- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001620
Implementation of a Telehealth Palliative Care Model for Persons With Dementia (IMPACT)
July 19, 2024 updated by: Joan Carpenter, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This single arm embedded pragmatic pilot clinical trial will provide data to assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention among 30 persons living with dementia (PLWD) and their care-partners newly admitted to one nursing homes (NH) for post-acute care.
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Collingswood Rehabilitation and Healthcare Center
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Stakeholders:
-PLWD who receives the intervention
PLWD:
- planned discharge within 48 hours of screening
- currently receiving hospice care
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: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Palliative Care Consultation in Post-Acute Care
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.
|
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).
|
|
No Intervention: Stakeholder Engagement
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations
Time Frame: 30 days post admission
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Hospitalizations
Time Frame: 30 days post admission
|
Number of hospitalization(s)
|
30 days post admission
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Completed Stakeholder Interviews/Focus Groups
Time Frame: 1 year
|
We engaged participants in focus groups and semi-structured interviews to deepen understanding of barriers and facilitators to telehealth palliative care implementation.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
August 4, 2021
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
July 27, 2021
First Submitted That Met QC Criteria
August 5, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 13, 2024
Last Update Submitted That Met QC Criteria
July 19, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00095001
- U54AG063546 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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