Clinical Research in Practice: The Journal of Clinical Research in Practice: The Journal of Team Hippocrates Team Hippocrates

A clinical decision report using: Bhavan KP, Brown LS, Haley RW. Self-Administered Outpatient Antimicrobial Infusion by Uninsured Patients Discharged from a Safety-Net Hospital: A Propensity-Score-Balanced Retrospective Cohort Study. PLoS Med . 2015;12(12): e1001922. https://doi.org/10.1371/journal.pmed.1001922 for a patient with fungal peritonitis requiring OPAT.

Mr. Gomez was specifically concerned about the treatment cost as he had recently started a new job as a pipe worker and was currently uninsured. When discussing this plan with Mr. Gomez, he said, "I have no clue how I can pay for this with my new job and no insurance. I will have to decide between trying to pay for this medicine and my rent. I'll lose my place." Mr. Gomez was dismayed that the hospitalization had further set him back financially as he admittedly currently lived paycheck to paycheck and helped to financially support his brother. In addition, Mr. Gomez had stated that intermittent abdominal pain over the past year, caused him to miss repeated workdays, resulting in inability to maintain a steady job. Mr. Gomez also lacked a financial support system. While homecare administered antimicrobial therapy would get him out of the hospital and back to work sooner, the financial burden of this care was steep. To address Mr. Gomez's financial concerns, we investigated outpatient parenteral antibiotic therapy (OPAT) options that would adequately treat fungal peritonitis while being cost-effective.

Clinical Question
Which treatment options are available to provide cost-effective care for uninsured patients requiring OPAT?

Description of Related Literature
PubMed was used to conduct a literature search. Initially, the search term used was: "outpatient intravenous medically uninsured." This initial search resulted in three articles. Due to the low number of results, each of these individual results were carefully examined to determine their applicable nature to the clinical question.
Owing to the lack of adequate results from the initial search, an additional PubMed search was conducted with the search term "outpatient intravenous insurance." This search term yielded 154 results. Of these 154 results, 150 articles were removed from consideration based on a cursory search of the articles' contents not being applicable. These articles were removed from consideration at this stage if they did not explicitly detail the use of at home infusions of antimicrobial agents. Articles that did not discuss the financial aspect of OPAT in relation to patients of lower SES or uninsured patients were also removed. Finally, medical subject headings (MeSH) terms were reviewed, and a Google Scholar search was conducted to reveal any overlooked studies. This revealed two additional overlooked articles.
In total, six results were more closely examined to determine their applicability to the clinical question.
A review article by Poretz 1991 introduced the scope of home intravenous antibiotic therapy, including the financial aspects of the clinical practice. 5 Brown and Sands 1998 discussed the cost-effective nature of OPAT and innovation of infusion pumps, but failed to offer strategies to reduce the financial burden of OPAT itself. 6 A retrospective cohort study by Yan et al. 2016, exploring the shortterm clinical outcomes of 104 patients discharged on OPAT from a Canadian hospital lacking a formal self-administered OPAT (S-OPAT) program showed 43% of patients visited the emergency room and 26% of patients required readmission within 60 days for infection-related issues. 7 While highlighting the clinical necessity of a formal S-OPAT program, this study failed to explore the financial impact of OPAT programs for uninsured patients and was limited by the study design and sample size.
Three studies detailed strategies to lower the financial burden of OPAT in uninsured patients. In Bhavan et al. 2015, uninsured patients were educated in S-OPAT in order to decrease the financial burden of antimicrobial outpatient therapy. 4 In Butcher 2017, uninsured patients requiring long-term administration of antimicrobials were treated at an outpatient clinic specifically devised to relieve the financial burden of IV antibiotics on the uninsured. 8 While Butcher 2017 offered a solution (subsidized outpatient clinic for the uninsured requiring OPAT) to the clinical question, it failed to present concrete data detailing the success of the program or compare it to a control group. Hamad et al. 2020 detailed a hospital-sponsored S-OPAT pilot program for 17 uninsured patients and BRADY J. Self-administered OPAT (S-OPAT) is a potential cost-effective equivalent option for uninsured patients requiring OPAT. Clin Res Prac. There is a dearth of published studies to address this specific question of cost-effective equivalent alternatives to the healthcare professional administered OPAT (H-OPAT). Provided this, ultimately Bhavan et al. 2015, a retrospective cohort study, was the most relevant to the clinical question as it proposed a novel cost-effective strategy. 4 This article offered a cost-effective alternative to OPAT for uninsured patients-the self-administration of OPAT-and compared the effectiveness of S-OPAT to the standard H-OPAT, that is OPAT that is administered by a healthcare professional. 4 The Grade of Recommendation using the SORT criteria for self-administration of OPAT is Grade B, based on limited quality patientoriented evidence. 10

Critical Appraisal
Bhavan et al. 2015 assesses the clinical efficacy of S-OPAT compared to traditional H-OPAT. 7 The study design was a retrospective cohort study with the level of evidence using the SORT criteria being Level 2: limited-quality patient-oriented evidence. 10 The S-OPAT program involved training uninsured patients in the self-administration of IV antimicrobial agents and included testing patient's ability to self-administer prior to discharge to ensure competency. 4 This retrospective cohort study had a total of 1168 patients, which consisted of Parkland Hospital patients requiring OPAT between 2009-2013: 944 patients in the S-OPAT group and 224 patients in the H-OPAT group. 4 All data was collected from electronic medical record chart review. To evaluate the efficacy of S-OPAT compared to H-OPAT, the study looked at both 30-day readmission rate (primary outcome) and 1-year mortality rate (secondary outcome) in both groups. 4 Between the two groups, controlling for confounding and selection bias, the S-OPAT patients had a 47% lower 30-day readmission rate: the adjusted hazard ratio was 0.53 and a p-value of 0.003. 4 Adjusting for confounding and selection bias, 1-year mortality rates between S-OPAT and H-OPAT were not significantly different: the adjusted hazard ratio was 0.86 and a p-value of 0.73. 4 From this data, the study concluded that S-OPAT is an effective and financially advantageous clinical strategy for uninsured patients requiring long term IV antimicrobial therapy.
The study has several weaknesses, the main one being study design. This study is a retrospective cohort study and not a randomized controlled clinical trial. 4 The determining factor for group placement was health insurance enrollment, which allows for considerable selection bias and confounding because the patient populations will differ substantially in various socioeconomic characteristics. 4 Because the S-OPAT patients were placed in the treatment group because they lacked insurance, this group had a larger quantity of disadvantaged patients, referred to by Bhaven et al. as "the working poor," who generally have the most financial difficulty in obtaining health insurance, but do not quality for government programs such as Medicare/Medicaid. 4 This is demonstrated in this study by S-OPAT and H-OPAT patient groups having statistically significant differences in baseline characteristics including: age, race/ethnicity, language, home location, and BMI. 4 The researchers attempted to correct the inherent selection bias in nonrandom group placement by developing propensity scores to model membership in either OPAT group. 4 This attempted to approximate a randomized study, but residual selection bias could remain that is not factored into the propensity score calculation process.
A randomized controlled clinical trial would decrease the selection bias and confounding associated with this observational retrospective study design and be able to more appropriately answer if S-OPAT provides equivalent care to H-OPAT.
Importantly, S-OPAT required the development of education materials, pamphlets, competency testing through an established standardized protocol. 4 Due to the amount of preparation and infrastructure required to initiate and enact self-administration of OPAT, this therapeutic maneuver is not currently feasible at our hospital.

Clinical Application
Concerning OPAT, Mr. Gomez's primary concern was cost due to his financial situation. Thus, S-OPAT, a costeffective alternative to H-OPAT, was investigated as a feasible alternative. While the study by Bhavan et al. 2015 demonstrated that S-OPAT was both a clinically-and cost-effective alternative to traditional H-OPAT, the patients in the study benefited from large-scale infrastructure changes and educational programs at the participating hospital.
While the financial benefits of S-OPAT did address the financial concern, Mr. Gomez was also worried about undertaking the responsibility of self-administering his antimicrobials. Mr. Gomez admitted that he had not graduated high school and that "science was not his best subject." Thus, he did not feel comfortable undertaking this responsibility without a healthcare professional, especially with our hospital currently lacking S-OPAT education.

New Knowledge Related to Clinical Decision Science
In the process of making clinical decisions, physicians often overlook the financial cost and the patient's comfort level with the proposed treatment. These aspects were important for Mr. Gomez, an uninsured man without a high school education requiring OPAT. Bhavan et al. 2015 demonstrated evidence that S-OPAT by uninsured patients is a cost-effective and acceptable clinical strategy. However, our hospital lacked the educational program and infrastructure described in the study. Thus, Mr. Gomez did not feel that he was prepared to handle S-OPAT.
Patient comfort with proposed treatment is essential for maintaining the physician-patient therapeutic alliance. Mr. Gomez's hesitancy for S-OPAT was one of the most important aspects to consider in the shared decision-making process. While S-OPAT may have saved Mr. Gomez money, his discomfort with the treatment had the potential to lead to further complications including rehospitalization, potentially adding to his health and financial burdens. If the treatment decision had been made solely based on finances, Mr. Gomez's hesitancy with this approach would have been overlooked. Thus, when different social aspects of a patient's life conflict with each other, it is most important to consider the patient's comfort level with the proposed clinical decision.
Moreover, a treatment plan should be devised collaboratively, considering not only clinical outcomes, but also the financial burden and the patient's comfort with the proposed treatment. While H-OPAT was not the most affordable choice for Mr. Gomez, it was the treatment choice that he was most comfortable pursuing when accounting for his medical knowledge base. If the patient had felt more comfortable with S-OPAT by having a support system that included medical professionals, or if our hospital had a formal S-OPAT educational program, then this could have resulted in the decision to pursue more cost-effective S-OPAT. By ensuring that multiple aspects of the treatment decision are considered and analyzed-with focus paid to the patient's comfort level-the chosen treatment has a greater chance of meaningful success and benefit for the patient.