Overview

This trial is active, not recruiting.

Condition palliative care
Treatment palliative care team (pcteam)
Sponsor University of Rochester
Collaborator University of California, Irvine
Start date April 2013
End date January 2017
Trial size 31 participants
Trial identifier NCT01990742, PCORI-641

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Palliative care teams will be established and will round with residents in the intervention homes.
palliative care team (pcteam)
Palliative care teams will be established and will round with residents in the intervention nursing homes.
(No Intervention)
Usual care will be provided to residents in the control homes.

Primary Outcomes

Measure
in-hospital death
time frame: 1 year

Secondary Outcomes

Measure
hospitalizations
time frame: in the last 6 months of life

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - long-stay nursing home residents (>90 days) Exclusion Criteria: - rehabilitative, post-acute residents (<90 days)

Additional Information

Official title Improving Palliative and End-of-Life Care in Nursing Homes
Principal investigator Helena Temkin-Greener, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Rochester.