Supportive Care for Cognitively Impaired Patients and Families
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Stanford University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To identify the number of participants who express supportive care needs in both arms.
Study Overview
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 persons who participate in the Stanford ADRC 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) elicit their goals of care and 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes will be assessed by blinded research associates
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Institutionalized (not a community dweller) at the time of entry into the study;
- •Have severe dementia and are incapable of responding to the outcome measures at baseline.
- •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.
Arms & Interventions
Usual care
one random half of patients will receive usual care
Intervention: nurse-led supportive care assessment (Behavioral)
intervention arm
one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)
Intervention: nurse-led supportive care assessment (Behavioral)
Outcomes
Primary Outcomes
To identify the number of participants who express supportive care needs in both arms.
Time Frame: Day 0, 4 months, one year
Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period). We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses.
Change in Zarit Caregiver Burden scores over time:
Time Frame: Day 0, 4 months, one year, 18 months
The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.
Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.
Time Frame: Day 0, 4 months, one year, 18 months
In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. We will monitor the EHR to track if the doctor documents goals of care in the chart.AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the doctor. Both forms have to be uploaded into the electronic health records.
Secondary Outcomes
- Differences in Edmonton Symptoms Assessment Scale (ESAS) scores(Day 0, 4 months, one year, 18 months)
- Change in Patient Activation Measure over time(one year, two years)
Investigators
VJ Periyakoil
Director. Palliative Care Education & Training
Stanford University