NCT05001620

Brief Summary

Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this study will assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) and their care-partners newly admitted to nursing homes (NHs) for post-acute care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

July 27, 2021

Results QC Date

May 17, 2024

Last Update Submit

July 19, 2024

Conditions

Keywords

DementiaPalliative CareTelehealthNursing Homes

Outcome Measures

Primary Outcomes (1)

  • Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations

    Investigators will determine a recommendation adherence score after each participants' encounter. Each recommendation will be assigned 2 points, then will define full (2 points), partial (1 point) and no adherence (0 point) to each recommendation. Investigators will sum the points for each SNF-PCC recommendation and use this as the denominator. Investigators will sum each recommendation with full, partial, no adherence and use this as the numerator. The fraction will be converted to a percentage ranging from 0-100% reflecting the recommendation adherence score.

    30 days post admission

Secondary Outcomes (1)

  • Number of Hospitalizations

    30 days post admission

Other Outcomes (1)

  • Number of Participants With Completed Stakeholder Interviews/Focus Groups

    1 year

Study Arms (2)

Palliative Care Consultation in Post-Acute Care

EXPERIMENTAL

Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.

Other: Palliative Care Consultation

Stakeholder Engagement

NO INTERVENTION

We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.

Interventions

The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).

Palliative Care Consultation in Post-Acute Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stakeholders:
  • (1) PC provider
  • (2) Social Work (SW) NH champions
  • (3) post-acute care unit nursing staff and providers (including medical directors)
  • (4) NH leadership, information technology staff
  • (5) PLWD and their care partner(s).
  • Person Living with Dementia (PLWD)
  • documented dementia diagnosis
  • admitted for post-acute care
  • age ≥ 60 years
  • if unable to participate in a conversation or lacking capacity to make healthcare decisions as determined by the NH staff/providers, a care partner who can act as a surrogate decision maker in the PCC-PAC.

You may not qualify if:

  • Stakeholders:
  • PLWD who receives the intervention
  • PLWD:
  • planned discharge within 48 hours of screening
  • currently receiving hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collingswood Rehabilitation and Healthcare Center

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

Despite multiple, iterative adaptations to implementation, including recruiting new sites and clinical partners, we were unable to enroll the targeted 30 patients in the trial. Two PLWD enrolled in the clinical trial, one completed the study.

Results Point of Contact

Title
Dr. Joan G. Carpenter
Organization
University of Maryland School of Nursing

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 12, 2021

Study Start

August 4, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations