Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
654 participants
Study Classification
OBSERVATIONAL
Study Start Date
2005-10-31
Study Completion Date
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
NCT05900362
Congestive Heart Failure
NOT_YET_RECRUITING
NA
Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring
NCT03010774
Sleep Quality
COMPLETED
NA
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
NCT02973243
Cardiac Arrest
Renal Failure
Respiration Failure
+2 more
COMPLETED
Testing the Effects of Telehealth Monitoring on Rehospitalization and Self Care for Heart Failure Patients in Home Care
NCT00300261
Heart Failure
COMPLETED
PHASE3
Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
NCT03554564
Peripheral Artery Disease
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pain
Heart Failure, Congestive
Signs and Symptoms
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
outpatients selected from random visits in primary care, oncology, and cardiology clinics
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* Patients who do not speak English.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl A. Lorenz, MD MSHS
Role: PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIR 03-150
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
NCT06364748
COMPLETED
NA
Use of Simulation to Improve VAD Self-management
NCT03073005
COMPLETED
NA
Home Monitoring Study for Surgical Patients
NCT07231653
NOT_YET_RECRUITING
High-Risk Veteran Initiative
NCT05050643
ACTIVE_NOT_RECRUITING
NA
Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial
NCT06731166
NOT_YET_RECRUITING
NA
An Evaluation of Concordance of Smartwatch ECG and One Clinical ECG and Comparison of The Two ECGS in Terms of Predictive Risks
NCT05617391
ACTIVE_NOT_RECRUITING
ECG Validation Study
NCT05445726
ACTIVE_NOT_RECRUITING
PHASE2
Improving Service Delivery Through Access Points
NCT00012623
COMPLETED
Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
NCT04362553
COMPLETED
Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery
NCT05866874
RECRUITING
Cardiac Monitor Employee Study
NCT03826225
COMPLETED
A Validation Study of Selfie Technology for Assessment of Vital Signs
NCT05117762
UNKNOWN
Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?
NCT06361862
COMPLETED
NA
Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care
NCT02893462
RECRUITING
Machine Learning-based Early Clinical Warning of High-risk Patients
NCT05410171
UNKNOWN
NA
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
NCT04706221
COMPLETED
NA
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
NCT04112576
COMPLETED
Telemonitoring in Patients With Heart Failure
NCT00502255
COMPLETED
NA
Integrated Telemonitoring and Nurse Support Evaluation
NCT01700218
UNKNOWN
NA
Developing and Assessing Competencies for Caregivers and Patients With Ventricular Assist Devices
NCT00178009
COMPLETED
Evaluation of Drug Display in Critical Care Setting
NCT00715507
COMPLETED
A Randomized Controlled Trial of a Video Decision Aid in the ICU
NCT01776333
UNKNOWN
NA
Adult Social Interaction
NCT04350268
UNKNOWN
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
NCT03906812
WITHDRAWN
NA
CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
NCT05726526
RECRUITING
NA