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Validation of Pain as a Vital Sign Among Veterans With Advanced Illness

18 Years
Not Enrolling
Pain, Heart Failure, Congestive, Signs and Symptoms

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Trial Information

Validation of Pain as a Vital Sign Among Veterans With Advanced Illness

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

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

Outcome Time Frame:

cross sectional, visit based

Safety Issue:


Principal Investigator

Karl A. Lorenz, MD MSHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Greater Los Angeles Health Care System


United States: Federal Government

Study ID:

IIR 03-150



Start Date:

October 2005

Completion Date:

September 2008

Related Keywords:

  • Pain
  • Heart Failure, Congestive
  • Signs and Symptoms
  • Veterans
  • Pain
  • Palliative Care
  • Cardiology
  • Reproducibility of Results
  • Health Personnel
  • Heart Failure, Congestive
  • Heart Failure
  • Signs and Symptoms



VA Greater Los Angeles Health Care SystemWest Los Angeles, California  90073