- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01603160
Improving Emergency Department Management of Adults With Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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:
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of SCD patients meeting high user criteria
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
|
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
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paula Tanabe, MSN, MPH, PhD, RN, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00032162
- 1R18HS019646-01A1 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sickle Cell Disease
-
Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Hilton...CompletedSickle Cell Disease | Sickle Cell Anemia in Children | Sickle Cell Thalassemia | Sickle Cell SC DiseaseUnited States
-
Nova Laboratories LimitedCompletedSickle Cell Disease | Sickle Cell Hemoglobin C | Sickle Cell-beta-thalassemia | Sickle-Cell; Hemoglobin Disease, ThalassemiaUnited Kingdom, Jamaica
-
SangartCompletedSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseUnited Kingdom, France, Jamaica, Lebanon
-
SangartWithdrawnSickle Cell Disease | Anemia, Sickle Cell | Sickle Cell Anemia | Hemoglobin SC Disease | Sickle Cell Disorders | Sickle Cell Hemoglobin C DiseaseFrance, United Kingdom, Netherlands, Turkey, Bahrain, Belgium, Brazil, Lebanon, Qatar
-
University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Heart, Lung, and Blood Institute (NHLBI)TerminatedSickle Cell Anemia | Sickle Cell-hemoglobin C Disease | Sickle Cell-β0-thalassemiaUnited States
-
University of RegensburgRecruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | HbS Disease | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SGermany, Austria
-
Centre Hospitalier Intercommunal CreteilRecruitingSickle-Cell Disease Nos With CrisisFrance
-
HemaQuest Pharmaceuticals Inc.TerminatedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Egypt, Canada, Jamaica
-
HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica
Clinical Trials on Quality Improvement
-
Institute for Clinical Effectiveness and Health...Inter-American Development BankUnknownColorectal NeoplasmsArgentina
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); Heart and Stroke Foundation...Completed
-
Institute for Clinical Effectiveness and Health...Ministry of Public Health, ArgentinaUnknownCardiovascular Diseases | Quality ImprovementArgentina
-
Dartmouth-Hitchcock Medical CenterConcord Hospital; MGH Multiple Sclerosis Clinic; University of Vermont Multiple... and other collaboratorsCompletedMultiple SclerosisUnited States
-
Brigham and Women's HospitalCompletedGestational Diabetes Mellitus
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR); AstraZeneca; Canadian Diabetes... and other collaboratorsCompletedType 2 Diabetes MellitusCanada
-
HealthPartners InstituteNovartis; TriHealth Inc.; William Beaumont Hospitals; Advocate Medical Group; Baystate... and other collaboratorsCompleted
-
US Department of Veterans AffairsCompletedSmoking | Smoking Cessation | Quality ImprovementUnited States
-
University of California, DavisCompleted