Abstract
Introduction:
Indwelling pleural catheters (IPC) are effective at palliating benign and malignant pleural effusions (MPE). They have also been found to be cost effective from a third-party payor perspective. Little is known of the impact IPCs have on patient-centered quality of life outcomes such as financial burden and patient and caregiver burden. We performed a cross-sectional survey study evaluating the impact of IPCs on multiple patient and caregiver quality of life metrics.
Methods:
Patients ≥ 18 years old with an IPC in place for 2 months were eligible. Twenty patients were recruited over a 10-month period. Patients completed the CDC-Health Related Quality of Life (HRQOL)-4 and a HRQOL-financial questionnaire. The primary objective was to describe the socio-economic impact of IPCs. Demographic and IPC specific data were collected. Descriptive statistics were used.
Results:
The mean (SD) age was 64.3 (0.70). The indication was MPE in 19/20. All patients had medical insurance. Medicare or Medicaid (CMS) comprised 10/20 of payors. The median (IQR) copay for private insurers was $238.45 (72-875); 11/20 had additional costs related to the IPC; 4/20 had significant life changes after the IPC; 17/20 received assistance from a non-paid caregiver; 6/20 patients could not do activities because of the IPC and this negatively impacted QOL in 3/6 of those patients.
Conclusion:
Patients with IPCs may experience negative life consequences, incur additional medical expenses, and require assistance from a non-paid caregiver. Activities may be negatively impacted by IPC. Discussion of alternative means of symptom palliation and pleurodesis would be beneficial.
Keywords
Introduction
Malignant pleural effusions (MPE) are common with an estimated 126,000 cases diagnosed each year in the U.S. with associated inpatient costs in excess of 1.5 billion dollars annually. 1 The most common causes of MPE are lung, breast and lymphoma and typically portend a poor prognosis with average survival of 6 months. 2 Current guidelines recommend a definitive intervention for symptom relief if 1) the effusion recurs after one thoracentesis, 2) symptoms were relieved with the original thoracentesis and 3) the patient has a life expectancy of > 30 days. 2 This can be achieved with either an indwelling pleural catheter (IPC) or talc pleurodesis (performed via a chest tube or by video-assisted thoracoscopy). In the U.S., IPCs have become the preferred procedure for many physicians because of their clinical efficacy in relieving dyspnea, improving quality of life (QOL), reducing hospital length of stay and overall superior cost-effectiveness. 2 -5
Similarly, benign pleural effusions (BPE) due to solid organ dysfunction (congestive heart failure, hepatic hydrothorax or end stage renal disease) herald advanced disease and have been associated with a poor 1 year survival approaching that of MPE in some circumstances. 6 IPCs have recently been approved by the U.S. Food and Drug Administration for treatment of benign, recurrent BPE based upon limited data that suggests similar improvements in QOL with comparable cost savings and pleurodesis rates to that of MPE. 7
However, cost-effectiveness has only been analyzed from a third-party payor perspective. 4,5,8 -11 Little information is available regarding out of pocket expenses or other patient-centered socioeconomic impacts of IPCs in real-world use. These expenses and impact on a patient’s care-giver network may be more substantial than previously realized. Knowledge of this information would be of great value in goals of care discussions and may potentially influence the choice of pleural intervention. We performed a cross sectional survey study to evaluate the consequences of IPC placement on multiple patient and caregiver quality of life metrics to better ascertain the role of IPCs on patient-relevant outcomes.
Methods
We conducted a cross sectional study involving administration of 2 separate surveys given at the same time to patients. The study was conducted at Vanderbilt University Medical Center, Nashville, TN USA (institutional review board #181122). Patients were recruited by retrospective chart review with subsequent telephone or email contact, or were approached during routine clinic visits or hospitalizations. Written informed consent was obtained from all patients or their surrogate decision maker.
All patients 18 years of age and older who had unilateral or bilateral IPCs (PleurX®; Becton, Dickinson and Company; Franklin Lakes, NJ) in place for ≥ 2 months were recruited. Patients were excluded if talc was administered on the same side of the IPC, if they were unable to provide informed consent or complete the questionnaires. The 2 surveys included 1) a validated Health Related Quality of Life (HRQOL) questionnaire (CDC-HRQOL 4) and 2) a patient-centered and societal cost questionnaire adapted specifically for this study were utilized. 12
Study data were collected and managed using Research Electronic Data Capture (REDCap). REDcap is a secure, web-based application that provides an intuitive user interface that streamlines project development and improves data entry through real-time validation rules, provides easy data manipulation, and provides an automated export mechanism to common statistical packages. Patients completed the surveys privately. A surrogate decision maker/care giver was allowed to be present to assist with survey completion if necessary. Demographic and clinical variables were stored in a similar manner. The primary objective was to 1) describe the financial impact of IPCs 2) determine overall satisfaction with the IPC and 3) characterize caregiver burden. Secondary endpoint was HRQOL. Data were aggregated by question type and presented in proportions, means, and medians, where appropriate.
Results
Between September 2018 and June 2019 31 patients were approached, 22 consented to participate, and 20 completed both surveys. Patient demographics, income range, medical insurance status, and details regarding the pleural effusion and IPC are presented in Table 1. The median age was 64 years (IQR, 58-71) and 65% (13/20) were female. Most (55%, 13/20) reported an annual income of < $50,000, with 35% (7/20) having an income < $25,000. All patients had medical coverage. Medicare or Medicaid(CMS) comprised 50% (10/20) of payors. Copays, when required by the patient’s insurance company, covered the cost of vacuum bottles and the dressing kit. In total, 25% (5/20) of patients had a copay. Only 1 patient from the CMS cohort had a co-pay of $100 and had an income range of $0 to <25,000. In contrast, the median copay for private insurers was $238.45 (IQR, $72-875). Of the 4 patients with a private insurance carrier and a copay, 2 had a median income range between $75,000-100,000 and 2 had a median income range between $50,000-75,000.
Patient Demographics and Baseline Characteristics.
a one subject did not know copay; IQR includes both medicare and private payors
b one patient with IPC placed for benign effusion due to refractory CHF
c Tissue diagnosis not confirmed, but imaging and clinical picture consistent with malignancy
All patients would choose the IPC if given the option again (Table 2). No subjects missed an important life event because of the IPC and all felt that they had enough financial resources to pay for the IPC. However, 30% (6/20) felt that there were activities they could no longer do because of the IPC and 50% (3/6) of these respondents stated this negatively impacted their quality of life (QOL) and well-being. However, no further explanation was provided by the respondents as to how their QOL was adversely affected. Additionally, 45% (9/20) felt that they could not achieve leisure travel goals because of the IPC. Again, no further specifics were given as to the nature of these goals.
IPC Specific Questions and Impact on Patient Caregivers.
a PleurX® was used instead of IPC to facilitate patient communication and understanding; b Quality of life; c Complications as reported by patients included infection requiring antibiotics (5/20) and with discomfort while sleeping (1/20)
Accruing additional medical costs associated with the IPC was common as 55% (11/20) of patients had additional costs related to the IPC. These costs included items in addition to the copay (if copay was required by the insurance company) and were either directly or indirectly related to the IPC. These costs included medical equipment (4 subjects), child-care related to the medical visit (1 subject), and miscellaneous items such as bandages (3 subjects). Notably, 3 patients had to make modifications to their home environment. No further information was given regarding the rationale or expense of the modifications or whether these modifications were directly related to the IPC.
The impact on caregivers was substantial (Table 2). An immediate family member, other relative, or friend provided IPC-related care to 85% (17/20) of patients, while 12% (2/17) of care givers took time off from work to assist with IPC management. Surprisingly, 20% (4/20) of subjects reported significant life changes after the IPC, including 1 change in residence to downsize due to loss of insurance from disability status and another 2 who were unable to live independently requiring them to move in with relatives.
Overall quality of life as assessed by the CDC-HRQOL 4 questionnaire showed that 30% of patients reported fair or poor health. The mean (SD) unhealthy physical, mental and activity limitation days as reported over a 30-day period were 20.2 (11.8), 7.2 (11.2), and 12.6 (13.4), respectively.
Discussion
Our study demonstrates that IPCs may have the potential to impose unexpected financial costs, additional impact on caregiver burden and may detrimentally affect patient-reported QOL. To our knowledge, data on out-of-pocket expenses and caregiver burden has not been reported previously.
The median copay of $238 for private insurers is substantial when one considers that this copay is paid by the patient every 2 or 4 weeks depending on the frequency of drainage and the need for vacuum bottles and dressing kits. The impact on caregivers was significant as 12% took time off from work for patient-related health care needs and were the primary socio-economic support for major life changes.
Our results are reported in the context that all would choose to have the IPC placed again if given the option and all felt comfortable with additional financial constraints imposed by the IPC. This paradoxical finding may be explained by the high degree of caregiver support that patients received, both financially and socially, and perhaps the lack of perceived alternative such as talc pleurodesis. It is possible that if caregiver support was not available, this response may have been different.
While data has consistently shown that IPCs improved dyspnea and overall HRQOL, 13,14 to date, cost-effectiveness studies have primarily focused on third party payors and markers of quality of life that may not be meaningful to individual patients. 4,5,8 -11,15 For example, a comprehensive cost-utility study by Shafiq and co-workers, using 100,000/quality adjusted life year (QALY) as a benchmark, analyzed 4 different management options with an analytical horizon of 6 months—repeated thoracentesis (RT), indwelling pleural catheter (IPC), chest-tube guide talc slurry (TS), thorascopic talc poudrage (TP), and a rapid pleurodesis protocol (RPP). They found that IPC, when compared to RT, provided an additional 0.06 quality adjusted life year (QALY), had an incremental cost effectiveness ratio (ICER) of 45,747$/QALYR and that IPC was the most cost-effective intervention over a 6 month treatment period. 5 While this study was helpful in its comparative strategy, the quality of life measures used are of little practical value to individual patients as the majority of patients with metastatic cancer are more interested in maintaining activities that have specific interest and enjoyment to them as individuals. Our survey study sought to explore these questions at the patient-centered level and is the first to report in detail the impact of specific financial and socioeconomic outcomes for patients with an IPC. The ASAP trial, a randomized controlled trial evaluating the IPC pleurodesis success rate of daily versus every other day drainage, did report on patient-centered costs that was collected in a satisfaction survey which was developed specifically for the study. The authors stated that “…supplies were covered by insurance either completely or with a co pay. Only a small proportion of the patients believed that the catheters posed a financial burden. 16 ” However, no further information was given.
Our study provides details as to the range of median copays for patients in light of the overall study population’s personal income and employment status. Of those who had copays, 3 were retired, one was on paid sick leave and another on disability status. Of those with copays, 2 had income ranges between $75,000-$100,000, while the remainder had an income < $75,000. The impact of copay cost can be put in perspective by data reporting pleurodesis frequency rates, a surrogate marker for when the IPC can be removed and drainage ceases. The ASAP trial reported pleurodesis rates of only 50% at 12 weeks if the effusion was drained daily, with a much lower rate of 24% if it was drained every other day over the same time period. In other words, in patients personally responsible for a copay, there is a 50% or 75% chance they may be paying this copay at 3 months depending on their drainage frequency and overall survival. 16 Typically, no copays are required by CMS; however, in our cohort, 1 patient with Medicare reported a copay of $100. Of those with private insurance carriers, 44% (4/9) had a copay. Thus, it would appear to be prudent for clinicians to have knowledge as to the type of insurance plan (and coverage provided) the patient has as this may help inform patient decisions regarding pleurodesis options.
The negative impact on activity QOL that was seen in a small number of patients was surprising given the aforementioned consistent reports on positive QOL after IPC placement. This may have been due to the lack of personal travel seen in 45% of the cohort, but this could not be confirmed as no further details were provided by the patients. Regardless of the cause, the potential impact on activities that are valuable to the patient (such as swimming, travel, etc) should be discussed prior to IPC placement and as part of a goals of care discussion.
In addition, the high level of caregiver support, with 80% being from an unpaid caregiver, is critical in informing discussions about IPCs with patients. While the concept behind IPCs is to allow outpatient management of pleural effusions, it is the assumption of many clinicians that patients may be draining the pleural fluid themselves, when in fact, patients rely heavily on members of one’s own social network. As such, discussions regarding the roll of caregivers should become a routine part of the IPC consent process.
Finally, the significant life events that occurred for a small percentage of the cohort, while difficult to directly attribute to the IPC itself, should none the less alert the clinician that metastatic cancer and the resultant impact (such as placement of an IPC) may impose a strain upon the patient’s financial and social network.
Our study has limitations. The sample size was small mainly because many patients were not alive beyond 2 months and were not eligible for study entry. As such, our results may not accurately reflect the experience of most patients with IPCs. Only 1 patient in our cohort had a BPE and our results may not be generalizable to this patient population. However, costs for IPC are identical regardless of the pleural effusion etiology and quality of life issues are likely similar as well. We were not able to ascertain whether it was the cancer diagnosis and treatment itself or the IPC specifically that lead to major life changes. It is possible that the cancer diagnosis was the primary driver in these circumstances and further studies are needed to explore this finding. Because the study was survey-based, we were not able to determine the rationale behind some answers to questions, particularly details of the negative QOL impact of the IPC.
While IPCs may be appropriate for many patients, it is possible that they may not be suited for all. IPCs may pose a much greater socio-economic burden on certain patients and their caregivers than realized by clinicians. A more nuanced and tailored approach based upon patients’ caregiver networks, life priorities, and financial resources may help in discussing alternative treatment options to IPC, such as pleurodesis, for symptom management. Further research incorporating caregiver burden and patient goals of care into treatment options is needed.
Footnotes
Authors’ Note
MA: study design, data collection, data analysis, drafting of manuscript; LR: study design, data collection, critical review of manuscript; RL: study design, data collection, critical review of manuscript; OR: study design, data collection, critical review of manuscript; EG: study design, critical review of manuscript; FM: study design, data collection, data analysis, critical review of manuscript; All authors gave final approval to the manuscript and are accountable for all aspects of the work. Dr. Rickman reports grants from Becton, Dickinson and Company, personal fees from Becton, Dickinson and Company, other from Becton, Dickinson and Company, outside the submitted work. This work was accepted for presentation in abstract form at the American Thoracic Society Conference, May 2020. This study was approved by the institutional review board at Vanderbilt University Medical Center (IRB#181122). Patient consent was obtained for all subjects.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
