Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02698761
Status:
TERMINATED
Last Update Posted:
2018-05-03
First Post:
2016-02-01
Brief Title:
A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises
Sponsor:
Valley Anesthesiology Consultants
Organization:
Valley Anesthesiology Consultants
Study Overview
Official Title:
A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Standard of care changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sickle cell disease SCD is the most common inherited blood disorder affecting 80000 to 90000 individuals in the United States10 There are 13000 hospital admissions for a sickle cell crises costing 448 million dollars annually10 In our hospital the sickle cell population is known to have some of the longest length of stays Between October 2014 and September 2015 there were 89 admissions for a vaso-occlusive crisis with an average length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than 20 days
We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain We hypothesize increased physical activity and proper sleep as implemented in the CPP are correlated with decreased hospital length of stay and decreased pain Additionally we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management
We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain We hypothesize increased physical activity and proper sleep as implemented in the CPP are correlated with decreased hospital length of stay and decreased pain Additionally we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management
Detailed Description:
Sickle cell disease SCD disease is inherited as an autosomal recessive trait that results in several interactive processes polymerization of hemoglobin S HbS hemolysis nitric oxide depletion and vaso-occlusion3 The most common manifestations of sickle cell disease are vaso-occlusive pain events specifically dactylitis which typically occurs as the first clinical manifestation4 As patients age the early onset peripheral pain moves to more central regions resulting in increased severity of vaso-occlusive crises4 Pain from the blockage of sickeled cells in vessels causes poor blood flow to a localized area There are few clinical and laboratory findings to indicate the severity of pain associated with sickle cell crisis4 making it difficult for a physician to identify the amount of pain the patient actually experiences Length of stay in the hospital depends largely on physician discretion and patient report
Sleep is instrumental to many aspects of physical and emotional health during childhood and adolescence Sleep disruption from pain is a significant concern in patients with sickle cell disease due to the prevalence of their acute and chronic pain7 In a study conducted by Daniel et al sickle cell patients between 4-10 years old were more likely to exhibit disrupted sleep specifically night-waking and sleep-disordered breathing than children who were not diagnosed with sickle cell disease from similar demographic backgrounds 7 Furthermore children with more severe forms of sickle cell disease were reported to have more restless sleep than children with less severe forms 7 Overall the literature suggests that sleep disruptions may interfere with childrens daily functions along with their ability to cope with SCD and its complications7 Daniel et al recommends discussing ways to improve sleep habits with children suffering from SCD because it may increase efficacy in pain management priapism and enuresis7 Another study by Valrie etal suggests that poor quality of sleep is correlated with increased occurrence of sickle cell disease pain the following day9 They also discovered that high pain severity was related to poor sleep quality and this relationship was exacerbated during stressful situations9 Developing a suitable sleeping environment eg removing the television or limiting the lighting will maximize sleep efficacy resulting in better health outcomes and quality of life7 There has been minimal research on evaluating the relationship between exercise and sickle cell disease in children and adolescents Studies conducted on sickle cell disease in adults with respect to the effects of exercise have produced mixed results partly due to patient comorbid illnesses In 2012 Chirico et al compared two fitness level group including subjects who did not partake in regular physical activity for two years prior to the study versus subjects who partook in regular weekly physical activity for several years leading up to the study 5 Both groups contained sickle cell trait carriers and subjects with normal hemoglobin 5 Subjects performed an incremental maximum exercise test while data was collected on heart rate via a chest monitor and on oxidative stress levels via blood samples at various points following completion of the exercise task 5 Results indicated regular physical activity helped to blunt the increase in oxidative stress and the decrease in nitric oxide metabolism and up regulation of antioxidant enzyme activities in response to exercise in sickle cell trait carriers 5 These findings suggest an attenuated sickle cell crisis in the subjects with regular exercise when compared with the sedentary group
Presently at Phoenix Childrens Hospital no protocol exists for management of sleep and exercise in sickle cell patients The most relevant policy named Parenting and Visitation includes guidelines regarding sleep and visiting hours but these are not well enforced In our hospital the sickle cell population is known to have some of the longest length of stays Between October 2014 and September 2015 there were 89 admissions for a vaso-occlusive crisis with an average length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than 20 days Prior research suggests that implementation of standardized care eg order sets protocols and flowcharts can improve compliance and patient outcomes 8 reduce overall length of stay and mitigate costs Therefore we have developed a new comprehensive care plan CPP that enhances standard of care by including the following care aspects
1 Patient Controlled Analgesia PCA PCA will be initiated and managed at the discretion of the Pain Management team Naloxone infusion will be available for opioid related side effects Once tapered patients will be transitioned to oral opioids to be administered as needed Patients will be discharged home when appropriate with oral opioids and weaning instructions
2 Other Medications All medications will be given during daytime hours if possible All home medications will be continued while inpatient Ketorolac will be given intravenously every 6 hours for 12 doses then switched to ibuprofen by mouth every 6 hours until discharge home Stool softeners will be utilized while on narcotics to prevent constipation A clonidine patch may be used for adjunct analgesia and anxiolysis A lidocaine patch may be used for localized pain
3 Pain Psychology Consultations will begin on Day 2 and continue as needed The psychologist will teach the patient sleep hygiene techniques and non-pharmacologic pain management skills including distraction diaphragmatic breathing progressive muscle relaxation and guided imagery with medical hypnosis
4 Physical Therapy Consultations will begin on Day 2 and continue as needed Patient is expected to spend time out of bed by Day 2 participating in light activity
5 Sleep Hygiene Will be introduced to the experimental group Patient must sleep between the hours of 10 PM and 5 AM daily Window blinds will be open by 8 AM Patient must be awake and ready to participate in therapies by 9 AM Napping will be at the discretion of the physician Practitioners should examine care orders critically such as routine vital signs and determine if it is safe andor appropriate to defer these during sleep Room lights will be turned off to help promote the circadian rhythm No video games television cell phones or computers will be allowed during this time
6 Extracurricular Will participate in child life activities as recommended eg Playroom or Zone TV phone computer and video games only between hours of 4-9 PM computer okay outside of hours only for school work
7 Other Patient will eat meals during regular daytime hours eg breakfast consumed before 9 am and shower daily No overnight visitors will be allowed
We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain We hypothesize increased physical activity and proper sleep as implemented in the CPP are correlated with decreased hospital length of stay and decreased pain Additionally we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management
Specific Aims Primary To determine the feasibility and efficacy of the CPP to reduce pain and length of stay in patients with sickle cell disease
ATo evaluate if patients who follow the CPP physical activity regimen will have less pain and shorter hospital stay than patients receiving standard of care
BTo measure if patients who follow the CPP sleep activity regimen will have less pain and shorter hospital stay than patients receiving standard of care
Study Design This is a prospective pilot study of 20 subjects who have sickle-cell disease and are admitted to Phoenix Childrens Hospital for an acute vaso-occlusive crisis Patients will be randomized via a random number generator with equal probability of assignment to either CPP experimental or standard of care control trial arm Eligible subjects and their family will be approached during the first day of hospital admission for consent to participate and randomization After randomization all subjects will be given multiple questionnaires to evaluate their current sleep habits activity levels and psychological constructs Procedures During the enrollment visit questionnaires will be administered to every subject to evaluate current sleep habits activity levels pain and quality of life Subjects will receive the Actiwatch Spectrum Pro and be given instructions on how to use it
Control Group Patient will receive standard of care Nursing staff will be aware of study presence but will not receive any specific instruction for the patient
Experimental Group During the enrollment visit patient will go over the new comprehensive care protocol with the study staff and will sign the agreement stating compliance Patient will be given a copy of the comprehensive care plan for reference Nursing staff will be aware of studys presence and will help to support patients compliance with sleep and other procedures according to care plan
Discharge Study staff will closely follow the patients progress in the hospital Once patient is ready for discharge they will have a visit with study investigators and be given one final PedsQL to complete An additional questionnaire will be given to the experimental group asking their opinion about the CPP The Actiwatch Spectrum Pro will be collected from the patients and be properly disinfected
MeasurementAssessments Actiwatch Spectrum Pro Monitoring Device The Actiwatch Spectrum Pro activity device will continuously monitor activity active minutes sleep minutes slept and quality and allow the subject to input their numerical pain or fatigue rating At the end of the patients trial the data will be extracted from the actiwatch and placed into the patients alphanumeric account that is monitored by the research personnel Patients or families will not have access to the accounts We will examine the minutes of activity per day and minutes of sleep per day and compare it to the pain scores recorded by looking at the data extracted from the Actiwatch Spectrum Pro
Analysis Baseline characteristics will be summarized within the two care groups using descriptive statistics including count and percent for categorical variables and the mean and standard deviation median and interquartile ranges for continuous variables Evaluation of the CPP with length of stay will be done using the T-test or the Kruskal-Wallis test depending on the length of stay distribution Analysis of variance for repeated measures will assess the effect of time on pain scores within care groups Differences in mean cumulative pain scores between care groups will also be examined daily during hospital stay
Additional analyses will investigate the association of care components physical activity and sleep with length of stay and pain scores using appropriate statistical methods as described above All statistical tests will have a significance level of 005
Sleep is instrumental to many aspects of physical and emotional health during childhood and adolescence Sleep disruption from pain is a significant concern in patients with sickle cell disease due to the prevalence of their acute and chronic pain7 In a study conducted by Daniel et al sickle cell patients between 4-10 years old were more likely to exhibit disrupted sleep specifically night-waking and sleep-disordered breathing than children who were not diagnosed with sickle cell disease from similar demographic backgrounds 7 Furthermore children with more severe forms of sickle cell disease were reported to have more restless sleep than children with less severe forms 7 Overall the literature suggests that sleep disruptions may interfere with childrens daily functions along with their ability to cope with SCD and its complications7 Daniel et al recommends discussing ways to improve sleep habits with children suffering from SCD because it may increase efficacy in pain management priapism and enuresis7 Another study by Valrie etal suggests that poor quality of sleep is correlated with increased occurrence of sickle cell disease pain the following day9 They also discovered that high pain severity was related to poor sleep quality and this relationship was exacerbated during stressful situations9 Developing a suitable sleeping environment eg removing the television or limiting the lighting will maximize sleep efficacy resulting in better health outcomes and quality of life7 There has been minimal research on evaluating the relationship between exercise and sickle cell disease in children and adolescents Studies conducted on sickle cell disease in adults with respect to the effects of exercise have produced mixed results partly due to patient comorbid illnesses In 2012 Chirico et al compared two fitness level group including subjects who did not partake in regular physical activity for two years prior to the study versus subjects who partook in regular weekly physical activity for several years leading up to the study 5 Both groups contained sickle cell trait carriers and subjects with normal hemoglobin 5 Subjects performed an incremental maximum exercise test while data was collected on heart rate via a chest monitor and on oxidative stress levels via blood samples at various points following completion of the exercise task 5 Results indicated regular physical activity helped to blunt the increase in oxidative stress and the decrease in nitric oxide metabolism and up regulation of antioxidant enzyme activities in response to exercise in sickle cell trait carriers 5 These findings suggest an attenuated sickle cell crisis in the subjects with regular exercise when compared with the sedentary group
Presently at Phoenix Childrens Hospital no protocol exists for management of sleep and exercise in sickle cell patients The most relevant policy named Parenting and Visitation includes guidelines regarding sleep and visiting hours but these are not well enforced In our hospital the sickle cell population is known to have some of the longest length of stays Between October 2014 and September 2015 there were 89 admissions for a vaso-occlusive crisis with an average length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than 20 days Prior research suggests that implementation of standardized care eg order sets protocols and flowcharts can improve compliance and patient outcomes 8 reduce overall length of stay and mitigate costs Therefore we have developed a new comprehensive care plan CPP that enhances standard of care by including the following care aspects
1 Patient Controlled Analgesia PCA PCA will be initiated and managed at the discretion of the Pain Management team Naloxone infusion will be available for opioid related side effects Once tapered patients will be transitioned to oral opioids to be administered as needed Patients will be discharged home when appropriate with oral opioids and weaning instructions
2 Other Medications All medications will be given during daytime hours if possible All home medications will be continued while inpatient Ketorolac will be given intravenously every 6 hours for 12 doses then switched to ibuprofen by mouth every 6 hours until discharge home Stool softeners will be utilized while on narcotics to prevent constipation A clonidine patch may be used for adjunct analgesia and anxiolysis A lidocaine patch may be used for localized pain
3 Pain Psychology Consultations will begin on Day 2 and continue as needed The psychologist will teach the patient sleep hygiene techniques and non-pharmacologic pain management skills including distraction diaphragmatic breathing progressive muscle relaxation and guided imagery with medical hypnosis
4 Physical Therapy Consultations will begin on Day 2 and continue as needed Patient is expected to spend time out of bed by Day 2 participating in light activity
5 Sleep Hygiene Will be introduced to the experimental group Patient must sleep between the hours of 10 PM and 5 AM daily Window blinds will be open by 8 AM Patient must be awake and ready to participate in therapies by 9 AM Napping will be at the discretion of the physician Practitioners should examine care orders critically such as routine vital signs and determine if it is safe andor appropriate to defer these during sleep Room lights will be turned off to help promote the circadian rhythm No video games television cell phones or computers will be allowed during this time
6 Extracurricular Will participate in child life activities as recommended eg Playroom or Zone TV phone computer and video games only between hours of 4-9 PM computer okay outside of hours only for school work
7 Other Patient will eat meals during regular daytime hours eg breakfast consumed before 9 am and shower daily No overnight visitors will be allowed
We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain We hypothesize increased physical activity and proper sleep as implemented in the CPP are correlated with decreased hospital length of stay and decreased pain Additionally we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management
Specific Aims Primary To determine the feasibility and efficacy of the CPP to reduce pain and length of stay in patients with sickle cell disease
ATo evaluate if patients who follow the CPP physical activity regimen will have less pain and shorter hospital stay than patients receiving standard of care
BTo measure if patients who follow the CPP sleep activity regimen will have less pain and shorter hospital stay than patients receiving standard of care
Study Design This is a prospective pilot study of 20 subjects who have sickle-cell disease and are admitted to Phoenix Childrens Hospital for an acute vaso-occlusive crisis Patients will be randomized via a random number generator with equal probability of assignment to either CPP experimental or standard of care control trial arm Eligible subjects and their family will be approached during the first day of hospital admission for consent to participate and randomization After randomization all subjects will be given multiple questionnaires to evaluate their current sleep habits activity levels and psychological constructs Procedures During the enrollment visit questionnaires will be administered to every subject to evaluate current sleep habits activity levels pain and quality of life Subjects will receive the Actiwatch Spectrum Pro and be given instructions on how to use it
Control Group Patient will receive standard of care Nursing staff will be aware of study presence but will not receive any specific instruction for the patient
Experimental Group During the enrollment visit patient will go over the new comprehensive care protocol with the study staff and will sign the agreement stating compliance Patient will be given a copy of the comprehensive care plan for reference Nursing staff will be aware of studys presence and will help to support patients compliance with sleep and other procedures according to care plan
Discharge Study staff will closely follow the patients progress in the hospital Once patient is ready for discharge they will have a visit with study investigators and be given one final PedsQL to complete An additional questionnaire will be given to the experimental group asking their opinion about the CPP The Actiwatch Spectrum Pro will be collected from the patients and be properly disinfected
MeasurementAssessments Actiwatch Spectrum Pro Monitoring Device The Actiwatch Spectrum Pro activity device will continuously monitor activity active minutes sleep minutes slept and quality and allow the subject to input their numerical pain or fatigue rating At the end of the patients trial the data will be extracted from the actiwatch and placed into the patients alphanumeric account that is monitored by the research personnel Patients or families will not have access to the accounts We will examine the minutes of activity per day and minutes of sleep per day and compare it to the pain scores recorded by looking at the data extracted from the Actiwatch Spectrum Pro
Analysis Baseline characteristics will be summarized within the two care groups using descriptive statistics including count and percent for categorical variables and the mean and standard deviation median and interquartile ranges for continuous variables Evaluation of the CPP with length of stay will be done using the T-test or the Kruskal-Wallis test depending on the length of stay distribution Analysis of variance for repeated measures will assess the effect of time on pain scores within care groups Differences in mean cumulative pain scores between care groups will also be examined daily during hospital stay
Additional analyses will investigate the association of care components physical activity and sleep with length of stay and pain scores using appropriate statistical methods as described above All statistical tests will have a significance level of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None