NCT04687917

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 14, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

November 13, 2025

Status Verified

October 1, 2025

Enrollment Period

2.3 years

First QC Date

December 18, 2020

Results QC Date

May 6, 2024

Last Update Submit

October 29, 2025

Conditions

Substance Use

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (4)

Facilitation, Training, Feedback, and Consultation (FTFC) Staff

ACTIVE COMPARATOR

A multilevel implementation strategy

Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy

Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff

EXPERIMENTAL

An enhanced version of the multilevel implementation strategy

Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy

Facilitation, Training, Feedback, and Consultation (FTFC) Clients

ACTIVE COMPARATOR

Clients served within the context of a multilevel implementation strategy

Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy

Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients

EXPERIMENTAL

Clients served within the context of an enhanced multilevel implementation strategy

Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy

Interventions

The facilitation, training, feedback, and consultation (FTFC) StrategyBEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation

Facilitation, Training, Feedback, and Consultation (FTFC) ClientsFacilitation, Training, Feedback, and Consultation (FTFC) Staff
The facilitation, training, feedback, consultation, and incentivization (FTFCI) StrategyBEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.

Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) ClientsFacilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years of age
  • + years of age
  • Diagnosed with HIV

You may not qualify if:

  • None
  • \* None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

  • 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.

    PMID: 40163072DERIVED

  • 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.

    PMID: 39149465DERIVED

  • 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.

    PMID: 38196639DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Dr. Bryan R. Garner
Organization
The Ohio State University
bryan.garner@osumc.edu
6142573462

Study Officials

  • Bryan R Garner, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2020

First Posted

December 29, 2020

Study Start

January 14, 2021

Primary Completion

April 30, 2023

Study Completion (Estimated)

May 31, 2026

Last Updated

November 13, 2025

Results First Posted

May 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

After deidentification, all of the individual participant data collected during the trial.

Time Frame
After study completion
Access Criteria
Anyone who wishes to access the data.
More information

Locations

US(1)