Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2013-09-27
2017-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hospice Problem Solving Intervention
NCT01444027
E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons
NCT05017129
Comprehensive Support for Alzheimer's Disease Caregivers
NCT00362284
Self-Management Behaviors of Caregivers of the Chronically Critically Ill
NCT03065829
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
NCT03002896
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palliative Care Team (PCTeam)
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.
Standard care
Usual care will be provided to residents in the control homes.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Palliative Care Team (PCTeam)
Palliative care teams will be established and will round with residents in the intervention nursing homes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Irvine
OTHER
University of Rochester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Helena Temkin-Greener
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helena Temkin-Greener, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCORI-641
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.