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NCT01990742: IMPACTT

Improving Palliative Care Through Teamwork

Completed NA Results posted Last updated 17 September 2018
What this trial tests

NA trial testing Palliative Care Team (PCTeam) in Palliative Care in 31 participants. Completed in 1 April 2017.

Timeline
27 September 2013
Primary endpoint
31 December 2016
1 April 2017

Quick facts

Lead sponsorUniversity of Rochester
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment31
Start date27 September 2013
Primary completion31 December 2016
Estimated completion1 April 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Palliative Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

GroupValue95% CI
Palliative Care Team (PCTeam)579
Standard Care441
Hospitalizations Secondary · 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

GroupValue95% CI
Palliative Care Team (PCTeam)0.34± 0.69
Standard Care0.29± 0.62
Number of Nursing Home Residents in Moderate-to-severe Pain Secondary · 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 sh

GroupValue95% CI
Palliative Care Team (PCTeam)235
Standard Care218

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Palliative Care Team (PCTeam)
Serious: 2852/2852 (100%)
Deaths: 2852/2852
Standard Care
Serious: 2978/2978 (100%)
Deaths: 2978/2978

Serious adverse events (1 terms)

ReactionSystemPalliative Care Team (PCTe…Standard Care
Death from causes not associated with the studyGeneral disorders

Most-reported serious reactions: Death from causes not associated with the study.

Data from ClinicalTrials.gov NCT01990742 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for interpersonal communication about end of life care between health practitioners and affected people.
    Ryan RE, Connolly M, Bradford NK, Henderson S, et al · · 2022 · cited 33× · PMID 35802350 · DOI 10.1002/14651858.cd013116.pub2
  2. Models for delivery and co-ordination of primary or secondary health care (or both) to older adults living in aged care facilities.
    Putrik P, Grobler L, Lalor A, Ramsay H, et al · · 2024 · cited 4× · PMID 38426600 · DOI 10.1002/14651858.cd013880.pub2

Verify or expand the search:

Other recruiting trials for Palliative Care

Currently open trials in the same condition.

Other University of Rochester trials

Trials by the same sponsor.

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