Improving Palliative Care Through Teamwork (IMPACTT)

August 17, 2018 updated by: Helena Temkin-Greener, University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Medicine and Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Palliative Care Team (PCTeam)
Palliative care teams will be established and will round with residents in the intervention homes.
Palliative care teams will be established and will round with residents in the intervention nursing homes.
No Intervention: Standard care
Usual care will be provided to residents in the control homes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: The last 90 days of life
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Nursing Home Residents in Moderate-to-severe Pain
Time Frame: up to 6 months prior to death
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helena Temkin-Greener, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PCORI-641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Palliative Care Team (PCTeam)

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