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Strategies for Enactment

Lastly, fidelity should include enhancements for enactment and ways to monitor and measure this aspect. Enhancement for enactment may include providing ongoing

Domain

Enhancements

Monitoring Procedures

Measurement

Trial

design

  • ? Based on theory
  • ? Manual of Procedures
  • ? External oversight by DSMB and IRB
  • ? Periodic reports to and review by DSMB or other oversight board
  • ? Regular investigator meetings

? Off protocoltracking forms

Interviewing

  • ? Interviewer manuals with question-byquestion codebook
  • ? Interviewer training and certification procedures
  • ? Weekly/biweekly interviewer meetings in which interviews are presented and discussed
  • ? Weekly tracking reports for follow-up interview scheduling
  • ? Double-check coding of all interviews by others than interviewer
  • ? Maintain blinding to study allocation
  • ? Maintain detailed list of coding decisions, which are routinely referred to
  • ? Audiotape of interview sessions and random review of more than 10% using a monitoring form from which to derive quantification of adherence to protocol
  • ? Direct observation of select interviews and ratings concerning
  • ? Adherence to protocol
  • ? Omissions
  • ? Commissions
  • ? Drift
  • ? Competence
  • ? Completed certification forms
  • ? Quality control questions at end of interview
  • ? Interviewer best guess as to group assignment
  • ? Study follow-up satisfaction interview of participants to assure quality of delivery
  • ? Ratings from monitoring forms used to review audiotape and/ or videotape sessions

Randomization

  • ? Randomization forms developed by statistician who does not reveal allocation and blocking scheme
  • ? Randomization occurs by a researcher who is not part of the project team
  • ? Periodic checks of randomization forms and allocations by statistician
  • ? Monitoring of randomization infractions using protocol-tracking forms

? Number of protocol violations

Alerts and Adverse

Event Tracking

  • ? Training in event-tracking form
  • ? Weekly review of events with principal investigator (PI)
  • ? Weekly reviews by project manager and PI to assure all alerts/adverse events have been documented and addressed adequately
  • ? Completion of tracking forms
  • ? DSMB and IRB oversight of adverse event tracking
  • ? Number of alerts and timely resolution
  • ? Number of adverse events and resolution

TABLE 12.3 Example of a Fidelity Plan (Continued)

Domain

Enhancements

Monitoring Procedures

Measurement

Delivery

Is the intervention delivered as intended?

Interventionist

  • ? Use of a treatment manual
  • ? Systematic training program
  • ? Certification process in which interventionist demonstrates knowledge and competencies
  • ? Use of interactive training including role-play to enhance learning
  • ? Ongoing regular meetings to review case presentations
  • ? Audiotaped sessions
  • ? Direct observation of sessions
  • ? Ongoing regular meetings to monitor cases and documentation
  • ? Completion of session- by-session tracking forms of activities per intervention session
  • ? Observation of select intervention sessions
  • ? Review of audiotapes for
  • ? Adherence to protocol
  • ? Omissions
  • ? Commissions
  • ? Drift
  • ? Competence
  • ? Knowledge test (pre-post)
  • ? Post evaluation of training by interventionists
  • ? Monitoring checklists that provide quantification of adherence to session protocols

Delivery to End User

  • (Participant)
  • ? Use of a range of techniques to enhance knowledge and skill acquisition
  • ? Calendar to track use of strategies
  • ? Study folder with study materials

? Completion of a "delivery assessment form" at completion of each session. Form documents treatment elements including dose and time spent

  • ? Quantification of dose and intensity
  • ? Checklist of activities completed at each session

Receipt

Did participant receive intervention as intended?

  • ? Participant provides return demonstration of a particular skill
  • ? Use of worksheets for reinforcement of information provided
  • ? Approach tailored to readiness of participant
  • ? Checking in at each session to evaluate what works and what is not working and address questions
  • ? Identification of barriers to participation
  • ? Checklist of level of receptivity, understanding of participant
  • ? Readiness ratings pre and post

Enactment

Did

caregiver

use

knowledge and/or skills as prescribed during, between, and after sessions?

? Validation of knowledge and skills

  • ? Review of strategies provided
  • ? Videotaping of select sessions
  • ? Measure of use or proximal outcome expected from intervention
  • ? Checklist of observed engagement
  • ? Follow-up survey of continued use of strategies
  • ? Observation checklist used by interventionist to rate participant use of strategies

DSMB, Data and Safety Monitoring Board; IRB, Institutional Review Board; PI, Principal Investigator.

validation of a participant’s knowledge and skills and progress in an intervention, as well as having procedures in place for continued monitoring and measurement of skills and adherence to the intervention protocol. Such strategies may include review or booster sessions, as well as use of follow-up surveys or observations to assess current level of engagement and use of previously taught skills and strategies (see Table 12.3).

 
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