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Help Veterans Experience Less Pain Study (HELP-Vets) (HELP-Vets)

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ClinicalTrials.gov Identifier: NCT00230932
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Pain Heart Failure, Congestive Signs and Symptoms

Detailed Description:
Background/Rationale: The Veterans Administration (VA) faces a substantial challenge in trying to improve symptomatic care. An important priority is how to ensure pain relief. Studies show that pain is a major symptom for patients with advanced chronic illness in general. Drawing upon different clinical paradigms for the evaluation and treatment of pain, this study focuses on improving measurement and interpretation of routine pain screening in ambulatory VA patients as an important step to improving end-of-life care. Objective(s): In a variety of outpatient settings (hospital-based, large outpatient multi-specialty, and community-based) at the VA Greater Los Angeles (GLA) and Long Beach (LB) Healthcare Systems, we conducted surveys to capture patient, nurse, and clinician perspectives to evaluate the reliability and validity of pain as a 5th vital sign. We assessed skills that may be associated with pain measurement practices of nursing staff. Clinician knowledge, attitudes, and behaviors regarding the need to alleviate pain detected on routine screening were evaluated. Methods: Screen, enroll, and survey 650 cognitively intact patients with advanced CHF, cancer, and advanced general medical illness stratified by self-reported health status immediately after they are seen in outpatient clinics (general medicine, oncology, and cardiology clinics). Patients were approached and surveyed immediately after the outpatient visit on validated pain instruments, measures of depression, other symptoms, quality of life, attitudinal barriers to treatment of pain, the pain rating process, and unmet needs and satisfaction with treatment of pain, depression, and other symptoms. All nursing staff working as pain raters in the general medicine, oncology, and cardiology clinics were surveyed to assess relevant skills that may be associated with pain measurement practices. All clinicians (physicians, nurse practitioners, and physician assistants) working as treatment providers in these clinics were surveyed after patient visits to assess knowledge, attitudes, and behaviors of clinicians with regard to the need to alleviate pain detected on routine screening. Results: We found that in approximately 50% of cases, clinic staff taking vital signs used informal (e.g., 'How do you feel?') rather than forma (e.g., 0-10 NRS) methods to assess pain, and that practice was associated with underestimation of patient-reported pain to research staff in about 30% of cases. Factors associated with underestimation of patient reported pain to nurses compared with research raters included more years of staff work experience, patient anxiety or PTSD disorders, and lower self-reported health. Overestimation was associated with adherence to the formal NRS and negatively associated with a better environment for pain rating. About 40% of patients had emotional distress which was higher among patients in moderate to severe pain (62%). Only prior diagnosis and sleep interference due to pain were associated with provider detection of distress. Status: Enrollment is closed; IRB approved at VA GLA and LB Healthcare Systems.

Study Design

Study Type : Observational
Actual Enrollment : 654 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Pain as a Vital Sign Among Veterans With Advanced Illness
Study Start Date : October 2005
Primary Completion Date : June 2007
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs
U.S. FDA Resources

Groups and Cohorts

Group 1
outpatients selected from random visits in primary care, oncology, and cardiology clinics

Outcome Measures

Primary Outcome Measures :
  1. patient reported pain to nurses (NRS) compared to research raters (NRS, BPI) [ Time Frame: cross sectional, visit based ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
654 veterans, 50% with fair to poor, and 50% with good to excellent self-reported health

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT00230932

United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Karl A. Lorenz, MD MSHS VA Greater Los Angeles Healthcare System, West Los Angeles, CA
More Information


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00230932     History of Changes
Other Study ID Numbers: IIR 03-150
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: November 2008

Keywords provided by VA Office of Research and Development:
Palliative Care
Reproducibility of Results
Health Personnel
Heart Failure, Congestive

Additional relevant MeSH terms:
Heart Failure
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases