Quality of End-of-life Care in Nursing HomesNCT00616473
Quality End-of-Life Care in Nursing Homes
An observational study of Quality of End-of-life Care in Nursing Homes, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to examine key organizational structures and processes (leadership, teamwork, communication, palliative care) and their impact on the quality of end-of-life care for dying residents and their family members. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Quality of End-of-life Care in Nursing Homes
- How many people
- 7,169 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2006to 1 Jan 2011
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nursing Homes in Nebraska and the Western half of Iowa, nursing home staff, and family members/significant other of nursing home residents
Who may be able to join
- 60 beds or greater
- 19 years of age or older
- trained to provide resident care
- 19 years of age or older
- somewhat to very involved in resident's care and decision-making
Who cannot join
- less than 60 beds
- less than 19 years of age
- staff on units exclusively Medicare or average length of stay less than 30 days
- not involved in resident's care and decision-making
- resident was in the nursing home less than 31 days
- resident was less than 65 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: The Impact of Quality End-of-Life Care in Nursing Homes
The purpose of this study is to examine key organizational structures and processes (leadership, teamwork, communication, palliative care) and their impact on the quality of end-of-life care for dying residents and their family members.
Read the detailed description
As the American population ages, nursing homes are rapidly becoming a dominant site for death. Currently, 25% of all deaths occur in nursing homes and 35% of all elders over the age of 85 die in nursing homes. By 2020, 40% of those over 65 will die in nursing homes. Nursing home residents die in pain with undue psychosocial suffering. For all permanently placed residents, death is inevitable. Nonetheless, how residents die, is not.
There have been long standing concerns about the quality of care and quality of life in nursing homes. Although there is some evidence that the quality of care for nursing home residents has improved, serious problems continue in areas that potentially affect end-of-life such as dehydration, pressure ulcers, and pain. Efforts to improve care have rarely considered the dynamic nature of nursing home structure and process factors, such as staffing levels, leadership of the director of nursing, or communication and teamwork among staff that facilitate or impede the organization's ability to improve care processes. Findings from our preliminary studies in nursing homes indicate that organizational structure and process factors make a difference in end-of-life care for residents and their family members. More specifically, staff education, staffing levels, leadership of the Director of Nursing (DON) and administrator, teamwork and communication among direct care staff, and incorporating palliative care clinical practices into day-to-day care had a profound impact on outcomes such as the honoring of end-of-life preferences, symptom management, and satisfaction with care. A more generalizable understanding of key structure and process factors and their relationship to resident care and outcomes at the end-of-life will provide a foundation for future intervention studies aimed at improving care.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Nursing Home Staff | Direct care staff | |
| 2 Family Members | Family members/Significant other of nursing home resident. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative care influence
Questionnaires (nursing home staff and family members) to assess the influence of palliative care on staff performance (communication, leadership, and teamwork).
Measured: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Secondary outcomes (2)
Staffing and quality of end-of-life care
Questionnaires (nursing home staff and family members) to assess the associations among structure (staffing), non-clinical (communication, leadership, teamwork) and clinical (palliative care) care processes and quality of end-of-life care.
Measured: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Modelling nursing home palliative care
Questionnaires (nursing home staff and family members) to assess modelling of nursing home palliative care (Unruh and Wan's expanded structure, process, and outcomes model).
Measured: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study start15 Dec 2006
- Primary completion1 Jan 2011
- Study completion1 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of End-of-life Care in Nursing HomesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Sarah A Thompson, RN, PhD, Principal investigator, University of NebraskaVirginia Tilden, RN, DNSC, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616473
- Sponsor's protocol ID
- 0433-06-FB
- Other IDs
- 7R01NR009547-02
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2008
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Quality End-of-Life Care in Nursing Homes
- ClinicalTrials.gov ID
- NCT00616473
- Acronym / sponsor ID
- 0433-06-FB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,169 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- 15 Dec 2006 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 1 Jan 2011 (actual)
- First posted
- 15 Feb 2008 (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.
The purpose of this study is to examine key organizational structures and processes (leadership, teamwork, communication, palliative care) and their impact on the quality of end-of-life care for dying residents and their family members.
Detailed description
As the American population ages, nursing homes are rapidly becoming a dominant site for death. Currently, 25% of all deaths occur in nursing homes and 35% of all elders over the age of 85 die in nursing homes. By 2020, 40% of those over 65 will die in nursing homes. Nursing home residents die in pain with undue psychosocial suffering. For all permanently placed residents, death is inevitable. Nonetheless, how residents die, is not.
There have been long standing concerns about the quality of care and quality of life in nursing homes. Although there is some evidence that the quality of care for nursing home residents has improved, serious problems continue in areas that potentially affect end-of-life such as dehydration, pressure ulcers, and pain. Efforts to improve care have rarely considered the dynamic nature of nursing home structure and process factors, such as staffing levels, leadership of the director of nursing, or communication and teamwork among staff that facilitate or impede the organization's ability to improve care processes. Findings from our preliminary studies in nursing homes indicate that organizational structure and process factors make a difference in end-of-life care for residents and their family members. More specifically, staff education, staffing levels, leadership of the Director of Nursing (DON) and administrator, teamwork and communication among direct care staff, and incorporating palliative care clinical practices into day-to-day care had a profound impact on outcomes such as the honoring of end-of-life preferences, symptom management, and satisfaction with care. A more generalizable understanding of key structure and process factors and their relationship to resident care and outcomes at the end-of-life will provide a foundation for future intervention studies aimed at improving care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Nursing Home Staff | – | –Direct care staff |
| 2 Family Members | – | –Family members/Significant other of nursing home resident. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing Homes in Nebraska and the Western half of Iowa, nursing home staff, and family members/significant other of nursing home residents
Key inclusion criteria (5 listed)
- 60 beds or greater
- 19 years of age or older
- trained to provide resident care
- 19 years of age or older
- somewhat to very involved in resident's care and decision-making
Key exclusion criteria (6 listed)
- less than 60 beds
- less than 19 years of age
- staff on units exclusively Medicare or average length of stay less than 30 days
- not involved in resident's care and decision-making
- resident was in the nursing home less than 31 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palliative care influence
Time frame: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Questionnaires (nursing home staff and family members) to assess the influence of palliative care on staff performance (communication, leadership, and teamwork).
2 secondary outcomes
Staffing and quality of end-of-life care
Time frame: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Modelling nursing home palliative care
Time frame: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
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 4 Dec 2023.
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.
Sarah A Thompson, RN, PhD principal investigator
University of Nebraska
Virginia Tilden, RN, DNSC principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of End-of-life Care in Nursing Homes, run by University of Nebraska 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 5 inclusion and 6 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 4 Dec 2023. 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?
Palliative care influence (time frame: At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2023.