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Table 4 Implementation outcomes

From: The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

Outcome variable(s)

Measure(s) and data collection procedures

Data source and reporter (when applicable)

Acceptability from patient’s perspective

Acceptability—reflecting the end users’ satisfaction with the intervention—will be assessed using the 4-item Acceptability of Intervention Measure (AIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater acceptability [90].

Paper survey (pat.)

Appropriateness from patient’s perspective

The intervention’s appropriateness, i.e., its perceived suitability to address problems within its target setting, will be assessed via the 4-item Intervention Appropriateness Measure (IAM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater appropriateness [90].

Paper survey (pat.)

Feasibility from patient’s perspective

The intervention’s perceived suitability for everyday use – will be assessed with the Feasibility of Intervention Measure (FIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater feasibility [90].

Paper survey (pat.)

Technology acceptability

The ratio of the number of data entry days to the number of technological problems, will be a measured using data gathered via the SMILeApp.

SMILe monitoring data base (SMILe Care)

Acceptability from CC’s perspective

Acceptability—reflecting the end users’ satisfaction with the intervention—will be assessed using the 4-item Acceptability of Intervention Measure (AIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater acceptability [90].

Paper survey (CC)

Appropriateness from CC’s perspective

The intervention’s appropriateness, i.e., its perceived suitability to address problems within its target setting, will be assessed via the 4-item Intervention Appropriateness Measure (IAM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater appropriateness [90].

Paper survey (CC)

Feasibility from CC’s perspective

The intervention’s perceived suitability for everyday use will be assessed with the Feasibility of Intervention Measure (FIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater feasibility [90].

Paper survey (CC)

Intervention fidelity

The gold standard measure of intervention delivery (observations/evaluations using prespecified criteria) [95] will be used: Intervention participants’ attendance as planned to face-to-face visits T0 – T8 (fully, partly or not at all) will be noted by the CC. Any deviation from the intervention protocol will be recorded in view of number, length, frequency of contacts, and delivered content.

CRF (RA)

Implementation pathway

To explore potential implementation process barriers and facilitators as well as problems experienced in its delivery, we will conduct focus group interviews with the alloSCT team including 10–15 health care professionals (i.e., haematologists, nurses, psycho-oncologists, management), who are involved in the in-patient and follow-up care, plus 10 individual intervention patient interviews.

Individual interviews (pat.)

Focus group interviews (health care professionals)

  1. Abbreviations. CC Care Coordinator, pat patient; RA Research Assistant