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

NCT02698761 | Terminated

• 1 other identifier: 15-129
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Sickle Cell Crisis; Vaso-Occlusive Crises

Keywords

Vaso-Occlusive Crises; Sickle Cell Disease; Decreasing Length of Stay; Comprehensive Care Plan

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Length of Stay in Days

  2 Years

Secondary Outcomes (1)

• Pain Scores

  2 Years

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Comprehensive Care Plan

EXPERIMENTAL

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

Interventions

Comprehensive Care Plan OTHER

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.

Comprehensive Care Plan

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Valley Anesthesiology Consultants: lead
• Phoenix Children's Hospital: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (4)

• Morrissey LK, Shea JO, Kalish LA, Weiner DL, Branowicki P, Heeney MM. Clinical practice guideline improves the treatment of sickle cell disease vasoocclusive pain. Pediatr Blood Cancer. 2009 Mar;52(3):369-72. doi: 10.1002/pbc.21847.

  PMID: 19023890 BACKGROUND

• Vijenthira A, Stinson J, Friedman J, Palozzi L, Taddio A, Scolnik D, Victor C, Kirby-Allen M, Campbell F. Benchmarking pain outcomes for children with sickle cell disease hospitalized in a tertiary referral pediatric hospital. Pain Res Manag. 2012 Jul-Aug;17(4):291-6. doi: 10.1155/2012/614819.

  PMID: 22891195 BACKGROUND

• Chirico EN, Martin C, Faes C, Feasson L, Oyono-Enguelle S, Aufradet E, Dubouchaud H, Francina A, Canet-Soulas E, Thiriet P, Messonnier L, Pialoux V. Exercise training blunts oxidative stress in sickle cell trait carriers. J Appl Physiol (1985). 2012 May;112(9):1445-53. doi: 10.1152/japplphysiol.01452.2011. Epub 2012 Feb 9.

  PMID: 22323645 BACKGROUND

• Fonarow GC, Gawlinski A, Moughrabi S, Tillisch JH. Improved treatment of coronary heart disease by implementation of a Cardiac Hospitalization Atherosclerosis Management Program (CHAMP). Am J Cardiol. 2001 Apr 1;87(7):819-22. doi: 10.1016/s0002-9149(00)01519-8.

  PMID: 11274933 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: March 4, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)