A Descriptive Cross-Sectional Study of Patient Experience Among Home Infusion Patients Administering Immune Globulin: A Comparison of Satisfaction Between IV and SC Administration
Danell Haines, PhD, Research Consultant
Michelle C. Simpson PharmD, BCSCP, MWC, National Home Infusion Association
Contact: Michelle C. Simpson PharmD, BCSCP, MWC Michelle.Simpson@NHIA.org
Abstract
Introduction
Immune globulin (Ig) preparations are administered to patients to treat a variety of diagnoses. Originally developed to increase and maintain IgG levels in patients with antibody deficiencies, immune globulin preparations are also part of the treatment plan for autoimmune or connective tissue disorders, neurologic diseases, and inflammatory conditions. Due to the growth of Ig therapy in the home, there is a need for more valid and comprehensive patient satisfaction data about the home infusion experience that can be used to improve patient care and outcomes. The objective of this research is to analyze patient satisfaction survey data from the National Home Infusion Foundation and evaluate patient satisfaction similarities and differences between 2 groups: intravenous and subcutaneous administration of immune globulin.
Methods
A descriptive cross-sectional study was performed to meet the objective. The data for this study was a secondary analysis of a data set from the National Home Infusion Foundation Benchmarking Program that collects data from home infusion patient satisfaction surveys. Starting in 2019, 127,353 home infusion patient satisfaction surveys were submitted by 29 home infusion providers across the United States. Of these surveys, 326 were from Ig patients, which represents 2.76% of the surveys completed and used in this study. To determine whether a significant difference (p ≤ .05) exists between the Ig therapy types and the response to each survey question, Fisher’s Exact Test was used for dichotomous questions (Yes/No responses) and Chi-Square was used for Likert scaled questions.
Results
Of the 326 surveys, 59.51% (n=194) were from intravenous immune globulin (IVIG) patients while 40.49% (n=132) were from subcutaneous immune globulin (SCIG) patients. The mean patient age for IVIG and SCIG was 57.51 (SD=16.94) and 49.01 (SD=23.40), respectively. When the IG type is cross tabulated by age group, there is a higher percentage of younger age groups that are administered SCIG than the older age groups and vice versa for IVIG. For the survey question, “I was satisfied with the overall quality of the services provided.” The top box score (Strongly Agree) for the IVIG patients was 84.38 while 86.36% of the SCIG patients strongly agreed. There was no significant difference (p = .710) between the 2 Ig therapy methods of administration. The top 2 response options (Strongly Agree and Agree) for this question are considered favorable and when combined, the IVIG patient percentage is 98.44% and is slightly higher than the SCIG patient combined score of 97.72%.
Discussion
This research study found no significant difference (p = .710) in overall patient satisfaction between patients who administer their Ig by either IV or SC routes and found similarly high rates of overall satisfaction. Patient care can be individualized in conjunction with changes in the patient’s clinical or personal situations, and that leads to high rates of patient satisfaction. Study results support patient preferences as a key factor in patient satisfaction.
Conclusion
Patient satisfaction with overall quality of home infusion services was not significantly different between home infusion patients who administer Ig by either the IV or SC method of administration.
Key Words
Home infusion, patient satisfaction, subcutaneous immune globulin, immunoglobulin, SCIG
Introduction
Immune globulin (Ig) preparations are administered to patients to treat a variety of diagnoses. Originally developed to increase and maintain IgG levels in patients with primary or acquired antibody deficiencies, immune globulin preparations are also part of the treatment plan for autoimmune or connective tissue disorders, neurologic diseases, and inflammatory conditions.1 A study of Ig utilization patterns of commercially insured and Medicare populations in the United States from 2009 through 2019 found that the number of Ig recipients grew by 71% (commercially insured) and 102% (Medicare).1 The study found that the increase in utilization was primarily driven by a rise in the number of enrollees receiving Ig. Over the timeframe studied, the prevalence of immunodeficiency more than tripled in the commercially insured group and doubled in the Medicare group. Patient diagnoses were classified into clinical conditions, and when studying utilization patterns, researchers found a high proportion of patients diagnosed with clinical conditions that need more frequent and higher dosages for efficacy.1 Another study comparing global data from 2013 to 2021 found considerable growth in the number of patients diagnosed and treated with Ig was attributed to newborn screening, implementing education and awareness activities, molecular diagnosis, and increased availability of genetic diagnostics.2
A review of the literature revealed patient satisfaction data specific to immune globulin therapy. For example, combined data from 2 trials with 113 patients enrolled, measured treatment satisfaction using Ig administered intravenously (IV) for 3 consecutive months in a clinic site of care followed by greater than 11 months of subcutaneous (SC) Ig administration at home. Results showed patients valued the convenience of the home site of care over the hospital site of care, and there was no difference in patient satisfaction concerning therapy-related problems between the IV and SC administration methods.3 The Centers for Medicare and Medicaid Services (CMS) Updated Interim Report to Congress, which focused on years 2014-2020, analyzed patient feedback from participants enrolled in a demonstration project that provides bundled payment for supplies and services for home administration of IVIG.4 Findings from the survey showed that 71% of enrolled patients reported better access to Ig treatments than non-enrollees and listed advantages of home IVIG, including reduced transportation barriers, reduced risk of infection, increased treatment adherence, and one-on-one nursing care. Compared to non-enrollees, patients enrolled in the home IVIG demonstration project reported being in better health overall and found a significant drop in self-reported serious health issues related to their immunodeficiency.4
Considering Ig treatment requires repetitive infusions, patient preferences were studied related to Ig administration. Patients preferred SC over IV for independence and less adverse drug reactions, and patients preferred clinician-administered IV treatments when SC compliance was low.5 Self-administration of SCIG required more training, education, and individual responsibility, which positively influenced adherence.5 Convenience and global satisfaction were similar across both IV and SC administration groups. Patients who transitioned from IV to SC experienced a change from hospital-based to home-based patient administration. The study found improved perceptions in general health evaluated over 12 months, including improvements in pain and vitality assessments. The patients reported a decrease in the number of missed work and school days. The positive outcomes were associated with better training experience, infusion efficiency and longer-term therapy patients, which highlight the importance of continually offering patients information and choice of infusion options.6
Due to the dramatic growth of Ig therapy in the home, there is a need for more valid and comprehensive patient satisfaction data about the home infusion experience that can be used to improve patient care and outcomes. The objective of this research is to analyze IVIG and SCIG patient satisfaction survey data. This study will evaluate patient satisfaction similarities and differences between IVIG and SCIG that could be attributed to pharmacy services, patient administration, and nursing related factors.
Methods
Study Design
To determine the level of patient satisfaction among home infusion IVIG and SCIG patients, a descriptive cross-sectional study was performed. A comparison of patient satisfaction outcomes between IV and SC administration of immune globulin was also conducted.
Data Source
The data for this study was a secondary analysis of an existing data set that included no patient identifiers. The original data set was from the National Home Infusion Foundation Benchmarking Program (NHIF) that collects data from home infusion patient satisfaction surveys. The over-arching purpose of the benchmarking program is home infusion quality assurance.
In 2017, NHIF developed a standardized and validated patient satisfaction survey to ensure that patient data could be compared and benchmarked universally.7 Using Delphi methodology, survey questions and response options were written using a 15-member home infusion expert panel to validate and establish consensus for the questions. The validated survey questions were pilot tested and included a phone interview with patients who completed the survey. The final survey included 12 questions with 22 data points, as shown in Appendix A. The survey was made available to the home and specialty infusion industry in 2017.
Home infusion provider locations participated in the NHIF Patient Satisfaction Survey Benchmarking program voluntarily by submitting their patient data quarterly using a formatted data entry Excel® file and an instruction guide that included definitions. All patient identifiers as noted by the Health Insurance Portability and Accountability Act (HIPAA), such as name, phone number, social security number, medical record number, and address, were removed before being entered into the Excel file and submitted to NHIF. To assist in the home infusion provider de-identifying process, a unique data participation code was assigned to each participating location using a third party, and data was submitted using a secure data entry portal that was password protected and available through program registration by the provider. Data was anonymous to NHIF. The data for this study was a secondary analysis of an existing data set used for quality assurance and included no patient identifiers; thus, this study was exempt from full Institutional Review Board (IRB) review.
Data Collection
Starting in 2019, 127,353 home infusion patient satisfaction surveys were submitted to NHIF by 29 home infusion providers across the United States. Of these surveys, 24,159 were completed and returned for a return rate of 18.97%. Of the returned surveys, 326 were from Ig patients, which represents 2.76% of the surveys completed and used in this study.
Analysis
Data was analyzed using IBM SPSS Statistics, Version 29.0.2.0. Patient demographics are reported by frequency and percentage while the results for survey questions are reported by top box score. The top box scoring method accounts for the percentage of respondents who selected the highest-rated option for the given survey question. For example, if the survey response option included Highly Agree, Agree, Uncertain, Disagree, and Highly Disagree, the top box would be Highly Agree and the presented score would be the percentage of patients who chose this option. To determine whether a significant difference (p ≤ .05) exists between the Ig therapy types and the response to each survey question, Fisher’s Exact Test was used for dichotomous questions (Yes/No responses) and Chi-Square was used for Likert scaled questions.
Results
This study analyzed data from 326 immune globulin home infusion patient satisfaction surveys representing 29 home infusion providers across the United States. Not all patient cases included every study variable. For example, patient gender was recorded for 191 individuals, while data for Survey Question 11 were available for 324 patients. Of these surveys, 59.51% (n=194) were from IVIG patients while 40.49% (n=132) were from SCIG patients.
Patient Demographics
When administration type was analyzed by gender, male and female breakdown was nearly equal for the IV group, and there were more females than males in the SC group (Table 1). The mean patient age for IVIG and SCIG was 57.51 (SD=16.94) and 49.01 (SD=23.40) respectively. When the Ig type is cross tabulated by age group, as shown in Table 2, there is a higher percentage of younger age groups that are administered SCIG than the older age groups and vice versa for IVIG.
Ig Patient Satisfaction Survey Results
The most recognized and compared patient satisfaction question in the medical profession is Question 11, “I was satisfied with the overall quality of the services provided.” The top box score (Strongly Agree) for the IVIG patients was 84.38% of the patients strongly agreed with the survey statement. The percentage of SCIG patients who gave the statement a top box score was 86.36%. As noted in Table 3, there was no significant difference (p = .710) between the 2 Ig therapy methods of administration and Question 11. The top 2 response options (Strongly Agree and Agree) for this question are considered favorable. When the 2 percentages are combined, the IVIG patient combined percentage (98.44%) is slightly higher than the SCIG patient combined score of 97.72%, as shown in Table 4.
The 5 survey questions that focused on the patient’s understanding of instructions (Questions 10 a-e), received a top box patient score of 100% by the SCIG patients and scores between 90.79% and 100% for the IVIG patients. There were no significant differences between the 2 Ig groups on these 5 questions. Questions about the operation and cleanliness of the infusion pump (Questions 1 and 2) received top box scores 97.53% and higher from both Ig types. The pharmacy and nursing staff top box ratings by both Ig patient groups were between 92.97% and 96.72% with no significant difference between the groups.
The only survey question that showed a significant difference (p = <.001) between the 2 Ig therapy types was question Q10e, “I understood the instructions provided for how to use the home infusion pump.” All the SCIG patients indicated that they understood the instructions provided while 90.79% of the IVIG patients indicated an understanding, however it is not typical for IVIG patients to self-infuse and manage the pump as a nurse administers IV infusions.
Discussion
This research study found no significant difference (p = .710) in overall patient satisfaction between patients who administer their Ig by either IV or SC routes and found similarly high rates of overall satisfaction. Patient care can be individualized in conjunction with changes in the patient’s clinical or personal situations, and that leads to high rates of patient satisfaction. Study results support patient preferences as a key factor in patient satisfaction. Patient preference for the administration method impacts not only overall satisfaction but also adherence to lifelong treatment. A case report of a patient who was followed through the process of transitioning Ig administration methods from IV to SC and back to IV emphasized the importance of patient choice. The case report highlighted the impact of the administration method on patient lifestyle and how a patient situation can change over time.8 According to an observational study that collected patient preference data using surveys with questions related to IV and SC variables found patients reported that the site of care was the most essential attribute and the route of administration was the least important of the attributes surveyed.9 Another similar study, a prospective observational study, followed adult Ig patients who were monitored over an 18-month duration of Ig treatment. Analysis of the individual health-related quality of life (HRQoL) measures revealed that differences in route and dosing schedules did not impact HRQoL in patients receiving Ig when treatment choice is shared between the patient and prescriber.10
Returned surveys in this study showed a significant difference between IV group (90.79%) and SC group (100%) in the top score response to the survey question, “I understood the instructions provided for how to use the home infusion pump.” The difference is attributed to the IV group having a nurse available at every infusion, and the nurse was the person solely responsible for use of the infusion pump. Patients in the SC group were independent with their infusions and the patient would be the person responsible for use of the infusion pump.
The score of 100% in the SC group is evidence of a high proficiency of teaching and successful use of the infusion pumps for self-administration of SCIG. On a similar question, “The home infusion pump worked properly,” the response from the SC group was also 100%, although not a significant difference from the IV group.
One of the lower scores reported was in the SC group to the question, “The response I received to phone calls of help on the weekends or during evening hours met my needs,” at 77.05% in the SC group and 85.56% in the IV group. Patients who are independently self-administering their Ig will often schedule administration times that are outside of regular business hours. The response to this question may indicate an area where resources are needed to improve the quality of pharmacy or nursing services during these times.
When the IVIG and SCIG overall patient satisfaction (Question 11) scores (84.38% and 86.36%) are compared to the other home infusion therapies, the Ig scores are slightly higher. In a 2020 analysis of all home infusion therapy types aggregated (n=7,381), the top box percentage for overall patient satisfaction was 82.15%.11 This study also revealed that the top box percentage for anti-infective patients (n=3,683) was 83.16%.11 This suggests that Ig patients are slightly more satisfied with the overall quality of the services provided than all other therapy types combined, and when compared separately to anti-infective therapy.
A limitation of this study is the generalizability of data. It is not known if the provider locations represented all regions of the United States since they were self-selected to participate in the NHIF Benchmarking Program. As with any patient satisfaction survey, there is the possibility of social desirability bias where the patient may be hesitant to provide honest answers, or they answer in a way they believe is more socially acceptable. Finally, another limitation is that the data variables of the study did not include detail on the patient diagnosis for their Ig treatment or length of time since diagnosis. Future research could include evaluation and analysis by diagnosis, particularly comparing immune deficiencies to other diseases such as inflammatory conditions or neurologic indications.
Conclusions
Patient satisfaction with overall quality of home infusion services was not significantly different between home infusion patients who administer immune globulin by either the IV or SC method of administration.
Disclosures
Study funded by contributions made to NHIF.
References
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