Improving Pain Management for Older Adults in the Emergency Department (ED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01962610
First received: September 10, 2013
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Abdominal Pain Care
Other: ePCA and Pain keycept intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Management of Acute Pain for Older Adults in the ED Setting

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Analgesia order [ Time Frame: at ED visit ] [ Designated as safety issue: No ]
    pain care outcomes - analgesic medication ordering status

  • Analgesia Administration [ Time Frame: at ED visit ] [ Designated as safety issue: No ]
    pain care outcomes - Times from ED arrival to analgesic medication administration


Secondary Outcome Measures:
  • Patient Pain Care Satisfaction [ Time Frame: at ED visit ] [ Designated as safety issue: No ]
    Eligible subjects will be surveyed at ED discharge with regard to pain scores, desire for analgesic medication and satisfaction with pain care.


Estimated Enrollment: 900
Study Start Date: June 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ePCA and Pain keycept intervention
Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
Other: ePCA and Pain keycept intervention
Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit.
No Intervention: Usual Care
No study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962610

Contacts
Contact: Ula Y Hwang, MD, MPH (212) 241-7862 Ula.Hwang@mountsinai.org

Locations
United States, New York
Icahn School of Mediciine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Ula Y Hwang, MD, MPH         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Ula Y Hwang, MD, MPH Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01962610     History of Changes
Other Study ID Numbers: GCO 10-1414, 5R21AG040734-02
Study First Received: September 10, 2013
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Pain care
emergency
clinical decision support
abdominal pain

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014