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Managing Acute Pain in Critically Ill Non-communicative Palliative Care Patients

NCT02127086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2022-03-21

No results posted yet for this study

Summary

The purpose of this project is to test an innovative method for managing pain in acutely ill hospitalized patients who are not able to report their pain verbally to health care professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management of medication side effects. The researchers will evaluate whether patients who are managed with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain management strategies than those who are not managed with the PAIN Algorithm.

The study design is a non-randomized quasi-experimental cohort design with two cohorts who will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG), or control cohort, defined as receiving pain assessment and management practices that nurses are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with analgesic order sets will be introduced to nurses and physicians on all participating units as the intervention. Patients enrolled in this phase will be considered the intervention group (IG), also called the experimental cohort. Nurses will be enrolled from the participating inpatient units to provide data on the clinical utility of the PAIN Algorithm

Conditions

  • Critically Ill

Interventions

OTHER

Intervention Group

The PAIN Algorithm and analgesic order sets to be used by nurses to assess and reassess pain and opioid-related side effects will include orders for: 1) managing pain based on MOPAT Behavioral Dimension cut scores, 2) pre-medication before painful procedures, 3) titration of drugs, and 4) managing major opioid side effects. The order sets will start with small doses of opioids that will be titrated upwards for peak analgesic effect and allow for adjustment for patient characteristics and type of pain while simultaneously monitoring for and treating side effects.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Carl Shanholtz, MD · University of Maryland, Baltimore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-06-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127086 on ClinicalTrials.gov