Improving Pain Management for Older Adults in the Emergency Department (ED)
Primary Purpose
Abdominal Pain Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ePCA and Pain keycept intervention
Sponsored by
About this trial
This is an interventional health services research trial for Abdominal Pain Care focused on measuring Pain care, emergency, clinical decision support, abdominal pain
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.
Sites / Locations
- Icahn School of Mediciine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ePCA and Pain keycept intervention
Usual Care
Arm Description
Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
No study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
Outcomes
Primary Outcome Measures
Analgesia order
pain care outcomes - analgesic medication ordering status
Analgesia Administration
pain care outcomes - Times from ED arrival to analgesic medication administration
Secondary Outcome Measures
Patient Pain Care Satisfaction
Eligible subjects will be surveyed at ED discharge with regard to pain scores, desire for analgesic medication and satisfaction with pain care.
Full Information
NCT ID
NCT01962610
First Posted
September 10, 2013
Last Updated
November 4, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT01962610
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
(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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain Care
Keywords
Pain care, emergency, clinical decision support, abdominal pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
4693 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ePCA and Pain keycept intervention
Arm Type
Experimental
Arm Description
Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
Intervention Type
Other
Intervention Name(s)
ePCA and Pain keycept intervention
Intervention Description
Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit.
Primary Outcome Measure Information:
Title
Analgesia order
Description
pain care outcomes - analgesic medication ordering status
Time Frame
at ED visit
Title
Analgesia Administration
Description
pain care outcomes - Times from ED arrival to analgesic medication administration
Time Frame
at ED visit
Secondary Outcome Measure Information:
Title
Patient Pain Care Satisfaction
Description
Eligible subjects will be surveyed at ED discharge with regard to pain scores, desire for analgesic medication and satisfaction with pain care.
Time Frame
at ED visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ula Y Hwang, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Mediciine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Pain Management for Older Adults in the Emergency Department (ED)
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