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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA052294 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Active Comparator | A multilevel implementation strategy |
|
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Experimental | An enhanced version of the multilevel implementation strategy |
|
| Facilitation, Training, Feedback, and Consultation (FTFC) Clients | Active Comparator | Clients served within the context of a multilevel implementation strategy |
|
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients | Experimental | Clients served within the context of an enhanced multilevel implementation strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The facilitation, training, feedback, and consultation (FTFC) Strategy | Behavioral | A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Staff-level Implementation Consistency | The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase. | Assessed at the end of month 12 |
| 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. | Assessed at the end of month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at 4-weeks from the baseline assessment |
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Inclusion Criteria:
Inclusion criteria for staff participants:
Inclusion criteria for client participants:
Exclusion Criteria:
Exclusion criteria for staff participants:
Exclusion criteria for client participants:
* None
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| Name | Affiliation | Role |
|---|---|---|
| Bryan R Garner, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40163072 | Derived | Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613. | |
| 39149465 | Derived | Garner BR, Tueller SJ, Bradshaw M, Speck KJ, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa MR, Zehner M, Ford JH 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a parallel cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2024 Aug 9:rs.3.rs-4614222. doi: 10.21203/rs.3.rs-4614222/v1. |
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After deidentification, all of the individual participant data collected during the trial.
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After study completion
Anyone who wishes to access the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Facilitation, Training, Feedback, and Consultation (FTFC) | A multilevel implementation strategy 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 |
| FG001 | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) | A 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study includes cluster-randomization of both staff participants and client participants. For each of the two implementation strategy conditions we have separated staff participants from client participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | client participants | Assessed at the end of month 12 |
|
1 year
As also noted in the participant flow section, the Training, Feedback, Consultation, and Facilitation condition includes 161 participants, which is composed of 44 HSO staff and 117 HSO clients, whereas the Training, Feedback, Consultation, Facilitation, and Incentivization condition includes 43 HSO staff and 224 HSO clients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facilitation, Training, Feedback, and Consultation (FTFC) Staff | A multilevel implementation strategy 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bryan R. Garner | The Ohio State University | 6142573462 | bryan.garner@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2020 | May 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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Cluster-randomized trial
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Single blind masking
| The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy | Behavioral | A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. |
|
| 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. | Assessed at 4-weeks from the baseline assessment |
| 38196639 | Derived | Garner BR, Tueller S, Bradshaw M, Speck K, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa M, Zehner M, Ford J 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3685134. doi: 10.21203/rs.3.rs-3685134/v1. |
| 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 |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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.
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of month 12 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | days of reduced use | Assessed at 4-weeks from the baseline assessment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | change in scale score | Assessed at 4-weeks from the baseline assessment |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Facilitation, Training, Feedback, and Consultation (FTFC) Clients | A multilevel implementation strategy 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 | 0 | 117 | 0 | 117 | 0 | 117 |
| EG002 | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | An enhanced version of the multilevel implementation strategy The facilitation, training, feedback, consultation, and incentivization (FTFC + Incentivization) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG003 | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients | An enhanced version of the multilevel implementation strategy The facilitation, training, feedback, consultation, and incentivization (FTFC + Incentivization) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. | 0 | 224 | 0 | 224 | 0 | 224 |
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