Respiratory Syncytial Virus Prevention Outreach Project
The Journal - October 2009
Tex Med . 2009;105(10):e1.
By Angelo P. Giardino, MD, PhD, MPH; Xuan G. Tran, MHA; and Deborah A. Whitmire, BS
Dr Giardino, medical director; Xuan G. Tran, manager, Health Services Research & CME; and Deborah A. Whitmire, Texas Children's Health Plan, Houston, Texas. Send correspondence to Angelo P. Giardino, MD, PhD, PO Box 301011, NB-8391, Houston, TX 77230-1011.
The study was supported by an unrestricted educational grant from MedImmune and the authors are solely responsible for content.
The objective of the study is to determine whether early identification, outreach, and intervention would increase compliance with palivizumab prophylaxis for respiratory syncytial virus prevention for members of a Texas Medicaid managed care organization. The study cohort was selected from administrative claims data. The observational study period ran from October 1, 2006, to March 31, 2007. Letters, educational materials, and postcards were mailed and outbound telephone calls were placed to qualified members. In addition, letters were sent to primary care providers. Of the 1236 identified members, the 2,238 letters, educational materials, and reminder postcards mailed resulted in 1091 injections to 394 identified members. Only 10% of the 394 members completed their qualified doses as suggested by the guideline. Even with the most intensive outreach, compliance is not highly assured. We must explore other strategies to overcome barriers in this preventive medicine program.
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (ie, bronchiolitis or pneumonia) among young children. Each year, approximately 100,000 children throughout the United States are hospitalized due to RSV infections.1 Palivizumab (Synagis) is administered intramuscularly in a dose of 15 mg/kg once a month during the RSV season, which typically starts in Texas in October and ends in March. This prophylaxis has a high likelihood of preventing severe RSV lower respiratory tract disease in infants and children younger than 24 months who have chronic lung disease (CLD) or a history of premature birth (≤35 weeks of gestation). A study conducted by the IMpact-RSV Study Group showed that palivizumab prophylaxis reduced hospitalization due to RSV by 55% (10% placebo vs 4.8% palivizumab). 2
The purpose of this study was to determine whether early identification, outreach, and education have an impact in increasing adherence to palivizumab prophylaxis. Also, we explored an untapped opportunity for our staff to educate families and communicate with primary care providers (PCPs) about the RSV prophylaxis. Education and parents' perceptions are key components in compliance with the treatment. A study conducted by Langkamp and Hlavin reported the compliance rate (67%) was much higher for a child whose parent perceived that palivizumab would protect their child compared with 48% in the noncompliant group.3 The outcomes examined in this study were the number of members of a Texas Medicaid managed care organization identified for outreach and the number of qualified members who received the appropriate number of palivizumab doses. Our primary aims were to identify qualified members and to provide outreach and education to increase dosing compliance.
The study cohort was selected from administrative and/or claims data. The observational study period was October 1, 2006, to March 31, 2007. Palivizumab is typically administered monthly, beginning just before the onset of the RSV season (October in Southeastern Texas), with the last dose given near the end of the RSV season (March). The timing of the season may vary by region within the United States. During the study, the Texas Medicaid program approved up to 6 doses of palivizumab per patient.
- Texas Children's Health Plan (TCHP) members who are 24 months or younger (date of birth on or after September 30, 2004) at the start of the RSV season who have the following: hemodynamically significant heart disease or CLD that required any of the following therapies within the past 6 months: supplemental oxygen, digitalis, steroids, diuretics, and mechanical ventilation.
- Members who are younger than 12 months (date of birth on or after September 30, 2005) at the start of the RSV season and are 28 or fewer completed weeks gestational age at birth.
- Members who are younger than 6 months (date of birth on or after March 31, 2006) at the start of RSV season and are 29 to 32 completed weeks gestational age at birth or 32 to 35 completed weeks gestational age with severe neuromuscular disease or significant congenital anomalies of the airway expected to compromise respiratory reserve.
Outreach and Intervention
Educational outreach to members who qualify for palivizumab consisted of letters, educational materials, postcards, and outbound telephone calls by case managers. In addition, letters were sent to primary care providers encouraging them to assist in the intervention or referral of the qualified members to a specialty "Synagis" clinic. The Synagis clinics administered the palivizumab injections and provided case management to the patients who sought care in their clinic. Case management included educational and telephonic outreach for scheduling and rescheduling missed appointments and reminders to TCHP members. The clinical staff contacted TCHP members after missed appointments; members received two telephone calls. After two unsuccessful telephone calls, a notification letter was sent to the member's primary care provider.
We also collaborated with several "Synagis" specialty clinics within the Houston/Harris County and the Harris expansion area to monitor members' adherence and obtained data (palivizumab injection dates, doses, and missed doses) for reporting purposes. We reached out and attempted to collaborate with all the clinics that had contracts with TCHP; however, the attempts did not prove as successful as we had hoped. Compliance data were calculated as a percentage based on actual monthly injections given during the RSV season to the member and divided by the intended number of doses to be administered for the season.
Analyses were performed using descriptive statistics (means and frequency).
A total of 1236 TCHP members were identified as being potentially eligible to receive palivizumab based on the following review of Texas Medicaid and the application of criteria recommended by the American Academy of Pediatrics at the time of the study. TCHP sent 2238 letters, educational materials, and reminder postcards that resulted in 1091injections to 394 identified members from October 1, 2006, to March 31, 2007 ( Figure 1 ).
Five hundred and sixty-nine (52.15%) of 1091 injections were administered within 28 to 30 days of the anticipated date, which is within compliance of palivizumab guidelines. Three hundred and seventy-four members received 1091 palivizumab injections. In addition, 20 members received palivizumab through other sources; 18 members did not receive the RSV prevention intervention, while 2 members received case management from TCHP Maternal Child Program case managers.
A total of 2238 letters and reminder postcards were mailed to 1236 TCHP members from September 2006 to February 2006. The number of letters mailed out decreased in December 2006, the third month of intervention, due to the tightening of the ICD-9 codes used to identify the members. The change was implemented after feedback from providers stating that our list of inclusion ICD-9 codes was too broad and requesting that we narrow the list. Furthermore, those who did not qualify, according to their PCPs, were removed from future mailings. Those members whose addresses were undeliverable or who had no forwarding addresses were removed, as well. This was done only after numerous attempts to locate the correct mailing address. We were not able to contact 5.6% of the members because of invalid addresses.
Of those members who were reached, 92% (361 members) were qualified to receive 6 doses of palivizumab prophylaxis. However, only 12% received 6 injections, 14% received 5 injections, 16% received 4 injections, 13% received 3 injections, 21% received 2 injections, and 24% received only 1 injection. Figure 2 shows the number of doses received per qualified series.
TCHP Maternal Child Program case managers conducted further telephone outreach and provided education to those members who received a palivizumab injection. The case managers contacted the members monthly by telephone to educate and reinforce the importance of treatment compliance. If the case managers were unable to contact the members after two telephone attempts, they would contact the clinic to see if the member received his or her monthly injection and document the results. A postcard was also mailed to the member after two unsuccessful telephone attempts. Therefore, some members received case management both by TCHP case managers and by the Synagis specialty clinics where the members received their injections.
A total of 465 (80%) injections) of the 1091 injections given to 373 members were within compliance of the 28-to-30-day period recommended by palivizumab guidelines. Another 12 (2%) of the members received the injections earlier than recommended, 11% received their injections from 31 to 45 days after the recommended period, and 7% delayed their treatments until 46 or more days after the recommended dates ( Figure 3 ). This was calculated on the basis of the date of service:
Current series date of service - Previous series date of service = Compliance date
Total number of compliance date/group x 100 = Percentage compliance rate/group
Total number of occurrence
Most members received their injections through the Synagis specialty clinics where comprehensive clinical evaluations of children with infectious disease included RSV. A small percentage (10%) of our members received their injections through primary care providers, the county's public health system or other venues including infusion centers that are not under contract with TCHP.
As a subset project, in collaboration with one of the larger specific specialty clinics, TCHP collected data from members receiving care from the clinic with regard to barriers that prevented them from keeping their appointments. Data were collected when a member missed an appointment, and the patient was queried for the reason of the missed appointment by the schedulers at the clinic. The data were recorded, and a report was generated and given to TCHP monthly. Some of the recurring barriers included transportation issues, parental personal conflicts (including appointments that conflicted with work schedules), family illness, and insurance issues (including a change of insurance plan during the season) ( Figure 4 ).
- A change in billing contract occurred with one of the providers during the season; the new contract was implemented in January 2007, which made it difficult for us to track the claims data.
- Reminder cards were sent only to members identified by TCHP case managers, claims data, or collaborative partners. Those who did receive the injections and were not detected by case management or collective partnership did not receive reminder cards. This fact may impact our compliance rate. For example, the 26 members who have pharmacy claims for palivizumab medication did not have provider claims submitted for administering the injections.
Monthly palivizumab injections decrease the risk of RSV-related hospitalization during RSV season in high-risk infants born at fewer than 35 weeks of gestation. Our objective was to identify TCHP members (based on both the Texas Medicaid and American Academy of Pediatrics recommendations for palivizumab prophylaxis among children at the time of the study), educate parents, facilitate care, and increase compliance with palivizumab prophylaxis. Even with the most intensive outreach, compliance is not highly assured. Only 11% of the 394 members completed their recommend therapy as suggested by the guidelines. This rate is far below the level of compliance we targeted to achieve in our intervention.
Based on the results and feedback, the process of identification, outreach, and education is only one component that ensures compliance. Other components included demographics, neonatal variables, and parental attitudes, which also influenced the outcome of RSV prophylaxis compliance. Further investigation is needed as to why compliance is not met.
Noncompliance is the greatest issue in this study group. We must address these issues to increase the compliance rate for at-risk populations. We must explore other strategies for overcoming barriers in this preventive medicine program. One strategy that may be important for overcoming barriers is the use of a home health service provider. Home health nurses would contact the family to schedule appointments to visit the member's home and provide education and treatment. This would eliminate some barriers that include rescheduled/canceled/no-show appointments, transportation issues, and parental conflicts. A study conducted by Golombek, Berning and Lagamma5 showed 969 (67%) of the 1446 infants who received their monthly injections in the home setting received 98% of their injections on schedule and completed all the recommended doses, whereas only 477 (33% of the 1446 infants) received their injections in the pediatrician's office with a compliance rate of 89%. Parents indicated that the in-home prophylaxis program was more convenient than the physician's office setting. For future RSV seasons, we are exploring enhancement of home health services to our RSV at-risk population.
- Shay DK, Holman RC, Roosevelt GE, Clarke MJ, Anderson LJ. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children 1979-1997. J Infect Dis . 2001;183(1):16-22.
- The IMpact-RSV Study Group . Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3, pt 1):531-537.
- Langkamp DL, Hlavin SM. Factors predicting compliance with palivizumab in high-risk infants. Am J Perinatol . 2001;18(6):345-352.
- Texas Medicaid Vendor Drug Program - Synagis ® (Palivizumab) Prior Authorization Request & Prescription Form. http://www.hhsc.state.tx.us/hcf/vdp/vdpsynagiswrx_20060815.doc . Accessed October 2006.
- Golombek SG, Berning F, Lagamma EF. Compliance with prophylaxis for respiratory syncytial virus infection in a home setting. Pediatr Infect Dis J . 2004;23(4):318-322.
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