Table 5 Feasibility challenges, solutions and recommendations
Challenges | Solutions and recommendations | |
|---|---|---|
Feasibility | ||
Recruitment rate | - Recruitment was protracted. The reasons were: - Insufficient dedicated research personnel coupled with competing full-time workloads - Structured screening process prevented identification of all eligible patients - Exclusion criteria too restrictive | Solutions: - Employment of an RA - Community nursing referral screening tool was developed - Transportation was provided for some participants to clinics - Amendments to some exclusion criteria - Some participants were treated in their homes |
Retention | - Participant burden was increased for some frail participants - There was limited availability of transportation to clinics | Recommendations: - Employment of a dedicated trial manager - A comprehensive screening process to identify potential participants at the beginning of the study - Establish centralised intake system to identify potential patients at first CN contact - In-depth review of nursing resources including skill mix prior to commencement of study - Include home visits for treatments in a larger study |
Resources | - Insufficient human resources to conduct the research within the timeframe - Poor continuity of nursing services especially for home visits - Some patients could not attend clinics - Re-calibration of photo digital planimetry software required for wound measurement accuracy | Solutions: - Further institution support was acquired during study - Support from experienced clinical nurses to administer intervention and collect data - The application of the intervention was able to be accommodated within existing clinic schedules - Information technology support was acquired Recommendations: - Review treatment location options - Collaboration with health service management regarding staff backfill to promote continuity - Study-specific investigators and support staff - Usual care wound products for multisite larger study as per health service formulary; negotiate for in-kind supply of wound products for a multisite RCT - Use dedicated study equipment |
Management | - Oversight of the study was difficult for CI and RA due to competing full-time workload - Participant burden was high - Prolonged consent, randomisation and baseline data collection processes - Poor quality photos of some wounds - Existing resources made available by health service for wound size measurements were insufficient - Research data were collected parallel to health service data resulting in some duplication and extended nurse time - Data collected by clinicians untrained in study processes resulted in higher rates of missing data | Solutions: - Ensured computer software for data entry and analysis available and appropriate - Ensured technology to acquire, store and measure wound photography appropriate - Separated recruitment processes from baseline data collection - Established secure data storage - There was easy access to information technology support - Wound size measurements by wound specialist nurse Recommendations: - Trial-specific investigators, data collectors and administrative team with no competing interests - Shorten recruitment processes - Revise and reduce the size and number of data collection tools and data collection time points |
Scientific | - Change to intervention protocol required for some participants due to negative clinical response | Solutions: - Intervention ceased, changed to usual care Recommendations: - Investigate potential use of placebo |