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Table 2 Implementation challenges, examples, threats to research integrity, and strategies for overcoming

From: Tool for evaluating research implementation challenges: A sense-making protocol for addressing implementation challenges in complex research settings

Challenge Example Threat to research integrity Strategies (RD = research design, RS = research staffing, RI = research implementation)
Research Setting
Competing clinical demands on staff Staff unable to leave floor to attend study activities Intervention dose, effectiveness RD: Design intervention with flexibility (group or individual, classroom or on nursing station, online or paper materials), combine activities when possible.
RS: Pairs of research staff may be able to complete intervention and data collection more efficiently.
RI: Identify and use times of day and venues most convenient for staff. Clearly explain study time requirements and obtain commitment from administration during nursing home recruitment. Use advisory board of site employees to inform implementation.
Unable to identify staff for additional training for sustaining intervention after study ends Sustainability RI: Include nursing home management in study early to garner enthusiasm and support for release time. Identify and use meaningful incentives. Do not select staff a priori based on their role, but await understanding of particular nursing homes setting and the emergence of a champion with appropriate skills.
Nursing home staff turnover, schedule changes, and absenteeism Frequent staff list changes, changes in shift Drop-out rates RD: Include plan for adding new staff participants to study prospectively, when possible. Power study appropriate for dropout rates, measure turnover and include in analysis plan.
Intervention dose, effectiveness
RI: Include plan for study procedures to occur during new staff orientation.
RS: Schedule research staff for all shifts during data collection.
Nursing home staff diversity Variety of literacy levels, educational backgrounds, and primary language makes study intervention and data collection challenging Data validity RD: Include a variety of materials targeted for different staffing types at appropriate educational levels. Use multiple delivery methods such as written, oral, storytelling. Develop formal methods of assessing intervention receipt such as skill enactment.
Recruitment and Retention
Nursing home work culture Staff in facilities with hierarchical, punitive work cultures less willing to participate Recruitment and Retention Provide locked drop boxes for surveys and consents. Provide tear-off cover pages on surveys so that staff can remove identifying information other than study number prior to return. Identify private areas for staff-researcher interactions.
Research Protocol
Intensity of research work in nursing home Researcher fatigue Protocol fidelity RI: Schedule one to two days a week for which the interventionist does not travel to the nursing home.
Data collection errors
RS: Pair research staff in each home to provide breaks, flexibility.
Complex interventions with multiple components Difficult to ensure that the interventions are delivered to all staff across multiple sites in similar dose and quality Fidelity RD: Include fidelity measurements and assessment in design.
RI: Use detailed intervention manuals with interventionist training, monitoring and feedback protocols.
Research Team
Lack of familiarity with the NH setting Research staff alienate nursing home staff when they unknowingly interrupt key activities or exhibit ‘ignorance’ of setting Recruitment RS: Plan extensive training period with time spent in nursing home and with nursing home staff. Include readings and key points about setting in training materials. Pair more and less experienced staff together.
Retention
Inefficiency