The Art and Science of Infusion Nursing Carla Duff, MSN, CPNP, CCRP Patty Riley, BAN, RN, CRNI® Annette Zampelli, MSN, CRNP Elyse Murphy, BSN, RN
Participant Survey Results From the Starting Hizentra Administration with Resources and Education (SHARE) Program ABSTRACT Increased use of specialized infusion therapies has necessitated training of health care providers and patients. The Starting Hizentra Administration with Resources and Education (SHARE) program provided 709 US participants with information to educate patients with primary immunodeficiency disease (PIDD) on self-administration of 20% subcutaneous immunoglobulin (SCIG). Postprogram surveys assessed participants’ experience and opinion of 20% SCIG. The most frequent questions about 20% SCIG regarded subcutaneous challenges (29%). Participants stated that all attributes of SCIG were beneficial (51%), and they expressed interest in future programs on non-PIDD diseases (26%). Survey results will assist in future SHARE and other relevant educational program optimization. Key words: nurses, primary immunodeficiency, subcutaneous immunoglobulin, survey
Author Affiliations: University of South Florida, Tampa, Florida (Ms Duff); and CSL Behring LLC, King of Prussia, Pennsylvania (Mss Riley, Zampelli, and Murphy). Carla Duff, MSN, CPNP, CCRP, is a pediatric nurse practitioner in the Division of Pediatric Allergy and Immunology at the University of South Florida/All Children’s Hospital in St. Petersburg, Florida. She has many years of experience with clinical immunology and managing immunoglobulin replacement therapy for primary immunodeficient patients. Patty Riley, BAN, RN, CRNI®, is a medical science liaison in immunology for CSL Behring. She has three decades of clinical experience in adult critical care, neurology, and immunology. DOI: 10.1097/NAN.0000000000000020
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hronic diseases present particular challenges to patients and health care providers because these conditions require treatment over an extended period.1,2 Thus, truly effective management of these diseases allows the patient to maintain a satisfactory quality of life and to control health care costs.1 In addition, a number of chronic illnesses are relatively rare, and so it is difficult for some patients to find local health care providers with experience treating these conditions.3 For these reasons, many patients have assumed a larger role in the management of their own chronic medical conditions. Education and training of patients with chronic diseases encourages a collaborative partnership in their own health care, permitting them greater independence and responsibility for their treatment. Studies have confirmed that patients who are well educated Annette Zampelli, MSN, CRNP, is a medical science liaison with CSL Behring with expertise in immunoglobulin therapies for over 20 years in the disease state areas of immunology, hematologyoncology, neurology, and transplant. Elyse Murphy, BSN, RN, is a medical science liaison with CSL Behring with expertise in immunoglobulin therapies for over 30 years in the disease state areas of immunology, hematology-oncology, neurology, and transplant. Funding Source: This program was funded by CSL Behring. CSL Behring was involved in the program design, analysis, and interpretation of data and provided funding for medical writing assistance. The authors were involved in the program design, analysis, and interpretation of data; critically revised the manuscript; and made the final decision to submit this paper for publication. Conflict of Interest/Disclosure Information: Carla Duff serves on the nurse advisory committee for the Immune Deficiency Foundation and is a nurse consultant for CSL Behring. Elyse Murphy, Patty Riley, and Annette Zampelli are employees of CSL Behring. Corresponding Author: Carla Duff, University of South Florida, 601 5th St South, Box 7890, St. Petersburg, FL 33701 (cduff@ health.usf.edu).
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about their disease and treatment achieve enhanced outcomes.4-6 From a patient perspective, expectation management during the treatment process must be adequately addressed. Nurse educator programs have proven valuable in training nurses to educate patients with chronic conditions,7-9 enabling successful selfmanagement and allaying patients’ concerns about their treatment and disease, and leading to positive outcomes among patients with these conditions.10 Primary immunodeficiency diseases (PIDDs) are a group of chronic conditions that usually require lifelong treatment.1 The most common PIDDs are humoral antibody deficiencies characterized by reduced serum levels of immunoglobulin, leading to recurrent infections.11 Standard treatment consists of purified immunoglobulin administered intravenously (IVIG) or subcutaneously (SCIG).12 A number of advantages of SCIG compared with IVIG have led many patients to choose the SCIG route of administration.13 After an initial training period, during which they are instructed in proper selfadministration procedures with confirmation of proficiency, patients are usually able to perform infusions in the home setting. Self-administration of SCIG requires familiarity with and mastery of the infusion techniques and management of potential injection site reactions. Patients should know what to expect during and after SCIG administration, should be able to communicate clearly with their health care providers, and should understand the importance of treatment flexibility for the possible improvement of the infusion regimen. Patients also need to understand the importance of treatment adherence (including continuation of the prescribed treatment regimen as well as use of proper infusion techniques) and other issues critical to the maintenance of successful therapy. For those patients who are unable or unwilling to self-administer, infusion nurse specialists, or possibly a member of the patient’s family, must continue to administer the treatment. Infusion therapies, such as immunoglobulin administration, have evolved in recent years from relatively rare treatments reserved for critically ill patients to common treatments for a variety of chronic conditions such as autoimmune and neuromuscular diseases, pulmonary arterial hypertension, and diabetes. The expanded use of infusion therapies warrants health care providers’ acquisition of the necessary expertise in order to use these treatments.14 As a pertinent example of this, nurses usually train patients in the self-administration of subcutaneous (SC) medications.1,15 Therefore, it is incumbent on the nurse-educator to be well informed regarding proper infusion techniques and potential side effects of SC administration. This includes having sufficient knowledge of the properties of the medication, the ability to optimize and individualize the infusion regimen in association with the prescriber, and an understanding of the benefits that patients will derive
from treatment. A well-educated nurse is better equipped to manage patient expectations, which has a positive effect on adherence, outcomes, time savings, and cost savings among patients with chronic conditions requiring SC therapy.1,15,16 Nurses also can provide patients with important information regarding PIDD, serve as advocates for patients and families, and assist patients as they gain experience in self-administration. Although other liquid immunoglobulin formulations have been approved, Hizentra (Immune Globulin Subcutaneous [Human], 20% Liquid; CSL Behring LLC) is the only 20% SCIG product approved for the treatment of PIDD.17 To achieve proper training of patients in the self-administration of this formulation, the Starting Hizentra Administration with Resources and Education (SHARE) program was developed and implemented to educate nurses on the fundamental aspects of PIDD and 20% SCIG infusion regimens. After each SHARE program session, participants were surveyed to evaluate their perceptions about the quality of the SHARE program and SCIG. The results of the compiled surveys are presented here.
METHODS SHARE Program The SHARE program was conducted throughout the United States at the request of interested parties, including nurses, physicians, and pharmacists. The primary reason for development of the program was to enable nurses to properly educate patients to selfadminister SCIG. The SHARE program was therefore designed to 1. Provide an overview of PIDD and available therapies 2. Inform participants about the nurse’s role in administration of 20% SCIG 3. Teach techniques for patient self-administration of 20% SCIG The SHARE program begins by presenting participants with clinical background material on PIDD. The number and types of PIDDs are provided to SHARE program participants along with representative examples of specific disorders, such as common variable immunodeficiency and X-linked agammaglobulinemia. The program emphasizes the susceptibility of patients with PIDD to infectious diseases and the increased incidence of autoimmune disorders and malignancy, and it addresses the warning signs and hallmarks of PIDD. The SHARE program provides data from pivotal clinical trials demonstrating the safety and efficacy of SCIG in the prevention of serious bacterial infections in patients with PIDD and explains the most commonly
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reported adverse events. The importance of establishing a collaborative partnership between patients and their caregivers and of managing patients’ expectations throughout their treatment is highlighted. The program provides effective teaching tips and reviews factors that promote patient learning. Of primary importance during the SHARE program is teaching the practicalities of 20% SCIG infusion. These techniques are presented in detail and enable nurses to become comfortable with performing and teaching the entire skill set to patients with PIDD. Also reinforced is the need for continued patient monitoring after patients begin self-administration at home, as adjustments to the infusion process may be necessary, in consultation with the prescriber, to improve tolerability and the well-being of patients. SHARE program participants are informed of a number of online resources that are available to patients with PIDD, the parents of children with this condition, and health care professionals wishing to learn more about the disease. The ultimate aim of the program is to make SCIG treatment user friendly, thereby improving patient outcomes. SHARE Program Survey At the conclusion of each SHARE program session, participants were asked to complete a written survey to evaluate their clinical experience with PIDD, their opinion of various aspects of the treatment, and their opinion of the SHARE program itself. Survey questions included participants’ experience in treating or administering SCIG to patients with PIDD, the most frequent questions participants had regarding 20% SCIG, the most beneficial attributes of this treatment, and areas for future educational or outreach programs. Excerpted survey questions are listed in Table 1. One question asked about participant experience with Vivaglobin (Immune Globulin Subcutaneous [Human] 16% Liquid; CSL Behring), an SCIG that is no longer available in the United States.
TABLE 1
SHARE Program Survey Questions Survey Question
Total Interpretable Responses
1. In your practice, how many patients are currently being treated for PIDD?a
256
2. In your practice, how many patients are currently being treated for PIDD? Number on SCIG.a
190
3. In your practice, how many patients are currently being treated for PIDD? Number on IVIG therapy.a
234
4. Have you ever managed a patient on 16% immune globulin subcutaneous (human)? If yes, how many?a,b
104
5. Based on this program, will you be more confident in your ability to instruct and manage patients on 20% SCIG? Yes or No
425
6. Did the program meet your expectations? (1 = poor; 2 = fair; 3 = average; 4 = good; 5 = excellent)
494
7. How well did the program meet the following objectives? (1 = poor; 2 = fair; 3 = average; 4 = good; 5 = excellent) • Learning about management of PIDD with 20% SCIG
511
• Understanding the nurse’s role in subcutaneous administration of 20% SCIG
502
• Teaching techniques for patient selfadministration of 20% SCIG
504
8. What is your top question or concern about 20% SCIG administration?c
224
9. In general, what do you find most beneficial about 20% SCIG? A. IgG steady-state levels; B. Patient independence/convenience; C. Improved tolerability over IVIG; D. Other, please specify.
155
Data Analysis
10. What are your areas of interest for future educational programs/offerings?d
100
Researchers analyzed survey data from SHARE programs conducted from July 12, 2010, through June 8, 2011. Participants provided the number of patients with PIDD that they treated, along with the number who received IVIG or SCIG (Questions 1-3). Yes or no answers to Question 5, which addressed participants’ confidence in the instruction of SCIG techniques, were tabulated according to the answer. The answers to Questions 6 and 7, in which participants were asked to rate the program, were tabulated according to the strength of the response (1 = poor through 5 = excellent). Write-in answers to Questions 8 and 10 were arranged by category. For Question 8, the category of
11. Please provide recommendations to improve the SHARE nurse training program.
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Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin; SHARE, Starting Hizentra Administration with Resources and Education. a The percentage of participants who treated an arbitrary cutoff of ≤5 was calculated. b 16% SCIG (Vivaglobin, CSL Behring) is an SCIG that is no longer marketed in the United States. c Write-in answers were placed in one of the following categories: infusion regimen, physical/chemical properties, SC challenges, adverse events, efficacy. d Write-in answers were placed in one of the following categories: diseases outside of PIDD, SCIG outside of PIDD, patient advocacy, nursing outreach programs, 20% SCIG continuation/updates, miscellaneous.
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infusion regimen included concerns such as infusion sites, rate, and volume; the category of physical/chemical properties included factors such as immunoglobulin A content, viscosity, and storage; and the category of SC challenges included product availability and cost, patient assistance, patient and nurse education, patient compliance, and similar issues. Answers to Question 9 were added and presented graphically. Write-in answers to Question 11 regarding recommendations for improvements to the SHARE program were not categorized but are presented using representative examples.
RESULTS Participants A total of 709 attendees participated in the SHARE program, the majority of whom were nurses, although physicians and participants in pharmacy-related positions were also represented (Table 2). Participants practiced primarily in urban locations, in all regions of the United States (Table 2). Nurses represented medical practices and home infusion agencies (Table 2), with SCIG and PIDD experience ranging from none to extensive. Among responding program participants, 67% (127 of 190 interpretable responses) reported that they had ≤5 patients in their practice being treated with SCIG. Postprogram Survey Responses
TABLE 2
SHARE Program Participants Characteristic Degree/license RN
208 (32.7)
BS/BSN
15 (2.4)
LPN/LVN
28 (4.4)
APN
43 (6.8)
Pharmacy related
47 (7.4)
Physician
13 (2.0)
Other Unknown
46 (7.2) 237 (37.2)
Geographic region Northeast
141 (19.9)
South
370 (52.2)
Midwest
122 (17.2)
West
76 (10.7)
Practice location Urban
308 (53.2)
Rural
198 (34.2)
Suburban
73 (12.6)
Practice setting Hospital
Not all program participants answered every survey question, and not all survey responses were interpretable on the basis of the individual question. Therefore, only interpretable responses were used in final survey tabulations. Of the 709 participants, 72% answered at least 1 survey question listed in Table 1. The majority of respondents (96%; 408 of 425 responses) stated that their confidence in instructing and managing patients on 20% SCIG was increased after participation in the SHARE program. Most respondents (80%; 395 of 494 responses; Table 3) considered the SHARE program “excellent” at meeting their expectations. The individual objectives of the program were also given “excellent” ratings by the majority of respondents (Table 3). The most frequent question regarding 20% SCIG among responding participants related to SC challenges such as product availability and patient selection (29%; 66 of 224 interpretable responses; Figure 1). Respondents also had questions regarding the infusion regimen (ie, volume, rate, conversion from other products) (21%; 47 of 224) and safety (18%; 41 of 224). Only 3% of the questions (6 of 224) related to the efficacy of 20% SCIG. Many responding participants had no questions (24%; 54 of 224) regarding the product.
Number (%)
87 (18.7)
Outpatient/physician office
120 (25.8)
Home infusion
259 (55.6)
Abbreviations: APN, advanced practice nurse; BS, bachelor of science; BSN, bachelor of science in nursing; LPN, licensed practical nurse; LVN, licensed vocational nurse; RN, registered nurse.
When questioned about the benefits of SCIG, the majority of respondents (92%; 142 of 155 interpretable responses) selected more than 1 benefit. More than half of the participants (51%; 79 of 155) considered all presented attributes of SCIG to be beneficial (Figure 2). The combination of immunoglobulin G (IgG) serum steadystate levels and patient independence/convenience were chosen as the most beneficial attributes of SCIG by 31% (48 of 155) of respondents; when they chose only a single beneficial attribute, patient independence/convenience was most frequently cited (6%; 9 of 155). No single area for future educational programs dominated in participant responses (Figure 3); the most frequently chosen area was disease state information in areas other than PIDD (26%; 26 of 100 interpretable responses). Respondents also expressed interest in nursing outreach programs (24%; 24 of 100) such as actual demonstrations, hands-on training, or instructional DVDs, and continuing
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TABLE 3
Percentage of Participant Responses to the SHARE Program Survey Questions 6 and 7 Question
n
Excellent, %
Good, %
Average, %
Fair, %
Poor, %
494
80.0
18.0
2.0
0
0
1. Learning about management of PIDD with 20% SCIG
511
79.1
20.2
1.0
0
0
2. Understanding the nurse’s role in SC administration of 20% SCIG
502
81.9
17.5
0.6
0
0
3. Teaching techniques for patient self-administration of 20% SCIG
504
78.8
19.4
1.8
0
0
Did the program meet your expectations? How well did the program meet the following objectives?
Abbreviations: PIDD, primary immunodeficiency disease; SC, subcutaneous; SCIG, subcutaneous immunoglobulin.
updates on 20% SCIG (20%; 20 of 100). Programs on the use of SCIG for non-PIDD conditions were chosen by only 4% (4 of 100) of respondents. Among the comments or suggestions for improving the SHARE program were “possibly seeing an actual infusion,” “dosing vs rate vs volume calculations,” and “site reaction pictures/troubleshooting.”
DISCUSSION Patients with chronic conditions such as PIDD need to be educated in many areas, including treatment expectations (short- and long-term) and options, the importance of adherence, and treatment administration. To be able to adequately educate the patient, the health care provider also needs proper training. Expertise in infusion therapies has become a specialized practice among infusion nurses and other health care providers who may perform this service. The SHARE program was
Figure 1 SHARE program survey participant responses to Question 8, “What is your top question or concern about 20% SCIG administration?” Abbreviations: SC, subcutaneous; SCIG, subcutaneous immunoglobulin.
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designed and implemented to ensure that these groups possess adequate knowledge regarding PIDD, 20% SCIG, and the recommended administration procedures. Importantly, 96% of the participants indicated that the program increased their confidence in treating and managing PIDD patients. In general, participants felt that the program met their expectations and achieved its objectives. Results of the surveys taken by program participants will allow designers of this and future programs to address any potential deficiencies in the presentation as well as recognize areas that are of particular interest to those charged with educating patients. Optimizing patient education facilitates healthy patient outcomes by providing the necessary skills needed in chronic care management of PIDD. This survey of SHARE program participants revealed that the benefits of SCIG are generally appreciated by nurses. One such benefit is the relatively constant IgG
Figure 2 SHARE program survey participant responses to Question 9, “In general, what do you find most beneficial about 20% SCIG?” Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; SCIG, subcutaneous immunoglobulin.
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Figure 3 SHARE program survey participant responses to Question 10, “What are your areas of interest for future educational programs/ offerings?” Abbreviations: PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin.
serum level achieved with SCIG, or “steady-state” (Figure 4).18,19 The more frequent dosing regimen and slower absorption of IgG into the systemic circulation after SC administration contribute to this steady-state effect. In contrast, high peaks and low troughs occur with IVIG therapy; the risk of infection may increase during the troughs.20 Breakthrough infections including cases of pneumonia are generally reduced with higher trough levels in patients receiving immunoglobulin replacement therapy, although a threshold IgG value required to prevent infections appears highly individualized.20-22 In addition, there is evidence that steady-state IgG is associated with an increase in patients’ health perceptions and vitality.19,23 Other benefits of SCIG therapy are increased patient independ-
Figure 4 Serum immunoglobulin levels after infusion of SCIG and IVIG. Data from a 34-year-old male with X-linked agammaglobulinemia receiving (A) a single 5% IVIG infusion of 30 g (solid line shows the average over the 21-day period) and (B) 16% SCIG of 12 g every 7 days for 21 days. Reproduced with permission.28 Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; SCIG, subcutaneous immunoglobulin.
ence and convenience associated with at-home administration,23,24 as well as a decreased risk of systemic reactions compared with IVIG.25,26 Some participants also wrote in their own responses indicating that 20% SCIG has further benefits of relatively lower volumes and infusion times compared with lower concentration products. The majority of participants recognized the importance of steady-state serum levels: 84% included this in their response. Less than 3% of SHARE program participants expressed concern with the efficacy of 20% SCIG. Nevertheless, the survey indicated that a substantial number of participants (20%) desired additional or continued information regarding the specifics of 20% SCIG infusions. Participants also expressed interest in additional educational and outreach programs and, in particular, programs regarding nonPIDD diseases. Education and training programs have demonstrated value for patients requiring SC injections for other chronic, non-PIDD conditions. A nurse-led training program has been shown to enhance the ability of patients with injection anxiety to self-administer interferon β-1a for their multiple sclerosis.27 Among a group of children in Scotland with Crohn’s disease, 94% were able to switch from hospital-based treatment to at-home methotrexate therapy after nurse-led instruction in SC administration, which resulted in a median savings of 41.6 hours per year of travel time and an annual cost savings of GB £730 (US $1376) per patient.16 The proper training of nurses will positively affect patients who choose SC treatment; an educated nurse is able to educate the patient, thus achieving better patient (US $1376) outcomes. This has been demonstrated in diabetes cases, where self-management training that included certified diabetes educators resulted in patient cost-savings, improved treatment adherence, and improved blood glucose monitoring.10 The inclusion of participants from various practice settings was a particular strength of the SHARE program. For example, participants who are employed in a hospital setting are less likely to perform SCIG infusions themselves, but the knowledge gained from attending the program provides valuable information needed to help determine whether SCIG is the appropriate treatment option for an individual patient. In addition, the program allows for training a large audience with diverse backgrounds. It is important that the focus of the SHARE program was to train the trainers—the nurses responsible for educating patients with PIDD who will self-administer SCIG. This assists in the establishment of a collegial network among nurse educators and will be important for career support and information sharing among this group of specialty nurses. Certain limitations were associated with this study. The survey was not completed by all participants. No pre- or postprogram evaluations were given to determine
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the increase in practical knowledge gained from the program. In addition, portions of the survey should be revised to better differentiate the various SCIG attributes. One limitation of the SHARE program itself is that no hands-on experience was gained during participation in the program, which was a suggestion for improvement by a few participants. Also, the lag time occurring between SHARE program attendance and actual implementation of patient training is problematic, because participants may forget portions of the material, and, to date, there is no long-term follow-up for the program. The SHARE program serves as a pilot for chronic diseases in which treatment is shifted to patient-controlled self-administration. This empowers patients to exert control over their own treatment. Therefore, the continuum of care with chronic disease transitions from health care system dependence to greater patient independence and autonomy. The partnership between better-educated, confident patients and health care practitioners will result in improved outcomes for the population with PIDD.
9.
10.
11.
12.
13.
14.
15.
ACKNOWLEDGMENTS
16.
Medical editorial support was provided by Daniel McCallus, PhD, at Complete Publication Solutions, LLC; this support was funded by CSL Behring LLC, King of Prussia, Pennsylvania.
17.
REFERENCES
18.
1. Burton J, Murphy E, Riley P. Primary immunodeficiency disease: a model for case management of chronic diseases. Prof Case Manag. 2010;15(1):5-10, 12-14. 2. Holman H, Lorig K. Patient self-management: a key to effectiveness and efficiency in care of chronic disease. Public Health Rep. 2004;119(3):239-243. 3. Bellinger JD, Hassan RM, Rivers PA, Cheng Q, Williams E, Glover SH. Specialty care use in US patients with chronic diseases. Int J Environ Res Public Health. 2010;7(3):975-990. 4. Ciccone MM, Aquilino A, Cortese F, et al. Feasibility and effectiveness of a disease and care management model in the primary health care system for patients with heart failure and diabetes (Project Leonardo). Vasc Health Risk Manag. 2010;6: 297-305. 5. Wong FK, Chow SK, Chan TM. Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial. Int J Nurs Stud. 2010;47(3):268-278. 6. Davies MJ, Heller S, Skinner TC, et al. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ. 2008;336(7642):491-495. 7. Ferrell BR, Grant M, Ritchey KJ, Ropchan R, Rivera LM. The pain resource nurse training program: a unique approach to pain management. J Pain Symptom Manage. 1993;8(8):549-556. 8. Lineker SC, Bell MJ, Badley EM. Evaluation of an interprofessional educational intervention to improve the use of
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experiences of subcutaneous self-infusions and home therapy. J Adv Nurs. 1995;21(5):917-927. 25. Gardulf A, Andersen V, Bjorkander J, et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995;345(8946):365-369. 26. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of
intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20(2):94-100. 27. Mohr DC, Cox D, Merluzzi N. Self-injection anxiety training: a treatment for patients unable to self-inject injectable medications. Mult Scler. 2005;11(2):182-185. 28. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112(1):1-7.
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Participant Survey Results From the Starting Hizentra Administration with Resources and Education (SHARE) Program ABSTRACT Increased use of specialized infusion therapies has necessitated training of health care providers and patients. The Starting Hizentra Administration with Resources and Education (SHARE) program provided 709 US participants with information to educate patients with primary immunodeficiency disease (PIDD) on self-administration of 20% subcutaneous immunoglobulin (SCIG). Postprogram surveys assessed participants’ experience and opinion of 20% SCIG. The most frequent questions about 20% SCIG regarded subcutaneous challenges (29%). Participants stated that all attributes of SCIG were beneficial (51%), and they expressed interest in future programs on non-PIDD diseases (26%). Survey results will assist in future SHARE and other relevant educational program optimization. Key words: nurses, primary immunodeficiency, subcutaneous immunoglobulin, survey
Author Affiliations: University of South Florida, Tampa, Florida (Ms Duff); and CSL Behring LLC, King of Prussia, Pennsylvania (Mss Riley, Zampelli, and Murphy). Carla Duff, MSN, CPNP, CCRP, is a pediatric nurse practitioner in the Division of Pediatric Allergy and Immunology at the University of South Florida/All Children’s Hospital in St. Petersburg, Florida. She has many years of experience with clinical immunology and managing immunoglobulin replacement therapy for primary immunodeficient patients. Patty Riley, BAN, RN, CRNI®, is a medical science liaison in immunology for CSL Behring. She has three decades of clinical experience in adult critical care, neurology, and immunology. DOI: 10.1097/NAN.0000000000000020
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hronic diseases present particular challenges to patients and health care providers because these conditions require treatment over an extended period.1,2 Thus, truly effective management of these diseases allows the patient to maintain a satisfactory quality of life and to control health care costs.1 In addition, a number of chronic illnesses are relatively rare, and so it is difficult for some patients to find local health care providers with experience treating these conditions.3 For these reasons, many patients have assumed a larger role in the management of their own chronic medical conditions. Education and training of patients with chronic diseases encourages a collaborative partnership in their own health care, permitting them greater independence and responsibility for their treatment. Studies have confirmed that patients who are well educated Annette Zampelli, MSN, CRNP, is a medical science liaison with CSL Behring with expertise in immunoglobulin therapies for over 20 years in the disease state areas of immunology, hematologyoncology, neurology, and transplant. Elyse Murphy, BSN, RN, is a medical science liaison with CSL Behring with expertise in immunoglobulin therapies for over 30 years in the disease state areas of immunology, hematology-oncology, neurology, and transplant. Funding Source: This program was funded by CSL Behring. CSL Behring was involved in the program design, analysis, and interpretation of data and provided funding for medical writing assistance. The authors were involved in the program design, analysis, and interpretation of data; critically revised the manuscript; and made the final decision to submit this paper for publication. Conflict of Interest/Disclosure Information: Carla Duff serves on the nurse advisory committee for the Immune Deficiency Foundation and is a nurse consultant for CSL Behring. Elyse Murphy, Patty Riley, and Annette Zampelli are employees of CSL Behring. Corresponding Author: Carla Duff, University of South Florida, 601 5th St South, Box 7890, St. Petersburg, FL 33701 (cduff@ health.usf.edu).
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about their disease and treatment achieve enhanced outcomes.4-6 From a patient perspective, expectation management during the treatment process must be adequately addressed. Nurse educator programs have proven valuable in training nurses to educate patients with chronic conditions,7-9 enabling successful selfmanagement and allaying patients’ concerns about their treatment and disease, and leading to positive outcomes among patients with these conditions.10 Primary immunodeficiency diseases (PIDDs) are a group of chronic conditions that usually require lifelong treatment.1 The most common PIDDs are humoral antibody deficiencies characterized by reduced serum levels of immunoglobulin, leading to recurrent infections.11 Standard treatment consists of purified immunoglobulin administered intravenously (IVIG) or subcutaneously (SCIG).12 A number of advantages of SCIG compared with IVIG have led many patients to choose the SCIG route of administration.13 After an initial training period, during which they are instructed in proper selfadministration procedures with confirmation of proficiency, patients are usually able to perform infusions in the home setting. Self-administration of SCIG requires familiarity with and mastery of the infusion techniques and management of potential injection site reactions. Patients should know what to expect during and after SCIG administration, should be able to communicate clearly with their health care providers, and should understand the importance of treatment flexibility for the possible improvement of the infusion regimen. Patients also need to understand the importance of treatment adherence (including continuation of the prescribed treatment regimen as well as use of proper infusion techniques) and other issues critical to the maintenance of successful therapy. For those patients who are unable or unwilling to self-administer, infusion nurse specialists, or possibly a member of the patient’s family, must continue to administer the treatment. Infusion therapies, such as immunoglobulin administration, have evolved in recent years from relatively rare treatments reserved for critically ill patients to common treatments for a variety of chronic conditions such as autoimmune and neuromuscular diseases, pulmonary arterial hypertension, and diabetes. The expanded use of infusion therapies warrants health care providers’ acquisition of the necessary expertise in order to use these treatments.14 As a pertinent example of this, nurses usually train patients in the self-administration of subcutaneous (SC) medications.1,15 Therefore, it is incumbent on the nurse-educator to be well informed regarding proper infusion techniques and potential side effects of SC administration. This includes having sufficient knowledge of the properties of the medication, the ability to optimize and individualize the infusion regimen in association with the prescriber, and an understanding of the benefits that patients will derive
from treatment. A well-educated nurse is better equipped to manage patient expectations, which has a positive effect on adherence, outcomes, time savings, and cost savings among patients with chronic conditions requiring SC therapy.1,15,16 Nurses also can provide patients with important information regarding PIDD, serve as advocates for patients and families, and assist patients as they gain experience in self-administration. Although other liquid immunoglobulin formulations have been approved, Hizentra (Immune Globulin Subcutaneous [Human], 20% Liquid; CSL Behring LLC) is the only 20% SCIG product approved for the treatment of PIDD.17 To achieve proper training of patients in the self-administration of this formulation, the Starting Hizentra Administration with Resources and Education (SHARE) program was developed and implemented to educate nurses on the fundamental aspects of PIDD and 20% SCIG infusion regimens. After each SHARE program session, participants were surveyed to evaluate their perceptions about the quality of the SHARE program and SCIG. The results of the compiled surveys are presented here.
METHODS SHARE Program The SHARE program was conducted throughout the United States at the request of interested parties, including nurses, physicians, and pharmacists. The primary reason for development of the program was to enable nurses to properly educate patients to selfadminister SCIG. The SHARE program was therefore designed to 1. Provide an overview of PIDD and available therapies 2. Inform participants about the nurse’s role in administration of 20% SCIG 3. Teach techniques for patient self-administration of 20% SCIG The SHARE program begins by presenting participants with clinical background material on PIDD. The number and types of PIDDs are provided to SHARE program participants along with representative examples of specific disorders, such as common variable immunodeficiency and X-linked agammaglobulinemia. The program emphasizes the susceptibility of patients with PIDD to infectious diseases and the increased incidence of autoimmune disorders and malignancy, and it addresses the warning signs and hallmarks of PIDD. The SHARE program provides data from pivotal clinical trials demonstrating the safety and efficacy of SCIG in the prevention of serious bacterial infections in patients with PIDD and explains the most commonly
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reported adverse events. The importance of establishing a collaborative partnership between patients and their caregivers and of managing patients’ expectations throughout their treatment is highlighted. The program provides effective teaching tips and reviews factors that promote patient learning. Of primary importance during the SHARE program is teaching the practicalities of 20% SCIG infusion. These techniques are presented in detail and enable nurses to become comfortable with performing and teaching the entire skill set to patients with PIDD. Also reinforced is the need for continued patient monitoring after patients begin self-administration at home, as adjustments to the infusion process may be necessary, in consultation with the prescriber, to improve tolerability and the well-being of patients. SHARE program participants are informed of a number of online resources that are available to patients with PIDD, the parents of children with this condition, and health care professionals wishing to learn more about the disease. The ultimate aim of the program is to make SCIG treatment user friendly, thereby improving patient outcomes. SHARE Program Survey At the conclusion of each SHARE program session, participants were asked to complete a written survey to evaluate their clinical experience with PIDD, their opinion of various aspects of the treatment, and their opinion of the SHARE program itself. Survey questions included participants’ experience in treating or administering SCIG to patients with PIDD, the most frequent questions participants had regarding 20% SCIG, the most beneficial attributes of this treatment, and areas for future educational or outreach programs. Excerpted survey questions are listed in Table 1. One question asked about participant experience with Vivaglobin (Immune Globulin Subcutaneous [Human] 16% Liquid; CSL Behring), an SCIG that is no longer available in the United States.
TABLE 1
SHARE Program Survey Questions Survey Question
Total Interpretable Responses
1. In your practice, how many patients are currently being treated for PIDD?a
256
2. In your practice, how many patients are currently being treated for PIDD? Number on SCIG.a
190
3. In your practice, how many patients are currently being treated for PIDD? Number on IVIG therapy.a
234
4. Have you ever managed a patient on 16% immune globulin subcutaneous (human)? If yes, how many?a,b
104
5. Based on this program, will you be more confident in your ability to instruct and manage patients on 20% SCIG? Yes or No
425
6. Did the program meet your expectations? (1 = poor; 2 = fair; 3 = average; 4 = good; 5 = excellent)
494
7. How well did the program meet the following objectives? (1 = poor; 2 = fair; 3 = average; 4 = good; 5 = excellent) • Learning about management of PIDD with 20% SCIG
511
• Understanding the nurse’s role in subcutaneous administration of 20% SCIG
502
• Teaching techniques for patient selfadministration of 20% SCIG
504
8. What is your top question or concern about 20% SCIG administration?c
224
9. In general, what do you find most beneficial about 20% SCIG? A. IgG steady-state levels; B. Patient independence/convenience; C. Improved tolerability over IVIG; D. Other, please specify.
155
Data Analysis
10. What are your areas of interest for future educational programs/offerings?d
100
Researchers analyzed survey data from SHARE programs conducted from July 12, 2010, through June 8, 2011. Participants provided the number of patients with PIDD that they treated, along with the number who received IVIG or SCIG (Questions 1-3). Yes or no answers to Question 5, which addressed participants’ confidence in the instruction of SCIG techniques, were tabulated according to the answer. The answers to Questions 6 and 7, in which participants were asked to rate the program, were tabulated according to the strength of the response (1 = poor through 5 = excellent). Write-in answers to Questions 8 and 10 were arranged by category. For Question 8, the category of
11. Please provide recommendations to improve the SHARE nurse training program.
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Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin; SHARE, Starting Hizentra Administration with Resources and Education. a The percentage of participants who treated an arbitrary cutoff of ≤5 was calculated. b 16% SCIG (Vivaglobin, CSL Behring) is an SCIG that is no longer marketed in the United States. c Write-in answers were placed in one of the following categories: infusion regimen, physical/chemical properties, SC challenges, adverse events, efficacy. d Write-in answers were placed in one of the following categories: diseases outside of PIDD, SCIG outside of PIDD, patient advocacy, nursing outreach programs, 20% SCIG continuation/updates, miscellaneous.
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infusion regimen included concerns such as infusion sites, rate, and volume; the category of physical/chemical properties included factors such as immunoglobulin A content, viscosity, and storage; and the category of SC challenges included product availability and cost, patient assistance, patient and nurse education, patient compliance, and similar issues. Answers to Question 9 were added and presented graphically. Write-in answers to Question 11 regarding recommendations for improvements to the SHARE program were not categorized but are presented using representative examples.
RESULTS Participants A total of 709 attendees participated in the SHARE program, the majority of whom were nurses, although physicians and participants in pharmacy-related positions were also represented (Table 2). Participants practiced primarily in urban locations, in all regions of the United States (Table 2). Nurses represented medical practices and home infusion agencies (Table 2), with SCIG and PIDD experience ranging from none to extensive. Among responding program participants, 67% (127 of 190 interpretable responses) reported that they had ≤5 patients in their practice being treated with SCIG. Postprogram Survey Responses
TABLE 2
SHARE Program Participants Characteristic Degree/license RN
208 (32.7)
BS/BSN
15 (2.4)
LPN/LVN
28 (4.4)
APN
43 (6.8)
Pharmacy related
47 (7.4)
Physician
13 (2.0)
Other Unknown
46 (7.2) 237 (37.2)
Geographic region Northeast
141 (19.9)
South
370 (52.2)
Midwest
122 (17.2)
West
76 (10.7)
Practice location Urban
308 (53.2)
Rural
198 (34.2)
Suburban
73 (12.6)
Practice setting Hospital
Not all program participants answered every survey question, and not all survey responses were interpretable on the basis of the individual question. Therefore, only interpretable responses were used in final survey tabulations. Of the 709 participants, 72% answered at least 1 survey question listed in Table 1. The majority of respondents (96%; 408 of 425 responses) stated that their confidence in instructing and managing patients on 20% SCIG was increased after participation in the SHARE program. Most respondents (80%; 395 of 494 responses; Table 3) considered the SHARE program “excellent” at meeting their expectations. The individual objectives of the program were also given “excellent” ratings by the majority of respondents (Table 3). The most frequent question regarding 20% SCIG among responding participants related to SC challenges such as product availability and patient selection (29%; 66 of 224 interpretable responses; Figure 1). Respondents also had questions regarding the infusion regimen (ie, volume, rate, conversion from other products) (21%; 47 of 224) and safety (18%; 41 of 224). Only 3% of the questions (6 of 224) related to the efficacy of 20% SCIG. Many responding participants had no questions (24%; 54 of 224) regarding the product.
Number (%)
87 (18.7)
Outpatient/physician office
120 (25.8)
Home infusion
259 (55.6)
Abbreviations: APN, advanced practice nurse; BS, bachelor of science; BSN, bachelor of science in nursing; LPN, licensed practical nurse; LVN, licensed vocational nurse; RN, registered nurse.
When questioned about the benefits of SCIG, the majority of respondents (92%; 142 of 155 interpretable responses) selected more than 1 benefit. More than half of the participants (51%; 79 of 155) considered all presented attributes of SCIG to be beneficial (Figure 2). The combination of immunoglobulin G (IgG) serum steadystate levels and patient independence/convenience were chosen as the most beneficial attributes of SCIG by 31% (48 of 155) of respondents; when they chose only a single beneficial attribute, patient independence/convenience was most frequently cited (6%; 9 of 155). No single area for future educational programs dominated in participant responses (Figure 3); the most frequently chosen area was disease state information in areas other than PIDD (26%; 26 of 100 interpretable responses). Respondents also expressed interest in nursing outreach programs (24%; 24 of 100) such as actual demonstrations, hands-on training, or instructional DVDs, and continuing
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TABLE 3
Percentage of Participant Responses to the SHARE Program Survey Questions 6 and 7 Question
n
Excellent, %
Good, %
Average, %
Fair, %
Poor, %
494
80.0
18.0
2.0
0
0
1. Learning about management of PIDD with 20% SCIG
511
79.1
20.2
1.0
0
0
2. Understanding the nurse’s role in SC administration of 20% SCIG
502
81.9
17.5
0.6
0
0
3. Teaching techniques for patient self-administration of 20% SCIG
504
78.8
19.4
1.8
0
0
Did the program meet your expectations? How well did the program meet the following objectives?
Abbreviations: PIDD, primary immunodeficiency disease; SC, subcutaneous; SCIG, subcutaneous immunoglobulin.
updates on 20% SCIG (20%; 20 of 100). Programs on the use of SCIG for non-PIDD conditions were chosen by only 4% (4 of 100) of respondents. Among the comments or suggestions for improving the SHARE program were “possibly seeing an actual infusion,” “dosing vs rate vs volume calculations,” and “site reaction pictures/troubleshooting.”
DISCUSSION Patients with chronic conditions such as PIDD need to be educated in many areas, including treatment expectations (short- and long-term) and options, the importance of adherence, and treatment administration. To be able to adequately educate the patient, the health care provider also needs proper training. Expertise in infusion therapies has become a specialized practice among infusion nurses and other health care providers who may perform this service. The SHARE program was
Figure 1 SHARE program survey participant responses to Question 8, “What is your top question or concern about 20% SCIG administration?” Abbreviations: SC, subcutaneous; SCIG, subcutaneous immunoglobulin.
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designed and implemented to ensure that these groups possess adequate knowledge regarding PIDD, 20% SCIG, and the recommended administration procedures. Importantly, 96% of the participants indicated that the program increased their confidence in treating and managing PIDD patients. In general, participants felt that the program met their expectations and achieved its objectives. Results of the surveys taken by program participants will allow designers of this and future programs to address any potential deficiencies in the presentation as well as recognize areas that are of particular interest to those charged with educating patients. Optimizing patient education facilitates healthy patient outcomes by providing the necessary skills needed in chronic care management of PIDD. This survey of SHARE program participants revealed that the benefits of SCIG are generally appreciated by nurses. One such benefit is the relatively constant IgG
Figure 2 SHARE program survey participant responses to Question 9, “In general, what do you find most beneficial about 20% SCIG?” Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; SCIG, subcutaneous immunoglobulin.
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Figure 3 SHARE program survey participant responses to Question 10, “What are your areas of interest for future educational programs/ offerings?” Abbreviations: PIDD, primary immunodeficiency disease; SCIG, subcutaneous immunoglobulin.
serum level achieved with SCIG, or “steady-state” (Figure 4).18,19 The more frequent dosing regimen and slower absorption of IgG into the systemic circulation after SC administration contribute to this steady-state effect. In contrast, high peaks and low troughs occur with IVIG therapy; the risk of infection may increase during the troughs.20 Breakthrough infections including cases of pneumonia are generally reduced with higher trough levels in patients receiving immunoglobulin replacement therapy, although a threshold IgG value required to prevent infections appears highly individualized.20-22 In addition, there is evidence that steady-state IgG is associated with an increase in patients’ health perceptions and vitality.19,23 Other benefits of SCIG therapy are increased patient independ-
Figure 4 Serum immunoglobulin levels after infusion of SCIG and IVIG. Data from a 34-year-old male with X-linked agammaglobulinemia receiving (A) a single 5% IVIG infusion of 30 g (solid line shows the average over the 21-day period) and (B) 16% SCIG of 12 g every 7 days for 21 days. Reproduced with permission.28 Abbreviations: IgG, immunoglobulin G; IVIG, intravenous immunoglobulin; SCIG, subcutaneous immunoglobulin.
ence and convenience associated with at-home administration,23,24 as well as a decreased risk of systemic reactions compared with IVIG.25,26 Some participants also wrote in their own responses indicating that 20% SCIG has further benefits of relatively lower volumes and infusion times compared with lower concentration products. The majority of participants recognized the importance of steady-state serum levels: 84% included this in their response. Less than 3% of SHARE program participants expressed concern with the efficacy of 20% SCIG. Nevertheless, the survey indicated that a substantial number of participants (20%) desired additional or continued information regarding the specifics of 20% SCIG infusions. Participants also expressed interest in additional educational and outreach programs and, in particular, programs regarding nonPIDD diseases. Education and training programs have demonstrated value for patients requiring SC injections for other chronic, non-PIDD conditions. A nurse-led training program has been shown to enhance the ability of patients with injection anxiety to self-administer interferon β-1a for their multiple sclerosis.27 Among a group of children in Scotland with Crohn’s disease, 94% were able to switch from hospital-based treatment to at-home methotrexate therapy after nurse-led instruction in SC administration, which resulted in a median savings of 41.6 hours per year of travel time and an annual cost savings of GB £730 (US $1376) per patient.16 The proper training of nurses will positively affect patients who choose SC treatment; an educated nurse is able to educate the patient, thus achieving better patient (US $1376) outcomes. This has been demonstrated in diabetes cases, where self-management training that included certified diabetes educators resulted in patient cost-savings, improved treatment adherence, and improved blood glucose monitoring.10 The inclusion of participants from various practice settings was a particular strength of the SHARE program. For example, participants who are employed in a hospital setting are less likely to perform SCIG infusions themselves, but the knowledge gained from attending the program provides valuable information needed to help determine whether SCIG is the appropriate treatment option for an individual patient. In addition, the program allows for training a large audience with diverse backgrounds. It is important that the focus of the SHARE program was to train the trainers—the nurses responsible for educating patients with PIDD who will self-administer SCIG. This assists in the establishment of a collegial network among nurse educators and will be important for career support and information sharing among this group of specialty nurses. Certain limitations were associated with this study. The survey was not completed by all participants. No pre- or postprogram evaluations were given to determine
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the increase in practical knowledge gained from the program. In addition, portions of the survey should be revised to better differentiate the various SCIG attributes. One limitation of the SHARE program itself is that no hands-on experience was gained during participation in the program, which was a suggestion for improvement by a few participants. Also, the lag time occurring between SHARE program attendance and actual implementation of patient training is problematic, because participants may forget portions of the material, and, to date, there is no long-term follow-up for the program. The SHARE program serves as a pilot for chronic diseases in which treatment is shifted to patient-controlled self-administration. This empowers patients to exert control over their own treatment. Therefore, the continuum of care with chronic disease transitions from health care system dependence to greater patient independence and autonomy. The partnership between better-educated, confident patients and health care practitioners will result in improved outcomes for the population with PIDD.
9.
10.
11.
12.
13.
14.
15.
ACKNOWLEDGMENTS
16.
Medical editorial support was provided by Daniel McCallus, PhD, at Complete Publication Solutions, LLC; this support was funded by CSL Behring LLC, King of Prussia, Pennsylvania.
17.
REFERENCES
18.
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experiences of subcutaneous self-infusions and home therapy. J Adv Nurs. 1995;21(5):917-927. 25. Gardulf A, Andersen V, Bjorkander J, et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995;345(8946):365-369. 26. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of
intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20(2):94-100. 27. Mohr DC, Cox D, Merluzzi N. Self-injection anxiety training: a treatment for patients unable to self-inject injectable medications. Mult Scler. 2005;11(2):182-185. 28. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112(1):1-7.
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