The specific aim of the pragmatic trial is to:
Test a MH navigator model to promote early access, engagement, coordination, and
personalization of mental health treatment and services as soon as early symptoms of
mental health problems are detected in children.
The navigator model and implementation to be tested include:
Automated identification of early symptoms for children meeting study criteria to
populate an Epic "reporting workbench" for eligibility screening and randomization;
Virtual collection of self-reported, standardized assessment scores;
Psychologists interpreting assessment scores and providing feedback to families and
PCPs;
Trained clinicians serving as MH "navigators" to conduct family outreach, engage
them in MH care, and coordinate with and between clinicians for up to 6-months;
An Epic reporting workbench for MN navigators to manage their active panel of
patients;
An Epic "smart form" to facilitate the MH navigator's outreach, monitoring and
follow-up to their panel;
Up to 4 video-based behavioral health sessions with the MH navigator, as needed,
while barriers to initiation of ongoing mental health services can be explored and
addressed over the 6-month period.
This study will employ an encouragement trial design, an alternative to a traditional RCT
design. Guardians of randomized youth are offered the opportunity to receive additional
services (navigation, FAST brief therapy sessions), but allowed to choose whether to
receive the services. That is, acceptance of or adherence to the offered study services
is not a condition of participation. Whether or not guardians choose to accept
intervention services from the beginning is a measure of the effectiveness of the
program. Guardians who decline the additional services (navigation, FAST sessions) must
remain in the intervention arm in order to measure the effectiveness of the intervention
without bias. This allows an intent-to-treat comparison between arms. That is, patients
remain enrolled in the study regardless of the navigators' ability to contact the family
by phone or the family's perceived need for or willingness to accept or participate in
study-based services.
Investigators will conduct a two-group, randomized and pragmatic encouragement trial to
compare outcomes between study arms (intervention; usual care control) in 2 health care
systems. The follow up period for the trial will be 6-months. A parallel arm design is
used to eliminate response bias stemming from the nature of the study.
The MH navigator will review the medical record for each patient automatically identified
for the study. This review will occur prior to any arm assignment. Those found to have
exclusions will be marked ineligible. Patients deemed eligible will then be randomly
assigned to one of two study arms.
Eligibility review will be completed no earlier than 14 calendar days after the index
event. This is to allow for any follow-up after the clinic visit (e.g., patient initiates
MH specialty treatment). The review will occur no later than 21 days after the index
event.
Study staff will use a predetermined randomization schedule. The lead biostatistician at
KP Washington will generate the master assignment sequence before the first patient is
randomized. Randomization allocation tables will be created by the lead biostatistician,
who will oversee randomization at each site. Randomization will be stratified by age
(4-6, 7-9, 10-11/12 (depending on site, KPNC 10-11. KPWA 10-12)) and sex.
Only subjects assigned to the intervention will be contacted by the navigator and offered
the intervention. Outcomes for all subjects entering the intervention arm, regardless of
whether the family accepted the MH navigation program, will be attributed to the
intervention. That is, outcomes for subjects will be assigned on an intent-to-treat basis
regardless of the extent to which they engage with the study clinician or the study
navigator. Cross over prevention is therefore functionally not-applicable due to the
study design and the analytic plan.
Each intervention arm subject's primary care provider will be sent an introductory staff
message by the study navigator prior to contacting the patient. The message will invite
the provider to respond within 3 days if they do not wish their patient to be outreached
by the study for any reason.
Families contacted by the navigator may decline mental health navigation at the onset or
at any time during the follow up period. Acceptance will be tracked.
Families who agree to navigation will first be offered a formal assessment in order to
ascertain the primary mental health diagnosis and any co-occurring mental health
disorders (e.g., substance use). After completing the online parent/guardian
self-assessment, parents/guardians will meet for 30 minutes with a mental health
clinician to review their answers, discuss diagnoses, and refer the family back to the
navigator for connection to care or study-provided tele-video visits.
Families offered tele-video therapy visits may decline it at any time. Acceptance and
adherence will be tracked as outcomes for those to whom it is offered.
The study clinician may withdraw an offer of tele-video visits if concerns regarding
privacy or safety of the child/family arise with regard to the treatment modality. If
this occurs, the family/child will be navigated to sessions with an in-person therapist.
Control Arm:
Data will be collected at baseline and 6-month follow-up from the standardized
instruments and automated sources for all eligible subjects randomized to the control
arm. Safety monitoring data will be collected from automated data 3 times per year for
NIMH DSMB reports.
Families who agree to participate will first be offered a formal assessment in order to
ascertain the primary mental health diagnosis and any co-occurring mental health
disorders (e.g., substance use). After completing the online parent/guardian
self-assessment, parents/guardians will meet for 30 minutes with a mental health
clinician to review their answers, discuss diagnoses, and refer the family back to their
primary care provider.
Study clinicians will document clinically relevant information from their assessment in a
telephone encounter and route these to the child's KP primary care provider in Epic as
well as the site navigator.
Study telephone encounters are not billable visits. Only clinically relevant information
is incorporated into telephone visit notes.
Control arm participants do not receive navigation.
Intervention Arm:
Six months of follow up data will be collected from the standardized instruments and
automated sources for all eligible subjects randomized to the intervention arm. Safety
monitoring data will be collected from automated data 3 times per year for NIMH DSMB
reports.
An Epic reporting workbench and smart form will support the MH navigator's in managing
their active panels. Navigators will be prompted to follow up with subjects at the
appropriate time points, log outreach attempts and outcomes, note subjects' acceptance or
refusal of navigation, and (if offered) tele-video therapy visits, and track subjects
ongoing acceptance of the intervention.
The MH navigator will contact the patient's primary care/pediatrics provider via Epic
staff message within 2 business days of a new intervention subject appearing on their
reporting workbench.
Navigators will use a standardized message (Epic Smartphrase). The message will (a)
introduce the MH navigator to the provider, (b) briefly describe the extra support the
study can offer, and (c) inform the provider that s/he may reply to the message to
decline navigation for their patient for any reason.
Navigators will enter in their Epic smart form:
Providers are allowed 3 business days to actively decline the offer of study support
before the navigator outreaches the family.
If a provider declines navigation on their patient's behalf the patient will not be
contacted. The subject remains in the study; 6-months of automated data will be
collected for the intent to treat analysis. The navigator will enter onto the smart
form:
o Provider Agreed MHN = Declined
If a provider accepts or does not respond in the 3-day timeframe, subject outreach
will begin. The navigator will use the Patient Care Notes field as appropriate and
set the smart form to:
MH navigators at each site will outreach intervention arm families by phone to offer up
the navigation program.
Up to 3 cycles of outreach, 2 weeks apart, will be made. For each of the 3 cycles of
outreach, the Navigator will make up to 3 attempts to reach the family with in a 1-week
period, with up to two messages left.
If not reached after 3 cycles of outreach are completed, the smart form will be
coded:
o Family Agreed MHN = No Response
If reached and family agrees, the smart form will be coded:
o Family Agreed MHN = Agreed
If reached and family declines, the smart form will be coded:
o Family Agreed MHN = Declined. The navigator will notify the provider to inform
him/her that the program was declined; the study will not outreach the family
further.
Families who agree may choose to discontinue navigation at any time during the
6-month follow up period. If a family agrees and then opts to end early, the smart
form will be coded:
o MHN Ended Early = Date ended will be entered. The reason ended early will also be
captured.
Families/patients may report that the index MH symptoms have resolved. These
patients/families will be offered a 'watchful waiting' approach. Subjects accepting
'watchful waiting' will be outreached by phone at least quarterly but not past
6-months post-randomization.
Families who agree to participate will first be offered a formal assessment in order to
ascertain the primary mental health diagnosis and any co-occurring mental health
disorders (e.g., substance use). After completing the online parent/guardian
self-assessment, parents/guardians will meet for 30 minutes with a mental health
clinician to review their answers, discuss diagnoses, and refer the family back to the
navigator for connection to care or study-provided tele-video visits.
Study clinicians will document clinically relevant information from their assessment in a
telephone encounter and route these to the child's KP primary care provider in Epic as
well as the site navigator. Study telephone encounters are not billable visits. Only
clinically relevant information is incorporated into telephone visit notes.
Navigators will document clinically relevant discussion (post assessment) in a telephone
encounter and route these to the child's KP primary care provider in Epic. Study
telephone encounters are not billable visits. Study-related (administrative) notes remain
in the smart form; only clinically relevant information is incorporated into telephone
visit notes.
Navigators will outreach families in the program by phone at least monthly during the
6-month study period. The navigator will inquire about the child's status and re-evaluate
barriers to access on follow up navigation calls. They will use motivational interviewing
techniques (e.g., reflective listening, asking open ended questions) with the child
and/or parents (as age appropriate) to encourage them to engage in psychosocial
treatments, attempt to motivate them to start treatment (as needed), and identify and
help problem solve ways to minimize barriers to starting therapy. When barriers exist,
the navigator will offer assistance in facilitating specialty treatment initiation and
assess appropriateness of tele-video therapy sessions until ongoing MH services can be
arranged.
Families/patients reporting that index symptoms have resolved will be offered a 'watchful
waiting' approach. Subjects accepting 'watchful waiting' will be outreached by phone at
least quarterly, but not beyond the end of the 6-month follow-up period.