From: Guidance for conducting feasibility and pilot studies for implementation trials
Purpose | Measures | Examples of potential implementation feasibility and pilot study measures (including as part of Hybrid Type 1 trials) | Examples of potential implementation pilot trial measures (including as part of Hybrid Type 2 trials) |
---|---|---|---|
To assess potential implementation strategy effects | Adoption: the proportion and representativeness of settings and staff that adopt the innovation [60] | Assessment of implementation strategy effects are not typically part of non-pilot feasibility or Type 1 Hybrid trials b | Percent and type of service providers utilising the intervention Percent and type of support system teams/ staff members undertaking the implementation strategies [60] |
Fidelity (adherence): the degree to which the innovation is implemented as intended by developers [70] | Measures such as content, frequency, duration, and coverage as prescribed by its designers [70]. Number and type of adaptations made to implementation strategies including information on how and why [68]. | ||
Reach (penetration) Participation rate in the innovation by the intended audience [62] | The proportion of support systems staffs’ participation in the delivery of the implementation strategy [46]. | ||
Sustainability (maintenance): continuation or maintenance of the innovation’s desired changes [62] | Uptake of implementation strategies by support systems continued at a specified time(s) post the initial intervention [15]. | ||
To inform the design or development of the implementation strategy (determinants) | Adaptability: the degree to which the innovation can be adapted to meet local needs [65] | Organisations’ view of the flexibility required for future implementation strategies. | To what extent did support systems find they could tailor or adapt implementation strategies (whilst maintaining core components) [46] |
Acceptability: Service providers or support system’s satisfaction with the innovation [62] | If service providers and / or support systems approve of proposed future implementation strategies (such as content or proposed delivery) | If service providers or support systems found the implementation components agreeable, for example in terms of content or delivery [46, 62] | |
Feasibility: actual fit or suitability of the innovation for everyday use [62] | If service providers and/ or support systems staff agree with the suitability of proposed future implementation strategies | If service providers and support systems staff agree that the implementation strategies were able to be successfully undertaken [46]. | |
Compatibility (appropriateness): perceived fit of the innovation with organisation’s values, mission, priorities [71] | If support systems agree that any future proposed implementation strategy is in line with organisational priorities | If support systems agree that the implementation strategies are in line with organisational priorities [46]. | |
Dose (satisfaction) Satisfaction with the dose of the innovation received [72] | Implementation strategies typically not delivered in non-pilot feasibility or Hybrid Type 1 trials | If support systems are satisfied with the amount of support and resources received as part of implementation strategies [46]. | |
Complexity Perception of difficulty of implementation/ number of components of the innovation [65] | If service providers or support systems perceive difficulty carrying out proposed future implementation strategies For example, due to duration, scope, intricacy and disruptiveness. | If support systems found the implementation strategies difficult to undertake. For example, due to duration, scope, intricacy and disruptiveness [65]. | |
Context Political, economic or social influences on implementation of the innovation [46] | If any organisational political, economic or social factors would influence the uptake of future implementation strategies. | If any organisational political, economic or social factors did influence the uptake of implementation strategies [46]. | |
Culture Organisational norms, values or basic assumptions influencing implementation of the innovation [65] | If setting or organisational values, norms and assumptions influence may influence the uptake of future implementation strategies. For example, work structures and behaviours. | If setting or organisational values, norms influenced the uptake of the implementation strategies For example, work structures and behaviours [65]. | |
Self-efficacy Self-belief in the ability to execute goals of the innovation [46] | If support systems staff believe in their capacity (e.g. knowledge and skills) to complete any future implementation strategies | If support systems staff agree they had the capacity (e.g. knowledge and skills) to undertake implementation strategies [46]. | |
Cost Measures of the cost or relative cost of implementation of the innovation [62] | Collection of data to help project cost of future implementation. | Cost to deliver the innovation [62]. | |
To assess feasibility of trial methods | Feasibility of future trial design to conduct a full trial [17] | If the organisation and/or support systems perceive proposed future implementation trial design components to be feasible For example, feasibility of proposed recruitment methods, acceptability of data collection procedures and tools etc. | If the pilot trial design and methods are feasible to replicate as part of a larger implementation trial. For example, the feasibility of recruitment methods, site and participant retention, implementation data collection procedures and tools etc. [17, 44] |