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

NCT02127086 | Completed DMC

• 2 other identifiers: HP-000532724R01NR013664-04
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute pain severity; Non-communicative patients; PAIN algorithm; Multi-dimensional Pain Assessment Tool (MOPAT)

Outcome Measures

Primary Outcomes (1)

• Acute pain severity (patient outcome variable)

  Is measured using: (1) Multi-dimensional Objective Pain Assessment Tool (MOPAT) a measure of acute pain severity consisting of two dimensions -Behavioral Dimension of four items scored from 0-3 depending on severity and Physiologic Dimension of four items scored as no change or change from usual. Because the Physiologic Dimension has lower reliability and literature indicating that physiologic indicators are not consistent measures of acute pain, only the Behavioral Dimension scores is to make decisions about orders in the analgesic order set.

  Acute pain severity measured with same tool daily for 7 days

Secondary Outcomes (1)

• Use of pharmacologic pain management strategies (patient outcome variable)

  electronic health record data downloaded from each patient record after completing 7 days on study

Other Outcomes (3)

• Clinical utility (nurse outcome variable)

  32 months

• Patterns of pain (patient outcome variable)

  7 days

• Concurrent pain related conditions (patient outcome variable)

  7 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Intervention Group

Usual Care Group

NO INTERVENTION

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

Interventions

Intervention Group OTHER

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.

Also known as: PAIN algorithm, Analgesic Order Set, Experimental Arm

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosed with potentially life-threatening conditions accompanied by acute pain
• With or without concurrent pain-related conditions
• Unable to self-report pain
• Receiving care on the participating units

You may not qualify if:

• Receiving paralytic agents
• Sedated and with a Richmond Agitation Sedation Scale score of -5
• Able to communicate pain through any verbal or physical means such as nodding or wiggling fingers
• Assigned to a participating unit
• Working at least 36 hours/week
• Routinely rotating between participating and non-participating units

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Virginia Commonwealth University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl Shanholtz, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: March 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)