Improving Emergency Department Management of Adults With Sickle Cell Disease

NCT01603160 | Completed DMC

• 2 other identifiers: Pro000321621R18HS019646-01A1
• Study Type: observational
• Target: 715
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to design, implement and test quality improvement measures to improve the care of adults with sickle cell disease in the emergency department.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Emergency Department; Quality Improvement

Outcome Measures

Primary Outcomes (2)

• Number of SCD patients meeting high user criteria

  High user criteria include: No Primary Care Physician, \>3 painful episodes per year, \>3 ED visits or hospitalizations per year, difficulty getting appointments with PCP. Specific outcome measures include: decrease in the number of ED visits and hospitalizations, as well as improvement in the proportion of physician, social service, and psychiatric service referrals made for high risk/high utilizer patients when indicated. Data will be collected via quarterly medical record reviews (every quarter) and patient interviews (quarters 3-10).

  3, 6, 9, 12, 15, 18, 21, 24, and 27 months

• Change in clinical performance indicators and patient and clinician outcome measures

  This outcome is exploratory and designed to be hypothesis generating. A combination of clinical performance indicators and patient and clinician outcomes will be analyzed, including Triage Score (correct/incorrect), Time to initial analgesic from arrival (minutes from arrival to administration of 1st dose), and patient satisfaction with ED analgesic management.

  3, 6, 9, 12, 15, 18, 21, 24, and 27 months

Study Arms (1)

Emergency Department Staff

Interventions put in place in the Emergency Department will effect most staff who work in the ED, but different sub-groups will be approached for participation in specific aspects of the study: * All ED attending and resident physicians and ED nurses will be invited to complete the SCD Attitudes survey. * Select ED Staff will be invited to be members of the QI team and will be invited to participate in the FMECA. * Members of the QI team will be invited to participate in a focus group.

Behavioral: Quality Improvement

Interventions

Quality Improvement BEHAVIORAL

There are no interventions for the individual patient. The changes in processes developed by the quality improvement team will be made for all adults with sickle cell disease, not just adults who consent to interviews. A proactive risk assessment methodology, Failure Modes, Effects, and Criticality Analysis (FMECA), will be used in two EDs to identify the vulnerabilities, risks, and weak points (failures) in the systems and processes involved in four key decisions of the ED-SCANS. Based on the aggregated results of the FMECA's, generalizable quality improvement interventions (QII's) will be developed and implemented with the purpose of changing the way emergency care for adults with SCD is delivered and organized.

Emergency Department Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient subjects will be recruited from the Duke University and Wake Forest Emergency Departments. All ED attending and resident physicians and ED nurses will be invited to complete the SCD Attitudes survey. Ten clinicians at Duke and 10 clinicians at Wake Forest will be recruited to participate in the FMECA's.

You may qualify if:

• years and older
• Ability to read and understand English
• Diagnosis of Sickle Cell Disease

You may not qualify if:

• Diagnosis of Sickle Cell Trait, vs. Disease
• Attending or resident physician, or nurse in the Emergency Department
• None

Sponsors & Collaborators

• Duke University: lead
• Wake Forest University Health Sciences: collaborator
• Northwestern University: collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Emergencies

Interventions

Quality Improvement

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Study Officials

• Paula Tanabe, MSN, MPH, PhD, RN

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: May 22, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

US (1)