TMI Project: The Tailored-Motivational Interviewing Project

Sponsor
Wayne State University (Other)
Overall Status
Completed
CT.gov ID
NCT03181022
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Mental Health (NIMH) (NIH)
111
2
4
59.3
55.5
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interviewing
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Development of an MI Implementation Intervention in Adolescent HIV Care Settings
Actual Study Start Date :
Dec 8, 2015
Actual Primary Completion Date :
Nov 17, 2020
Actual Study Completion Date :
Nov 17, 2020

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. MI Coach Rating Scale [Change from pre- to post-training and implementation (12 months)]

    Fidelity to Motivational Interviewing by HIV care providers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Center Detroit Michigan United States 48201
2 Adolescent AIDS Program Bronx New York United States 10467

Sponsors and Collaborators

  • Wayne State University
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karen MacDonell, PhD, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier:
NCT03181022
Other Study ID Numbers:
  • R34MH103049-01
First Posted:
Jun 8, 2017
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karen MacDonell, PhD, Associate Professor, Wayne State University

Study Results

No Results Posted as of Apr 9, 2021