Trial Outcomes & Findings for Addressing Barriers to Care for Substance Use Disorder Pilot Study (NCT NCT06317987)
NCT ID: NCT06317987
Last Updated: 2026-07-31
Results Overview
Proportion of patients who agree to a care coordinator's offer to be contacted by a care navigator
ACTIVE_NOT_RECRUITING
NA
74 participants
The day that care navigation was offered (same day)
2026-07-31
Participant Flow
Patients with an eligible visit from 7/9/2024-9/15/2024 through 11/27/2024 per electronic health records. A Waiver of Informed Consent was obtained for care coordinator participation in the study.
Care coordinators are randomly assigned to a study arm,, and patients who visit care coordinators are classified as being part of the arm that their care coordinator was assigned to.
Participant milestones
| Measure |
Care Navigation: Patients
Mental health care coordinators offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual. Patients who visit these care coordinators are enrolled in the analysis.
|
Services as Usual: Patients
Mental health care coordinators offer substance use resources and treatment options to patients as usual. Patients who visit these care coordinators are enrolled in the analysis.
|
Care Navigation: Care Coordinators
Mental health care coordinators offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual.
|
Services as Usual: Care Coordinators
Mental health care coordinators offer substance use resources and treatment options to patients as usual
|
|---|---|---|---|---|
|
Overall study
STARTED
|
34
|
40
|
2
|
2
|
|
Overall study
COMPLETED
|
34
|
40
|
2
|
2
|
|
Overall study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1
STARTED
|
15
|
6
|
2
|
2
|
|
Period 1
COMPLETED
|
15
|
6
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
19
|
34
|
2
|
2
|
|
Period 2
COMPLETED
|
19
|
34
|
2
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing Barriers to Care for Substance Use Disorder Pilot Study
Baseline characteristics by cohort
| Measure |
Care Navigation: Patients
n=34 Participants
Mental health care coordinators offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual. Patients who visit these care coordinators are enrolled in the analysis.
|
Services as Usual: Patients
n=40 Participants
Mental health care coordinators offer substance use resources and treatment options to patients as usual. Patients who visit these care coordinators are enrolled in the analysis.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18-25 years
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Age, Customized
Age · 26-45 years
|
23 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Age, Customized
Age · 46-64 years
|
7 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Age, Customized
Age · 65-75 years
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Age, Customized
Age · 76 years or older
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
29 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
55 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: The day that care navigation was offered (same day)Population: This analysis was conducted among patients who visited care coordinators assigned the Usual Care + Care Navigation condition (i.e., the experimental group). The outcome was measured for patients only, not care coordinators.
Proportion of patients who agree to a care coordinator's offer to be contacted by a care navigator
Outcome measures
| Measure |
Care Navigation Patients: Period 1
n=15 Participants
During the first period of the pilot (7/9/2024-9/15/2024), mental health care coordinators offered and referred patients to a care navigator in addition to offering substance use resources and treatment options as usual. The target population in period 1 was patients who had an assessment and treatment planning visit for SUD with an enrolled care coordinator. Outcome data were collected from EHR data of patients who visited care coordinators, but care coordinators themselves were not monitored for outcomes.
|
Care Navigation Patients: Period 2
n=19 Participants
During the second period of the pilot (9/16/2024-11/27/2024), mental health care coordinators offered and referred patients to a care navigator in addition to offering substance use resources and treatment options as usual. The target population in period 2 was patients who had evidence of substance use as determined by the care coordinator during their assessment and treatment planning visit for mental health treatment with the care coordinator.
|
|---|---|---|
|
Rate of Patient Interest in Care Navigation
|
14 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From study launch to end of accrual (anticipated 16 weeks; see recruitment goals above)Proportion of patients who consent to the study among those who agree to be contacted by a care navigator
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 30 days laterProportion of patients who utilize treatment within 30 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 60 days laterProportion of patients who utilize treatment within 60 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 90 days laterProportion of patients who utilize treatment within 90 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 30 days laterNumber of SUD treatment visits within 30 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 60 days laterNumber of SUD treatment visits within 60 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time Frame: From patient's clinical assessment appointment to 90 days laterNumber of SUD treatment visits within 90 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From patient's clinical assessment appointment to up to 90 days laterTime-to-event measure of SUD treatment utilization
Outcome measures
Outcome data not reported
Adverse Events
Care Navigation (Pilot)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Kaiser Permanente requires a 30-day review and comment period for any proposed publication or presentation when Kaiser Permanente employees are not involved in results dissemination. The PI is also restricted from disclosing identifying information about patients, members, providers, facilities, business units or regions, unless approved in writing by Kaiser Permanente before publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER