Clinical trial NCT01603160: Improving Emergency Department Management of Adults With Sickle Cell Disease
Official title: Improving Emergency Department Management of Adults With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Emergency Department
Quality Improvement
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Northwestern University
First posted: 2012-05-22
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Detailed description: There is a critical need to consistently provide best practice care for adult patients with sickle cell disease (SCD) who present to emergency departments (EDs). Patients with SCD suffer a shortened lifespan, and often die of many disease associated complications in their 4th and 5th decade of life. These complications include, but are not limited to: stroke, sepsis, pulmonary embolus, acute chest syndrome, and multi-system organ failure. Patients typically present to the ED with severe acute pain that requires rapid analgesic administration, often with high doses of opioids. The perception among many clinicians is that these patients, usually African American, are "drug seeking". This results in delays to administration of analgesics and inferior pain management. Finally, a small proportion of adults with SCD have a large number of visits. A recent study revealed that approximately 25% of adult patients with SCD had more than six ED visits per year with about 10% having more than 23 visits. Several patients had up to 175 visits over a 2-year period. There is also evidence that SCD patients with more than two hospitalizations/year are at an increased risk of death. ED clinicians are often frustrated when they see the same patient for multiple ED visits. This also leads to inadequate analgesic management. These issues highlight the suboptimal effectiveness of the process and systems of ED care for adults with SCD. ED practices for SCD care would significantly benefit from re-design and implementation of innovative best practice management strategies to optimize ED evaluation and management of VOC-related pain and facilitate appropriate referral to a primary care provider.

The ED-SCANS is a validated and reliable decision support tool developed by the principal investigator to help guide ED clinicians in delivering best practice care to adults with SCD. However, optimal integration of the tool within ED systems and process of care and the effect of the tool on both ED system and patient outcomes have not been evaluated. This study is the next logical step in the implementation of the ED-SCANS. The proposed study will use four key decisions of the ED-SCANS (triage, analgesic management, identification of high risk patients, and patient referral for care) as a framework to improve the processes and systems in ED management of adults with SCD. 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. These re-designed systems and processes (interventions) will be developed to be generalizable to most EDs, with minor modifications. A formal program evaluation will be conducted to determine the barriers and facilitators to implementation of the interventions. Preliminary, hypothesis generating data will be collected for selected outcomes related to each of the four decisions associated with the ED-SCANS. A toolbox of educational materials and electronic medical record prompts for EDs will be developed to facilitate implementation of the ED-SCANS at EDs across the country. This study will therefore focus on (1) developing an optimal implementation strategy using formal risk assessment (FMECA) and quality improvement (PDSA) methods focused on four key decisions of the ED-SCANS: Decision 1: triage, Decision 2: analgesic management, Decision 3: identification of high risk patients, and Decision 7: patient referral for care to improve the processes and systems involved in the care of adults with SCD and (2) conducting a formal program evaluation consisting of a process evaluation (to understand whether the optimal implementation strategy performs as intended (e.g. actual versus planned) through assessment of the barriers and facilitators to the implementation) and an outcomes evaluation of relevant clinical performance indicators, and patient and clinician outcomes. The outcome evaluation is designed to be hypothesis generating, not hypothesis testing. Finally, a toolbox of educational materials and other implementation tools such as decision support tools (e.g., documentation templates) will be developed during the project.

Eligibility criteria: Inclusion Criteria for Patient Subjects:

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

Exclusion Criteria for Patient Subjects:

* Diagnosis of Sickle Cell Trait, vs. Disease

Inclusion Criteria for Clinician Subjects:

* Attending or resident physician, or nurse in the Emergency Department

Exclusion Criteria for Clinician Subjects:

* None

Primary outcomes:
measure: Number of SCD patients meeting high user criteria
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
measure: Change in clinical performance indicators and patient and clinician outcome measures
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Paula Tanabe, MSN, MPH, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: