Intervention Fidelity, Treatment Fidelity Darlene Bjorklund, MA, APRN, BC, (CNS) School of Nursing PhD Student Pre-Doctoral Clinical & Translational Research Program 2007 Summer Fellowship University of Minnesota Academic Health Center
Overview of Study Anxiety Self Management for Patients Receiving Mechanical Ventilation PI Linda Chlan, PhD, RN Funded by NINR, NIH
Overview of Study (Con t) A multi-site study 5 hospitals with a total of 9 critical care units Target N 186 subjects Randomized into one of three groups: Usual care rest periods Noise abatement headphones Headphones with music of the subjects choice
Framework Treatment Implementation NIH Guidelines will be used as the framework for this study (Bellg et al, 2004) Lichstein model (1994) was used to develop the NIH Guidelines Used to evaluate and monitor the study protocol, and the understanding and use of the intervention by subjects
Operational Definitions Treatment Fidelity The overall implementation of a study (Moncher & Prinz, 1991, Bellg et al, 2004) Includes three components: treatment integrity treatment receipt treatment enactment
Operational Definitions Treatment Integrity Focus is primarily on the providers (Research Assistants) NIH Guidelines: Monitoring and Improving Provider Training Monitoring and Improving Delivery of Treatment Taught In regards to this study: Treatment Integrity will be defined as whether the intervention was implemented in the intended fashion Were all eligible individuals offered the opportunity to participate? Are all individuals screened, enrolled and evaluated as defined in the protocol?
Operational Definitions (Con t) Treatment Receipt Identifies the ability of the subject to understand the treatment and use the treatment intervention Focus is primarily on the subject (patient and RNs) NIH Guideline: Monitoring and Improving Receipt of Treatment In regards to this study: Is the subject able to understand listening to music, wearing the noise abatement headphones or rest periods when they want to promote relaxation?
Operational Definitions (Con t) Treatment Enactment The ability of the subject to apply the intervention to his/her daily life Focus is primarily on the subject (patient and RNs) NIH Guideline: Improving and monitoring enactment of treatment skills In regards to this study: Is the subject using the intervention? Is the bedside RN reminding the patient of the study and supporting use of the intervention?
Monitoring and Improving provider Training (NIH guideline) Goal: Consistency of treatment implementation is obtained and maintained by the research team Provide consistency in training of Research Assistants Provide consistency of protocol implementation by Research Assistants
Monitoring and Improving provider Training (con t) Plan: treatment manual, one primary trainer, document screening reports, RA involvement with process evaluation, on-going discussions regarding the protocol, issues will be addressed ASAP Evaluation: verbal understanding of process, completion of training by primary trainer, 100% completion of checklists
Monitoring & Improving Delivery of Treatment (NIH Guideline) Goal: Consistency of protocol adherence will be obtained and maintained RAs will provide consistent application of the study protocol Bedside RNs will be consistent when approaching potential participants
Monitoring & Improving Delivery of Treatment (con t) Plan: treatment manual/guidelines used, scripts, involvement of lead RNs Evaluation: increased number of potential participants approached and enrolled, 80% of Nurse Forms completed, 100% completion of checklists, zero protocol violations
Monitoring and Improving Receipt of Treatment (NIH Guideline) Goal: Participants will demonstrate an understanding and the ability to use the headphones/music intervention as directed RAs will verify participant s ability to understand the study RAs will verify participants ability to use the intervention
Monitoring and Improving Receipt of Treatment (con t) Plan: Five established questions will be asked to demonstrate participants understanding of the study, RAs will evaluate if adjustments need to be made Evaluation: participants will acknowledge understanding of five questions, 100% completion of protocol checklists, complete screening reports
Monitoring & Improving Enactment of Treatment skills (NIH Guideline) Goal: Participants are able to use the intervention appropriately RAs assess participants cognitive status with each visit RAs assess participants ability to use the appropriate equipment (headphones, CD player, CDs)
Monitoring & Improving Enactment of Treatment skills (con t) Plan: cognitive status discussed with bedside RN, assess participants ability to use equipment, if needed, develop a plan to provide assistance to the participant in the use of the equipment Evaluation: documented amount of time headphones were used, 80% completion of Nurse Forms.
Future Research Evaluate the discussion of Treatment Implementation within the nursing research literature Development of a Treatment Implementation framework that is nursing focused Does a Treatment Implementation Framework improve reliability and validity of nursing research?
Presenting the findings Midwest Nursing Research Society abstract submission Manuscript submission Local Research Conferences University of Minnesota, School of Nursing Bethel University, School of Nursing
Fellowship Learning Ability to see the BIG picture Involvement in a multi site research study Screening/enrolling/data collection Data Entry Auditing of data Process improvement development Development of Journal Club Writing opportunities
Acknowledgements Linda Chlan, PhD, RN -PI & mentor Karen Lindstrom Bremer Project Coordinator Jill Guttormson, RN Lead Research Assistant Vicki Niedzwieski, RN Research Assistant Deb Portesan, RN Research Assistant