Improving Emergency Department Management of Adults With Sickle Cell Disease

NCT ID: NCT01603160

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 715 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Sickle Cell Disease

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Quality Improvement

Intervention Type: 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.

Interventions

Quality Improvement

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Diagnosis of Sickle Cell Trait, vs. Disease

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula Tanabe, MSN, MPH, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

1R18HS019646-01A1

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Pro00032162

Identifier Type: -

Identifier Source: org_study_id