Trial Outcomes & Findings for Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (NCT NCT02907944)

Last Updated: 2023-05-08

Results Overview

Study team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period.

Recruitment status

COMPLETED

Study phase

Target enrollment

3838 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2023-05-08

Participant Flow

At each of the 6 month assessment stages, the numbers fluctuate based on the number of patients identified in the electronic health record (EHR) and the number of clinicians and staff that completed each survey. The numbers at each stage are part of a sliding cohort where direct follow up with patients and clinicians longitudinally is not part of the design. Assessment of patients using EHR began 6 months prior to the assessment of clinicians and staff using surveys.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Patient Characteristics Patients from 4 clinics at each phase in the implementation facilitation design.	Clinician/Staff Characteristics Clinician/staff participants from 4 clinics at each phase phase in the implementation facilitation design.
Overall Study STARTED	3517 4	70 4
Overall Study Control Period	4259 4	69 4
Overall Study Intervention Period	3780 4	59 4
Overall Study Evaluation Period	3786 4	58 3
Overall Study Maintenance Period	4036 4	88 4
Overall Study COMPLETED	3514 4	62 4
Overall Study NOT COMPLETED	3 0	8 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Specific Measure

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: Unduplicate count of participants from control stage to intervention stage.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=277 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=296 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=955 Participants Patients diagnosed with Tobacco Use Disorder
Change in Provision of Addiction Treatments Control (Baseline)	66 Participants	20 Participants	268 Participants
Change in Provision of Addiction Treatments Intervention (6 months)	33 Participants	15 Participants	183 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Unique patients assessed across the two time points by disorder type.

Study team will use the electronic medical record to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 12 month Evaluation period.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=299 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=293 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=993 Participants Patients diagnosed with Tobacco Use Disorder
Change in Provision of Addiction Treatments Evaluation (12 months)	38 Participants	15 Participants	190 Participants
Change in Provision of Addiction Treatments Control (Baseline)	66 Participants	20 Participants	268 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All those included in the multiple control and intervention phases across sites.

ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4259 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=3780 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Antiretroviral Therapy (ART) Receipt	4106 Participants	3547 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: All patients monitored across all (multiple) control and evaluation periods.

ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4259 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=3786 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Antiretroviral Therapy (ART) Receipt	4106 Participants	3508 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: All patients monitored across all control (multiple) and intervention periods.

Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level "blips" that have no clinical significance.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4085 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=3165 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Viral Suppression	3849 Participants	2880 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: All patients monitored across all control (multiple) and evaluation periods.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4085 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=3138 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Viral Suppression	3849 Participants	2830 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: Unduplicated count of survey respondents at each administration.

The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=69 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=59 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
VACS Index	23.53 units on a scale Interval 22.94 to 24.12	24.54 units on a scale Interval 23.76 to 25.32	—

SECONDARY outcome

Timeframe: 12 months

Population: Unduplicated count of survey respondents at each administration.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=69 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=58 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
VACS Index	23.53 units on a scale Interval 22.94 to 24.12	25.12 units on a scale Interval 24.31 to 25.94	—

SECONDARY outcome

Timeframe: 6 months

Population: Patients identified at the control period to follow up with at the end of the intervention period.

Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4259 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Retention in HIV Care	3567 Participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Patients identified at the control period to follow up with at the end of the evaluation period.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=4259 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder Patients diagnosed with Tobacco Use Disorder
Retention in HIV Care	3450 Participants	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Unduplicated count of survey respondents for the intervention period.

Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=59 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=59 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=59 Participants Patients diagnosed with Tobacco Use Disorder
Organizational Readiness	4.46 units on a scale Interval 4.25 to 4.67	4.14 units on a scale Interval 3.91 to 4.37	4.31 units on a scale Interval 4.09 to 4.52

SECONDARY outcome

Timeframe: 12 months

Population: Unduplicated count of survey respondents for the maintenance period.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=58 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=58 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=58 Participants Patients diagnosed with Tobacco Use Disorder
Organizational Readiness	4.37 units on a scale Interval 4.18 to 4.56	4.05 units on a scale Interval 3.86 to 4.24	4.13 units on a scale Interval 3.89 to 4.36

SECONDARY outcome

Timeframe: 6 months

Population: Unduplicated count of survey respondents for the intervention period.

Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=59 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=59 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=59 Participants Patients diagnosed with Tobacco Use Disorder
Provider Readiness	6.75 units on a scale Interval 5.93 to 7.57	6.22 units on a scale Interval 5.41 to 7.03	7.24 units on a scale Interval 6.49 to 8.0

SECONDARY outcome

Timeframe: 12 months

Population: Unduplicated count of survey respondents for the maintenance period.

Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

Outcome measures

Outcome measures
Measure	Opioid Use Disorder Patients n=58 Participants Patients diagnosed with Opioid Use Disorder (OUD).	Alcohol Use Disorder Patients n=58 Participants Patients diagnosed with Alcohol Use Disorder (AUD).	Tobacco Use Disorder n=58 Participants Patients diagnosed with Tobacco Use Disorder
Provider Readiness:	7.28 units on a scale Interval 6.47 to 8.1	7.16 units on a scale Interval 6.42 to 7.9	7.50 units on a scale Interval 6.69 to 8.32

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Fiellin, MD

Yale School of Medicine

Phone: (203) 688-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Patient Characteristics n=4 Clinics Presented are the characteristics of patients across 4 clinics in the control (baseline) phase in the implementation facilitation design.	Clinician/Staff Characteristics n=4 Clinics Presented are the characteristics of clinician/staff participants across 4 clinics in the control (baseline) phase in the implementation facilitation design.	Total n=8 Clinics Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 12 • n=3647 Participants	58 years STANDARD_DEVIATION 41 • n=70 Participants	NA years STANDARD_DEVIATION NA • n=3717 Participants
Sex: Female, Male Female	1407 Participants n=3647 Participants	51 Participants n=70 Participants	1458 Participants n=3717 Participants
Sex: Female, Male Male	2240 Participants n=3647 Participants	19 Participants n=70 Participants	2259 Participants n=3717 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	781 Participants n=3647 Participants	12 Participants n=70 Participants	793 Participants n=3717 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2859 Participants n=3647 Participants	52 Participants n=70 Participants	2911 Participants n=3717 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=3647 Participants	6 Participants n=70 Participants	13 Participants n=3717 Participants
Race/Ethnicity, Customized Race · Asian	19 Participants n=3647 Participants	6 Participants n=70 Participants	25 Participants n=3717 Participants
Race/Ethnicity, Customized Race · Black	1814 Participants n=3647 Participants	10 Participants n=70 Participants	1824 Participants n=3717 Participants
Race/Ethnicity, Customized Race · White	1118 Participants n=3647 Participants	45 Participants n=70 Participants	1163 Participants n=3717 Participants
Race/Ethnicity, Customized Race · Other	689 Participants n=3647 Participants	8 Participants n=70 Participants	697 Participants n=3717 Participants
Race/Ethnicity, Customized Race · Missing	7 Participants n=3647 Participants	1 Participants n=70 Participants	8 Participants n=3717 Participants
Region of Enrollment United States	3647 participants n=3647 Participants	70 participants n=70 Participants	3717 participants n=3717 Participants
Public insurance Yes	1725 Participants n=3647 Participants • Patient Specific Measure	—	1725 Participants n=3647 Participants • Patient Specific Measure
Public insurance No	740 Participants n=3647 Participants • Patient Specific Measure	—	740 Participants n=3647 Participants • Patient Specific Measure
Public insurance Missing	1182 Participants n=3647 Participants • Patient Specific Measure	—	1182 Participants n=3647 Participants • Patient Specific Measure
Self-Pay Yes	21 Participants n=3647 Participants • Patient Specific Measure	—	21 Participants n=3647 Participants • Patient Specific Measure
Self-Pay No	2444 Participants n=3647 Participants • Patient Specific Measure	—	2444 Participants n=3647 Participants • Patient Specific Measure
Self-Pay Missing	1182 Participants n=3647 Participants • Patient Specific Measure	—	1182 Participants n=3647 Participants • Patient Specific Measure
Private or commercial insurance Yes	985 Participants n=3647 Participants • Patient Specific Measure	—	985 Participants n=3647 Participants • Patient Specific Measure
Private or commercial insurance No	1480 Participants n=3647 Participants • Patient Specific Measure	—	1480 Participants n=3647 Participants • Patient Specific Measure
Private or commercial insurance Missing	1182 Participants n=3647 Participants • Patient Specific Measure	—	1182 Participants n=3647 Participants • Patient Specific Measure
Completed Visits at Baseline	2 Clinic Visits n=3647 Participants • Patient Specific Measure	—	2 Clinic Visits n=3647 Participants • Patient Specific Measure
Prescribed Antiretroviral Therapy Yes	3430 Participants n=3647 Participants • Patient Specific Measure	—	3430 Participants n=3647 Participants • Patient Specific Measure
Prescribed Antiretroviral Therapy No	217 Participants n=3647 Participants • Patient Specific Measure	—	217 Participants n=3647 Participants • Patient Specific Measure
Detectable HIV viral load (>200 copies/mL) Yes	325 Participants n=3647 Participants • Patient Specific Measure	—	325 Participants n=3647 Participants • Patient Specific Measure
Detectable HIV viral load (>200 copies/mL) No	2774 Participants n=3647 Participants • Patient Specific Measure	—	2774 Participants n=3647 Participants • Patient Specific Measure
Detectable HIV viral load (>200 copies/mL) Missing	548 Participants n=3647 Participants • Patient Specific Measure	—	548 Participants n=3647 Participants • Patient Specific Measure
Hepatitis C virus infection Yes	522 Participants n=3647 Participants • Patient Specific Measure	—	522 Participants n=3647 Participants • Patient Specific Measure
Hepatitis C virus infection No	3072 Participants n=3647 Participants • Patient Specific Measure	—	3072 Participants n=3647 Participants • Patient Specific Measure
Hepatitis C virus infection Missing	53 Participants n=3647 Participants • Patient Specific Measure	—	53 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) <50	31 Participants n=3647 Participants • Patient Specific Measure	—	31 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) 50-99	42 Participants n=3647 Participants • Patient Specific Measure	—	42 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) 100-199	154 Participants n=3647 Participants • Patient Specific Measure	—	154 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) 200-349	336 Participants n=3647 Participants • Patient Specific Measure	—	336 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) 350-499	480 Participants n=3647 Participants • Patient Specific Measure	—	480 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) >500	1697 Participants n=3647 Participants • Patient Specific Measure	—	1697 Participants n=3647 Participants • Patient Specific Measure
CD4 cell count categorized (cells/μL) Missing	907 Participants n=3647 Participants • Patient Specific Measure	—	907 Participants n=3647 Participants • Patient Specific Measure
Clinician (physicians, physician assistant, nurse practitioner) Yes	—	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Clinician (physicians, physician assistant, nurse practitioner) No	—	36 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	36 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Time working at clinic	—	7 years STANDARD_DEVIATION 8 • n=70 Participants • Clinician and Staff Participant Specific Measure	7 years STANDARD_DEVIATION 8 • n=70 Participants • Clinician and Staff Participant Specific Measure
Time per week spent working at HIV clinic	—	31 hours n=70 Participants • Clinician and Staff Participant Specific Measure	31 hours n=70 Participants • Clinician and Staff Participant Specific Measure
Ever prescribed medications to treat tobacco use disorder	—	32 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	32 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Ever provided counseling to treat tobacco use disorder	—	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Ever prescribed medications to treat unhealthy alcohol use	—	14 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	14 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Ever provided counseling to treat unhealthy alcohol use	—	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	34 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Ever provided counseling to treat opioid use disorder	—	32 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	32 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Hold a waiver that allows buprenorphine (eg, Suboxone) prescribing	—	11 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	11 Participants n=70 Participants • Clinician and Staff Participant Specific Measure
Ever prescribed oral or injectable (eg, Vivitrol) naltrexone to treat opioid use disorder	—	5 Participants n=70 Participants • Clinician and Staff Participant Specific Measure	5 Participants n=70 Participants • Clinician and Staff Participant Specific Measure