University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
Phase: NA
Conditions: Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Frontotemporal Lobar Degeneration, Memory Disorders
Sponsor: University of California, San Francisco

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Care Ecosystem: Navigating Patients and Families Through Stages of Care 
NCT02213458 
August 6, 2018 

Care Ecosystem Study Protocol 
Pre-screening procedures:  
Potential patient participants will be identified by providers at the various recruitment sites. 
Potential patient or caregiver participants may also self-refer within or outside of the targeted 
recruitment sites.  The Research Coordinator (RC) will conduct a preliminary chart review to 
confirm patient subject’s eligibility and to determine if the patient meets the inclusion criteria (a 
request for a “waiver for consent for screening” is attached).  If the patient is outside of the 
UCSF medical record system, appropriate medical release will be obtained by the Research 
Coordinator in order to obtain medical records for determining eligibility. 
Initial Encounter: 
The RC contacts the potential subject and their caregiver to discuss the study and to assess their 
interest in participating. The RC meets with the potential subject and caregiver in-person or by 
phone.  If by phone, consent forms will be provided to the potential subject and caregiver, and 
HIPAA form for the patient will be sent in advance along with the Quick Dementia Rating 
System (QDRS) form for the caregiver to complete. The primary purpose of this encounter is to 
determine eligibility and to sign the consent forms, one for the patient and one for the caregiver, 
and to obtain dementia stage through the QDRS form if patient and caregiver consent. 
Consent: 
Consent will be completed once the patient and caregiver have demonstrated understanding of 
the study, have had their questions answered, and agree to participate. Additionally, the Capacity 
Assessment Record will be used for each patient participant during the consent process and the 
caregiver (surrogate consent) will be involved as needed. 
Baseline Outcome Assessment: 
A Baseline Outcome Assessment will be performed following the consent. This includes 
all  baseline measures, the National Institute of Neurological Disorders and Stroke-Canadian 
Stroke Network (NINSD-CSN) Vascular Cognitive Impairment Harmonization Standards 5-
Minute Protocol for the patient, and demographic data and baseline characteristics for the patient 
and the caregiver. If the patient has a personal medication list, the RC will obtain a 
copy.  Baseline Outcome Assessment will be completed over the phone at a later date.  A list of 
the survey response scales will be provided in advance to assist with answering questions over 
the phone. 
Randomization: 
Patient subjects will be randomized with their caregiver (2:1) to Navigated Care or to Survey of 
Care. We will randomize participants to one of the two arms of the trial in a 2:1 ratio in 
Navigated Care vs. Survey of Care treatment arms. Allocation concealment will be ensured, as 
the randomization code will not be released until the participants are recruited into the trial and 
all baseline measures, including diagnostic evaluation, are taken. Following randomization, the 
subject and their caregiver will be informed of the next steps (when they will be contacted by 
study staff). 
Outcome Measures: 

Outcome measures will be completed at different stages during the study. These stages are 
selected to both provide important information regarding the Care Ecosystem and 
patient/caregiver concerns while minimizing subject burden. There are 4 categories of outcome 
measures: Baseline, Agile (Navigated Care only, at month 3 and 9 post baseline annually), Short 
(every 6 months), and Full (annually). All subjects (patients and caregivers), regardless of 
randomization assignment receive Baseline, Short and Full measures. Outcome survey questions 
will be answered by patients on themselves (if they have capacity to respond), by caregivers on 
behalf of the patient, and caregivers on themselves.  Specifically, we will be asking caregivers 
about their experience with the patient’s care, their needs regarding care, how prepared they are 
for changes in the patient’s health, their mood (depression, anxiety), and how they are feeling 
overall about their health. Subjects in Navigated Care complete the Agile measures that rate their 
satisfaction with the program so that improvements can be made in a responsive and efficient 
manner. Outcome measures will be administered by a research coordinator who is not involved 
with the provision of care. Names will not be linked to the questionnaires when results are 
presented to the care team unless requested by the caregiver. 
  
Contact initiated by study staff: 
Care Team Navigators (CTNs) will contact subjects (patients and caregivers) who are enrolled in 
Navigated Care on a monthly basis to help guide and support the caregiver and patient with their 
dementia care. CTNs will not require a formal medical background but likely have a relevant BA 
or successful experience working with this population.  CTNs will inquire about new problems, 
medication changes, experience with care, needs regarding care, how prepared the caregiver and 
the patient are for future changes in their health, how the patient and caregiver are feeling, and 
caregiver well-being. See the sample script in the appendix. CTNs will also provide help with 
dementia care education, planning for the future, managing stress, and dealing with medications. 
Patients and caregivers can contact their CTN at any time for questions, problems, and concerns, 
and clinic staff will be providing after-hours coverage for calls from patients and caregivers. The 
CTN will refer to a member of the clinical team as appropriate. If pertinent, the CTN will 
generate a message (fax, email, phone call) to the patient’s provider describing the outcome of 
the contact.  We estimate the caseload for each CTN to be approximately 80-90 patients with 
monthly touchpoints lasting 15 minutes on average.  Detailed models of CTN activity were 
developed on our experience as health care professionals interacting with patients and their 
families throughout the course of disease. 
  
CTNs will mail a letter to primary care providers informing that their patient was enrolled into 
the intervention along with graphic of the intervention model.  Additionally, the CTN will 
include a preferred contact sheet for the provider to complete and return. 
  
RCs will contact Navigated Care (intervention group) and Survey of Care (control group) 
participants at scheduled intervals (Baseline, 6 months, and annually) in order to complete 
outcome measures. If the RC identifies a risk or concern, they will contact the patient or 
caregiver’s provider so that the provider can follow-up. 
  
  
Focus Groups with Primary Care Providers: 

Eligible PCPs will be invited to attend the Focus Group via: email invitation and group 
announcement via the primary care practice site medical director.  PCPs will sign up (“first come 
first served” until the maximum Focus Group number is reached, with one back-up spot 
available to accommodate for cancellations or no-shows).  The Focus Group will run 60-90min 
depending on how many participants attend.  Each participant will receive and review a copy of 
the Focus Group participation info sheet and provide their verbal consent.  Focus Group will 
comprise of an orientation to/overview of the DCE and then the Survey.  Focus Group will be led 
by a geriatrician/primary care liaison member of the study.  Survey answers and discussion will 
be documented in-time by a scribe.  All transcripts will be reviewed by the geriatrician/primary 
care liaisons and core themes summarized for the study Leadership and care team navigators.