The Tailored-Motivational Interviewing Project (TMI Project)

April 7, 2021 updated by: Karen MacDonell, PhD, Wayne State University

Development of an MI Implementation Intervention in Adolescent HIV Care Settings

The purpose of the Tailored Motivational Interviewing Project (TMI) is to develop an implementation intervention to increase evidence-based patient-provider communication strategies using a Motivational Interviewing (MI) framework.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this implementation science study is to develop an implementation intervention to increase evidence-based patient-provider communication strategies using a Motivational Interviewing (MI) framework. Providers who demonstrate communication consistent with MI are informative, provide support and respect for the patient, and facilitate collaboration, and generally have patients who are more satisfied, more committed to treatment regimens, and have better health outcomes. MI is already embedded in the clinical guidelines for HIV care and HIV risk reduction. However, the inconsistent implementation of clinical guidelines is a constant concern. Fidelity of implementation refers to the degree to which staff members actually implement programs as intended by the developer, or how faithful they are to specification of the evidence-based practice. Several studies suggest that delivering MI with high fidelity can be difficult for many practitioners, but practitioners benefit from carefully designed, multicomponent interventions to help them understand and use evidence- based practices. These implementation interventions consist of a strategy or set of strategies to increase implementation of evidence-based practice. Thus, the primary goal of this study is to develop and pilot test a multi-level implementation intervention to increase MI fidelity and improve patient-provider communication in adolescent HIV care settings within the Adolescent Trials Network for HIV/AIDS (ATN). Leading the way in implementation science in health care is the VA's Quality Enhancement Research Initiative (QUERI), created to link research activities to clinical services in "real time" to promote the rapid uptake of best clinical practices and improvement in patient outcomes. Utilizing the QUERI model of implementation intervention development, this study will prepare for a full-scale implementation intervention trial with the following aims: 1) To develop a measure of MI fidelity to ensure methodological rigor, acceptability and feasibility of administration, and clinical usefulness (Phase 1a). This includes comparing ratings of 200 recordings of full patient-provider interactions with ratings of thin slices (recording 1 minute every 5 minutes); 2) To conduct evidence-based tailoring of MI training for adolescent HIV care settings (Phase 1b). Phase 1 also includes coding utilizing sequential analysis of the 200 recordings to identify those specific provider communication behaviors that predict subsequent youth motivational statements; 3) To collaboratively develop the implementation intervention with HIV clinic teams associated with the ATN (Phase 2). A formative evaluation will be conducted to provide local diagnostic data regarding barriers and facilitators to adoption and create development panels - local development teams made up of clinicians and administrators from the site, and study staff to address barriers and facilitators from formative evaluation and draft locally-customized clinical care and multi-level implementation strategies with initial sustainability plans; 4) To pilot test the implementation intervention and process/outcome evaluation protocols at two ATN sites (Phase 3) to prepare for a full-scale implementation trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • University Health Center
    • New York
      • Bronx, New York, United States, 10467
        • Adolescent AIDS Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients: HIV+, current patient in HIV adolescent care clinic
  • Providers: Provider in HIV adolescent care clinic

Exclusion Criteria:

  • Unable to consent to participate (lack of English fluency)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Phase 1a
To develop a measure of MI fidelity to ensure methodological rigor, acceptability and feasibility of administration, and clinical usefulness (Phase 1a). Ratings of 200 recordings of full patient-provider interactions with ratings of thin slices (recording 1 minute every 5 minutes) will be compared.
NO_INTERVENTION: Phase 1b
To conduct evidence-based tailoring of MI training for adolescent HIV care settings (Phase 1b). Coding via sequential analysis will be conducted of the 200 recordings to identify those specific provider communication behaviors that predict subsequent youth motivational statements.
NO_INTERVENTION: Phase 2
To collaboratively develop the implementation intervention with 2 clinic teams associated with the ATN (Phase 2). A formative evaluation will be done to provide local diagnostic data regarding barriers and facilitators to adoption and create development panels - local development teams made up of clinicians and administrators from the site, and study staff to address barriers and facilitators from formative evaluation and draft locally-customized clinical care and multi-level implementation strategies with initial sustainability plans.
EXPERIMENTAL: Phase 3
To pilot test the implementation intervention and process/outcome evaluation protocols at two ATN sites in preparation for a full-scale trial.
Behavioral: Motivational Interviewing
HIV care providers will be asked to attend an MI training workshop lasting a total of 12 hours. The workshop will be conducted by members of the MI Network of Trainers. MI training relies on experiential activities and cooperative learning methods. After the training, study staff will monitor MI fidelity, or how providers are using the MI skills, using the MI Coach Rating Scale. This will occur 3 times prior to the training, 3 times during the practice period, and then quarterly. They will be asked to complete an audiotaped standardized patient interaction (approximately 30 minutes) with one of the study staff. These will be coded and providers will be informed of their competency level for all but the pre-training role plays. Coaching will be provided for all participants during the practice period. For the quarterly role plays, no coaching occurs unless their score indicates they need additional coaching (an additional 45 minute session with an MI trainer).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MI Coach Rating Scale
Time Frame: Change from pre- to post-training and implementation (12 months)
Fidelity to Motivational Interviewing by HIV care providers
Change from pre- to post-training and implementation (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH103049-01 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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