Broadly defined, the intervention or treatment is any change, addition or subtraction, from care being given or from the environment of the participant
Chapter 17
Intervention
Interventions
Broadly defined, the intervention or treatment is any change, addition or subtraction, from care being given or from the environment of the participant
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Interventions
Three dimensions of interventions are:
Intensity of care
Focus of care
Complexity of care
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Examples of Interventions
Educational
Self-care
Lifestyle changes
Population-level
Naturally occurring events
Biofeedback
Animal models
Over-the-counter medications, herbals, and supplements
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Examples of Interventions
Physical care
Psychotherapeutic
Care management and coordination
Transitional care
Multicomponent
Administrative and managerial changes in care process
Alternative and complementary interventions
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Multicomponent Interventions
Several interventions provided simultaneously
Capitalizes on potential for synergy
Difficult to know which aspect(s) had an effect
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Selecting Interventionists
Look for the following characteristics in people who will be implementing the intervention:
Knowledge and skill related to the intervention
Dependability
Good judgment
Objectivity
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Training Interventionists
Training should cover:
Purpose of study
Background information
Importance of maintaining protocol
Human subjects considerations
The intervention protocol
Study design
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Training Interventionists
Training should cover:
Rationale
An outline of the treatment(s) that will be given
Fill in the details needed to actually carry out the intervention
Approach to participant
Relationship to staff
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Training Interventionists
Training should cover:
Recording responses to treatment
Expectations of interventionists
Authorship
Communication with other team members and investigators
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Working with Facility Staff
Permission may be required
Staff should be fully informed about the purpose of the study
Staff roles in the study need to be explained
Staff may need to be trained
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Working with Facility Staff
Be respectful of staff time and regular responsibilities
Agree upon patient participation documentation
Utilize staff knowledge of participants
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Implementation
Monitor adherence to protocol
Monitor participant safety
If the study is complex and poses a higher level of risk, a data safety monitoring board (DSMB) is needed
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Implementation
Serious adverse events (SAEs) are expected to be reported immediately to the DSMB and the IRB and may include:
Death
Life-threatening event
Hospitalization
Disability
Congenital anomaly
Treatment is required to prevent permanent damage
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Implementation
The IRB usually requires a written plan for data and safety monitoring and may include:
Level of risk to participant
Plan for monitoring
Frequency and specifics of data reviews and reports
To whom the results of the reviews will be submitted to
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