NCT00230932

Brief Summary

Our purpose is to evaluate the reliability and validity of the '5th vital sign' in everyday practice settings and to compare the relationship of pain to other symptoms and pain treatment in patients with cancer, CHF, and patients with complex general medical illness and poor self-reported health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

November 1, 2008

Enrollment Period

1.7 years

First QC Date

September 29, 2005

Last Update Submit

April 6, 2015

Conditions

PainHeart Failure, CongestiveSigns and Symptoms

Keywords

VeteransPainPalliative CareCardiologyReproducibility of ResultsHealth PersonnelHeart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • patient reported pain to nurses (NRS) compared to research raters (NRS, BPI)

    cross sectional, visit based

Study Arms (1)

Group 1

outpatients selected from random visits in primary care, oncology, and cardiology clinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

654 veterans, 50% with fair to poor, and 50% with good to excellent self-reported health

You may qualify if:

  • Patients seeking care in VA outpatient primary care, oncology, cardiology, or community based outpatient clinics, for advanced cancer, congestive heart failure, and advanced, complex general medical illness stratified by self-reported health.
  • Patients will be screened for fair or poor general medical health status, health conditions (cancer, CHF), cognition and ability to complete a researcher-assistant guided survey (e.g., hearing intact).
  • All nursing staff and pain treatment staff (resident and staff physician, PA, NP) in general medicine, oncology, and cardiology care at selected study sites and related community-based clinics will be asked to participate.

You may not qualify if:

  • Patients who are hearing and/or cognitively impaired.
  • Patients who do not speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (19)

  • Lorenz KA, Shugarman LR, Lynn J. Health care policy issues in end-of-life care. J Palliat Med. 2006 Jun;9(3):731-48. doi: 10.1089/jpm.2006.9.731. No abstract available.

    PMID: 16752979RESULT

  • Walling AM, Asch SM, Lorenz KA, Roth CP, Barry T, Kahn KL, Wenger NS. The quality of care provided to hospitalized patients at the end of life. Arch Intern Med. 2010 Jun 28;170(12):1057-63. doi: 10.1001/archinternmed.2010.175.

    PMID: 20585072RESULT

  • Shugarman LR, Asch SM, Meredith LS, Sherbourne CD, Hagenmeier E, Wen L, Cohen A, Rubenstein LV, Goebel J, Lanto A, Lorenz KA. Factors associated with clinician intention to address diverse aspects of pain in seriously ill outpatients. Pain Med. 2010 Sep;11(9):1365-72. doi: 10.1111/j.1526-4637.2010.00931.x. Epub 2010 Aug 30.

    PMID: 20807347RESULT

  • Goebel JR, Sherbourne CD, Asch SM, Meredith L, Cohen AB, Hagenmaier E, Lanto AB, Simon B, Rubenstein LV, Shugarman LR, Lorenz KA. Addressing patients' concerns about pain management and addiction risks. Pain Manag Nurs. 2010 Jun;11(2):92-8. doi: 10.1016/j.pmn.2009.03.009. Epub 2009 Sep 12.

    PMID: 20510839RESULT

  • Shugarman LR, Goebel JR, Lanto A, Asch SM, Sherbourne CD, Lee ML, Rubenstein LV, Wen L, Meredith L, Lorenz KA. Nursing staff, patient, and environmental factors associated with accurate pain assessment. J Pain Symptom Manage. 2010 Nov;40(5):723-33. doi: 10.1016/j.jpainsymman.2010.02.024. Epub 2010 Aug 8.

    PMID: 20692807RESULT

  • Stone SC, Mohanty SA, Gruzden C, Lorenz KA, Asch SM. Emergency department research in palliative care: challenges in recruitment. J Palliat Med. 2009 Oct;12(10):867-8. doi: 10.1089/jpm.2009.0139. No abstract available.

    PMID: 19807230RESULT

  • Grudzen CR, Koenig WJ, Hoffman JR, Boscardin WJ, Lorenz KA, Asch SM. Potential impact of a verbal prehospital DNR policy. Prehosp Emerg Care. 2009 Apr-Jun;13(2):169-72. doi: 10.1080/10903120802471923.

    PMID: 19291552RESULT

  • Seow H, Snyder CF, Mularski RA, Shugarman LR, Kutner JS, Lorenz KA, Wu AW, Dy SM. A framework for assessing quality indicators for cancer care at the end of life. J Pain Symptom Manage. 2009 Dec;38(6):903-12. doi: 10.1016/j.jpainsymman.2009.04.024.

    PMID: 19775860RESULT

  • Grudzen CR, Timmermans S, Koenig WJ, Torres JM, Hoffman JR, Lorenz KA, Asch SM. Paramedic and emergency medical technicians views on opportunities and challenges when forgoing and halting resuscitation in the field. Acad Emerg Med. 2009 Jun;16(6):532-8. doi: 10.1111/j.1553-2712.2009.00427.x. Epub 2009 May 11.

    PMID: 19438412RESULT

  • Goebel JR, Doering LV, Shugarman LR, Asch SM, Sherbourne CD, Lanto AB, Evangelista LS, Nyamathi AM, Maliski SL, Lorenz KA. Heart failure: the hidden problem of pain. J Pain Symptom Manage. 2009 Nov;38(5):698-707. doi: 10.1016/j.jpainsymman.2009.04.022. Epub 2009 Sep 3.

    PMID: 19733032RESULT

  • Zubkoff L, Lorenz KA, Lanto AB, Sherbourne CD, Goebel JR, Glassman PA, Shugarman LR, Meredith LS, Asch SM. Does screening for pain correspond to high quality care for veterans? J Gen Intern Med. 2010 Sep;25(9):900-5. doi: 10.1007/s11606-010-1301-5. Epub 2010 Mar 14.

    PMID: 20229139RESULT

  • Lorenz KA, Krebs EE, Bentley TG, Sherbourne CD, Goebel JR, Zubkoff L, Lanto AB, Asch SM. Exploring alternative approaches to routine outpatient pain screening. Pain Med. 2009 Oct;10(7):1291-9. doi: 10.1111/j.1526-4637.2009.00709.x.

    PMID: 19818039RESULT

  • Sherbourne CD, Asch SM, Shugarman LR, Goebel JR, Lanto AB, Rubenstein LV, Wen L, Zubkoff L, Lorenz KA. Early identification of co-occurring pain, depression and anxiety. J Gen Intern Med. 2009 May;24(5):620-5. doi: 10.1007/s11606-009-0956-2. Epub 2009 Mar 24.

    PMID: 19308333RESULT

  • Goebel JR, Doering LV, Evangelista LS, Nyamathi AM, Maliski SL, Asch SM, Sherbourne CD, Shugarman LR, Lanto AB, Cohen A, Lorenz KA. A comparative study of pain in heart failure and non-heart failure veterans. J Card Fail. 2009 Feb;15(1):24-30. doi: 10.1016/j.cardfail.2008.09.002. Epub 2008 Nov 13.

    PMID: 19181290RESULT

  • Cadogan MP, Edelen MO, Lorenz KA, Jones M, Yosef J, Hascall T, Simon B, Harker JO, Ferrell B, Saliba D. The relationship of reported pain severity to perceived effect on function of nursing home residents. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):969-73. doi: 10.1093/gerona/63.9.969.

    PMID: 18840802RESULT

  • Lorenz KA, Sherbourne CD, Shugarman LR, Rubenstein LV, Wen L, Cohen A, Goebel JR, Hagenmeier E, Simon B, Lanto A, Asch SM. How reliable is pain as the fifth vital sign? J Am Board Fam Med. 2009 May-Jun;22(3):291-8. doi: 10.3122/jabfm.2009.03.080162.

    PMID: 19429735RESULT

  • Dy SM, Asch SM, Lorenz KA, Weeks K, Sharma RK, Wolff AC, Malin JL. Quality of end-of-life care for patients with advanced cancer in an academic medical center. J Palliat Med. 2011 Apr;14(4):451-7. doi: 10.1089/jpm.2010.0434. Epub 2011 Mar 10.

    PMID: 21391819RESULT

  • Riopelle D, Wagner GJ, Steckart J, Lorenz KA, Rosenfeld KE. Evaluating a palliative care intervention for veterans: challenges and lessons learned in a longitudinal study of patients with serious illness. J Pain Symptom Manage. 2011 Jun;41(6):1003-14. doi: 10.1016/j.jpainsymman.2010.09.023. Epub 2011 Mar 12.

    PMID: 21402457RESULT

  • Malin JL, O'Neill SM, Asch SM, Dy SM, Walling AM, Tisnado D, Antonio AL, Lorenz KA. Quality of supportive care for patients with advanced cancer in a VA medical center. J Palliat Med. 2011 May;14(5):573-7. doi: 10.1089/jpm.2010.0464. Epub 2011 Mar 17.

    PMID: 21413885RESULT

MeSH Terms

Conditions

PainHeart FailureSigns and Symptoms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Karl A. Lorenz, MD MSHS

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2007

Study Completion

September 1, 2008

Last Updated

April 7, 2015

Record last verified: 2008-11

Locations

US(1)