Triggered Palliative Care for Advanced Dementia

Alzheimer Disease Clinical Trial

Official title:

Triggered Palliative Care for Advanced Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719938
• Other study ID #: 15-1350
• Secondary ID: R21AG052140Pilot
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: January 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.

Description:

Alzheimer's disease and related dementias affect 5 million Americans at an annual cost of $215 billion. Dementia is a contributing cause for 1 in 3 deaths, and is the only major cause of death with no effective prevention or treatment. Dementia-specific palliative care is needed to address the unique symptoms and treatment decisions relevant to this disease.

Investigators therefore propose to develop and pilot test a model of palliative care consultation for advanced dementia patients, triggered by hospitalization for a serious acute illness. After systematic refinement of operational protocols and tools with stakeholders, they will enroll persons with advanced dementia plus an acute illness associated with high risk of death in the coming year. Patients will be enrolled with their family decision-makers (N=60 dyads) in a randomized feasibility trial. Intervention dyads will receive specialty palliative care consultation during hospital admission, plus post-discharge collaborative care by their outpatient primary care provider and a palliative care nurse practitioner. Control dyads will receive usual care.

The research objective is to generate preliminary data for a large multi-site randomized controlled trial of a model of palliative care consultation for advanced dementia.

Specific aims are:

Aim 1: To develop a best-practice model of palliative care consultation for advanced dementia triggered by hospital admission for serious acute illness.

Aim 2: To conduct a pilot randomized trial of triggered palliative care consultation for advanced dementia (versus usual care) to demonstrate the feasibility of conducting a larger randomized trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of dementia from Alzheimer's or other underlying cause

• Global Deterioration Scale (GDS) Stage 5, 6 or 7

• acute illness hospitalization

Exclusion Criteria:

• No English-speaking family decision-maker

• Primary physician expects study to be too stressful for family caregiver

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Specialty Palliative Care
Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Icahn School of Medicine at Mount Sinai, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)	Includes emergency department visits and hospital admissions during measure interval	From time of hospital discharge up to 60 days
Secondary	Patient Comfort End of Life in Dementia (CAD-EOLD)	Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort.	60 days
Secondary	Caregiver Strain	Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress.	Interview at 60 days after hospitalization
Secondary	Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up	Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.	From time of hospital discharge up to 60 days
Secondary	Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)	Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed	From time of hospital discharge up to 60 days
Secondary	Number of Palliative Care Domains in Treatment Plan	Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan.	From time of hospital discharge up to 60 days
Secondary	Number of Participants With Burdensome Treatments	Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement.	From time of hospital discharge up to 60 days