Abdominal Pain Care Clinical Trial
Official title:
Improving Management of Acute Pain for Older Adults in the ED Setting
The goals of this exploratory study are to determine the feasibility of integrating
electronic clinical decision support into routine clinical pain care for adults in the ED
setting and gather data on whether or not such clinical decision support is effective in
improving pain care outcomes in the ED. The use of an electronic pain care alert (ePCA)
prompting doctors to provide acute pain care for adult patients with complaints of severe
abdominal pain will be compared to patients seen by clinicians with routine ED care.
Hypothesis: The ePCA will improve the quality of acute pain care for patients.
This study will compare the effectiveness of the combined electronic pain care alert (ePCA)
and "pain keycepts" (i.e., embedded pain care concepts/algorithms within clinician
documentation templates) intervention versus routine care on acute pain care outcomes for
geriatric abdominal pain patients in severe pain.
Hypothesis: The ePCA and pain keycept will improve the quality of acute pain care (i.e.,
Geriatric pain care quality indicators that include improved pain evaluation and pain
treatment (better pain assessment documentation, earlier administration of analgesic
medication, greater reduction of pain levels)) for geriatric abdominal pain patients in
severe pain.
Study Design: This is an exploratory randomized trial of the intervention versus usual
clinical care (control).
1. (Pre-intervention abdominal pain care baseline): Prior to any implementation of the
ePCA, baseline Epic process of pain care measures for abdominal pain patients will be
collected for a 4-month period. Study variables will be collected to determine baseline
patient-related and abdominal pain care data. Baseline data will be used for two
purposes. To determine if there: 1.) is an improvement in the quality of pain care
received post-intervention and 2.) are treatment diffusion effects with the control
(routine care) physicians who do not receive ePCAs (i.e., after the intervention period
has commenced, are differences in process of pain care outcomes found for the control
group versus pre-intervention baseline group).
2. This will be a randomized comparative effectiveness trial gathering pilot data on the
efficacy of the ePCA to improve with ED pain care for adults with severe abdominal
pain. To study the effect of the ePCA intervention, the alert will be randomized to
RESIDENT physicians, who will be randomly assigned to groups designated in the Epic EMR
(electronic medical record) (i.e., the alert will be triggered for some residents, and
not triggered for other residents (usual care) for the entire study period). Both
groups will have equal privileges in all ways (i.e., documentation and ordering) except
that BPAs will or will not be integrated for intervention vs. control. Investigators
will be blinded to randomization assignments and subjects (resident physicians) will be
blinded to study aims. Residents will always remain in their initial randomized arm.
The unit of analysis will be the ED visit. To study the impact of the ePCA on pain care
outcomes, pilot data will be collected with prospective survey from abdominal pain patients,
automated data reports from Epic and MSDW, and medical record review. Eligible subjects
enrolled and consented will be surveyed at discharge from the ED with regard to pain scores,
desire for analgesic medication, and satisfaction with pain care. While evidence from the
Surgical and Emergency Medicine (EM) literature indicate early analgesia does not obscure
clinical diagnoses, not result in diagnostic delays, nor impedes informed consent, some
clinicians may withhold analgesia due to the continued misguided belief that analgesia may
mask diagnostic findings or invalidate consent. For this reason, data will also be collected
of whether or not the patient required surgical consultation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research