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Table 1 Summary of multilevel planning and intervention using the Consolidated Framework for Implementation Research (CFIR)

From: Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting

CFIR domain

CFIR constructs

Main constraints/barriers/challenges [facilitators]

Solutions

Implementation strategiesa

Intervention characteristics

Relative advantage

[Compliance with HBRA without incurring additional cost]

Convey human and financial benefits of intervention to leadership and stakeholders

Develop stakeholder relationships; involve executive boards

Complexity

Involvement of multiple stakeholders

Collaborate closely and gain their support

Develop stakeholder relationships; identify and prepare champions

Trialability

Busy outpatient clinic; integration with clinic workflow to ensure smooth operations and patient safety

Understand clinic workflow; conduct pilot to test and refine

Conduct cyclical small tests of change; tailor strategies

Adaptability

Different workflow and clinic cultures in both sites

Adjust implementation process to fit the different clinic environments

Promote adaptability; tailor strategies; conduct cyclical small tests of change

Outer setting

External policies and incentives

HBRA regulations caused an increase in resources required to support research

Align resources by integrating clinical and research efforts to recruit patients for clinical research

(This is the motivation for the intervention)

Inner setting

Structural characteristics

Minimal overlap in operations and manpower between research activities and clinical services

Design the intervention to allow optimization of resources

-

Culture

Research is secondary to clinical service

Change management

Identify and prepare champions; train and educate stakeholders

Implementation climate

Potential conflict with institution and clinic priorities

Convey human and financial benefits of intervention to leadership and stakeholders

Develop stakeholder relationships; involve executive boards

Readiness for implementation

Potential negative impact due to structural characteristics, culture, and implementation climate

Address barriers from structural characteristics, culture, and implementation climate

Identify and prepare champions; train and educate stakeholders; develop stakeholder relationships

Characteristics of individuals

Knowledge and beliefs about the intervention

Inadequate knowledge of research and its importance amongst clinic operations staff

Staff training

Develop educational materials; make training dynamic; conduct ongoing training; provide assistance

Self-efficacy

Need to assure clinic operations staff of their abilities to carry out the intervention

Role play during training sessions to build up confidence; CRCs to work alongside clinic operations staff to emphasize dynamic work-sharing

Conduct ongoing training; make training dynamic; provide assistance; model and simulate change

Process

Planning

Novel and complex nature of the intervention, and the importance of seamless integration with clinic processes

Careful planning before implementation together with stakeholders involved and institution leadership

Develop stakeholder relationships; involve executive boards

Engaging

Need for appropriate personnel to lead, manage, and champion the intervention

Appoint committee with two co-leaders to govern and lead the implementation; engage CRCs and senior clinic operations staff to champion the intervention

Develop stakeholder relationships; involve executive boards; identify and prepare champions; obtain formal commitments

Executing

Feasibility of pre-consultation intervention and dynamic collaboration between clinic operations staff and CRC

Conduct pilot in two stages to examine the feasibility of pre-consultation intervention and dynamic collaboration separately

Assess for readiness and identify barriers and facilitators; conduct cyclical small tests of change; purposefully examine the implementation

Reflecting and evaluating

Morale of staff and long-term sustainability

Positive publicity and talks; gather feedback and make appropriate adjustments to workflow

Model and simulate change; capture and share local knowledge; obtain and use feedback

  1. aImplementation strategies mapped to the Expert Recommendations for Implementing Change (ERIC) [19]