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A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises

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ClinicalTrials.gov Identifier: NCT02698761
Recruitment Status : Terminated (Standard of care changed)
First Posted : March 4, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Phoenix Children's Hospital
Information provided by (Responsible Party):
Valley Anesthesiology Consultants

Brief Summary:

Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to 90,000 individuals in the United States.[10] There are 13,000 hospital admissions for a sickle cell crises, costing $448 million dollars annually.[10] 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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Crisis Vaso-Occlusive Crises Other: Comprehensive Care Plan Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises
Study Start Date : April 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

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Arm Intervention/treatment
No Intervention: Standard of Care
Patient will receive standard of care. Subject will have an actiwatch to compare activity and sleep habits. Nursing staff will be aware of study presence but will not receive any specific instruction for the patient.
Experimental: Comprehensive Care Plan
Patient will abide by the comprehensive care plan and sign an agreement stating compliance. Subject will have an actiwatch to compare activity and sleep habits. Nursing staff will be notified of study and support patient's compliance with study procedures.
Other: Comprehensive Care Plan

Care Plan

  1. Patient Controlled Analgesia (PCA). PCA will be initiated and managed at the discretion of the Pain Management team.
  2. Other Medications. All medications will be given during daytime hours, if possible.
  3. Pain Psychology.
  4. Physical Therapy. Patient is expected to spend time out of bed by Day 2 participating in light activity.
  5. Sleep Hygiene. Patient sleeps between the hours of 10 PM and 5 AM daily. Window blinds open by 8 AM. Patient must be awake and ready to participate in therapy by 9 AM.
  6. Extracurricular. 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 (e.g. breakfast consumed before 9 am) and shower daily.




Primary Outcome Measures :
  1. Length of Stay [ Time Frame: 2 Years ]
    Length of Stay in Days


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 2 Years ]
    pain scores assessed daily for each patient using the (Visual Analog Scale) VAS scale.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between 12 and 18 years of age who are admitted to the hospital for an acute vaso-occlusive crisis
  • Patients must require a demand PCA and able to tolerate oral pain medications

Exclusion Criteria:

  • - Requires a continuous PCA
  • Unwilling to be compliant with the assigned arm of study (e.g. Non-compliance with sleep or visiting regimen, or questionnaires)
  • Non-English speaking child or parent (questionnaires not available/validated in another language)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698761


Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
Valley Anesthesiology Consultants
Phoenix Children's Hospital

Publications:
Responsible Party: Valley Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT02698761     History of Changes
Other Study ID Numbers: 15-129
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Valley Anesthesiology Consultants:
Vaso-Occlusive Crises
Sickle Cell Disease
Decreasing Length of Stay
Comprehensive Care Plan

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn