Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

Infantile Spasms, Non-Intractable Clinical Trial

Official title:

Decreasing Parental Stress and Costs While Improving Overall Satisfaction of Caregivers of Infants With Infantile Spasms on ACTH Therapy Utilizing Innovative Telemedicine Technology: A Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086992
• Other study ID #: 18-0579
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: Clinical Practice Specialist
• Phone: 720-777-6915
• Email: jennifer.coffman[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study plans to learn more about how the use of new telemedicine technology can help with parental stress, costs, and overall satisfaction in care. Investigators are studying this in families who have children with a specific seizure type called infantile spasms and being treated with a medication called ACTH (adrenocorticotropic hormone). Infantile spasms is a rare epileptic encephalopathy that occurs within the first two years of life. It is associated with complicated and expensive treatment and poor developmental outcomes. Participants will be randomly placed in one of two groups. The first group will continue with the traditional monitoring practices primarily performed by their pediatrician. The second group will use telemedicine technology to be monitored. Investigators will then compare the two groups to see if there are any differences in parental stress, costs of care, and/or overall satisfaction with care. The primary hypothesis is that compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will report less parenting stress at 2 and 4 weeks of treatment.

Description:

Infantile Spasms, historically call West Syndrome, is an infantile epileptic encephalopathy, typically occurring within the first two years of life. Infantile Spasms is often characterized by hypsarrhythmia on encephalogram (EEG) and developmental plateau or regression. It is estimated that Infantile Spasms affects 2 to 5 per 10,000 live births. The etiology of Infantile Spasms is varied and often unclear at the time of diagnosis. In almost half of cases it is linked to hypoxic-ischemic encephalopathy, chromosomal abnormalities, perinatal stroke, tuberous sclerosis complex, or periventricular leukomalacia or hemorrhage. While historically treatment options have been widely variable, over the past several years three pharmacologic therapies have been adopted, including ACTH, oral corticosteroids (OCS), and vigabatrin. ACTH was approved for use for multiple neurologic conditions in 1952 and specifically for Infantile Spasms in 2010. Unfortunately, as a hormone therapy, ACTH carries several potentially severe side effects including adrenal insufficiency, immunosuppression, electrolyte imbalances, and more commonly elevated blood pressure thought to lead to serious cardiac changes. Complexity of ACTH therapy requires close monitoring. ACTH is administered intramuscularly twice a day for the initial two weeks with a complicated weaning schedule over the subsequent 2 weeks. Between the required monitoring and complicated administration regimen, ACTH therapy is often overwhelming and confusing for caregivers, and can lead to medication errors. Unfortunately, primary care (PCP) monitoring for ACTH has proved to be inconsistent. Barriers for families have included: families without an identified PCP, families without the means to get to their PCP at the recommended intervals (rural location or inadequate transportation), PCP's without the correct equipment to monitor infants, limited office hours, and PCP with little comfort in managing side-effects when they present. This has resulted in disjointed care, and last-minute attempts to obtain needed monitoring in less-than-ideal settings (e.g., urgent care, hospital, neurology clinic) - all with additional expense to families. Treatment with ACTH is associated with high direct and indirect costs. Treatment of Infantile Spasms with ACTH carries a significant financial burden for families. In August 2007, the cost for one vial of ACTH, then manufactured by Questcor Pharmaceuticals and now by Mallinckrodt Pharmaceuticals, increased from $1650 to $23,000. Current, non-discounted pricing is $34,400 per vial. The average therapy calls for 3-4 vials, with a total price tag between $103,200 and $137,600. Any potential for medication error further exacerbates costs of therapy. Consumer-incurred costs of ACTH therapy have not previously been reported. Direct costs of ACTH therapy for caregivers include, at a minimum, the out-of-pocket expense for the drug as well as required PCP, neurology, and EEG follow-up. It is not uncommon, due to complications of monitoring, that caregivers sustain additional direct costs seeking monitoring in unplanned ways (e.g., urgent care/ED visits). In addition, prophylactic treatment with antibiotics and H2 blockers to combat potential side effects is necessary and adds to caregiver expense. Indirect costs include loss of productivity due to work absences and non-paid loss of productivity (e.g., homemaker). Expense of transportation and travel can also be significant. Considering the potential severe side-effects of ACTH, the complicated medication regime, the rigorous required follow-up, the costs inherent in the therapy alone and those due to complications, it is hypothesized that parenting stress for parents of babies with IS is high. Support for these families is critical to successful ACTH therapy. Historically at Children's Hospital Colorado, there has been no structured support outside of the initial admission for diagnosis/start of therapy and follow-up neurology appointments. This study is intended to explore and compare parenting stress of parents/caregivers caring for babies with IS being treated with ACTH and secondarily, overall treatment satisfaction. Remote biometric monitoring led by highly skilled registered nurses could offer a novel, feasible, cost-effective strategy to support families of infants with IS during treatment with ACTH. Although there is currently no published literature exploring the use of telehealth or remote monitoring in the specific treatment of Infantile Spasms, its successful use in other complex conditions underscores its potential for benefit. In addition to optimization of disease-related outcomes, remote monitoring has high potential to reduce financial burden and parenting stress on parent/caregivers. This proposed study will utilize a prospective randomized clinical trial design. - Infants and caregivers of infants who meet the inclusion criteria will be invited to participate. They will be randomized to the intervention or usual care group in accordance with a random number generator program through the Biostatistics Core at CHCO. Randomization will be stratified by payor source. The study hypotheses include: 1. Compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will report less parenting stress at 2 and 4 weeks of treatment. 2. Compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with 4 weeks of ACTH utilizing nurse-led remote biometric monitoring will experience a decrease in direct (including travel) and indirect cost of care. 3. Compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will experience greater overall satisfaction with treatment. All caregivers will be given the standard education on Infantile Spasms, ACTH and ACTH administration. The control group will continue to receive standard care for ACTH monitoring and follow-up, which includes: 1. Blood pressure monitoring by PCP recommended to occur a minimum of two times per week. Depending on the results and PCP's comfort in managing any aberrant results, the PCP may or may not share them with the patient's primary neurologist. 2. Nurse follow-up phone call at 1 week of therapy to assess spasm frequency, monitoring and medication adherence, side-effects, complications of therapy, validate the dosing schedule, confirm required follow-up appointments (Neurology and EEG), answer any questions, and provide support. Data collected during these calls is routed to the patient's primary neurologist for review. 3. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist. 4. Neurology appointment at 2 weeks of therapy The intervention group will receive and be instructed on the use of a re-useable digital health kit that will include an electronic tablet with integrated monitoring and telehealth software and manual or automatic blood pressure machine with appropriate sized cuff. The software utilized is web-based and has the capability to integrate into an organization's electronic health record. It allows for the real-time monitoring by healthcare professionals and the establishment of alerts. Appropriate research personnel will be responsible for this monitoring. In addition to biometric monitoring, the software allows for individualized health and other surveys to gain immediate patient feedback. Finally, the tablet and software support video telemedicine visits in the patient home. The following interventions will be utilized in the intervention group: 1. Caregivers will take blood pressure three times per week (ideally, Monday, Wednesday, Friday) and will uploaded into the monitoring software/tablet. A neurology nurse will monitor these results, transcribe them into the patient's medical record, and route them to the patient's primary neurologist for review and potential follow-up. 2. Caregivers will complete a twice-a-week side-effect and adherence survey in the software/tablet. The results of this survey will be transcribed into the patient's medical record and routed to the patient's primary neurologist for review and potential follow-up. 3. A neurology nurse will conduct a video telehealth visit with the caregiver to assess spasm frequency, monitoring and medication adherence, side-effects, complications of therapy, validate the dosing schedule, confirm required follow-up appointments (Neurology and EEG), answer any questions, and provide support between days 7-10 and again between days 21-24 of therapy. This will be documented as a telehealth nurse-visit and routed to the patient's primary neurologist for review and potential follow-up. 4. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist. 5. Neurology appointment at 2 weeks of therapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 30 Months

Eligibility

Inclusion Criteria:

• Patients admitted to CHCO, Anschutz and Colorado Springs hospitals, under the age of 30 months with a primary diagnosis of Infantile Spasms and started on first-time ACTH and their primary caregiver (parent/guardian).

Exclusion Criteria:

• Infants with recurrent Infantile Spasms and retreatment with ACTH and their primary caregiver (parent/guardian).
• Infants with existing home health nursing services and their primary caregiver (parent/guardian).
• Infants with prolonged inpatient admissions beyond 7 days after initiation on ACTH and their primary caregiver (parent/guardian).
• Infants whose caregivers do not read, write, and/or speak English with sufficient proficiency to provide informed consent and their primary caregiver (parent/guardian).
• Neonates less than 31 days old and their primary caregiver (parent/guardian).
• Infants that have been hospitalized since birth and their primary caregiver (parent/guardian).
• Infants that are wards of the state and their primary caregiver (guardian).
• Infants that reside in a geographic location with no major network cell service and their primary caregiver (parent/guardian).

Related Conditions & MeSH terms

• Infantile Spasms, Non-Intractable
• Muscle Cramp
• Spasm
• Spasms, Infantile

Intervention

Other:
• Remote monitoring
Caregivers will be able to monitor blood pressure from home and upload in a cloud-based application on a hand-held tablet. In addition, this technology will administer surveys to the caregiver to assess for therapy side effects and adherence. Nurse-led telemedicine visits will also be utilized. The healthcare team will be able to monitor these parameters remotely.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Mallinckrodt

Country where clinical trial is conducted

United States, 

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare parental stress between intervention group and control group	Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress.	At study enrollment (prior to hospital discharge)
Primary	Compare parental stress between intervention group and control group	Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress.	Mid-therapy (between week 2 and 3 of therapy)
Primary	Compare parental stress between intervention group and control group	Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress.	At therapy completion (end of week 4, with 7 days to complete)
Primary	Compare overall satisfaction with treatment between intervention group and control group	Overall treatment satisfaction will be measured by the Treatment Satisfaction Questionnaire for Medications, version 9 (TSQM v9) survey. This is a previously validated survey. The scores for the TSQM v9 can range from 1-100, with a higher score indicating greater satisfaction.	At therapy completion (end of week 4, with 7 days to complete)
Primary	Compare expenses between intervention group and control group	Caregivers will be asked to provide details on both direct and indirect costs incurred during therapy. This will be measured by collecting both healthcare utilizations rates, actual out-of-pocket expenses, and lost productivity measures. Combined direct and indirect expenses will be combined and compared.	At mid-therapy (between week 2 and 3 of therapy)
Primary	Compare expenses between intervention group and control group	Caregivers will be asked to provide details on both direct and indirect costs incurred during therapy. This will be measured by collecting both healthcare utilizations rates, actual out-of-pocket expenses, and lost productivity measures. Combined direct and indirect expenses will be combined and compared.	At therapy completion (end of week 4, with 7 days to complete)