Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06048783
• Other study ID #: 220111005
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: Pontificia Universidad Catolica de Chile
• Contact: Leyla Alegria, MSc
• Phone: +56223549024
• Email: lmalegri[@]uc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Studies in hospitalized patients have shown that a large percentage of them consider religion or spirituality to be an important factor in enabling them to cope with a serious illness. Studies conducted in the ICU, have shown that spiritual care from a chaplain/priest is associated with increased satisfaction in family members of critically ill patients, however, the focus has traditionally been on offering support to family members and not to patients. Interventions for critically ill patients have mostly been implemented by chaplains or a member of the health care team, primarily nurses. Although these studies show promising results in terms of quality of life, they mostly reflect the perspective of the health teams and not that of the patients, they are not evaluated with standardized instruments and, in general, they are not standardized strategies.

Given that this will be one of the first studies with patients who received care in the ICU, it is proposed to conduct a pilot and feasibility study to gather lessons to implement a larger study. Studies of this type place greater emphasis on evaluating the feasibility of implementing the intervention and therefore this study will seek to: (1) evaluate the feasibility of implementing the intervention in a hospital setting, including participant recruitment procedures; (2) evaluate how the intervention, format and manner of implementation is received by participants; (3) preliminarily evaluate the impact on psychological symptomatology associated with PICS at the end of the intervention, at 3 and 6 months post-intervention.

Showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, may contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. Although the technological and advanced life support offered by the ICU is essential for critical patients, but survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.

Description:

Many patients who survive a critical illness suffer physical, psychological and cognitive problems, negatively impacting their quality of life, which has been termed Post-ICU Syndrome (PICS). Some studies have reported a residual effect several months after discharge from the ICU, affecting people's quality of life and functionality. Among the psychological symptoms of PICS are described symptoms of depression, anxiety and post-traumatic stress disorder (PTSD). It is estimated that at least 50% of ICU survivors will present psychological symptoms of PICS at discharge and other studies report that a quarter of survivors present PTSD symptoms one year after discharge from the ICU.

Spirituality should be an essential element of health care, as it is part of the essence of being human. International accreditation associations and scientific societies suggest incorporating spiritual care into the usual standards of care. Studies of hospitalized patients have shown that a large percentage of patients consider religion or spirituality to be an important factor in enabling them to cope with serious illness. And although previous studies have shown that chaplain/priest care is associated with increased satisfaction in family members of critically ill patients, the focus has traditionally been on offering support to family members and not to patients. However, there is a growing recognition of the need for a comprehensive approach in health care to provide spiritual support to ICU patients that is evaluated and contributes to improving the quality of life of these individuals. On the other hand, showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, can contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. The technological and advanced life support offered by the ICU is essential for critically ill patients, but the survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.

The proposed design aims to evaluate the feasibility of implementing a spiritual accompaniment intervention for patients who received care in the ICU, and to begin to implement it during hospitalization. This will provide information regarding the feasibility of implementing an intervention of this type in this context, offering it during hospitalization and its remote implementation process, once the patient is discharged. Considering that these studies work with small samples, it is not necessary to estimate the sample calculation. However, in order to obtain some preliminary results of the effect of the intervention, a sample of 15 people per group will be recruited and followed up until 6 months after discharge, which will allow us to evaluate changes over time in PICS symptoms. It is proposed that the intervention will begin during hospitalization, so that it will have a preventive nature and help mitigate the impact of ICU hospitalization on the development of mental health symptoms in patients. Participants will be randomly assigned to groups and will be evaluated considering intention to treat. On the other hand, gathering the perspective of volunteers, patients and research support team will provide us with inputs to improve the intervention and the best way to implement it.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient who has had at least 72 hours of Invasive Mechanical Ventilation

• Patient currently in ICU

• Glasgow 15 at the moment of the screening

Exclusion Criteria:

• Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening.

• Patients with primary neurological or neurosurgical disease.

• Presence of mental or intellectual disability prior to hospitalization or communication/language barriers.

• Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer).

• Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization).

• No fixed address for follow-up.

• Patients with moderate to severe visual or hearing impairment.

• Early limitation of therapeutic effort.

Related Conditions & MeSH terms

• Critical Illness
• Mental Disorders
• Psychological Disorder

Intervention

Behavioral:
• Program of systematic and periodic spiritual accompaniment and care
Systematic and periodic spiritual accompaniment and care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enrollment	Proportion of eligible patients that are consented and enrolled in the trial	From recruitment to enrollment (i.e. up to 120 days)
Primary	Attendance Rate	Proportion of participants who attend all three intervention sessions	2 weeks
Primary	Follow-up rate	Proportion of patients who attend all follow-up assessment	3 and 6 months post ICU discharge
Primary	Intervention Satisfaction Survey	Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.	1-2 weeks and 3 months after the last session
Secondary	Intervention Satisfaction Survey	Volunteer satisfaction with the spiritual care and accompaniment intervention will be assessed by a satisfaction survey.	1-2 weeks after the last session
Secondary	Post traumatic syndrome assessed by the Revised impact event scale (IES-R)	The post traumatic syndrome will be evaluated thanks to the chilean version of the Revised impact event scale (IES-R) giving a score going from 0 to 88. This scale has a score from 0 to 88, defining a post-traumatic stress disorder with a score higher than 43.	3 and 6 months post ICU discharge
Secondary	Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.	3 and 6 months post ICU discharge
Secondary	Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered	At the end of the study, three focus group will be held with the participants, volunteers and the research team. In the focus group, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Thematic analysis method will be used in the evaluation of the data.	2-3 weeks after the last session