Substance Use
Conditions
Brief summary
An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.
Detailed description
A cluster-randomized type 3 hybrid trial with HIV service organizations across the United States. The primary aims is to test the effectiveness of an innovative pay-for-performance (P4P) strategy for improving the implementation of a motivational interviewing-based brief intervention for substance use.
Interventions
BEHAVIORALThe facilitation, training, feedback, and consultation (FTFC) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
BEHAVIORALThe facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
Sponsors
National Institute on Drug Abuse (NIDA)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blind masking
Intervention model description
Cluster-randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria for staff participants: * 18+ years of age Inclusion criteria for client participants: * 18+ years of age * Diagnosed with HIV
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staff-level Implementation Consistency | Assessed at the end of month 12 | The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase. |
| Staff-level Implementation Quality | Assessed at the end of month 12 | The cumulative sum quality score that each HSO staff participant demonstrated during the implementation phase. Each motivational interviewing brief intervention (MIBI) is rated on a scale from 0 (zero quality) to 12 (highest quality possible). Each individual MIBI quality score is summed to create a cumulative sum quality score. Higher scores indicated higher quality (i.e. motivational interviewing fidelity). The lower limit is zero. There is not an upper limit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance | Assessed at 4-weeks from the baseline assessment | A staff-level measure representing the average level of client participant change (follow-up minus baseline) in the number of days clients used their primary substance (i.e., the substance the client identified a willingness to talk about during the MIBI) during the past 28 day |
| Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score | Assessed at 4-weeks from the baseline assessment | A staff-level measure of the average change (follow-up minus baseline) in their client participant's Generalized Anxiety Disorder 7-item (GAD-7) scale score. The GAD-7 ranges from 0 to 21, with higher scores indicating greater generalized anxiety. For change in the GAD-7 between baseline and follow-up (follow-up minus baseline), scores range from -20 to 20 and negative numbers are better as they indicate decreasing generalized anxiety. For this study, we examined the average GAD-7 change score that the HSO staff had with their client participants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff A multilevel implementation strategy provided to staff
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation | 44 |
| Facilitation, Training, Feedback, and Consultation (FTFC) Clients A multilevel implementation strategy that client participants are cluster-randomized
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation | 117 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. | 43 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients An enhanced version of the multilevel implementation strategy that client participants are cluster-randomized.
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. | 224 |
| Total | 428 |
Baseline characteristics
| Characteristic | Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Facilitation, Training, Feedback, and Consultation (FTFC) Clients | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 8 Participants | 3 Participants | 18 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 109 Participants | 40 Participants | 206 Participants | 399 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 38 Participants | 10 Participants | 53 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 79 Participants | 33 Participants | 171 Participants | 310 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 0 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 51 Participants | 21 Participants | 129 Participants | 212 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 0 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 4 Participants | 4 Participants | 2 Participants | 16 Participants |
| Race (NIH/OMB) White | 23 Participants | 51 Participants | 16 Participants | 73 Participants | 163 Participants |
| Region of Enrollment United States | 44 Participants | 117 Participants | 43 Participants | 224 Participants | 428 Participants |
| Sex: Female, Male Female | 31 Participants | 20 Participants | 27 Participants | 74 Participants | 152 Participants |
| Sex: Female, Male Male | 13 Participants | 97 Participants | 16 Participants | 150 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 117 | 0 / 43 | 0 / 224 |
| other Total, other adverse events | 0 / 44 | 0 / 117 | 0 / 43 | 0 / 224 |
| serious Total, serious adverse events | 0 / 44 | 0 / 117 | 0 / 43 | 0 / 224 |
Outcome results
Primary
Staff-level Implementation Consistency
The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase.
Time frame: Assessed at the end of month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Staff-level Implementation Consistency | .73 client participants | Standard Deviation 1.55 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Staff-level Implementation Consistency | 2.35 client participants | Standard Deviation 6.67 |
Primary
Staff-level Implementation Quality
The cumulative sum quality score that each HSO staff participant demonstrated during the implementation phase. Each motivational interviewing brief intervention (MIBI) is rated on a scale from 0 (zero quality) to 12 (highest quality possible). Each individual MIBI quality score is summed to create a cumulative sum quality score. Higher scores indicated higher quality (i.e. motivational interviewing fidelity). The lower limit is zero. There is not an upper limit.
Time frame: Assessed at the end of month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Staff-level Implementation Quality | 4.61 score on a scale | Standard Deviation 9.87 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Staff-level Implementation Quality | 12.39 score on a scale | Standard Deviation 20.57 |
Secondary
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance
A staff-level measure representing the average level of client participant change (follow-up minus baseline) in the number of days clients used their primary substance (i.e., the substance the client identified a willingness to talk about during the MIBI) during the past 28 day
Time frame: Assessed at 4-weeks from the baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance | -1.11 days of reduced use | Standard Deviation 4.93 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance | -5.95 days of reduced use | Standard Deviation 17.25 |
Secondary
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score
A staff-level measure of the average change (follow-up minus baseline) in their client participant's Generalized Anxiety Disorder 7-item (GAD-7) scale score. The GAD-7 ranges from 0 to 21, with higher scores indicating greater generalized anxiety. For change in the GAD-7 between baseline and follow-up (follow-up minus baseline), scores range from -20 to 20 and negative numbers are better as they indicate decreasing generalized anxiety. For this study, we examined the average GAD-7 change score that the HSO staff had with their client participants.
Time frame: Assessed at 4-weeks from the baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score | -0.14 change in scale score | Standard Deviation 3.63 |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score | -2.63 change in scale score | Standard Deviation 8.67 |