Efficacy of the Intensive Care Unit Diary: A Mixed-Method Study Protocol

Abstract Background: Multiple international studies report on the use of diaries in intensive care units. Some highlight the benefits for patients, others focus on family members, and few consider the vision of professionals. Most use quantitative methods. Limitations such as small sample sizes and short follow-up periods affect many studies. Therefore, further research with larger samples and a longer follow-up period, employing a mixed-methods approach is suggested. This protocol was designed to evaluate the efficacy of the use of intensive care unit diaries for patients and families, as well as to understand professionals’ experiences and satisfaction with intensive care unit diaries. Method/Design: Mixed-method study: a quantitative phase followed by a qualitative phase. Phase 1: Randomised, parallel, non-blinded, multicentre clinical trial, with an experimental group (diary) and a control group (no diary), to identify the efficacy of the diary in improving quality of life and preventing post-traumatic stress and anxiety/depression in patients and family. Measurement tools include the SF-36 Health Questionnaire, EIE-R scale, and HADS scale, administered 2-, 6- and 12-months post-discharge. Each group comprises 120 cases. Data analysis will use IBM-SPSS (v.24) To evaluate the satisfaction of professionals a survey will be carried out. Phase 2: Hermeneutic phenomenological study with theoretical sampling. Size of 38-72 patients/family members until theoretical data saturation is reached. Data collection from in-depth interviews and field diary 6 months after discharge. Phenomenological analysis according to Smith. Guba and Lincoln’s rigour criteria. Discussion: This research will provide knowledge regarding the benefits and limitations of the use of diaries, based on quantitative and qualitative data, and will promote reflection on their implementation, considering patients, family, and professionals. This study will provide new knowledge about the satisfaction of professionals with diary implementation. This multicentre study will provide valuable information on the contribution of diaries in clinical practice and their impact on patient recovery and the experiences of families and professionals. If the efficacy of the diary is confirmed, it will mark a significant advancement in the care of critically ill patients, contributing to the expansion of their use. Trial registration: ClinicalTrials.gov Identifier: NCT05288140. First Published: March 21, 2022.