- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016831
Mapping Approaches to Prepare for Implementation Transfer (MAP-IT) (MAP-IT)
March 11, 2021 updated by: Jennifer Becan, Texas Christian University
Despite demonstrated effectiveness, evidence based practices are not widely incorporated into existing residential and outpatient treatments.
For implementation (and sustainment) of effective practices to be successful, it is critical that agencies be able to independently assess their own strengths and weaknesses and develop plans for organizational improvement.
This application will extend scientific and field knowledge by providing a low-cost and sustainable alternative for improving agency preparedness for change.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
For implementation (and sustainment) of new interventions to be successful, it is critical that barriers are identified and addressed prior to change.
It is challenging, however, for agencies to independently assess their own strengths and weaknesses and to develop plans for organizational improvement.
Furthermore, the sheer number of strategies to promote implementation makes it difficult for agency leadership to decipher which are most appropriate for their own contexts and needs.
This application proposes to develop and pilot test Mapping Approaches to Prepare for Implementation Transfer (MAP-IT), an organizational intervention that includes four key elements: (1) guidelines on forming an implementation workgroup to inform and promote implementation efforts, (2) instruction on mechanisms known to impact implementation, (3) tools and instruction for conducting an agency-driven diagnosis of potential implementation barriers, and (4) tools for developing an implementation blueprint to address identified barriers (including instruction on strategies for addressing potential barriers prior to implementation).
The premise of this application is significant in that MAP-IT would provide a low-cost (agency-driven opportunity for deliberate implementation preparedness, without ongoing external coaching) and sustainable (skill development for multiple individuals within the organization that can be applied to future implementation efforts) alternative to promoting organizational adoption of new practices.
The specific aims of the proposed research are as follows: Aim 1 - Synergistically integrate and adapt three established implementation intervention tools to promote deliberate agency implementation preparation - organizational assessment and feedback; taxonomy of implementation strategies; and visual-spatial decision making techniques - as combined into a comprehensive training and manualized bundle, MAP-IT.
AIM 2 - Conduct a 2-arm cluster randomized efficacy trial of the MAP-IT intervention with 12 substance abuse treatment community-based residential and juvenile justice secure agencies serving adolescents (including those with opioid use disorders) randomized to either MAP-IT (EBP and MAP-IT trainings) or the non-intervention control condition (EBP training only).
Successful completion of the aims is expected to (1) establish preliminary evidence for the efficacy of a low-cost, sustainable alternative for improving implementation preparation that agencies can use to support and expedite implementation transfer, (2) shift the current paradigm by encouraging researchers (designing uptake studies) and health care agencies (independently striving to implement new practices) to place greater emphasis on pre-implementation preparations for change, (3) provide an empirical examination of how exploration and preparation can support implementation, using established measurement platforms and theoretical frameworks, and (4) provide documentation of agency selection of implementation strategies for promoting change in real-world settings.
Findings from the proposed R21 will inform intervention effectiveness testing and implementation strategy selection in a future R01 aimed at improving uptake of best practices within behavioral healthcare delivery services using a full-scale randomized control trial.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- 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
-
-
Texas
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Fort Worth, Texas, United States, 76109
- Texas Christian University
-
-
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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical staff employed at adolescent substance use treatment agencies located in Texas with equal representation of community-based residential and secure justice agencies
Exclusion Criteria:
-
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Mapping Enhanced Counseling (MEC) only
a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
|
a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
|
|
EXPERIMENTAL: Mapping Approaches to Prepare for Implementation Transfer
an implementation intervention to explore and address agency preparation needs in order to promote implementation success (includes MEC training)
|
a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
an implementation intervention to explore and address agency preparation needs in order to promote implementation success
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preparation Intentions
Time Frame: Month 1, Month 2
|
The proximal outcome (for hypothesis 1), preparation intentions (to address perceived implementation barriers through intentions to change organizational practices and use implementation strategies), is a continuous measure and will come from the TCU Workshop Evaluation Form (WEVAL).
|
Month 1, Month 2
|
|
Preparation Actions
Time Frame: Month 6
|
The distal outcome (for hypothesis 2), preparation actions (to address perceived implementation barriers through changes in organizational practices and use of implementation strategies), is a continuous measure and will come from the TCU Workshop Assessment Follow-up Form (WAFU).
|
Month 6
|
|
Organizational Climate
Time Frame: Baseline, Month 6
|
The distal outcome (for hypothesis 3), organizational climate (change in mission, cohesion, autonomy, communication, stress, and proclivity to change), is 6 scale measures and will come from the TCU Survey of Organizational Functioning and Leadership (SOFL).
|
Baseline, Month 6
|
|
Staff Attributes
Time Frame: Baseline, Month 6
|
The distal outcome (for hypothesis 3), staff attributes (change-oriented staff attributes including professional growth, efficacy, influence, and adaptability), is 4 scale measures and will come from the TCU Survey of Organizational Functioning and Leadership (SOFL).
|
Baseline, Month 6
|
|
Transformational Leadership
Time Frame: Baseline, Month 6
|
The distal outcome (for hypothesis 3), transformational leadership (change in leader attributes including encourages innovation, inspirational motivation, develops others, and task delegation), is 4 scale measures and will come from the TCU Survey of Organizational Functioning and Leadership (SOFL).
|
Baseline, Month 6
|
|
Implementation Climate
Time Frame: Baseline, Month 6
|
The distal outcome (for hypothesis 3), implementation readiness (pressure for change, organizational incentives and rewards, and leadership engagement in change process across time), is 3 scale measures and will come from the TCU Survey of Organizational Functioning and Leadership (SOFL).
|
Baseline, Month 6
|
|
Evidence Based Practice Attitude Scale (EBPAS)
Time Frame: Baseline, Month 6
|
The distal outcome (for hypothesis 3), Evidence Based Practice Attitude Scale (EBPAS) is 4 scales to measure change in likelihood of adopting EBP given requirements to do so, intuitive appeal of EBP, openness to new practices, and perceived divergence of usual practice with research based/academically developed interventions.
|
Baseline, Month 6
|
|
EBP Implementation Adoption
Time Frame: Month 6
|
The distal outcome (for hypothesis 4) measures adoption of the specified evidence-based practice (e.g., EBP sessions conducted).
|
Month 6
|
|
EBP Penetration
Time Frame: Month 6
|
The distal outcome (for hypothesis 4) measures penetration of the specified evidence-based practice (e.g., proportion of staff trained and using the EBP, proportion of clients receiving the EBP).
|
Month 6
|
|
EBP Fidelity
Time Frame: Month 6
|
The distal outcome (for hypothesis 4) measures implementation fidelity to the specified evidence-based practice (e.g., proportion of EBP sessions that adhered to core components).
|
Month 6
|
|
Implementation Efficiency
Time Frame: Month 6
|
The distal outcome (for hypothesis 5), implementation efficiency (e.g., time to prepare agency for implementation, train staff on the EBP, implement the EBP) is a continuous measure and will come from the Stages of Implementation Completion (SIC).
|
Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennfer R Becan, Ph.D., Texas Christian University
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)
September 1, 2019
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (ACTUAL)
July 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 15, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 5R21DA044261-02 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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