Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial

Riordan, Fiona; Racine, Emmy; Smith, Susan M.; Murphy, Aileen; Browne, John; Kearney, Patricia M.; Bradley, Colin; James, Mark; Murphy, Mark; McHugh, Sheena M.

doi:10.1186/s40814-020-00608-y

Pilot and Feasibility Studies

Table 4 Data collection conducted as part of the process evaluation

From: Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial

Data items	Timing	Outcome(s)
Data items	Timing	Appropriateness^b	Acceptability^b	Reach^b	Feasibility^b	Fidelity^b	Costs^a
Source: Audit data Level: Patient Content:				✓		✓
• Number of patients eligible to receive the intervention	Baseline
• Number of phone reminders; record on the audit file that (a) patient phoned (and date), (b) spoke to the patient and (c) delivered the scripted message.	On-going
• Number of letter reminders	On-going
• Number of in person reminders; review patient files and record whether the electronic alert has been deleted. Deleting the electronic alert will be taken to indicate that the intervention was delivered (self-report).	At 6 months
Source: Research processes Level: Practice Content:					✓	✓	✓
Recruitment • Recruitment and retention rates, which will be used to inform the sample size calculation for the definitive trial • The time taken to recruit practices, collect data and install the intervention (i.e., training and audit set up) to inform the planning of a larger definitive trial	At recruitment Baseline				✓
Feedback • Any complaints or feedback about the intervention or research process during the trial	During delivery				✓
Briefing • Number and type of staff who attend (i.e., practice nurse, GP, administrator); • Time taken to deliver briefing/training; • Participants who attend will be asked for suggestions on how to improve the briefing; • Usual care at the practice, that is, whether they already remind patients, and how this is done at the practice.	During delivery		✓		✓	✓	✓
Researcher phone calls • Staff member assigned to delivery of different intervention components • Why they were assigned to this role • Changes to role assignment and reason for change • Changes to intervention protocol • Any additional resources used to deliver the intervention; for example, additional appointments resulting from the phone call or letter, further phone calls as a follow-up to the original reminder (e.g., ringing the patient back to confirm some detail) • Number of patients who contacted practice for information or came to the practice looking for help with the consent form. • Estimate of the time commitment to the study including time taken to participate in audit and feedback (including verification with programme), incorporate face to face reminders into consultations and to deliver reminder phone calls and issue letters.	Monthly, and reviewed at 6 months				✓	✓	✓
Method: Staff questionnaires Level: Practice Content: • Acceptability of Intervention Measure (AIM) • Intervention Appropriateness Measure (IAM) • Feasibility of Intervention Measure (FIM)	At 6 months	✓	✓		✓
Method: Staff interviews Level: Practice	At 6 months		✓		✓	✓
Method: Patient interviews or focus groups Level: Patient	At 6 months		✓			✓

^aData collected on resource use, after which monetary values will be assigned to give cost estimates as part of the economic evaluation
^bAccording to Proctor et al., appropriateness is the ‘perceived fit, relevance or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer and/or perceived fit of the innovation to address a particular issue or problem’; Acceptability is the ‘perception among implementation stakeholders that a given treatment, service, practice or innovation is agreeable, palatable or satisfactory’; Reach (penetration) is defined as the ‘integration of a practice within a service setting and its subsystems’; Feasibility is defined as the ‘extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting’ [58]

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ISSN: 2055-5784

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