Improving Palliative Care Through Teamwork (IMPACTT)

• ClinicalTrials.gov Identifier: NCT01990742
• Recruitment Status: Completed
• First Posted: November 21, 2013
• Results First Posted: August 20, 2018
• Last Update Posted: September 17, 2018
• Sponsor: University of Rochester
• Collaborator: University of California, Irvine
• Information provided by (Responsible Party): Helena Temkin-Greener, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Palliative Care	Behavioral: Palliative Care Team (PCTeam)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Palliative and End-of-Life Care in Nursing Homes
• Actual Study Start Date: September 27, 2013
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: April 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Palliative Care Team (PCTeam); Palliative care teams will be established and will round with residents in the intervention homes.	Behavioral: Palliative Care Team (PCTeam); 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.

Outcome Measures

Primary Outcome Measures :

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 [ 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.

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, New York

University of Rochester School of Medicine and Dentistry

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

University of California, Irvine

Investigators

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

More Information

• Responsible Party: Helena Temkin-Greener, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01990742
• Other Study ID Numbers: PCORI-641
• First Posted: November 21, 2013
• Results First Posted: August 20, 2018
• Last Update Posted: September 17, 2018
• Last Verified: August 2018