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Abdominal Pain CareNCT01962610

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

A study testing ePCA and Pain keycept intervention in people with Abdominal Pain Care, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Abdominal Pain Care
What is being tested?
ePCA and Pain keycept intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,693 participants
Where
1 siteUnited States
Study dates
Jun 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Icahn School of Mediciine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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.

Read the 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.

Being tested
ePCA and Pain keycept intervention
Keywords
Pain care, emergency, clinical decision support, abdominal pain
Medical subject headings
Emergencies, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ePCA and Pain keycept interventionOther

    Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit.

Study groups in NCT01962610
Study groupRoleWhat they receive
ePCA and Pain keycept interventionExperimentalStudy designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit
Receives: Other: ePCA and Pain keycept intervention
Usual CareNo interventionNo study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analgesia order

    pain care outcomes - analgesic medication ordering status

    Measured: at ED visit

  2. Analgesia Administration

    pain care outcomes - Times from ED arrival to analgesic medication administration

    Measured: at ED visit

Secondary outcomes (1)
  1. 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.

    Measured: at ED visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study startJun 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
4,693 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962610
Sponsor's protocol ID
GCO 10-1414
Other IDs
5R21AG040734-02
Status last verified
Nov 2015
First submitted
10 Sep 2013
Last updated
5 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ePCA and Pain keycept intervention in people with Abdominal Pain Care, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesia order (time frame: at ED visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.

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