Clinical trial NCT06569901: Strengthening Hope After ICU Discharge
Official title: To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Care
Keywords: Critical Care
Critical Illness
Critical Care Outcomes
Post-ICU
Hope
Intervention study
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
name: Diakonhjemmet Hospital
First posted: 2024-08-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After recruitment of 25 participants, they will be randomized into five clusters. One cluster at a time, will cross over to the intervention group. This recruitment period will be repeated three times to include a total of 75 participants. Prior the intervention, participants will receive "care as usual" and serve as controls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (ICU) patients in the rehabilitation phase. The main questions it aims to answer are:

To develop and implement a follow-up service to strengthen hope in ICU patients, and to evaluate the effect on hope in a stepped wedge randomized trial.

To identify possible predictive factors (facilitators and barriers) associated with hope.

Participants will be asked to take part in an ICU follow-up service, a "Hope Intervention" consisting of digital individual- and group conversations. The program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future.

We will compare the level of hope between participants who have completed the "Hope Intervention" to those that have not yet completed the program.

Detailed description: The ICU patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the ICU.

Having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. Hope is scarcely described in ICU patients.

Health care professionals need to learn how to best support ICU patients and promote hope during the rehabilitation period. Therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former ICU patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (SW-CRT). The secondary aim is to identify possible predictive factors associated with hope.

The intervention will start after hospital discharge and will be carried out in group sessions.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years
* ICU patient for \> 48 hours
* must be able to communicate verbally just after their ICU stay and be able to handle digital meetings

Exclusion Criteria:

* Patients with severe cognitive impairment
* Do not understand and speak Norwegian
* Patients with major psychiatric challenges, suicidal attempts as a reason for ICU stay
* Age over 85 years.

Primary outcomes:
measure: Hope
timeFrame: Baseline and 1,2,3,4 and 5 months after baseline
Secondary outcomes:
measure: Social Provsion Scale
timeFrame: Baseline and 1,2,3,4 and 5 months after baseline
measure: Charlson comorbidity Index
timeFrame: Within 2 months after inclucion
measure: Memorial Symptom Assessment Scale
timeFrame: Baseline and 1,2,3,4 and 5 months after baseline
measure: General Perceived Self-Efficacy Scale
timeFrame: Baseline and 1,2,3,4 and 5 months after baseline
measure: Cognitive Failure Questionnaire
timeFrame: Baseline and 1,2,3,4 and 5 months after baseline
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken HF, Bærum Hospital
state: Akershus
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustøen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
citation: Dufault K, Martocchio BC. Symposium on compassionate care and the dying experience. Hope: its spheres and dimensions. Nurs Clin North Am. 1985 Jun;20(2):379-91.