Clinical trial NCT01962610: Improving Pain Management for Older Adults in the Emergency Department (ED)
Official title: Improving Management of Acute Pain for Older Adults in the ED Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain Care
Keywords: Pain care
emergency
clinical decision support
abdominal pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 4693
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Resident physicians will be included if:

* they provide care to adult patients in the Icahn School of Medicine at Mount Sinai's ED.

Patients will be enrolled for survey and/or medical record review if

* All adult (≥20 years) patients seen in the Icahn School of Medicine at Mount Sinai's ED
* with severe pain (≥10 on a verbal pain scale of 0-10, 0=none, 10=severe)
* and chief complaints of abdominal pain will be eligible for retrospective and/or medical record review and prospective survey at ED discharge.

Primary outcomes:
measure: Analgesia order
timeFrame: at ED visit
measure: Analgesia Administration
timeFrame: at ED visit
Secondary outcomes:
measure: Patient Pain Care Satisfaction
timeFrame: at ED visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Mediciine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ula Y Hwang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: