decades.¹² A persistent gap in developing new approaches to treat and prevent VTE is the inadequate understanding of the underlying pathophysiology.¹³ Virchow’s triad—comprising abnormalities in blood components, the vessel wall and blood flow—defines our understanding of thrombotic risk and provides a foundation for fundamental and discovery-based research into the mechanisms driving VTE.¹⁴

Furthermore, reports indicate a high frequency of patients receiving inappropriate VTE prophylaxis, such as the use of the incorrect drug, dose, frequency or duration. Virchow’s triad—comprising abnormalities in blood components, the vessel wall and blood flow—defines our understanding of thrombotic risk and provides a platform for fundamental and discovery-based research into the mechanisms driving VTE.^{14 15} To our knowledge, no such research has been conducted in this specific study area. Therefore, this study aims to assess compliance with VTE prophylaxis guidelines and associated factors among admitted medical inpatients at the Mehal Meda General Hospital.

Methods and materials

Study area, design and period

A facility-based cross-sectional study was conducted at Mehal Meda General Hospital from 15 November 2023 to 15 January 2024. The hospital is located at Mehal Meda City, North Shoa Zone, Amhara Regional State, approximately 280 km north-east of Addis Ababa, the capital of Ethiopia. Mehal Meda serves as the administrative centre of Menz Gera Midir Woreda in the Amhara region. Currently, the town has one general hospital and several health centres. The hospital is staffed by 6 specialists, 12 general practitioners, 47 nurses and 10 laboratory staff, providing curative, preventive and rehabilitative services. Records indicate that 752 patients were admitted to the medical ward in the 3 months prior to the study.

Source population

The source population consisted of all medical inpatients admitted to Mehal Meda General Hospital.

Study population

The study population included all medical inpatients admitted to the hospital who were available during the data collection period.

Eligibility criteria

Inclusion criteria

Patients aged over 18 years who were admitted to the medical ward at Mehal Meda General Hospital were included.

Exclusion criteria

Patients with active bleeding, those diagnosed with DVT and those currently on anticoagulation treatment were excluded.

Sample size determination and sampling procedure

Sample size determination

The sample size was determined using a single population proportion formula based on a 31.6% prevalence from a previous study.⁹ A 95% confidence level and a 5% margin of error were used to obtain an optimum sample size.

$${\displaystyle {\displaystyle n=\frac{(Z\alpha /2)2p(1-p)}{d^2}}}$$

n=minimum sample size required

Z=the standardised normal distribution curve value for the 95% CI (1.96)

p=proportion of the students

d=margin of error

$${\displaystyle {\displaystyle \frac{n=(1.96{)}^{2}0.316(1-0.316)}{(0.05{)}^2}=332}}$$

By adding 10% non-response rate, the final sample size was 365.

Sampling technique and sampling procedure

To achieve the desired sample size of 365, participants were selected from Mehal Meda Hospital based on the facility’s most recent 3-month report, which showed a flow of 752 patients. Individual study participants were selected using systematic random sampling (k=752/365≈2). The first participant was chosen via a simple random sampling technique from the first two admitted patients; thereafter, every second patient was included until the required sample size was reached.

Study variables

Dependent variable

• Compliance with current VTE prophylaxis guidelines (Yes/No)

Independent variable

Sociodemographic factors

Age, sex, marital status, educational status, occupational status and residence.

Patient-related factors

Previous VTE use, patient’s capability to afford to buy the drugs, voluntarism, obesity, stroke, cancer, hypertension and renal failure.

Behaviour-related factors

Cigarette smoking, drinking alcohol and chat chewing.

Operational definitions

• VTE: VTE is a disease due to the formation of blood clots inside the veins, which has two forms either DVT or PE which is more dangerous.^{4 5}

• VTE prophylaxis guideline compliance: It is measured when the admitted medical inpatients fulfil three components: (1) Does the patient take anticoagulated prophylaxis of heparin? (2) Does the patient take the right dose of heparin (5000 international unit (IU) three times a day or 7500 IU two times per day)? (3) Did the patient take the prophylaxis within 24 hours after admission? If the patient scores 3 out of 3 from the given components, it is considered as compliance with the current VTE prophylaxis guideline (Yes). On the other hand, if the patient scores 2 and below from the above components, it is considered as not compliant with the VTE guideline (No).^{5 16}

Data collection tools and quality control

Data were collected using an interviewer-administered questionnaire and through medical chart reviews. The questionnaire was initially developed in English, translated into Amharic, and then back-translated into English to ensure its consistency. Clinical information was gathered via medical record reviews, while data on basic sociodemographics, patient behaviours and disease types were collected through interviewer-administered patient interviews. For the data collection process, four BSc nurses were assigned as data collectors and two BSc nurses served as supervisors. All staff received 1 day of training regarding the purpose of the study, the details of the questionnaire and protocols for ensuring respondent confidentiality. To assess understandability, the questionnaire was pretested at Debre Birhan Comprehensive Specialized Hospital among 19 admitted medical inpatients (representing 5% of the total sample size); modifications were made to the tool following this pretest. The supervisors and principal investigator subsequently checked all filled questionnaires for completeness.

Data processing and analysis

Data were entered into EpiData V.4.6 and exported to SPSS V.26 for cleaning and analysis. Various frequency tables, graphs and descriptive summaries were used to describe the study variables. Binary logistic regression was employed to identify factors associated with the outcome variable. A bivariable analysis was conducted to examine the relationship between the outcome and independent variables, using a value of p<0.3 as the cut-off point for inclusion in the multivariable logistic regression. The multivariable logistic regression was then performed, with a value of p<0.05 established as the threshold for statistical significance. To measure the strength of the association between dependent and independent variables, ORs were calculated, and 95% CIs were used to determine the significance of these associations.

Results

Sociodemographic characteristics of the study participants

From a total of 365 patients, 351 admitted patients were interviewed and their charts were reviewed during this study with a response rate of 96.16%. The mean age of the participants was 52.75 years with an SD of ±16.82. Half of the patients, 177 (50.4%), were male. The majority of the study participants, 269 (76.6%), were Orthodox by religion. More than half of the participants, 251 (71.5%), were rural dwellers (table 1).

Table 1. Sociodemographic characteristics of admitted patients in Mehal Meda Hospital, North-East Ethiopia, 2024 (n=351).

Characteristics	Category	Frequency	Per cent
Sex	Male	177	50.4
	Female	174	49.6
Age, years	18-40	88	25.1
	41-64	178	50.7
	≥65	85	24.2
Religion	Orthodox	269	76.6
	Muslim	60	17.1
	Protestant	13	3.7
	Catholic	9	2.6
Marital status	Single	17	4.8
	Married	258	73.5
	Divorced	55	15.7
	Widowed	21	6
Educational status	Unable to read and write	68	19.4
	Able to read and write	90	25.6
	Primary education	80	22.8
	Secondary education	62	17.7
	College and above	51	14.5
Occupation	Farmer	125	35.6
	Housewife	45	12.8
	Merchant	70	19.9
	Government employed	61	17.4
	Daily labourer	50	14.2
Residence	Rural	251	71.5
	Urban	100	28.5

Behaviours among the admitted patients

Among this study participants, 113 (32.2%) had a history of smoking. Nearly a fourth of the study participants had a history of alcohol use (130 (37%)) (table 2).

Table 2. Behaviour-related factors among the admitted patients at Mehal Meda Hospital, Ethiopia, 2024 (n=351).

Characteristics	Category	Frequency	Per cent
Cigarette smoking	Yes	113	32.2
	No	238	67.8
Alcohol drinking	Yes	130	37
	No	221	63
Chewing chat	Yes	98	27.9
	No	253	72.1

Patient-related factors

Among the study participants, 79 (22.5%) had an experience of previous VTE use. Nearly a third (27.4%) of the study participants were concomitantly obese. Similarly, a third (33%) of the study participants were patients with diabetes mellitus (DM) (table 3).

Table 3. Patient-related factors among the admitted patients at Mehal Meda Hospital, North-East Ethiopia, 2024 (n=351).

Characteristics	Category	Frequency	Per cent
Previous VTE use	Yes	79	22.5
	No	272	77.5
Patient can afford to buy drugs	Yes	137	39
	No	214	61
Voluntarism	Yes	136	38.7
	No	215	61.3
Obesity	Yes	96	27.4
	No	255	72.6
Comorbidity, heart failure	Yes	89	25.4
	No	262	74.6
Stroke	Yes	94	26.8
	No	257	73.2
Cancer	Yes	23	6.6
	No	328	93.6
Hypertension	Yes	101	28.8
	No	250	71.2
DM	Yes	116	33
	No	235	67
Renal failure	Yes	98	27.9
	No	253	72.1

DM, diabetes mellitus; VTE, venous thromboembolism.

Compliance with the current VTE prophylaxis guidelines

As per the findings of the study, 266 (75.8%, 95% CI 71.2% to 80.1%) of the admitted medical inpatients did not comply with VTE prophylaxis guidelines, and 85 (24.2%, 95% CI 19.9% to 28.8%) of the admitted medical inpatients complied with the current VTE prophylaxis guidelines (figure 1).

Figure 1. Compliance with venous thromboembolism (VTE) prophylaxis among admitted patients at Mehal Meda Hospital, Amhara Region, Ethiopia, 2024 (n=351).

Factors associated with compliance with VTE prophylaxis among admitted medical inpatients

In bivariable analysis, four variables namely, religion, marital status, comorbidity such as heart failure and DM were candidate variables for multivariable logistic regression with a value of p<0.3.

In multivariable logistic regression, two of four variables were significantly associated with compliance with VTE prophylaxis among admitted medical inpatients at a 5% level of significance. The significant predictors of compliance with VTE prophylaxis were comorbidity such as heart failure and DM.

Admitted medical patients who had comorbidity such as heart failure (adjusted OR (AOR) = 6.82, 95% CI 3.71 to 12.54) were 6.82 times more likely to have compliance with VTE prophylaxis as compared with those who had no comorbidity such as heart failure. On the other hand, those who had diabetes mellitus (AOR = 3.99, 95% CI 2.20 to 7.21) were four times more likely to comply with VTE prophylaxis guidelines than their counterparts (table 4).

Table 4. Factors associated with compliance of VTE prophylaxis among admitted patients at Mehal Meda Hospital, Amhara Region, Ethiopia, 2024 (n=351).

Variables	Compliance with VTE prophylaxis		COR (95% CI)	AOR (95% CI)
	No	Yes
Religion
Orthodox	209	60	1	1
Muslim	40	20	1.74 (0.95 to 3.20)	2.34 (0.91 to 4.79)
Protestant	11	2	0.63 (0.14 to 2.94)	1.00 (0.20 to 5.16)
Catholic	6	3	1.74 (0.42 to 7.17)	1.00 (0.17 to 5.80)
Marital status
Single	15	2	1	1
Married	189	69	2.74 (0.61 to 12.28)	2.27 (0.42 to 10.96)
Divorced	43	12	2.10 (0.42 to 10.45)	2.00 (0.37 to 10.84)
Widowed	19	2	0.79 (0.10 to 6.28)	0.84 (0.10 to 7.28)
Heart failure
No	220	42	1	1
Yes	46	43	4.90 (2.88 to 8.33)***	6.82 (3.71 to 12.54)***
DM
No	193	42	1	1
Yes	73	43	2.71 (1.64 to 4.48) ***	3.99 (2.20 to 7.22)***

*p<0.05, **p≤0.001, ***p<0.0001. Hosmer and Lemeshow test (p=0.45).

AOR, adjusted OR; COR, crude OR; DM, diabetes mellitus; VTE, venous thromboembolism.

Discussion

In this study, the overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was 24.2% (95% CI 19.9% to 28.8%). This finding is lower than findings from studies conducted in Argentina (60.6%),¹⁷ Spain (88.4%),⁴ Canada (54%),¹⁸ University of Alberta Hospital (79.6%).¹⁹ Moreover, it is lower as compared with the study conducted at the University of Gondar Referral Hospital (31.6%).⁹ The possible explanation for the existence of these discrepancies is because VTE prophylaxis guidelines are not practised uniformly or effectively across different countries, and variations may relate to socioeconomic and sociocultural differences.

The practical implication of failing to comply with these guidelines is a higher proportion of DVT and PE, which in turn results in high mortality and morbidity among inpatients. Although VTE is the most common preventable cause of death in hospitalised patients, pharmacological prophylaxis has been proven to reduce pulmonary risk by 57%.⁵

In this study, being a patient with heart failure was positively associated with compliance with venous thrombosis prophylaxis guidelines among admitted medical inpatients. This finding is in line with the study conducted in South Africa.²⁰ Healthcare providers often recognise that patients with heart failure are at a higher risk of VTE due to factors such as reduced mobility, blood stasis and systemic inflammation. This heightened awareness can lead to more vigilant adherence to prophylaxis guidelines for these patients. In addition, many clinical protocols specifically emphasise the importance of venous thrombosis prophylaxis in patients with heart failure because of their well-documented elevated risk. The other important variable that showed a positive association with venous thrombosis prophylaxis guidelines was patients with diabetes among admitted medical inpatients. Those who had diabetes mellitus complied with thromboembolism prophylaxis guidelines as compared with those who did not have diabetes mellitus. This finding is in line with the findings from a study in Spain.⁴ This might be related to the fact that healthcare providers often recognise that patients with diabetes mellitus are at a higher risk of thromboembolic events due to factors such as endothelial dysfunction, increased blood viscosity and associated comorbidities like hypertension and dyslipidaemia. This heightened awareness may lead to more vigilant application of prophylaxis measures in patients with diabetes. In addition, clinicians may perceive patients with diabetes as being more vulnerable to VTE, prompting stricter adherence to prophylaxis guidelines to prevent complications, especially during hospitalisation.

One of the most significant advantages of this study is that it provides a valuable source of information regarding compliance with current VTE prophylaxis guidelines. As an institution-based cross-sectional study, the design is limited in its ability to establish definitive causal relationships between the variables and compliance outcomes. Additionally, the study was done in a single centre that has very limited medical resources; the generalisability of the study is very limited.

Conclusion

The overall proportion of compliance with VTE prophylaxis guidelines among admitted medical inpatients was 24.2%. This was low as compared with previous studies conducted in different countries including Ethiopia. It was found that admitted medical inpatients with heart failure and diabetes showed a positive association with compliance with VTE prophylaxis guidelines. It is recommended that healthcare providers should provide VTE prophylaxis as per guidelines for admitted patients with diabetes and heart failure. Healthcare facilities should also provide supportive supervision to physicians to provide VTE prophylaxis for all admitted patients with diabetes and heart failure. In addition, the drug for VTE treatment should be made available.

Data availability statement

Data are available upon reasonable request.