Sickle Cell DiseaseNCT01603160
Improving Emergency Department Management of Adults With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 715 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years and older
- Ability to read and understand English
- Diagnosis of Sickle Cell Disease
- Attending or resident physician, or nurse in the Emergency Department
Who cannot join
- Diagnosis of Sickle Cell Trait, vs. Disease
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Quality Improvement
- Keywords
- Sickle Cell Disease, Emergency Department, Quality Improvement
- Medical subject headings
- Anemia, Sickle Cell, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality ImprovementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Quality Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, MSN, MPH, PhD, RN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603160
- Sponsor's protocol ID
- Pro00032162
- Other IDs
- 1R18HS019646-01A1
- Status last verified
- Mar 2015
- First submitted
- 16 Apr 2012
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Emergency Department Management of Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01603160
- Acronym / sponsor ID
- Pro00032162
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Emergency Department, Quality Improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Northwestern University
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Staff | – | Behavioral: Quality ImprovementInterventions 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 18 years and older
- Ability to read and understand English
- Diagnosis of Sickle Cell Disease
- Attending or resident physician, or nurse in the Emergency Department
Key exclusion criteria (2 listed)
- Diagnosis of Sickle Cell Trait, vs. Disease
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality ImprovementThere 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. | Behavioural | Emergency Department Staff |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Tanabe, MSN, MPH, PhD, RN principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SCD patients meeting high user criteria (time frame: 3, 6, 9, 12, 15, 18, 21, 24, and 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.