- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127086
Managing Acute Pain in Critically Ill Non-communicative Palliative Care Patients
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Acute pain severity measured with same tool daily for 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
electronic health record data downloaded from each patient record after completing 7 days on study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
32 months
|
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.
|
7 days
|
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).
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carl Shanholtz, MD, University of Maryland, Baltimore
Publications and helpful links
General Publications
- Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.
- Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available. Erratum In: Crit Care Med 2002 Mar;30(3):726.
- Malchow RJ, Black IH. The evolution of pain management in the critically ill trauma patient: Emerging concepts from the global war on terrorism. Crit Care Med. 2008 Jul;36(7 Suppl):S346-57. doi: 10.1097/CCM.0b013e31817e2fc9.
- Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
- Caraceni A, Cherny N, Fainsinger R, Kaasa S, Poulain P, Radbruch L, De Conno F. Pain measurement tools and methods in clinical research in palliative care: recommendations of an Expert Working Group of the European Association of Palliative Care. J Pain Symptom Manage. 2002 Mar;23(3):239-55. doi: 10.1016/s0885-3924(01)00409-2.
- Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.
- 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.
- Ahles TA, Blanchard EB, Ruckdeschel JC. The multidimensional nature of cancer-related pain. Pain. 1983 Nov;17(3):277-288. doi: 10.1016/0304-3959(83)90100-8.
- Arbour C, Gelinas C. Are vital signs valid indicators for the assessment of pain in postoperative cardiac surgery ICU adults? Intensive Crit Care Nurs. 2010 Apr;26(2):83-90. doi: 10.1016/j.iccn.2009.11.003. Epub 2009 Dec 30.
- Bailey FA, Burgio KL, Woodby LL, Williams BR, Redden DT, Kovac SH, Durham RM, Goode PS. Improving processes of hospital care during the last hours of life. Arch Intern Med. 2005 Aug 8-22;165(15):1722-7. doi: 10.1001/archinte.165.15.1722.
- Bausell RB, Li Y. Power analysis for experimental research. Cambridge, England: Cambridge University Press; 2002.
- Bertsche T, Askoxylakis V, Habl G, Laidig F, Kaltschmidt J, Schmitt SP, Ghaderi H, Bois AZ, Milker-Zabel S, Debus J, Bardenheuer HJ, Haefeli WE. Multidisciplinary pain management based on a computerized clinical decision support system in cancer pain patients. Pain. 2009 Dec 15;147(1-3):20-8. doi: 10.1016/j.pain.2009.07.009. Epub 2009 Aug 19.
- Botti M, Bucknall T, Manias E. The problem of postoperative pain: issues for future research. Int J Nurs Pract. 2004 Dec;10(6):257-63. doi: 10.1111/j.1440-172x.2004.00487.x.
- Cade CH. Clinical tools for the assessment of pain in sedated critically ill adults. Nurs Crit Care. 2008 Nov-Dec;13(6):288-97. doi: 10.1111/j.1478-5153.2008.00294.x.
- Cohen SP, Christo PJ, Moroz L. Pain management in trauma patients. Am J Phys Med Rehabil. 2004 Feb;83(2):142-61. doi: 10.1097/01.PHM.0000107499.24698.CA.
- Downing,MG. Palliative Performance Scale (PPSv3) version 2. Learning Center for Palliative Care. Victoria, BC. 2005.
- Perreault SD. Chromatin remodeling in mammalian zygotes. Mutat Res. 1992 Dec;296(1-2):43-55. doi: 10.1016/0165-1110(92)90031-4.
- 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.
- Gil Z, Smith DB, Marouani N, Khafif A, Fliss DM. Treatment of pain after head and neck surgeries: control of acute pain after head and neck oncological surgeries. Otolaryngol Head Neck Surg. 2006 Aug;135(2):182-8. doi: 10.1016/j.otohns.2006.03.005.
- 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.
- Herr K, Bjoro K, Decker S. Tools for assessment of pain in nonverbal older adults with dementia: a state-of-the-science review. J Pain Symptom Manage. 2006 Feb;31(2):170-92. doi: 10.1016/j.jpainsymman.2005.07.001.
- Herr K, Coyne PJ, Key T, Manworren R, McCaffery M, Merkel S, Pelosi-Kelly J, Wild L; American Society for Pain Management Nursing. Pain assessment in the nonverbal patient: position statement with clinical practice recommendations. Pain Manag Nurs. 2006 Jun;7(2):44-52. doi: 10.1016/j.pmn.2006.02.003.
- Herr K, Titler M, Fine P, Sanders S, Cavanaugh J, Swegle J, Forcucci C, Tang X. Assessing and treating pain in hospices: current state of evidence-based practices. J Pain Symptom Manage. 2010 May;39(5):803-19. doi: 10.1016/j.jpainsymman.2009.09.025.
- 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, DeLoney VG, Yeager KA, Owen DC, Peterson DE, Lin LS, Webster J. Maintaining study validity in a changing clinical environment. Nurs Res. 2000 Jul-Aug;49(4):231-5. doi: 10.1097/00006199-200007000-00007.
- 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. Occurrence of cancer pain. J Natl Cancer Inst Monogr. 2004;(32):51-6. doi: 10.1093/jncimonographs/lgh015.
- 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.
- Mercadante S, Radbruch L, Caraceni A, Cherny N, Kaasa S, Nauck F, Ripamonti C, De Conno F; Steering Committee of the European Association for Palliative Care (EAPC) Research Network. Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer. 2002 Feb 1;94(3):832-9. doi: 10.1002/cncr.10249.
- Mularski RA, Curtis JR, Billings JA, Burt R, Byock I, Fuhrman C, Mosenthal AC, Medina J, Ray DE, Rubenfeld GD, Schneiderman LJ, Treece PD, Truog RD, Levy MM. Proposed quality measures for palliative care in the critically ill: a consensus from the Robert Wood Johnson Foundation Critical Care Workgroup. Crit Care Med. 2006 Nov;34(11 Suppl):S404-11. doi: 10.1097/01.CCM.0000242910.00801.53.
- 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.
- Paice JA, Muir JC, Shott S. Palliative care at the end of life: comparing quality in diverse settings. Am J Hosp Palliat Care. 2004 Jan-Feb;21(1):19-27. doi: 10.1177/104990910402100107.
- Prescott PA, Soeken KL. The potential uses of pilot work. Nurs Res. 1989 Jan-Feb;38(1):60-2. doi: 10.1097/00006199-198901000-00015. No abstract available.
- Resnick B, Inguito P, Orwig D, Yahiro JY, Hawkes W, Werner M, Zimmerman S, Magaziner J. Treatment fidelity in behavior change research: a case example. Nurs Res. 2005 Mar-Apr;54(2):139-43. doi: 10.1097/00006199-200503000-00010.
- 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.
- Sessler CN, Grap MJ, Ramsay MA. Evaluating and monitoring analgesia and sedation in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S2. doi: 10.1186/cc6148. Epub 2008 May 14.
- . Shadish WR, Cook TD, Campbell DT. Experimental and Quasi-experimental Designs for Generalized Causal Inference. Belmont, CA: Wadsworth; 2002.
- Strickland OL, Jackson G, Gilead M, McGuire DB, Quarles S. Use of focus groups for pain and quality of life assessment in adults with sickle cell disease. J Natl Black Nurses Assoc. 2001 Dec;12(2):36-43.
- van Eyk HG, Terhorst C, de Vijlder MM. Fragmentation of human IgG globulin with papain, trypsin and pepsin. Clin Chim Acta. 1967 Jun;16(3):429-31. doi: 10.1016/0009-8981(67)90309-9. No abstract available.
- Teasdale G, Murray G, Parker L, Jennett B. Adding up the Glasgow Coma Score. Acta Neurochir Suppl (Wien). 1979;28(1):13-6. doi: 10.1007/978-3-7091-4088-8_2. No abstract available.
- Truog RD, Campbell ML, Curtis JR, Haas CE, Luce JM, Rubenfeld GD, Rushton CH, Kaufman DC; American Academy of Critical Care Medicine. Recommendations for end-of-life care in the intensive care unit: a consensus statement by the American College [corrected] of Critical Care Medicine. Crit Care Med. 2008 Mar;36(3):953-63. doi: 10.1097/CCM.0B013E3181659096. Erratum In: Crit Care Med. 2008 May;36(5):1699.
- Twaddle ML, Maxwell TL, Cassel JB, Liao S, Coyne PJ, Usher BM, Amin A, Cuny J. Palliative care benchmarks from academic medical centers. J Palliat Med. 2007 Feb;10(1):86-98. doi: 10.1089/jpm.2006.0048.
- Vallano A, Malouf J, Payrulet P, Banos JE; Catalan Research Group for the Study of Pain in the Hospital. Analgesic use and pain in the hospital settings. Eur J Clin Pharmacol. 2007 Jun;63(6):619-26. doi: 10.1007/s00228-007-0303-7. Epub 2007 Apr 20.
- Virik K, Glare P. Validation of the palliative performance scale for inpatients admitted to a palliative care unit in Sydney, Australia. J Pain Symptom Manage. 2002 Jun;23(6):455-7. doi: 10.1016/s0885-3924(02)00407-4. No abstract available.
- Walker KA, Nachreiner D, Patel J, Mayo RL, Kearney CD. Impact of standardized palliative care order set on end-of-life care in a community teaching hospital. J Palliat Med. 2011 Mar;14(3):281-6. doi: 10.1089/jpm.2010.0398.
- Waltz CF, Strickland OL, Lenz ER. Measurement in Nursing Research. Philadelphia, PA: FA Davis; 1984.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00053272
- 4R01NR013664-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critically Ill
-
Niveus Medical, Inc.Terminated
-
Hospital Sao DomingosCompletedCritically Ill PatientsBrazil
-
Fundació Institut de Recerca de l'Hospital de la...Unknown
-
NestléCompletedCritically Ill ChildrenUnited States
-
University of ZurichIntuitive SurgicalUnknown
-
Policlinico HospitalCompletedCritically Ill PatientsItaly
-
China Medical University HospitalRecruitingCritically Ill PatientsTaiwan
-
Hospital Sao DomingosCompletedCritically Ill PatientsBrazil
-
Ain Shams UniversityUnknownCritically-ill PatientsEgypt
-
Hôpital Edouard HerriotCompletedCritically Ill PatientsFrance
Clinical Trials on Intervention Group
-
Muğla Sıtkı Koçman UniversityNot yet recruiting
-
University of LiegeCentre Hospitalier Universitaire de Liege; Bial Foundation; FNRS (Télévie); Fondation...RecruitingPain | Cancer | Fatigue | Cognitive Impairment | Sleep Disturbance | Distress, EmotionalBelgium
-
Hospital de Clinicas de Porto AlegreUnknown
-
University of California, San FranciscoNational Cancer Institute (NCI); Cancer Prevention Institute of CaliforniaCompletedHereditary Breast and Ovarian Cancer Syndrome
-
University of Sao PauloCompletedAnxiety | Self Esteem
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases
-
University of OxfordOxford Brookes UniversityRecruitingOverweight/Obesity, AdolescentUnited Kingdom
-
Beijing Tsinghua Chang Gung HospitalRecruitingLifestyle Intervention | Non Communicable DiseasesChina