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Therapeutic inertia and contributing factors among ambulatory patients with hypertension

BMC Cardiovascular Disorders volume 24, Article number: 523 (2024) Cite this article

Abstract

Background

Therapeutic inertia refers to the failure of healthcare providers to initiate or intensify therapy based on current evidence-based guidelines, even when the desired treatment goal is not achieved. Despite poorly controlled hypertension, clinicians often hesitate to intensify treatment. Therapeutic inertia is currently receiving more attention as a significant reason for clinicians’ inability to effectively manage hypertension. However, in our setting, there is limited knowledge about therapeutic inertia and its contributing factors.

Objectives

The aim of this study was to investigate therapeutic inertia and contributing factors among ambulatory patients with hypertension.

Method

A prospective observational study was conducted at the cardiac clinic of Ayder comprehensive specialized hospital in the Tigray region of northern Ethiopia. Patients were recruited into the study during their medication refilling appointments using a simple random sampling technique. All patients were followed for a minimum of 6 months to assess therapeutic inertia, which was defined as the healthcare providers’ failure to initiate or intensify therapy based on current evidence-based guidelines when therapeutic goals were not achieved. Data were collected through patient interviews and review of their medical records. We utilized binary logistic regression analysis to determine factors associated with therapeutic inertia.

Result

The study included 282 participants, with an equal male-to-female ratio. The mean age of the participants was 56.6 ± 12.3 years. Among all participants, a majority (67.4%) had uncontrolled hypertension. The study revealed that 72% of patients with uncontrolled hypertension experienced therapeutic inertia. In response to this issue, we recommended dose escalation for 73% of the patients and the initiation of additional drug therapy for 27% of them. Multivariable analysis indicated that having three or more medications (AOR = 4.74, 95%CI = 1.94–11.61) and having stage II hypertension (AOR = 3.06, 95%CI = 1.32–7.08) were identified as independent predictors of therapeutic inertia.

Conclusion

The findings of our study indicated that a large proportion of the patients had poorly controlled hypertension, and a significant number of these patients also demonstrated therapeutic inertia. The number of medications and stage II hypertension were identified as independent predictors of therapeutic inertia. Therefore, it is crucial to prioritize patients at risk of therapeutic inertia and provide them with additional support. Moreover, practice based training should be given to clinicians in order to enhance treatment intensification and overall treatment outcome among ambulatory patients with hypertension.

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Introduction

Hypertension is recognized as a major risk factor for cardiovascular disease, impacting over 1.4 billion individuals globally, with a predominant prevalence in developing countries [1,2,3,4]. The prevalence of hypertension has been steadily rising worldwide, particularly in developing nations [1, 5]. Africa has emerged as the most heavily affected region, with approximately 46% of African adults experiencing elevated blood pressure [6, 7]. Based on the recent meta-analysis of observational studies, the prevalence of hypertension in Ethiopia is estimated to be between 20 and 30%, which makes it the most prevalent non-communicable disease [8,9,10]. In 2015, hypertension accounted for 10.7 million deaths and nearly 212 million disability adjusted life years [2]. According to World health organization (WHO) report, cardiovascular disease is the number one cause of death representing 31% of all global deaths and hypertension, accounts for approximately 45% of global cardiovascular disease morbidity and mortality [3]. In Ethiopia, non-communicable diseases account for 39% of all deaths, with cardiovascular disease representing 16% of this burden [11].

Several clinical outcome studies have persistently revealed that treating hypertension using evidence-based antihypertensive medications and/or adjusting lifestyle improves cardiovascular and cerebrovascular outcomes [12]. Optimal BP control is crucial to reduce morbidities and mortalities associated with cardiovascular complications [13, 14]. Scientific evidences from large randomized controlled clinical trials demonstrated that optimal management of hypertension result in 40% reduction from stroke, 25% reduction from myocardial infarction, and 30% reduction from cardiovascular mortality [15,16,17]. Evidence based clinical practice guidelines outline BP targets for the treatment of hypertension and adherence to the targets significantly lowers the complications and mortalities related with hypertension [12, 18]. However, achieving target BP levels remains a challenge in actual clinical practice, especially in developing countries [19]. Despite the availability of several effective therapeutic alternatives, hypertension control remains suboptimal worldwide [20,21,22,23]. In particular, BP remains uncontrolled in the majority of the hypertensive patients in Africa [19, 24, 25]. Similarly, hypertension control remained suboptimal in the majority of hypertensive patients in Ethiopia [26,27,28]. Several factors contribute to the poor control of hypertension [27, 29, 30], with therapeutic inertia being a significant contributor to uncontrolled hypertension [31, 32].

Therapeutic inertia refers to the failure of healthcare providers to initiate or intensify therapy according to current evidence-based guidelines when the desired therapeutic goals are not achieved [33, 34]. Currently, therapeutic inertia is increasingly recognized as a major cause of clinicians’ failure to effectively control hypertension [35]. Studies have indicated that therapeutic inertia regarding the management of chronic conditions such as hypertension, diabetes, and dyslipidemia may account for up to 80% of heart attacks and strokes [36, 37]. According to evidence-based guidelines, appropriate therapies should be initiated to effectively control hypertension. Additionally, treatment should be adjusted and intensified until the therapeutic goal is met [12, 38]. Numerous clinical trials have demonstrated that higher rates of treatment intensification lead to improved BP control [39, 40]. However, several studies have reported that treatment is not intensified in the majority of hypertensive patients, even when the treatment goal is not achieved in clinical practice [39, 41]. Consequently, it is crucial to make every effort to intensify and optimize treatment in order to achieve optimal control of hypertension. [39, 42, 43]. Therefore, every effort should be made to intensify and optimize treatment so as to attain optimal control of hypertension [12, 37].

According to Phillips et al. [33], therapeutic inertia was initially attributed to provider-related factors such as overestimation of care provided, reliance on subjective reasoning to justify the failure to intensify treatment, and lack of education, training, and organizational practices aimed at achieving therapeutic goals. Subsequent studies have shown that the factors contributing to therapeutic inertia can be classified into provider-related factors (accounting for 50%), patient-related factors (30%), and healthcare system-related factors (20%) [35, 44]. More importantly, specific factors such as age, comorbidity, medication side effects, poor patient-provider communication, unavailability of medications, number of medications, low health literacy, absence of clinical practice guidelines, medication cost, level of healthcare professionals, absence of symptoms, high patient volume, and time constraints have been identified as contributors to therapeutic inertia [35, 45,46,47,48].

Despite the availability of effective therapies, hypertension control remains suboptimal mainly due to therapeutic inertia [31]. Clinicians are often hesitant to escalate treatment despite poorly controlled hypertension [31, 32]. Although therapeutic inertia is increasingly being recognized as a major cause of clinicians’ failure to adequately control hypertension [31, 35], there is limited knowledge about its prevalence and contributing factors in Ethiopia. Therefore, conducting studies on therapeutic inertia in countries like Ethiopia, which face challenges such as limited healthcare resources, a poor healthcare system, low health literacy levels, and insufficiently trained healthcare professionals, is crucial. These studies aim to develop strategies to improve treatment intensification and overall treatment outcomes among hypertensive patients [49]. Hence, the objective of the present study was to investigate the prevalence of therapeutic inertia and its contributing factors in ambulatory patients with hypertension in Ethiopia.

Methods and materials

Study design and study setting

An institutional-based prospective observational study was conducted from October 2019 to March 2020 at the cardiac clinic of Ayder Comprehensive Specialized Hospital (ACSH). ACSH, located in the Tigray region of Northern Ethiopia, is a prominent public teaching and referral hospital serving approximately 10 million people in the catchment area.

Study participants

The study included adult patients aged 18 years and older diagnosed with hypertension, who had been regularly followed up for at least 6 months and were on at least one anti-hypertensive medication. Patients who were too ill to complete the interview, refused to give consent, or had incomplete medical records were excluded from the study. Participants were approached while waiting for their appointment in the waiting area of the cardiac clinic. Simple random sampling was used to recruit participants into the study. Before participating, all individuals were provided with a clear explanation of the study’s purpose, and written informed consent was obtained. To assess whether treatment was intensified or not, all patients were followed for at least 6 months.

Sample size determination and sampling technique

The sample size was calculated using a single population proportion sample size estimating formula (P = 50%), 95% level of confidence and 5% significance level. For population ≥ 10, 000, the formula can be given as;

$$\:\text{n=\:}\frac{{\left({\text{z}}_{\raisebox{1ex}{$1-{\alpha\:}$}\!\left/\:\!\raisebox{-1ex}{$2$}\right.}\:\right)}^{2}\text{P(1-P)}}{{\text{d}}^{2}},$$

where, n = minimum sample size, Z1−α/2 at 95% confidence level = 1.96, P = estimated prevalence of therapeutic inertia among patients with hypertension (50%), d = Margin of error to be tolerated (0.05). Substituting all in the above formula, n=384.

Since the total population in our study was < 10,000 (1040), the sample size can be recalculated using correction formula as follows:

$$\text{N}\text{f}=\text{n} \div \left(1+\frac{\text{n}}{\text{N}}\right),$$

where, n = minimum sample size (384), Nf = actual sample size using correction formula, N= actual population size (1040). Therefore, substituting all in the above formula, NF=280. Considering 10% of contingency for non-response rate, the minimum sample size required for this study was 308. Simple random sampling technique was employed to include participants in to the study.

Data collection

A structured data collection tool, comprising a questionnaire and data abstraction checklist, was developed to extract all relevant information. The questionnaire consisted of socio-demographic data, while the data abstraction checklist included clinical and treatment-related characteristics. Initially, the questionnaire was prepared in English and later translated into the local language (Tigrigna) and back-translated into English to ensure consistency in meaning. A panel of three experts, one from the clinical pharmacy department, one from the internal medicine department, and one from the nursing department, evaluated the Tigrigna-language version of the questionnaire for its content validity. The internal reliability (Cronbach’s α) of the Tigrigna-language version questionnaire was found to be 0.88, indicating good reliability. Prior to the actual data collection, a pre-test was conducted on a 5% sample, and the questionnaire was assessed for face validity. Based on the findings, slight amendments were made to the questionnaire. The data collection for this study was carried out by fifth-year clerkship pharmacy students who had received training and orientation.

Outcome measures

We defined therapeutic inertia as failure of health care providers to initiate or intensify therapy according to current evidence based guidelines when therapeutic goals are not reached [12, 33]. Therapeutic inertia was assessed for patients with complete medication records (including dose and administration frequency) and uncontrolled blood pressure during the study period. Blood pressure (BP) was deemed uncontrolled if the systolic BP was greater than or equal to 140 mmHg and/or the diastolic BP was greater than or equal to 90 mmHg for patients younger than 60 years old; or if the systolic BP was greater than or equal to 150 mmHg and/or the diastolic BP was greater than or equal to 90 mmHg for patients aged 60 years or older [12].

Data analysis

The data was entered into Epi Info (version 7) and analyzed using the Statistical Package for the Social Sciences (SPSS version 24.0). Descriptive statistics were utilized to summarize the baseline characteristics of patients and the prevalence of therapeutic inertia. To check for multicollinearity among predictor variables, the variance inflation factor (VIF) was examined, and it was determined that none of the variables were collinear. Univariable logistic regression analysis was performed to assess the association of each independent variable with therapeutic inertia. Moreover, independent variables with a p-value of less than 0.25 in the univariable binary logistic regression analysis were included in a multivariable binary logistic regression model to identify predictors of therapeutic inertia. A significance level of p < 0.05 was considered statistically significant for all analyses.

Result

Sociodemographic and disease related characteristics

We were able to approach 308 patients, out of which 282 participants were included in the final analysis of the study. We excluded 26 patients from the study due to unwillingness to respond (12), serious illness preventing response (7), and incomplete medical records (7). The mean age of the respondents was 56.6 (12.3) years, and approximately half (51.8%) were males. Two-thirds (68.2%) were unemployed, 39% had no formal education, 28% were alcohol consumers, while only 1.8% were cigarette smokers. Regarding disease-related characteristics, over one-third (36.5%) had been living with hypertension for more than five years. A majority (62.1%) had one or more comorbidities, and 78.2% were classified as having stage I hypertension. The majority of participants (61%) visited the hospital every two months for medication refills (Table 1).

Table 1 Sociodemographic and disease-related characteristics among ambulatory patients with hypertension in ACSH, 2020(n = 282)
Full size table

Treatment related characteristics

More than half (54.6%) of the participants took three or more medications and 17% experienced adverse effects. The most commonly prescribed drug was enalapril (56.7%) followed by hydrochlorothiazide (50.4%) and amlodipine (35.5%). Majorities (73.6%%) of the medications were prescribed by medical residents (Table 2).

Table 2 Treatment related characteristics among ambulatory patients with hypertension in ACSH, 2020(n = 282)
Full size table

Blood pressure control and therapeutic inertia

Out of the total, 190(67.4%) of the patients had uncontrolled BP. Among the patients who had uncontrolled BP (190), 137(72%) had therapeutic inertia. Of the total patients who had therapeutic inertia, 100 (73%) were in need of dose up-titration/escalation while 37(27%) were in need of additional drug therapy. Therefore, dose escalation and initiation of additional new drug therapy were recommended for 100 (73%) and (27%) patients, respectively (Table 3).

Table 3 Blood pressure control and therapeutic inertia among ambulatory patients with hypertension in ACSH, 2020(n = 282)
Full size table

Factors associated with therapeutic inertia

A univariable logistic regression analysis was conducted to compare hypertensive patients with and without therapeutic inertia, taking into account socio-demographic, clinical, and treatment-related characteristics. The findings revealed that the number of medications ≥ 3 (COR = 3.30, 95%CI = 1.72–6.38) and stage II hypertension (COR = 3.00, 95%CI = 1.30–6.42) were significantly associated with therapeutic inertia. Subsequently, variables with a significance level of P < 0.25 were further analyzed using a multivariate logistic regression model. Thus, covariates including the number of medications, hypertension stage, alcohol consumption, comorbidity, and prescriber status were included in the multiple logistic regression analysis. According to the multivariate analysis, a number of medications ≥ 3 (AOR = 4.74, 95%CI = 1.94–11.61) and stage II hypertension (AOR = 3.06, 95%CI = 1.32–7.08) were identified as independent predictors of therapeutic inertia (Table 4).

Table 4 Factors associated with therapetic inertia among ambulatory patients with uncontrolled hypertension in ACSH, 2020(n = 190)
Full size table

Discussion

Clinicians often hesitate to intensify treatment despite poorly controlled hypertension [31, 32]. Moreover, there may be a lack of awareness regarding the true extent of therapeutic inertia and its contributing factors. Thus, conducting this study will aid in understanding the precise issues in clinical practice and enabling clinicians to provide responsible patient care. Currently, therapeutic inertia is widely recognized as a significant reason behind clinicians’ inability to manage hypertension effectively [31, 35]. However, there is limited knowledge about therapeutic inertia and its contributing factors in our specific context. Consequently, our study aimed to explore therapeutic inertia and its contributing factors among ambulatory patients with hypertension.

Despite the fact that effective control of BP is crucial in reducing morbidity and mortality in patients with hypertension [31], our study found that two-thirds (67.4%) of participants had uncontrolled hypertension. Furthermore, treatment was not intensified for three-fourths of the patients despite their BP being uncontrolled. Similar findings were observed in other studies conducted in Zimbabwe (67.2%), Kenya (66.6%), and Nigeria (65%) [50,51,52]. In contrast, our study’s finding was higher compared to similar studies conducted in Chile (41.3%) and South Africa (43%) [53, 54]. The disparities in these results could potentially be attributed to differences in population demographics, disease distribution, health literacy, healthcare providers’ expertise and experiences, as well as the level of healthcare facilities [35].

Several clinical trials revealed that higher rates of treatment intensification have been associated with improved BP control [39, 40]. According to evidence-based guidelines, treatment needs to be optimized and intensified until the therapeutic goal is achieved [12]. However, in our study, treatment was not intensified in 137 (72%) of the participants, even though the goal was not reached. This finding aligns with a study conducted in Spain, where treatment intensification was not initiated in 75% of the cases [55]. On the contrary, our finding is higher compared to the results reported from the USA, where treatment intensification was observed in only 28.4% [56]. Possible reasons for this disparity could be the insufficient awareness of hypertension guidelines among clinicians, low levels of health literacy, and a poor healthcare system prevalent in developing countries, including Ethiopia [46].

More specifically, among the patients exhibiting therapeutic inertia, 100 (73%) were in need of dose escalation for their prescribed antihypertensive medications, while 37 (27%) required the addition of another antihypertensive drug therapy. This indicates that a majority of the patients with uncontrolled blood pressure were receiving low doses, despite the possibility of achieving the therapy’s goal through dose escalation. Furthermore, 27% of the patients needed additional drug therapy to better control their blood pressure. Consequently, we recommend dose escalation for 100 patients (73%) and the initiation of additional antihypertensive drug therapy for 37 patients (27%). Therefore, more effort needs to be done to optimize and intensify antihypertensive drug therapy so as to attain the desired BP targets.

In our study, we found that patients with stage II hypertension were more likely to experience therapeutic inertia compared to those with stage I hypertension. This finding is supported by similar findings from other studies [31, 57]. This could be justified that unintensified therapy may lead to more elevated BP [39, 57]. Therefore, it is crucial to pay more attention to patients with stage II hypertension as they are at a greater risk of experiencing adverse outcomes. Additionally, the number of medications taken was found to be significantly associated with therapeutic inertia in our study. Specifically, patients on three or more drug therapies were about five times more likely to have therapeutic inertia compared to those on a lesser number of drug therapies. Similarly, number of medication was significantly associated with therapeutic inertia in Spain study [55]. This can be explained by the possibility that clinicians may hesitate to prescribe additional drug therapy or increase the dosage for patients with multiple medications due to concerns about intolerance/adverse effects and noncompliance, which can arise from polypharmacy.

Finally, it is important to acknowledge the limitations of our study. The cross-sectional design used may limit the ability to establish a causal relationship between therapeutic inertia and its predictors. Additionally, the generalizability of our findings to other countries may be constrained by various factors such as differences in participant characteristics, disease distribution, clinicians’ expertise, healthcare infrastructure, and research methodologies. Therefore, caution should be exercised when extrapolating our results.

Conclusion

Our study revealed that the majority of patients had uncontrolled hypertension, and therapeutic inertia was found to be prevalent among these patients. The number of medications and stage II hypertension were identified as independent predictors of therapeutic inertia. Therefore, it is crucial to pay more attention to patients who are at risk of experiencing therapeutic inertia. Providing practice-based training and education to clinicians is essential in order to improve treatment intensification and overall treatment outcomes for ambulatory hypertensive patients. Additionally, we recommend researchers to conduct further longitudinal studies with improved study designs to gather sufficient information about the cause and effect relationship between therapeutic inertia and its risk factors.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

AOR:

Adjusted Odds Ratio

ADR:

Adverse Drug Reaction

BP:

Blood pleasure

CI:

Confidence Interval

COR:

Crude Odds Ratio

IQR:

Interquartile Range

SD:

Standard Deviation

SPSS:

Statistical Package for Social Science

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Acknowledgements

We would like to express our gratitude to the data collectors and working staff members of Mekelle University for their appreciable commitments and cooperation. Our gratefulness extended to patients with hypertension for their volunteer involvement in the study.

Funding

This research received no financial support.

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Authors and Affiliations

  1. Department of Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Mekelle University, Ethiopia, Mekelle, Tigray

    Yirga Legesse Niriayo, Solomon Girmay, Kidu Gidey & Solomon Weldegebreal Asgedom

  2. School of dental medicine, College of Health Sciences, Mekelle University, Mekelle, Tigray, Ethiopia

    Nigusse Tesfay

Authors
  1. Yirga Legesse Niriayo
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  2. Solomon Girmay
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  3. Nigusse Tesfay
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  4. Kidu Gidey
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  5. Solomon Weldegebreal Asgedom
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Contributions

YL and SG conceptualized and designed the study, and drafted the original manuscript. NT, KG and SW assisted in data analysis and interpretation. All authors have reviewed and approved the final version of the manuscript for submission.

Corresponding author

Correspondence to Yirga Legesse Niriayo.

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Ethics approval and consent to participate

Approval was obtained from the ethics review committee of the School of Pharmacy, College of Health Sciences, Mekelle University, for this study. The purpose and protocol of the study were thoroughly explained to all participants included in the study. Each patient provided written informed consent, ensuring their participation was voluntary. Strict confidentiality measures were in place to protect personal information. All methods employed in this study were conducted in compliance with approved institutional guidelines.

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Not applicable.

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The authors declare no competing interests.

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Niriayo, Y.L., Girmay, S., Tesfay, N. et al. Therapeutic inertia and contributing factors among ambulatory patients with hypertension. BMC Cardiovasc Disord 24, 523 (2024). https://doi.org/10.1186/s12872-024-04109-1

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Keywords

BMC Cardiovascular Disorders

ISSN: 1471-2261

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