Plans for assessment and collection of outcomes {18a}
diabetes, cognitive impairment, death, erythema, malnutrition
CARDIOVASCULAR DISEASE, ERYTHEMA, RECRUITMENT, ADVERSE EFFECTS, PRESSURE INJURY, NUTRITIONAL DEFICIENCIES, MALNUTRITION
After screening, consent, and randomisation, data are collected directly from the participant or their proxy, and their health record at baseline and then daily for up to 14 days until the trial endpoint (i.e. development of a new sacral HAPI, discharge, or death—whichever occurs first). Participants who develop a HAPI in either arm exit the prevention trial and are followed up for up to 14 days (until discharge or death—whichever comes first) for a total of up to 28 days, to provide data on PI treatment to support the economic evaluation.Each recruited participant’s hospital information (date of birth, unique record number) is recorded in an eCRF available only to investigator RMW, the CTC, and site ResNs to ensure participant confidentiality. Participants’ demographic and health data including gender, diagnosis or surgery, reason for admission, mobility status, body mass index, nutritional deficiencies, the type of and number of comorbidities (such as cardiovascular disease, diabetes, cognitive impairment, and malnutrition on admission), current smoking status, PI risk, existing PI (other than sacral) and its treatment/management, previous history of PI, number of days enrolled in the trial, and HLOS (documented at discharge for all participants) is recorded in a separate eCRF (electronic clinical research form). A photograph is taken of the patient's sacral skin and sent to the blinded outcome assessor to confirm its diagnosis. A trained CTC monitors recruitment and data collection across all sites and monthly reports are presented to the chief and associate investigators.As part of the process evaluation, where a patient is unable to provide information for self-report data (e.g. Patient Participation in Pressure Injury Prevention Scale, assessment of satisfaction and comfort), the ResN documents the reason [Data on resource utilisation associated with prevention are collected including the number of dressings used; personnel time to apply, remove, and change dressings; and any treatment required for any local adverse effects from the dressings. To enable an extended cost-benefit analysis, resources used to treat sacral HAPI are also recorded for those patients that develop a sacral PI during the trial. HLOS is recorded for all trial participants on discharge from hospital.Digital photography is a novel and practical solution to address blinding. Using study-specific and password-protected iPads, research nurses at each site take high-resolution, de-identified digital photographs of every participant’s sacrum at baseline and each subsequent day they are enrolled in the trial. Photographs are edited using Adobe photo editing software to “blur” surrounding skin to conceal atraumatic skin markings for participants in the intervention group or other markings that may indicate the participant is in the control group (e.g. clothing or bedsheets). Except for the baseline photograph, all modified photos are uploaded into a secure data collection platform and forwarded to a blinded outcome assessor on the same day they are taken. Where a stage 1 (i.e. non-balanceable erythema) is suspected, the patient is be repositioned where possible, the site reassessed after 30 min, and the photograph taken (35). For each photograph, the ResN notifies the blinded outcome assessor as to whether the skin is blanching or non-blanching. The patient exits the clinical study if it is determined they have developed a sacral HAPI which is reported to clinical staff. If the clinical staff caring for the patient diagnose a stage 1 HAPI (even if the blinded assessor did not), the patient is still exited from the study. However, this decision is not disclosed to and therefore does not influence the assessment of the blinded outcome assessor. If the patient has a sacral HAPI, they are included in the estimation of PI treatment costs.