Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990742
Other study ID # PCORI-641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2013
Est. completion date April 1, 2017

Study information

Verified date August 2018
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One in three Americans dies in a nursing home (NH) or in a hospital, shortly following transfer from a long-term care facility. The proportion of deaths occurring in NHs is projected to increase to 40% by 2020. Excellence in palliative and end-of-life (EOL) care must become a priority for these long-term care institutions. However, findings from NHs point to high incidence of pain and poor management of other symptoms and excessive reliance on hospitalizations, indicating inadequate EOL care quality. Expert opinion and research have suggested that poor EOL quality in NHs may be due to lack of palliative care training among staff and absence of EOL care protocols or guidelines, but research demonstrating that attention to these factors improves outcomes is absent. While dedicated care teams have been shown to improve outcomes for NH residents in need of specialized care, the impact of palliative care teams in improving resident outcomes has remained largely unstudied and untested. This will be the first randomized controlled trial to evaluate the impact of palliative care teams (PCTeam) on resident and staff outcomes, and care processes, in NHs.

Our objective is to demonstrate, using a randomized controlled trial design and a difference in difference analytic approach, that nursing home-based palliative care practice guidelines implemented through PCTeams will improve quality of care processes and outcomes for residents at the end of life.

We will adapt existing palliative care guidelines for EOL care, endorsed by the National Quality Forum (NQF), to the NH environment, deploy the adapted practice guidelines through a PCTeam model, and evaluate the effectiveness of this intervention on resident EOL outcomes and staff care processes and outcomes. The specific aims (SA) will address the following questions:

SA 1: Is PCTeam intervention effective in improving NH residents' EOL outcomes?

SA 2: Is PCTeam intervention effective in improving NH staff EOL care processes and outcomes?

In the context of these specific aims we will test the following hypotheses:

H1: Residents in NHs in the intervention arm, compared to the control, will achieve better EOL risk-adjusted outcomes and care processes with regard to:

- Pain

- Dyspnea

- Depression

- In-hospital deaths

- Hospitalizations

- Advance directives

H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve better EOL processes and outcomes measured by:

- Assessment of EOL symptoms

- Delivery of EOL care

- Communication/coordination among providers

- Communication with residents/families

- Teamwork effectiveness

- Staff satisfaction

H3: Family caregivers of decedent residents in the intervention NHs, compared to the control, will report receiving more patient and family centered care as measured by higher levels of satisfaction with:

- Shared decision making between providers, the patient and the family

- Care that is respectful of the patient wishes and dignity

- Attention to the emotional and spiritual needs of the family.

31 NHs in upstate New York have been recruited for the study (letters of support). Stakeholders include residents, family members, staff, policy makers, and others. The intervention will deploy theTeamSTEPPS, a team development model created by the Department of Defense and the Agency for Healthcare Research and Quality.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 1, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- long-stay nursing home residents (>90 days)

Exclusion Criteria:

- rehabilitative, post-acute residents (<90 days)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Palliative Care Team (PCTeam)
Palliative care teams will be established and will round with residents in the intervention nursing homes.

Locations

Country Name City State
United States University of Rochester School of Medicine and Dentistry Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Nursing Home Residents in Moderate-to-severe Pain Presence of moderate-to-severe pain within 6 months of the date of death, among decedents cared for in the enrolled nursing homes. The verbal descriptor pain scale, where the resident is asked to rate the intensity of their worst pain in the last five day was most often used, where 0 = no pain, 1 = mild pain , 2 = moderate pain, 3 = severe pain, 4 = very severe pain, and 9 = unable to answer. Lower numbers (0 or 1 ) on the scale are preferred, and a lower percentage of residents reporting pain intensity in the moderate or higher ranges is a better outcome. The verbal descriptor scale can be shared with elders verbally, as the name implies, or by asking the resident to point to a setting on a visual thermometer with these word choices. up to 6 months prior to death
Primary Hospital Site of Death: Number of Decedents Cared for in an Enrolled and Assigned NH Facility, Who Were Transferred to a Hospital and Died in the Hospital During the Study Period This outcome measure, Hospital Site of Death, assesses whether death occured in a nursing home or in a hospital following transfer from the nursing home, among nursing home residents who were cared for in an enrolled facility. 1 year
Secondary Hospitalizations Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes The last 90 days of life
See also
  Status Clinical Trial Phase
Completed NCT04673760 - The PROAKTIV Study N/A
Completed NCT03520023 - Critical Care and Palliative Care Medicine Together in the ICU N/A
Not yet recruiting NCT05434208 - Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL) N/A
Not yet recruiting NCT03267706 - Introducing the Palliative Care Comprehensive Tool in Family Medicine N/A
Completed NCT02845817 - Requests for Euthanasia and Assisted Suicide N/A
Recruiting NCT02778347 - Development and Validation of a Comprehensive Standardised Clinical Assessment Tool for Patient Needs N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01934413 - Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Recruiting NCT04052074 - Complementary Therapy in Home Palliative Care Patients and Their Caregivers N/A
Recruiting NCT05935540 - ACP-Family Programme for Palliative Care Patients and Their Family Member N/A
Active, not recruiting NCT02689375 - A Prospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin N/A
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Completed NCT06140004 - Home-Based Palliative Care Impact on Providers
Completed NCT04333719 - Prevalence of Deep Sedation in Terminal Palliative Phase
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I
Completed NCT06211816 - Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit N/A
Completed NCT04857060 - Palliative Care Educator N/A
Completed NCT04491110 - Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial N/A
Withdrawn NCT03959813 - Evaluation of the Impact of Psychomotricity on the Patients Body Experience in Palliative Care