Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03181022 |
Other study ID # |
R34MH103049-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 8, 2015 |
Est. completion date |
November 17, 2020 |
Study information
Verified date |
April 2021 |
Source |
Wayne State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.