Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    8857241 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02127086
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Carl Shanholtz, University of Maryland, College Park

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


Condition or disease Intervention/treatment Phase
Critically Ill Other: Intervention Group Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Acute Pain in Critically Ill Non-communicative Palliative Care Patients
Study Start Date : March 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Intervention Group
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
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.
Other Names:
  • PAIN algorithm
  • Analgesic Order Set
  • Experimental Arm

No Intervention: Usual Care Group
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



Primary Outcome Measures :
  1. Acute pain severity (patient outcome variable) [ Time Frame: Acute pain severity measured with same tool daily for 7 days ]
    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.


Secondary Outcome Measures :
  1. Use of pharmacologic pain management strategies (patient outcome variable) [ Time Frame: electronic health record data downloaded from each patient record after completing 7 days on study ]
    Pain management data charted by the nurses caring for patients in Phases 1 and 2 will be downloaded from the electrical health record into an Excel data file. These data are based on a clinical dataset and methods routinely used to monitor pain management and quality. These data include total amount of opioids administered, categorized into as needed (PRN) and scheduled drugs, and converted into morphine equivalents.


Other Outcome Measures:
  1. Clinical utility (nurse outcome variable) [ Time Frame: 32 months ]
    Clinical Utility is defined as the usefulness of a measure or an algorithm within a specific setting and clinical population including the extent to which it can be used by practicing nurses. In study phase 1 the clinical utility of the Multi-dimensional Pain Assessment Tool (MOPAT) and in study phase 2 measures the clinical utility of the PAIN Algorithm, including the analgesic order set, by adding items that appraise the algorithm and order set in terms of ease of use, guidance in managing pain, etc.

  2. Patterns of pain (patient outcome variable) [ Time Frame: 7 days ]
    The patterns of each patient's pain will be categorized by abstracting MOPAT scores from the Electronic Medical Record(EMR) and entering the data into an excel file, and analyzing using graphic techniques.

  3. Concurrent pain related conditions (patient outcome variable) [ Time Frame: 7 days ]
    Each patient's concurrent pain related conditions will be abstracted from the Electronic Medical Record (EMR).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Patients:

  • 18 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

Exclusion Criteria Patients:

  • 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

Inclusion Criteria Nurses:

  • Assigned to a participating unit
  • Working at least 36 hours/week

Exclusion Criteria Nurses:

  • Routinely rotating between participating and non-participating units

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127086


Locations
Layout table for location information
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Carl Shanholtz, MD University of Maryland, Baltimore

Publications:
Acute Pain Management Guideline Panel. Acute pain management: operative or medical procedures and trauma. Clinical practice guideline Publ No. 92-0032. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services; 1992.
Bausell RB, Li Y. Power analysis for experimental research. Cambridge, England: Cambridge University Press; 2002.
Downing,MG. Palliative Performance Scale (PPSv3) version 2. Learning Center for Palliative Care. Victoria, BC. 2005.
Foley K. Acute and chronic cancer pain syndromes. Chapter 8.2.2. In: Doyle D, Hanks G, Cherney NI, Calman K, eds. Oxford Textbook of Palliative Medicine 3rd ed. New York, NY: Oxford University Press 298-316, 2005.
Health Care Cost and Utilization Project (HCUP). Clinical Classifications Software (CCS) for ICD-9-CM. http://www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp#overview. Updated Jan 25, 2011. Accessed March 20, 2011.
International Association for the Study of Pain (IASP) Task Force on Acute Pain. Management of Acute Pain: A Practical Guide. Ready LB, Edwards WT, eds. Seattle, Washington; IASP Publications; 1992.
Johnston CC. Psychometric issues in the measurement of pain. In: Finley GA, McGrath PJ, eds. Measurement of Pain in Children and Infants. Seattle, WA: IASP Press 5-20, 1998.
Kaiser K, Dupee J, Petri L, Hill J, Smith D. Application of selected 2008 American pain society quality indicators for acute and chronic pain. Journal of Pain 8(4):S1-S70, 2007.
Kaiser K. Use of electronic medical records in pain management In: Pasero C, McCaffery M. Pain Assessment and Pharmacologic Management. Baltimore, MD: Mosby 837-857, 2011.
Kessler SM, Swetz KM. Prognostication in severe traumatic brain injury in adults. http://www.eperc.mcw.edu/fastFact/ff_239.htm. Accessed March 20, 2011.
Melzack R, Casey KL. Sensory, Motivational, and Central Control Determinants of Pain: A New Conceptual Model. Kenshalo D. (Ed.). Chas C. Thomas. Springfield, MA; 423-439, 1968.
. McGuire DB. The multidimensional phenomenon of cancer pain. In: McGuire DB, Yarbro CH, eds. Cancer Pain Management. Orlando, FL: Grune and Stratton 1-20, 1987.
McGuire DB, Ahles TA, Dudley WN, Yeager KA. Multidimensional conceptualization of acute oral pain in transplant and leukemia patients. Psycho-Oncology 8:6S23, 1999.
McGuire DB. The multiple dimensions of cancer pain: a framework for assessment and management. In: McGuire DB, Yarbro CH, Ferrell BR, eds. Cancer Pain Management 2nd ed. Boston, MA: Jones and Bartlett Publishers; 1-17: 1995.
McGuire DB, Kaiser K, Soeken K, Reifsnyder J, Keay T. Measuring pain in noncommunicative palliative care patients in the acute care setting: Psychometric evaluation of the multidimensional objective pain assessment tool (MOPAT). Journal of Pain and Symptom Management 41(1):299-300, 2011.
National Consensus Project for Quality Palliative Care (NCP). Clinical Practice Guidelines for Quality Palliative Care (2nd ed.). Brooklyn, NY: Author; 2009.
National Institute of Nursing Priority Expert Panel on Symptom Management: Acute Pain. 6. Symptom Management: Acute Pain. National Institute of Health Nursing Research, U.S. Department of Health and Human Services, U.S. Public Health Service, National Institutes of Health. Bethesda, MD: NIH Pub. No 94-24211; 1994.
National Priorities Partnership (NPP). National Priorities and Goals: Aligning our Efforts to Transform America's Healthcare. Washington, DC: National Quality Forum; 2008.
National Quality Forum (NQF). A National Framework and Preferred Practices for Palliative and Hospice Care Quality. Washington DC: Author; 2006.
Reyna YZ, Bennett MI, Bruera E. Ethical and practical issues in designing and conducting clinical trials in palliative care. In: Addington-Hall JM, Bruera E, Higginson IJ, Payne S, eds. Research Methods in Palliative Care. New York, NY: Oxford; 27-38, 2009.
Reynolds CM, Suber F, Curtis KM, Henriques HF. A novel pain management protocol results in more rapid analgesia for trauma patients. Society for Academy of Emergency Medicine 11(5):497, 2004.
. Shadish WR, Cook TD, Campbell DT. Experimental and Quasi-experimental Designs for Generalized Causal Inference. Belmont, CA: Wadsworth; 2002.
Waltz CF, Strickland OL, Lenz ER. Measurement in Nursing Research. Philadelphia, PA: FA Davis; 1984.

Layout table for additonal information
Responsible Party: Carl Shanholtz, Associate Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02127086     History of Changes
Other Study ID Numbers: HP-00053272
4R01NR013664-04 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Carl Shanholtz, University of Maryland, College Park:
Acute pain severity
Non-communicative patients
PAIN algorithm
Multi-dimensional Pain Assessment Tool (MOPAT)

Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs