Mapping Approaches to Prepare for Implementation TransferMAP-ITNCT04016831
Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
A study testing Mapping Enhanced Counseling (MEC) and Mapping Approaches to Prepare for Implementation Transfer (MAP-IT) in people with Mapping Approaches to Prepare for Implementation Transfer and Treatment Readiness and Induction Program, run by Texas Christian University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mapping Approaches to Prepare for Implementation Transfer, Treatment Readiness and Induction Program
- What is being tested?
- Mapping Enhanced Counseling (MEC) and Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical staff employed at adolescent substance use treatment agencies located in Texas with equal representation of community-based residential and secure justice agencies
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mapping Approaches to Prepare for Implementation Transfer, Treatment Readiness and Induction Program
- Being tested
- Mapping Enhanced Counseling (MEC), Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping Enhanced Counseling (MEC)Behavioural
a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)Other
an implementation intervention to explore and address agency preparation needs in order to promote implementation success
| Study group | Role | What they receive |
|---|---|---|
| Mapping Enhanced Counseling (MEC) only | Other | a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement Receives: Behavioral: Mapping Enhanced Counseling (MEC) |
| Mapping Approaches to Prepare for Implementation Transfer | Experimental | an implementation intervention to explore and address agency preparation needs in order to promote implementation success (includes MEC training) Receives: Behavioral: Mapping Enhanced Counseling (MEC); Other: Mapping Approaches to Prepare for Implementation Transfer (MAP-IT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation Intentions
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).
Measured: Month 1, Month 2
Preparation Actions
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).
Measured: Month 6
Organizational Climate
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).
Measured: Baseline, Month 6
Staff Attributes
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).
Measured: Baseline, Month 6
Transformational Leadership
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).
Measured: Baseline, Month 6
Implementation Climate
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).
Measured: Baseline, Month 6
Evidence Based Practice Attitude Scale (EBPAS)
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.
Measured: Baseline, Month 6
EBP Implementation Adoption
The distal outcome (for hypothesis 4) measures adoption of the specified evidence-based practice (e.g., EBP sessions conducted).
Measured: Month 6
EBP Penetration
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).
Measured: Month 6
EBP Fidelity
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).
Measured: Month 6
Implementation Efficiency
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).
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2020
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mapping Approaches to Prepare for Implementation TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an implementation intervention to explore and address agency preparation needs in order to promote implementation success
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Becan, Texas Christian University
- Investigators
- Jennfer R Becan, Ph.D., Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016831
- Sponsor's protocol ID
- 5R21DA044261-02
- Acronym
- MAP-IT
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2019
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)
- ClinicalTrials.gov ID
- NCT04016831
- Acronym / sponsor ID
- MAP-IT / 5R21DA044261-02
- Conditions
- Mapping Approaches to Prepare for Implementation Transfer, Treatment Readiness and Induction Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an implementation intervention to explore and address agency preparation needs in order to promote implementation success
| Arm | Type | Receives |
|---|---|---|
| Mapping Enhanced Counseling (MEC) only | Other | 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 |
| Mapping Approaches to Prepare for Implementation Transfer | Experimental | Behavioral: Mapping Enhanced Counseling (MEC), 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 (includes MEC training) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical staff employed at adolescent substance use treatment agencies located in Texas with equal representation of community-based residential and secure justice agencies
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Mapping Approaches to Prepare for Implementation Transfer, Mapping Enhanced Counseling (MEC) only |
| 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 | Other | Mapping Approaches to Prepare for Implementation Transfer |
Primary outcome
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).
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).
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).
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).
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).
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).
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.
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennfer R Becan, Ph.D. principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapping Enhanced Counseling (MEC) and Mapping Approaches to Prepare for Implementation Transfer (MAP-IT) in people with Mapping Approaches to Prepare for Implementation Transfer and Treatment Readiness and Induction Program, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparation Intentions (time frame: Month 1, Month 2). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.