NCT01990742

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 27, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 20, 2018

Completed
Last Updated

September 17, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

September 23, 2013

Results QC Date

June 30, 2017

Last Update Submit

August 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hospitalizations

    The last 90 days of life

Other Outcomes (1)

  • Number of Nursing Home Residents in Moderate-to-severe Pain

    up to 6 months prior to death

Study Arms (2)

Palliative Care Team (PCTeam)

EXPERIMENTAL

Palliative care teams will be established and will round with residents in the intervention homes.

Behavioral: Palliative Care Team (PCTeam)

Standard care

NO INTERVENTION

Usual care will be provided to residents in the control homes.

Interventions

Palliative care teams will be established and will round with residents in the intervention nursing homes.

Palliative Care Team (PCTeam)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

Limitations and Caveats

1. We were unable to distinguish the relative importance of the individual intervention components. 2. Our findings were confined to regional facilities, and may not be generalized elsewhere.

Results Point of Contact

Title
Dr. Helena Temkin-Greener
Organization
University of Rochester

Study Officials

  • Helena Temkin-Greener, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2013

First Posted

November 21, 2013

Study Start

September 27, 2013

Primary Completion

December 31, 2016

Study Completion

April 1, 2017

Last Updated

September 17, 2018

Results First Posted

August 20, 2018

Record last verified: 2018-08

Locations