UCLA CTSI Implementation Science Module

February 2013

Project Planning Worksheet

Investigator name and role in project: ______

Project title: ______

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1. Summarize your study’s primary policy/practice aims (e.g., improve care through implementation of a new evidence-based practice/innovation; evaluate a policy or practice-led implementation process). Describe the policy/practice problem or need motivating the study.

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2. Summarize your study’s primary research aims (i.e., its intended contributions to scientific knowledge) and the motivating science/research gap(s).

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3. If applicable: describe the innovation, research finding or effective practice or policy to be implemented, the evidence base supporting its effectiveness, and any additional factors indicating why implementation is appropriate at this time. (If additional effectiveness evidence is needed, describe the need and any plans for generating this evidence, including the possibility of a hybrid E-I study.)

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Project Planning Worksheet 1 February 2013 4. List the specific type of study you plan (i.e., pre-implementation, observational implementation, trial, including trial phase/s) and explain your choice.

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5. If applicable: describe prevailing/current clinical practice patterns and any existing data documenting the magnitude and pattern of quality/implementation gaps. Summarize existing data regarding key influences on current practices and any “root cause analysis” or diagnosis of the quality/implementation gaps. Summarize any information regarding barriers/facilitators to improvement or implementation.

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6. Describe any required data or new insights regarding current practice patterns, quality or implementation gaps and their root causes, and barriers/facilitators to change. Describe plans and methods for new data collection and analysis to produce new insights regarding current practice patterns, quality or implementation gaps and their root causes, and barriers/facilitators to change.

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7. What are the required changes in clinician or staff practices, organizational policies or procedures, etc.? What levels of the care delivery system are involved (clinician/staff, team, microsystem, department, clinic, facility, region, national)?

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Project Planning Worksheet 2 February 2013 8. Drawing from the information documented in worksheet items 5-7 above, describe the key implementation barriers and facilitators to be addressed and overcome.

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9. Describe the approach you will employ in designing your implementation strategy.

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10. Describe the key elements (components) of the implementation strategy, including the specific target (entity and behavior or behavioral determinant), the expected mechanism of operation and impact of the component, its theoretical foundation, and its operationalization (action/s, tools).

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11. Primary, secondary outcomes. Describe the primary and secondary outcomes to be measured, including dissemination/implementation outcomes and any health/public health/clinical/system outcomes (if a hybrid effectiveness/implementation study). Explain their links to the project goal(s), the implementation or QI program, and the project’s theoretical framework.

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Project Planning Worksheet 3 February 2013 12. Formative evaluation. Describe any planned formative evaluation, evaluability assessment or other preparatory evaluation, including the need, timing, planned use of results, and planned methods for data collection and analysis.

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13. Outcome/impact assessment (summative evaluation). Describe the key variables, data sources and measures for the primary and secondary outcomes and the analytical approach to be employed in explaining program impacts.

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14. Process evaluation. Describe any planned process evaluation including assessment of implementation fidelity/adaptation and measurement of mediators and moderators (and processes and mechanisms) of the implementation program, including the need, timing, use of results. Describe the key variables, data sources and measures and methods for data collection and analysis.

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15. Contextual analysis. Discuss any additional key contextual factors (not discussed in question 20 above) and analyses and planned reporting (particularly in reference to external validity of the study).

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Project Planning Worksheet 4 February 2013 16. Additional evaluation activities. Describe any additional evaluation components and explain the goals for these evaluation activities, including, as appropriate, the following:

Economic analysis. Described any planned cost, cost-effectiveness and other economic analysis, including data sources and measures and analysis methods. Discuss the reasons for inclusion or exclusion of an economic analysis.

Sustainability analysis. Describe (a) plans for sustaining the intervention; and (b) any planned sustainability analysis, including data sources and measures and analysis methods. Discuss the reasons for inclusion or exclusion of a sustainability analysis.

Scale-up/spread analysis. Describe any planned analysis of scale-up/spread potential and required modifications, including variables, data sources and measures and analysis methods. Discuss the reasons for inclusion or exclusion of a scale-up/spread analysis and the scope of proposed spread.

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17. Next steps. Summarize (a) plans for subsequent research activities, (b) plans for synthesis of these findings with other related findings, (c) development of policy- and practice-relevant tools and findings, including guidance for application, replication or scale-up and spread of the implementation program. Discuss guidance for local adaptation based on any findings from the contextual analysis and process evaluation.

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Project Planning Worksheet 5 February 2013 ______

Project Planning Worksheet 6 February 2013