Palliative CareIMPACTNCT05001620

Implementation of a Telehealth Palliative Care Model for Persons With Dementia

A study testing Palliative Care Consultation in people with Palliative Care and Dementia, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Palliative Care, Dementia
What is being tested?: Palliative Care Consultation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2021to 1 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Collingswood Rehabilitation and Healthcare Center
Rockville, Maryland, 20850

Other trials in United States

About this study

Read the 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.

Conditions: Palliative Care, Dementia
Being tested: Palliative Care Consultation
Keywords: Dementia, Palliative Care, Telehealth, Nursing Homes
Medical subject headings: Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Palliative Care ConsultationOther
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).

Study groups in NCT05001620
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days post admission

Secondary outcomes (1)

Number of Hospitalizations
Number of hospitalization(s)
Measured: 30 days post admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 20211 Jul 2023

First posted12 Aug 2021
Study start4 Aug 2021
Primary completion1 Jul 2023
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Palliative CareStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05001620
Sponsor's protocol ID: HP-00095001
Other IDs: U54AG063546
Acronym: IMPACT
Status last verified: Jul 2024
First submitted: 27 Jul 2021
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Palliative Care trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of a Telehealth Palliative Care Model for Persons With Dementia
ClinicalTrials.gov ID: NCT05001620
Acronym / sponsor ID: IMPACT / HP-00095001
Conditions: Palliative Care, Dementia
Keywords: Dementia, Palliative Care, Telehealth, Nursing Homes
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 4 Aug 2021 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 12 Aug 2021 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Palliative Care Consultation in Post-Acute Care	Experimental	Other: Palliative Care ConsultationSubjects 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.
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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

(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).

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Palliative Care ConsultationThe 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).	Other	Palliative Care Consultation in Post-Acute Care

Primary outcome

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.

1 secondary outcome

Number of Hospitalizations
Time frame: 30 days post admission

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palliative Care Consultation in Post-Acute Care	2	1
Stakeholder Engagement	14	14

Primary outcome: Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations

Time frame: 30 days post admission

Population analysed: no data were collected

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days post admission. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palliative Care Consultation in Post-Acute Care	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Stakeholder Engagement	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Palliative Care Consultation in people with Palliative Care and Dementia, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations (time frame: 30 days post admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.