Clinical trial NCT03881579: Supportive Care for Cognitively Impaired Patients and Families
Official title: Supportive Care for Cognitively Impaired Patients and Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Primary Palliative Care
Mild Cognitive Impairment
Keywords: palliative
supportive
MCI
palliative care
supportive care
serious illness
RCT
randomized clinical trial
mild cognitive impairment
primary palliative care
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized to one of two groups:

1. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse
Primary purpose: SUPPORTIVE_CARE

Brief summary: Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.

Detailed description: 200 ADRC participants will be recruited and randomized 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.

Eligibility criteria: Inclusion Criteria:

* All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
* All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).

Exclusion Criteria:

1. Institutionalized (not a community dweller) at the time of entry into the study;
2. Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.

Primary outcomes:
measure: To identify the number of participants who express supportive care needs in both arms.
timeFrame: Day 0, 4 months, one year
measure: Completion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.
timeFrame: Day 0, 4 months, one year, 18 months
measure: Change in Zarit Caregiver Burden scores over time:
timeFrame: Day 0, 4 months, one year, 18 months
Secondary outcomes:
measure: Differences in Edmonton Symptoms Assessment Scale (ESAS) scores
timeFrame: Day 0, 4 months, one year, 18 months
measure: Change in Patient Activation Measure over time
timeFrame: one year, two years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VJ Periyakoil
state: California
Study officials:
affiliation: Stanford University
name: VJ Periyakoil, MD
role: PRINCIPAL_INVESTIGATOR
References: