Table 3 FRAME constructs and additions/clarifications for this study

Process

When did the modification occur?

• Pre-implementation/planning

• Implementation

• Scale-up

• Maintenance/sustainment

• As our data were primarily from the implementation phase, we did not see data categorized as pre-implementation, scale-up, or maintenance

• Split pre-implementation and implementation into “When did it occur” and “For how long did it occur” to distinguish permanence of adaptation

Were adaptations planned?

• Planned/proactive (proactive adaptation)

• Planned/reactive (reactive adaptation)

• No modifications

Who participated in the decision to modify?

• Political leaders

• Program leaders

• Funders

• Administrator

• Program manager

• Intervention developer/purveyor

• Researcher

• Treatment/intervention team

• Individual practitioner

• Community members

• Recipients

• Changed to reflect relevant roles (researchers, patients, study-involved staff at practice, non-study-involved staff at practice, both researchers and practice staff, other)

What was modified?

• Content

• Contextual

• Training and evaluation

• Implementation and scale-up activities

• Expanded to reflect study changes (program content, who is involved, recruitment, time devoted, follow-up or tracking, scheduling, reimbursement, resources, other)

At what level of delivery (for whom/what is the modification made?)

• Individual

• Target intervention group

• Cohort of individuals

• Individual practitioner

• Clinic/unit level

• Organization

• Network system/community

• Modified slightly to reflect relevant players (individual- patient, individual- practice member, practice, study-initiated for intervention arm, study-initiated for entire project)

Contextual modifications are made to which of the following?

• Format

• Setting

• Personnel

• Population

• Added N/A option

What is the nature of the context modification?

• 15 selection choices including tailoring, packaging, loosening structure, and “drift”

• Answer choices did not fit well with our study, so we did not categorize, opting to capture as part of the open-ended “What was adapted”

Relationship fidelity/core elements?

• Fidelity consistent

• Fidelity inconsistent

• As we were comparing two study arms, further expanded “Fidelity inconsistent” to outside protocol (condition specific) for when one study arm was altered to look more similar to the other study arm

• Added “Became within protocol” for situations where data reflected an outside of protocol change that was brought back within protocol

Reasons

What was the goal?

• Increase reach or engagement

• Increase retention

• Improve feasibility

• Improve fit with recipient

• Address cultural factors

• Improve effectiveness/outcomes

• Reduce cost

• Increase satisfaction

• “Address cultural factors” was merged with “Improve fit with recipient” due to similarities and low number of cultural changes

• Added “Outside factors/just happened” and “Other or N/A”

Reasons (sociopolitical, organization/setting, provider, recipient)

• Sociopolitical

• Organization/setting

• Provider

• Recipient

• Not categorized, captured as part of open-ended “Why was it adapted” with free text

Not in FRAME

What we added (not in FRAME)

• N/A

• Free text around implications for time, cost, expertise, etc. (i.e., the impact of the adaptation)

• Free text around what made the change go well or not go well