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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

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

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.
90

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
    • Texas
      • 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

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:

  • 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

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.
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
Behavioral: Mapping Enhanced Counseling (MEC)
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)
Behavioral: Mapping Enhanced Counseling (MEC)
a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
Other: Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
an implementation intervention to explore and address agency preparation needs in order to promote implementation success

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Christian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

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.
September 1, 2019

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.
December 1, 2020

Study Completion (ANTICIPATED)

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.
October 1, 2021

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).
July 8, 2019

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.
July 8, 2019

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.
July 12, 2019

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.
March 15, 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.
March 11, 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.
March 1, 2021

More Information

Terms related to this study

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.
  • 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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