Improving Palliative Care Through Teamwork

Palliative Care Clinical Trial

— IMPACTT  

Official title:

Improving Palliative and End-of-Life Care in Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990742
• Other study ID #: PCORI-641
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Palliative Care

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