The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study

Anne Højager Nielsen, Sanne Angel, Ingrid Egerod, Torben Bæk Hansen, Anne Højager Nielsen, Sanne Angel, Ingrid Egerod, Torben Bæk Hansen

Abstract

Background: Critically ill patients and their relatives have complex needs for support during their stay in the intensive care unit (ICU) and the post-ICU rehabilitation period. Diaries written by nurses have proven beneficial for patients and relatives, preventing post-traumatic stress, anxiety and depression and helping patients and families find meaning. Actively involving relatives in writing a diary for critically ill patients is a new approach to helping relatives and patients cope; however, research is limited.The aim of this study is to test the hypothesis that a diary written by a close relative of a critically ill patient will reduce the risk of developing symptoms of post-traumatic stress disorder (PTSD) in the patient and relatives at 3 months post-ICU. Furthermore, the aim is to explore the perceptions and use of the diary and describe the diary content and structure.

Method: The intervention consists of a hard-cover notebook that will be given to a close relative to write a diary for the critically ill patient while in the ICU. Guidance will be offered by ICU nurses on how to author the diary. The effect of the intervention will be tested in a two-arm, single-blind, randomized controlled trial, which aims to include 100 patient/relative pairs in each group. The primary outcome studied is symptoms of post-traumatic stress (PTSS-14). Secondary outcomes are scores on anxiety and depression (HADS) and the Medical Outcomes Study Questionnaire Short Form 36 (SF-36). The narrative structure and content of the diary as well as its use will be explored in two qualitative studies.

Discussion: The results of this study will inform ICU nurses about the effects, strengths and limitations of prompting relatives to author a diary for the patient. This will allow the diary intervention to be tailored to the individual needs of patients and relatives.

Trial registration: NCT02357680. Registered September 3, 2015.

Keywords: Anxiety; Depression; Intensive care; Intensive care diaries; Mixed methods; Phenomenology; Post-traumatic stress; Randomized controlled trial.

Conflict of interest statement

Written informed consent will be obtained by the investigator or a smaller group of study nurses, who will receive special training. Relatives and patients will be informed about possible harm, such as experiencing psychological discomfort and re-experiencing the ICU stay when writing and reading the diary, as well as the potential benefits of the diary, such as an improved understanding of the critical time in the ICU before they give consent to participate in the study. If the patient does not consent to participation or dies before consent is obtained, the relative continues in the study. In any case the diary reflects the relatives’ personal record of the ICU experience, which is not part of the hospital records. This procedure has been approved of by the Health Research Committee of Region Central Jutland (identifier 1–10–72-371-14). The information for participants will follow Danish law and has been approved and regulated by the Health Research Ethics Committee of Region Central Jutland. All data referring to participants will be anonymized to protect confidentiality before publication. The study has been approved by the Danish Data Protection Agency (identifier 1–16–02-30-15), and all data will be stored accordingly.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT flow diagram

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