Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230932
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-09-29
Brief Title:
Help Veterans Experience Less Pain Study HELP-Vets
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Validation of Pain as a Vital Sign Among Veterans With Advanced Illness
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELP-Vets
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
Detailed Description:
BackgroundRationale 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 Objectives 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 eg How do you feel rather than forma eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None