Palliative CareNCT00106041
Study to Improve Care for Veterans During Serious Illness
A study testing Veterans Integrated Palliative Care Nurse Case Manager in people with Palliative Care, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. Previous work within and outside of the VA has demonstrated serious deficiencies in the quality of care delivered near the end of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care
- What is being tested?
- Veterans Integrated Palliative Care Nurse Case Manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the hospital's general medicine service and estimated to have at least a 25% risk of dying over the following year.
Who cannot join
- Inability to pass cognitive screen
- Homelessness
- No telephone
- Admission from or discharge to a nursing home or hospice care
- Enrollment in another healthcare program or study that duplicates services of this study
- Receives most healthcare/primary healthcare services outside the VA GLA catchment area
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Randomized Trial of Care Management to Improve End of Life Care
Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. Previous work within and outside of the VA has demonstrated serious deficiencies in the quality of care delivered near the end of life. Moreover, veterans in the VA system suffer from a higher rate of chronic and life-limiting illnesses and decrements in health-related quality of life compared with the age-matched controls. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200 that died as inpatients in VA acute or chronic care medical wards. The care model on which the proposed study is based is theoretically sound and has been piloted in a study that suggested its use can help the VA achieve substantial quality improvement at reduced costs.
Read the detailed description
Background / Rationale: Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200 that died as inpatients in VA acute or chronic care medical wards. Previous work within and outside of the VA has identified serious deficiencies in the quality of care delivered near the end of life. A pilot program of a collaborative care intervention in patients with advanced illness suggests that palliative care management may lead to improvements in processes and outcomes of care at reduced costs.
Objective(s): The purpose of this project is to test the effectiveness of a chronic illness model-based palliative care intervention that utilizes prognosis-based palliative care evaluation and longitudinal nurse care management on the processes and outcomes of end-of-life care at one VA medical center.
Methods: The study uses a randomized, controlled design. All patients admitted to the inpatient medical service during the enrollment period are screened for survival prognosis by their admitting resident physician. Patients estimated to have at least a 25% risk of dying over the following year and who meet other basic inclusion criteria are invited to participate. Consenting patients are randomized to intervention or usual care. The intervention entails initial palliative evaluation followed by nurse care management designed to promote informed goal-setting, symptom management, psycho/socio/spiritual support, and family support. Data collection activities include patient and caregiver surveys, chart reviews, and reviews of administrative databases. Primary study outcomes include caregiver-rated quality of death and dying, hospital-based resource use, and costs; secondary outcomes include patient quality of life, satisfaction with care, continuity and coordination of care, and patient self-determination
Status: Enrollment and follow up of veterans/patients in the study is complete. Follow up with the caregivers of patients who died is ongoing and projected to end in February 2008. Subject enrollment began on 08/04/04 and target enrollment of 400 patients was reached in November 2006. Of the 1354 non-duplicated patients admitted to the hospital and prognostically eligible for the study, 795 (59%) were excluded; 400 (30%) were enrolled; 142(10%) refused; and 17 (1%) were missed or did not respond to recruitment efforts. To date, 257 of 400 enrolled veterans (64%) have died and 152 after-death interviews have been conducted with caregivers.
Impact: If shown to be effective, the palliative care program tested in this study will be the first of its type to demonstrate success in a controlled trial, and it will be ready for larger-scale implementation studies that will inform models of end-of-life care delivery both within and outside of the VA. Administrators at VAs nationwide, including chiefs of service, chiefs of staff, hospital directors, and VISN directors will be able to use the plans and protocols developed in this project to develop programs at their own institutions. Nurses, generalist physicians, and specialists can gain important insights about the special needs of seriously ill patients and the role of care systems in delivering high-quality end of life care. Finally, the project has immediate relevance to the healthcare system at large, as it struggles to find effective end-of-life care delivery models.
- Conditions
- Palliative Care
- Being tested
- Veterans Integrated Palliative Care Nurse Case Manager
- Keywords
- end of life care, evaluation studies, quality of death and dying, palliative care, coordination of care, satisfaction with care, healthcare cost, utilization of healthcare resources, caregivers, veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veterans Integrated Palliative Care Nurse Case ManagerBehavioural
Palliative Care nurse case management
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Palliative Care Nurse Case Management Receives: Behavioral: Veterans Integrated Palliative Care Nurse Case Manager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare expenditures including inpatient, ICU, outpatient, pharmacy and total costs; utilization of healthcare resources; and quality of death and dying experience. Includes expenditures time of study enrollment until patient's death.
Measured: We will be tracking resource use until the death of the patient or the conclusion of the study, whichever comes first. Quality of the death and dying experience will be assessed within 90 days of death
Secondary outcomes (1)
Satisfaction with care, quality of care, symptom management, understanding of illness, continuity and coordination of care, end-of-life care preferences, advance care planning, and treatments.
Measured: This will be assessed during the first year of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kenneth E. Rosenfeld, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106041
- Sponsor's protocol ID
- IIR 02-294
- Status last verified
- Sep 2012
- First submitted
- 18 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner GJ, Riopelle D, Steckart J, Lorenz KA, Rosenfeld KE. Provider communication and patient understanding of life-limiting illness and their relationship to patient communication of treatment preferences. J Pain Symptom Manage. 2010 Mar;39(3):527-34. doi: 10.1016/j.jpainsymman.2009.07.012. Epub 2010 Feb 19.
PubMed 20171827Seow H, Snyder CF, Shugarman LR, Mularski RA, Kutner JS, Lorenz KA, Wu AW, Dy SM. Developing quality indicators for cancer end-of-life care: proceedings from a national symposium. Cancer. 2009 Sep 1;115(17):3820-9. doi: 10.1002/cncr.24439.
PubMed 19514090Goebel JR, Doering LV, Lorenz KA, Maliski SL, Nyamathi AM, Evangelista LS. Caring for special populations: total pain theory in advanced heart failure: applications to research and practice. Nurs Forum. 2009 Jul-Sep;44(3):175-85. doi: 10.1111/j.1744-6198.2009.00140.x.
PubMed 19691653Fromme EK, Hughes MT, Brokaw FC, Rosenfeld KE, Arnold RM. Update in palliative medicine 2008. Journal of palliative medicine. 2008 Jun 1; 11(5):769-75.
Casarett D, Pickard A, Amos Bailey F, Ritchie C, Furman C, Rosenfeld K, Shreve S, Shea JA. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008 Feb;35(2):115-25. doi: 10.1016/j.jpainsymman.2007.03.008. Epub 2007 Nov 28.
PubMed 18053680Lorenz KA, Lynn J, Dy SM, Shugarman LR, Wilkinson A, Mularski RA, Morton SC, Hughes RG, Hilton LK, Maglione M, Rhodes SL, Rolon C, Sun VC, Shekelle PG. Evidence for improving palliative care at the end of life: a systematic review. Ann Intern Med. 2008 Jan 15;148(2):147-59. doi: 10.7326/0003-4819-148-2-200801150-00010.
PubMed 18195339Lorenz KA, Rosenfeld K, Wenger N. Quality indicators for palliative and end-of-life care in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S318-26. doi: 10.1111/j.1532-5415.2007.01338.x. No abstract available.
PubMed 17910553Chang VT, Sorger B, Rosenfeld KE, Lorenz KA, Bailey AF, Bui T, Weinberger L, Montagnini M. Pain and palliative medicine. J Rehabil Res Dev. 2007;44(2):279-94. doi: 10.1682/jrrd.2006.06.0067.
PubMed 17551879Krouse RS, Mohler MJ, Wendel CS, Grant M, Baldwin CM, Rawl SM, McCorkle R, Rosenfeld KE, Ko CY, Schmidt CM, Coons SJ. The VA Ostomy Health-Related Quality of Life Study: objectives, methods, and patient sample. Curr Med Res Opin. 2006 Apr;22(4):781-91. doi: 10.1185/030079906X96380.
PubMed 16684439
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Care Management to Improve End of Life Care
- ClinicalTrials.gov ID
- NCT00106041
- Acronym / sponsor ID
- IIR 02-294
- Conditions
- Palliative Care
- Keywords
- end of life care, evaluation studies, quality of death and dying, palliative care, coordination of care, satisfaction with care, healthcare cost, utilization of healthcare resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. Previous work within and outside of the VA has demonstrated serious deficiencies in the quality of care delivered near the end of life. Moreover, veterans in the VA system suffer from a higher rate of chronic and life-limiting illnesses and decrements in health-related quality of life compared with the age-matched controls. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200 that died as inpatients in VA acute or chronic care medical wards. The care model on which the proposed study is based is theoretically sound and has been piloted in a study that suggested its use can help the VA achieve substantial quality improvement at reduced costs.
Detailed description
Background / Rationale: Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200 that died as inpatients in VA acute or chronic care medical wards. Previous work within and outside of the VA has identified serious deficiencies in the quality of care delivered near the end of life. A pilot program of a collaborative care intervention in patients with advanced illness suggests that palliative care management may lead to improvements in processes and outcomes of care at reduced costs.
Objective(s): The purpose of this project is to test the effectiveness of a chronic illness model-based palliative care intervention that utilizes prognosis-based palliative care evaluation and longitudinal nurse care management on the processes and outcomes of end-of-life care at one VA medical center.
Methods: The study uses a randomized, controlled design. All patients admitted to the inpatient medical service during the enrollment period are screened for survival prognosis by their admitting resident physician. Patients estimated to have at least a 25% risk of dying over the following year and who meet other basic inclusion criteria are invited to participate. Consenting patients are randomized to intervention or usual care. The intervention entails initial palliative evaluation followed by nurse care management designed to promote informed goal-setting, symptom management, psycho/socio/spiritual support, and family support. Data collection activities include patient and caregiver surveys, chart reviews, and reviews of administrative databases. Primary study outcomes include caregiver-rated quality of death and dying, hospital-based resource use, and costs; secondary outcomes include patient quality of life, satisfaction with care, continuity and coordination of care, and patient self-determination
Status: Enrollment and follow up of veterans/patients in the study is complete. Follow up with the caregivers of patients who died is ongoing and projected to end in February 2008. Subject enrollment began on 08/04/04 and target enrollment of 400 patients was reached in November 2006. Of the 1354 non-duplicated patients admitted to the hospital and prognostically eligible for the study, 795 (59%) were excluded; 400 (30%) were enrolled; 142(10%) refused; and 17 (1%) were missed or did not respond to recruitment efforts. To date, 257 of 400 enrolled veterans (64%) have died and 152 after-death interviews have been conducted with caregivers.
Impact: If shown to be effective, the palliative care program tested in this study will be the first of its type to demonstrate success in a controlled trial, and it will be ready for larger-scale implementation studies that will inform models of end-of-life care delivery both within and outside of the VA. Administrators at VAs nationwide, including chiefs of service, chiefs of staff, hospital directors, and VISN directors will be able to use the plans and protocols developed in this project to develop programs at their own institutions. Nurses, generalist physicians, and specialists can gain important insights about the special needs of seriously ill patients and the role of care systems in delivering high-quality end of life care. Finally, the project has immediate relevance to the healthcare system at large, as it struggles to find effective end-of-life care delivery models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Veterans Integrated Palliative Care Nurse Case ManagerPalliative Care Nurse Case Management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the hospital's general medicine service and estimated to have at least a 25% risk of dying over the following year.
Key exclusion criteria (7 listed)
- Inability to pass cognitive screen
- Homelessness
- No telephone
- Admission from or discharge to a nursing home or hospice care
- Enrollment in another healthcare program or study that duplicates services of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veterans Integrated Palliative Care Nurse Case ManagerPalliative Care nurse case management | Behavioural | Arm 1 |
Primary outcome
Healthcare expenditures including inpatient, ICU, outpatient, pharmacy and total costs; utilization of healthcare resources; and quality of death and dying experience. Includes expenditures time of study enrollment until patient's death.
Time frame: We will be tracking resource use until the death of the patient or the conclusion of the study, whichever comes first. Quality of the death and dying experience will be assessed within 90 days of death
1 secondary outcome
Satisfaction with care, quality of care, symptom management, understanding of illness, continuity and coordination of care, end-of-life care preferences, advance care planning, and treatments.
Time frame: This will be assessed during the first year of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 20171827Wagner GJ, Riopelle D, Steckart J, Lorenz KA, Rosenfeld KE. Provider communication and patient understanding of life-limiting illness and their relationship to patient communication of treatment preferences. J Pain Symptom Manage. 2010 Mar;39(3):527-34. doi: 10.1016/j.jpainsymman.2009.07.012. Epub 2010 Feb 19.
- Results publication: PubMed 19514090Seow H, Snyder CF, Shugarman LR, Mularski RA, Kutner JS, Lorenz KA, Wu AW, Dy SM. Developing quality indicators for cancer end-of-life care: proceedings from a national symposium. Cancer. 2009 Sep 1;115(17):3820-9. doi: 10.1002/cncr.24439.
- Results publication: PubMed 19691653Goebel JR, Doering LV, Lorenz KA, Maliski SL, Nyamathi AM, Evangelista LS. Caring for special populations: total pain theory in advanced heart failure: applications to research and practice. Nurs Forum. 2009 Jul-Sep;44(3):175-85. doi: 10.1111/j.1744-6198.2009.00140.x.
- Results publicationFromme EK, Hughes MT, Brokaw FC, Rosenfeld KE, Arnold RM. Update in palliative medicine 2008. Journal of palliative medicine. 2008 Jun 1; 11(5):769-75.
- Results publication: PubMed 18053680Casarett D, Pickard A, Amos Bailey F, Ritchie C, Furman C, Rosenfeld K, Shreve S, Shea JA. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008 Feb;35(2):115-25. doi: 10.1016/j.jpainsymman.2007.03.008. Epub 2007 Nov 28.
- Results publication: PubMed 18195339Lorenz KA, Lynn J, Dy SM, Shugarman LR, Wilkinson A, Mularski RA, Morton SC, Hughes RG, Hilton LK, Maglione M, Rhodes SL, Rolon C, Sun VC, Shekelle PG. Evidence for improving palliative care at the end of life: a systematic review. Ann Intern Med. 2008 Jan 15;148(2):147-59. doi: 10.7326/0003-4819-148-2-200801150-00010.
- Results publication: PubMed 17910553Lorenz KA, Rosenfeld K, Wenger N. Quality indicators for palliative and end-of-life care in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S318-26. doi: 10.1111/j.1532-5415.2007.01338.x. No abstract available.
- Results publication: PubMed 17551879Chang VT, Sorger B, Rosenfeld KE, Lorenz KA, Bailey AF, Bui T, Weinberger L, Montagnini M. Pain and palliative medicine. J Rehabil Res Dev. 2007;44(2):279-94. doi: 10.1682/jrrd.2006.06.0067.
- Results publication: PubMed 16684439Krouse RS, Mohler MJ, Wendel CS, Grant M, Baldwin CM, Rawl SM, McCorkle R, Rosenfeld KE, Ko CY, Schmidt CM, Coons SJ. The VA Ostomy Health-Related Quality of Life Study: objectives, methods, and patient sample. Curr Med Res Opin. 2006 Apr;22(4):781-91. doi: 10.1185/030079906X96380.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth E. Rosenfeld, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veterans Integrated Palliative Care Nurse Case Manager in people with Palliative Care, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare expenditures including inpatient, ICU, outpatient, pharmacy and total costs; utilization of healthcare resources; and quality of death and dying experience. Includes expenditures time of study enrollment until patient's death. (time frame: We will be tracking resource use until the death of the patient or the conclusion of the study, whichever comes first. Quality of the death and dying experience will be assessed within 90 days of death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106041, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.