Nursing Intervention in the Patient Being Discharged From the Intensive Care Unit

NCT04527627 | Completed

• 1 other identifier: HCB/2016/0484
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder (PTSD), are common among critical disease survivors. Interventions aimed to decrease ICU impact on patient mental well-being are needed. Methods/Design: The study will evaluate an educational nursing intervention addressed to ease the transition during ICU discharge by empowering the patient. A quantitative design will be used to measure the effectiveness of the nursing intervention through an experimental pre-test/post-test with control group design. Participants will consist of patients from three critical care units from three different hospitals. Data will be obtained from Hospital Anxiety and Depression Scale (HADS). Data will be analysed through descriptive and inferential statistics. Discussion: This study will help to develop and implement an intervention to help patients lessen anxiety and depression associated to their transition from ICU to the general ward.

Conditions

Anxiety; Depression

Keywords

empowerment patient; patient education; icu discharge; nursing interventions; anxiety; depression; post-traumatic stress disorder; post icu syndrome

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Level of anxiety and depression assessed by Hospital Anxiety and Depression Scale.

  The outcome 1 will be mesured with the anxiety and depression scale (HADS) after ICU discharge. The HADS measures the current status during the last week. A value of 10 is the cut-off point between the presence or absence of anxiety and depression.

  1 week

Secondary Outcomes (9)

• Level of anxiety and depression at ICU discharge assessed by Hospital Anxiety and Depression Scale

  Up to 2 days

• Level of anxiety and depression at the general ward stay assessed by Hospital Anxiety and Depression Scale

  After 2 days

• Severity level at ICU admission assessed by Acute Physiology and Chronic Health Evaluation (APACHE) II

  Day 1

• Duration of ICU stay

  Up to 60 days

• Sex: male or female

  Day 1

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

The nursing empowerment intervention will be administered in the experimental group

Behavioral: Nursing Empowerment Intervention

Control Group (CG)

NO INTERVENTION

The nursing empowerment intervention will not be administered in the control group

Interventions

Nursing Empowerment Intervention BEHAVIORAL

Nursing empowerment intervention The intervention will be carried out during the ICU discharge planning. A "Patient Information Guide for Intensive Care Unit patients" will be developed. The guide will be based on the findings obtained in a previous qualitative study and on previous studies on patient empowerment and education. Its structure will take into account the dimensions of empowerment: bio-physiological, functional, social, experience, ethics and the financial aspect. The guide will be reviewed by experts in the development of information guides for patients and family members and will be evaluated by the participating ICUs before use. EG patients will receive the intervention verbally and in booklet format from the study nurses at each ICU.

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• ICU stay \> 48h
• Speaker of one of the two official languages of the region Catalan or Spanish and carrying out a personal interview
• Glasgow Coma Score of 15
• Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) negative
• Provision of signed informed consent

You may not qualify if:

• \- Pre ICU admission diagnosis of mental illness

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (3)

Hospital de Bellvitge

Barcelona, Hospitalet de Llobregat, Spain

Location

Hospital Clínic of Barcelona

Barcelona, 08036, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Related Publications (14)

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  PMID: 29864552 RESULT

• Thomas S, Mehrholz J. Health-related quality of life, participation, and physical and cognitive function of patients with intensive care unit-acquired muscle weakness 1 year after rehabilitation in Germany: the GymNAST cohort study. BMJ Open. 2018 Jul 13;8(7):e020163. doi: 10.1136/bmjopen-2017-020163.

  PMID: 30007926 RESULT

• de Grood C, Leigh JP, Bagshaw SM, Dodek PM, Fowler RA, Forster AJ, Boyd JM, Stelfox HT. Patient, family and provider experiences with transfers from intensive care unit to hospital ward: a multicentre qualitative study. CMAJ. 2018 Jun 4;190(22):E669-E676. doi: 10.1503/cmaj.170588.

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• Stelfox HT, Lane D, Boyd JM, Taylor S, Perrier L, Straus S, Zygun D, Zuege DJ. A scoping review of patient discharge from intensive care: opportunities and tools to improve care. Chest. 2015 Feb;147(2):317-327. doi: 10.1378/chest.13-2965.

  PMID: 25210942 RESULT

• Won MH, Son YJ. Development and psychometric evaluation of the Relocation Stress Syndrome Scale-Short Form for patients transferred from adult intensive care units to general wards. Intensive Crit Care Nurs. 2020 Jun;58:102800. doi: 10.1016/j.iccn.2020.102800. Epub 2020 Jan 18.

  PMID: 31964557 RESULT

• Nikayin S, Rabiee A, Hashem MD, Huang M, Bienvenu OJ, Turnbull AE, Needham DM. Anxiety symptoms in survivors of critical illness: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2016 Nov-Dec;43:23-29. doi: 10.1016/j.genhosppsych.2016.08.005. Epub 2016 Aug 28.

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• Hatch R, Young D, Barber V, Griffiths J, Harrison DA, Watkinson P. Anxiety, Depression and Post Traumatic Stress Disorder after critical illness: a UK-wide prospective cohort study. Crit Care. 2018 Nov 23;22(1):310. doi: 10.1186/s13054-018-2223-6.

  PMID: 30466485 RESULT

• Cuzco C, Castro P, Marin Perez R, Ruiz Garcia S, Nunez Delgado AI, Romero Garcia M, Martinez Momblan MA, Benito Aracil L, Carmona Delgado I, Canalias Reverter M, Nicolas JM, Martinez Estalella G, Delgado-Hito P. Impact of a Nurse-Driven Patient Empowerment Intervention on the Reduction in Patients' Anxiety and Depression During ICU Discharge: A Randomized Clinical Trial. Crit Care Med. 2022 Dec 1;50(12):1757-1767. doi: 10.1097/CCM.0000000000005676. Epub 2022 Sep 30.

  PMID: 36178294 DERIVED

• Cuzco C, Castro Rebollo P, Marin Perez R, Nunez Delgado AI, Romero Garcia M, Martinez Momblan MA, Estrada Reventos D, Martinez Estalella G, Delgado-Hito P. Mixed-method research protocol: Development and evaluation of a nursing intervention in patients discharged from the intensive care unit. Nurs Open. 2021 Nov;8(6):3666-3676. doi: 10.1002/nop2.894. Epub 2021 May 6.

  PMID: 33955196 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Patient Participation; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Cecilia Cuzco, RN

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

• Pedro Castro, MD

  Hospital Clínic of Barcelona

  STUDY DIRECTOR

• Pilar Delgado-Hito, RN

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 26, 2020
• Study Start: September 1, 2019
• Primary Completion: February 20, 2021
• Study Completion: August 31, 2021
• Last Updated: October 14, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)