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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00616473
Other study ID # 0433-06-FB
Secondary ID 7R01NR009547-02
Status Completed
Phase
First received
Last updated
Start date December 15, 2006
Est. completion date January 1, 2011

Study information

Verified date November 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7169
Est. completion date January 1, 2011
Est. primary completion date January 1, 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria (Nursing Homes): - 60 beds or greater Exclusion Criteria (Nursing Homes): - less than 60 beds Inclusion Criteria (Nursing Home Staff): - 19 years of age or older - trained to provide resident care Exclusion Criteria (Nursing Homes): - less than 19 years of age - staff on units exclusively Medicare or average length of stay less than 30 days Inclusion Criteria (Family Member/Significant Other): - 19 years of age or older - somewhat to very involved in resident's care and decision-making Exclusion Criteria (Family Member/Significant Other): - 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

Study Design


Related Conditions & MeSH terms

  • Death
  • Quality of End-of-life Care in Nursing Homes

Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (3)

Lead Sponsor Collaborator
University of Nebraska National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Palliative care influence Questionnaires (nursing home staff and family members) to assess the influence of palliative care on staff performance (communication, leadership, and teamwork). At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Secondary 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. At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)
Secondary 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). At beginning of study (baseline), then again after 25 nursing home residents have died (assessed for 7 years)