Delirium Screening of the Elderly in the Emergency Department
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 7/20/2016 |
| Start Date: | July 2015 |
| End Date: | June 2017 |
| Contact: | Jane Saczynski, PhD |
| Email: | j.saczynski@neu.edu |
| Phone: | 617-373-5212 |
This study will refine and pilot test an innovative, emergency department (ED)-based
intervention for delirium screening, initial management, and communication with inpatient
providers, and examine the impact of this intervention on the rate of documentation of
delirium in the electronic health record by ED and inpatient providers. To achieve this, the
study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED,
involving 300 older patients (150 newly enrolled intervention participants, 150 historical
controls (comparison group) currently being collected), that has 4 key components:
systematic screening for delirium using the Confusion Assessment Method (CAM), informing
providers of the screening result, a checklist protocol for initial delirium management
based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and
communication with inpatient providers of delirium screening results.
The study has two primary aims. The first is to refine and test the feasibility and
acceptability of the SCREEN-ED intervention. The second is to examine the impact of
SCREEN-ED on rate of delirium documentation and secondary outcomes (length of hospital stay,
repeat ED visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled
intervention group compared with 150 already collected historical controls.
intervention for delirium screening, initial management, and communication with inpatient
providers, and examine the impact of this intervention on the rate of documentation of
delirium in the electronic health record by ED and inpatient providers. To achieve this, the
study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED,
involving 300 older patients (150 newly enrolled intervention participants, 150 historical
controls (comparison group) currently being collected), that has 4 key components:
systematic screening for delirium using the Confusion Assessment Method (CAM), informing
providers of the screening result, a checklist protocol for initial delirium management
based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and
communication with inpatient providers of delirium screening results.
The study has two primary aims. The first is to refine and test the feasibility and
acceptability of the SCREEN-ED intervention. The second is to examine the impact of
SCREEN-ED on rate of delirium documentation and secondary outcomes (length of hospital stay,
repeat ED visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled
intervention group compared with 150 already collected historical controls.
The investigators will develop and pilot test an intervention, Delirium Screening
(SCREEN-ED) in the ED, involving 300 older patients (150 newly enrolled intervention
participants, 150 historical controls (comparison group) currently being collected), that
has 4 key components: systematic screening for delirium using the CAM, informing providers
of the screening result, a checklist protocol for initial delirium management based on
clinical guidelines, and documentation in the Electronic Health Record (EHR) and
communication with inpatient providers of delirium screening results. The short-term goal is
to test the feasibility and acceptability of the intervention, and its immediate impact on
documentation of delirium in the EHR. The long-term goal is to utilize the information
gleaned from this developmental study to inform a large-scale multi-center randomized
clinical trial to test the impact of the SCREEN-ED strategy on clinical outcomes including
length of stay, repeat ED visits, rehospitalization, and mortality.
The study will enroll 150 patients to the intervention arm and will screen them for delirium
using the CAM. The screening results (positive or negative) will be provided verbally and in
the EHR to ED providers, and, in screen positive cases, ED physicians will be provided with
a checklist protocol for delirium management that will be embedded in the ED EHR.
Additionally, in admitted patients, the screening result will be entered into the inpatient
EHR. The study team will review ED and inpatient medical records and compare physician
documentation of delirium in SCREEN-ED compared with a historical comparison group currently
being collected.
The study will follow all patients (intervention and comparison) through medical record
review for 6 months to collect clinical outcomes, which will be examined as secondary
outcomes. The study will also examine the acceptability of the intervention with ED and
inpatient providers through focus groups prior to the roll-out of SCREEN-ED to refine the
intervention components and again in year 2 of the study, after the intervention period is
complete, to identify barriers and facilitators to intervention implementation.
Using the same system used to enroll the historical comparison group, patients will be
identified using the real-time ED EHR (PulseCheck™), which is populated on arrival with
detailed clinical information and links with the hospital EHR. After initial eligibility
screen, patients will be approached by trained study staff and introduced to the study.
Informed consent will be obtained and study staff will use a standardized Capacity for
Informed Consent Instrument that combines capacity assessment questions with interviewer
observation and that is used in a prior ED delirium study. If the patient fails the Capacity
assessment, a proxy will be asked to provide consent (with patient assent).
The PIs have worked to seamlessly integrate their staff into the workflow of the ED. They
expect enrollment to last ~40 weeks, requiring 4 patients be enrolled per week to meet a
sample size of 150 in the intervention group (recruitment rate of <10%, assuming 200
patients per week of which 25% are ineligible and 50% refuse).
The pilot SCREEN-ED intervention will test whether screening for delirium in the ED combined
with a checklist protocol for initial management is feasible and acceptable and increases
EHR documentation of delirium. Consenting participants enrolled in SCREEN-ED will be
administered a brief (<10 minutes), standardized questionnaire by a trained study staff
member from which the CAM will be scored. Immediately following the interview, the study
staff member will score the CAM and the screening result (positive or negative) and, in
positive cases, the severity stage of delirium (mild, moderate, severe) will be entered into
the EHR and verbally communicated to providers. For patients who screen positive, the
checklist protocol for delirium management will automatically appear in the EHR and the ED
physicians will be prompted to review and complete all applicable checklist items. In cases
where the patient is admitted, the diagnosis and severity will be entered into the EHR and
the admitting physicians will be directly informed through existing structured verbal and
written communication between the ED and admitting providers.
After the intervention period, the study team will conduct additional focus groups with 10
providers (MDs and nurses), including representatives from inpatient services , who will
provide qualitative data on the feasibility of implementation of the intervention and
contribute to systematic evaluation using the REAIM (reach, effectiveness, adoption,
implementation, maintenance) framework. The investigators will use a widely used focus-group
methodology designed to elicit a range of ideas, attitudes, experiences and reactions from
providers on the SCREEN-ED strategy. Semi-structured interview scripts will be developed to
generate discussion about providers' experiences with SCREEN-ED and changes in the
management of older patients as a result of its use. The checklist items will provide the
overall structure to the focus group discussions. Information from the focus groups,
providing direct accounts of provider experience, will compliment adherence data collected
from medical record review. Inpatient providers will describe how checklist protocols (e.g.,
diagnosis, treatment & communication) impacted the care they provided (e.g., Did they do
anything differently knowing the patient was diagnosed with delirium? Did results from
initial work-up contribute to their approach to the patient?). It is anticipated that with
three focus groups saturation will be reached (i.e., no new ideas are being contributed).
However, if this is not the case additional providers will be enrolled and conduct
additional groups until saturation is achieved.
Participants enrolled in an ongoing study of delirium that is validating a tool for family
members to identify delirium against the CAM will serve as the historical comparison group.
This study, which began enrollment in September 2013, has enrolled 120 participants to date
by enrolling approximately 2 days a week. The study will enroll intervention patients as
soon as possible after completion of comparison group enrollment to minimize temporal
separation and enhance comparability. Participants in the comparison group are screened for
delirium using the CAM following the same procedures described above for the intervention
group. Because the CAM is being used as the gold-standard against which to compare the new
screening instrument and was not being administered for screening purposes, CAM results are
not communicated to providers, are not incorporated into the EHR, and providers are not
given a delirium management checklist. Medical record abstraction elements in the
intervention and comparison groups will be identical.
(SCREEN-ED) in the ED, involving 300 older patients (150 newly enrolled intervention
participants, 150 historical controls (comparison group) currently being collected), that
has 4 key components: systematic screening for delirium using the CAM, informing providers
of the screening result, a checklist protocol for initial delirium management based on
clinical guidelines, and documentation in the Electronic Health Record (EHR) and
communication with inpatient providers of delirium screening results. The short-term goal is
to test the feasibility and acceptability of the intervention, and its immediate impact on
documentation of delirium in the EHR. The long-term goal is to utilize the information
gleaned from this developmental study to inform a large-scale multi-center randomized
clinical trial to test the impact of the SCREEN-ED strategy on clinical outcomes including
length of stay, repeat ED visits, rehospitalization, and mortality.
The study will enroll 150 patients to the intervention arm and will screen them for delirium
using the CAM. The screening results (positive or negative) will be provided verbally and in
the EHR to ED providers, and, in screen positive cases, ED physicians will be provided with
a checklist protocol for delirium management that will be embedded in the ED EHR.
Additionally, in admitted patients, the screening result will be entered into the inpatient
EHR. The study team will review ED and inpatient medical records and compare physician
documentation of delirium in SCREEN-ED compared with a historical comparison group currently
being collected.
The study will follow all patients (intervention and comparison) through medical record
review for 6 months to collect clinical outcomes, which will be examined as secondary
outcomes. The study will also examine the acceptability of the intervention with ED and
inpatient providers through focus groups prior to the roll-out of SCREEN-ED to refine the
intervention components and again in year 2 of the study, after the intervention period is
complete, to identify barriers and facilitators to intervention implementation.
Using the same system used to enroll the historical comparison group, patients will be
identified using the real-time ED EHR (PulseCheck™), which is populated on arrival with
detailed clinical information and links with the hospital EHR. After initial eligibility
screen, patients will be approached by trained study staff and introduced to the study.
Informed consent will be obtained and study staff will use a standardized Capacity for
Informed Consent Instrument that combines capacity assessment questions with interviewer
observation and that is used in a prior ED delirium study. If the patient fails the Capacity
assessment, a proxy will be asked to provide consent (with patient assent).
The PIs have worked to seamlessly integrate their staff into the workflow of the ED. They
expect enrollment to last ~40 weeks, requiring 4 patients be enrolled per week to meet a
sample size of 150 in the intervention group (recruitment rate of <10%, assuming 200
patients per week of which 25% are ineligible and 50% refuse).
The pilot SCREEN-ED intervention will test whether screening for delirium in the ED combined
with a checklist protocol for initial management is feasible and acceptable and increases
EHR documentation of delirium. Consenting participants enrolled in SCREEN-ED will be
administered a brief (<10 minutes), standardized questionnaire by a trained study staff
member from which the CAM will be scored. Immediately following the interview, the study
staff member will score the CAM and the screening result (positive or negative) and, in
positive cases, the severity stage of delirium (mild, moderate, severe) will be entered into
the EHR and verbally communicated to providers. For patients who screen positive, the
checklist protocol for delirium management will automatically appear in the EHR and the ED
physicians will be prompted to review and complete all applicable checklist items. In cases
where the patient is admitted, the diagnosis and severity will be entered into the EHR and
the admitting physicians will be directly informed through existing structured verbal and
written communication between the ED and admitting providers.
After the intervention period, the study team will conduct additional focus groups with 10
providers (MDs and nurses), including representatives from inpatient services , who will
provide qualitative data on the feasibility of implementation of the intervention and
contribute to systematic evaluation using the REAIM (reach, effectiveness, adoption,
implementation, maintenance) framework. The investigators will use a widely used focus-group
methodology designed to elicit a range of ideas, attitudes, experiences and reactions from
providers on the SCREEN-ED strategy. Semi-structured interview scripts will be developed to
generate discussion about providers' experiences with SCREEN-ED and changes in the
management of older patients as a result of its use. The checklist items will provide the
overall structure to the focus group discussions. Information from the focus groups,
providing direct accounts of provider experience, will compliment adherence data collected
from medical record review. Inpatient providers will describe how checklist protocols (e.g.,
diagnosis, treatment & communication) impacted the care they provided (e.g., Did they do
anything differently knowing the patient was diagnosed with delirium? Did results from
initial work-up contribute to their approach to the patient?). It is anticipated that with
three focus groups saturation will be reached (i.e., no new ideas are being contributed).
However, if this is not the case additional providers will be enrolled and conduct
additional groups until saturation is achieved.
Participants enrolled in an ongoing study of delirium that is validating a tool for family
members to identify delirium against the CAM will serve as the historical comparison group.
This study, which began enrollment in September 2013, has enrolled 120 participants to date
by enrolling approximately 2 days a week. The study will enroll intervention patients as
soon as possible after completion of comparison group enrollment to minimize temporal
separation and enhance comparability. Participants in the comparison group are screened for
delirium using the CAM following the same procedures described above for the intervention
group. Because the CAM is being used as the gold-standard against which to compare the new
screening instrument and was not being administered for screening purposes, CAM results are
not communicated to providers, are not incorporated into the EHR, and providers are not
given a delirium management checklist. Medical record abstraction elements in the
intervention and comparison groups will be identical.
Inclusion Criteria:
- 65 years presenting to the ED between 2pm and 11pm (highest ED census) 7 days a week
Exclusion Criteria:
- Patients who are being evaluated for severe head injury and those who present with
delirium tremens due to the difficulty of distinguishing delirium from head injury
and because delirium tremens has a distinct etiology, course and outcomes.
- Patients who are aphasic, comatose, terminally ill, deaf, or are non-English
speaking.
We found this trial at
1
site
Click here to add this to my saved trials
