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Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS)

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ClinicalTrials.gov Identifier: NCT03799432
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
North Carolina Child Treatment Program
National Child Traumatic Stress Network
UCLA-Duke National Center for Child Traumatic Stress
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 9, 2018
First Posted Date  ICMJE January 10, 2019
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Fidelity to COAST-IS [ Time Frame: 1 year ]
    Fidelity to COAST-IS will be measured with a fidelity assessment tool adapted from the Stages of Implementation Completion measure, which assesses organizations' progression through eight stages of implementation (engagement through competency [conceptualized as the start of sustainment]).
  • Fidelity to TF-CBT [ Time Frame: 6 months ]
    Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session.
  • Fidelity to TF-CBT [ Time Frame: 1 year ]
    Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03799432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2019)
  • Organizational Readiness for Implementing Change (ORIC) [ Time Frame: Baseline, 1 year ]
    The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
  • Evidence-based Practice Attitudes Scales (EBPAS) [ Time Frame: Baseline, 1 year ]
    The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Inner Setting of the Consolidated Framework for Implementation Research [ Time Frame: Baseline, 1 year ]
    This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Thirty items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive).
  • Scale for Implementation Climate [ Time Frame: Baseline, 1 year ]
    The six items comprising this measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
  • Psychological Safety Scale (PSS) [ Time Frame: Baseline, 1 year ]
    The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive).
  • Implementation Leadership Scale (ILS) [ Time Frame: Baseline, 1 year ]
    The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Implementation Citizenship Behavior Scale (ICBS) [ Time Frame: Baseline, 1 year ]
    The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Prior Experiences with Implementation [ Time Frame: Baseline, 1 year ]
    This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative).
Original Other Pre-specified Outcome Measures
 (submitted: January 7, 2019)
  • Organizational Readiness for Implementing Change (ORIC) [ Time Frame: Baseline, 1 year ]
    The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
  • Evidence-based Practice Attitudes Scales (EBPAS) [ Time Frame: Baseline, 1 year ]
    The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Inner Setting of the Consolidated Framework for Implementation Research [ Time Frame: Baseline, 1 year ]
    This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Twenty-nine items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive).
  • Implementation Climate Scale (ICS) [ Time Frame: Baseline, 1 year ]
    The six items comprising the ICS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive).
  • Psychological Safety Scale (PSS) [ Time Frame: Baseline, 1 year ]
    The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive).
  • Implementation Leadership Scale (ILS) [ Time Frame: Baseline, 1 year ]
    The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Implementation Citizenship Behavior Scale (ICBS) [ Time Frame: Baseline, 1 year ]
    The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive).
  • Prior Experiences with Implementation [ Time Frame: Baseline, 1 year ]
    This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative).
 
Descriptive Information
Brief Title  ICMJE Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
Official Title  ICMJE Improving the Implementation and Sustainment of Evidenced Based Practices in Mental Health: Developing and Piloting the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies
Brief Summary The purpose of this study is to partner with the North Carolina Child Treatment Program (NC CTP) and the SAMHSA-funded National Child Traumatic Stress Network (NCTSN) to develop and pilot the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). The COAST-IS intervention will involve coaching organizational leaders and therapists to use Intervention Mapping to select and tailor strategies. Intervention Mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. After collaboratively developing COAST-IS in Year 1, the investigators will conduct a randomized pilot trial of the intervention within an NC CTP learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus COAST-IS condition. Participants will include organizational leaders (e.g., CEOs/Directors, Clinical Directors, Supervisors) and therapists (e.g., Licensed Clinical Social Workers, Licensed Psychologists, Licensed Professional Counselors). The investigators will evaluate COAST-IS in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of COAST-IS; 2) to evaluate organizational stakeholders' fidelity to the core elements of Intervention Mapping; and 3) to demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. This work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. Ultimately, COAST-IS may have the potential to improve implementation and sustainment of a wide-range of EBPs in mental health and other health sectors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Psychological Trauma
  • Mental Health
Intervention  ICMJE
  • Other: COAST-IS
    COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach.
  • Other: TF-CBT Learning Collaborative
    The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning.
Study Arms  ICMJE
  • Experimental: TF-CBT Learning collaborative + COAST-IS
    In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support.
    Interventions:
    • Other: COAST-IS
    • Other: TF-CBT Learning Collaborative
  • Active Comparator: TF-CBT Learning collaborative
    Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls.
    Intervention: Other: TF-CBT Learning Collaborative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative
  • Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist
  • Direct involvement in the organization's implementation of TF-CBT
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Byron J Powell, PhD 314-935-2817 bjpowell@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03799432
Other Study ID Numbers  ICMJE 17-0978
1K01MH113806-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • North Carolina Child Treatment Program
  • National Child Traumatic Stress Network
  • UCLA-Duke National Center for Child Traumatic Stress
Investigators  ICMJE
Principal Investigator: Byron J Powell, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP