Strengthening Hope After ICU Discharge

To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Care
• Intervention / Treatment: Behavioral: Hope Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin W Sunde, Msc; Phone Number: +4792095804; Email: krflat@ous-hf.no
• Study Contact Backup: Name: Hanne Birgit Alfheim, PhD; Phone Number: +4767509017; Email: halfheim@vestreviken.no

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital
    • Contact: Kristin W Sunde, MSc; Email: krflat@ous-hf.no
  • Oslo, Norway
    • Diakonhjemmet Hospital
    • Contact: Annikken Hansson; Phone Number: +4722451500; Email: annikken.hansson@diakonsyk.no
    • Contact: Julie Berntsen, MSc; Phone Number: +4722451500; Email: juliejohanne.berntsen@diakonsyk.no
  • Akershus
    • Drammen, Akershus, Norway
      • Vestre Viken HF, Bærum Hospital
      • Contact: Hanne Birigit Alfheim, PhD; Email: halfheim@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cluster A; Cluster A will participate in the Hope Intervention shortly after randomization. Prior the intervention the participants will serve as controls.	Behavioral: Hope Intervention; Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.
Experimental: Cluster B; Cluster B will participate in the Hope Intervention when Cluster A ends, approximately four weeks after randomization. Prior the intervention the participants will serve as controls.	Behavioral: Hope Intervention; Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.
Experimental: Cluster C; Cluster C will participate in the Hope Intervention when Cluster B ends, approximately eight weeks after randomization. Prior the intervention the participants will serve as controls.	Behavioral: Hope Intervention; Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.
Experimental: Cluster D; Cluster D will participate in the Hope Intervention when Cluster C ends, approximately 12 weeks after randomization. Prior the intervention the participants will serve as controls.	Behavioral: Hope Intervention; Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.
Experimental: Cluster E; Cluster E will participate in the Hope Intervention when Cluster D ends, approximately 16 weeks after randomization. Prior the intervention the participants will serve as controls.	Behavioral: Hope Intervention; Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hope	Level of hope will be measured by Herth Hope Index (HHI). Baseline is measured after the patient has been discharged from the hospital. The HHI consists of 12 items measuring levels of hope related to cognitive and affective factors. Item scores range from 1 (strongly disagree) to 4 (strongly agree) and the total score ranges from 12 to 48. A high score indicates higher level of hope.	Baseline and 1,2,3,4 and 5 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Provsion Scale	Level of social support will be measured by Social Provision Scale (SPS). Baseline is measured after hospital discharge. The SPS consists of 16 assertions about social support that may apply to the individual. Item scores options are; strongly disagree, disagree, agree, and strongly agree. The total score ranges from 16-64, and a high score indicates a high level of social support.	Baseline and 1,2,3,4 and 5 months after baseline
Charlson comorbidity Index	Data on comorbidity will be measured with Charlson comorbidity Index (CCI) , collected from the medical record. The CCI categorize the patients' comorbidities and each comorbidity has an associated weight (from 1 to 6). The total scor ranges from 0-37, and the higher the score, the more likely the predicted outcome will result in mortality.	Within 2 months after inclucion
Memorial Symptom Assessment Scale	Level of symptoms is measured by Memorial Symptom Assessment Scale (MSAS). MSAS consist of 28 predefined symptomes, were 0 indicated not having the symptom and 1 indicates having the symptom. Maximum number of predefined symptoms is 28, and indicates a worse outcome. If the respondent answers "yes" on a symptom, they are asked at what time the symptom occured, and to rate the severity and distress of the symptom using a numeric rating scale from 0 to 10. Zero indicating "not at all" and 10 "very much". A higher score indicates a worse outcome. Baseline is measured after hospital discharge.	Baseline and 1,2,3,4 and 5 months after baseline
General Perceived Self-Efficacy Scale	Level of a general sense of perceived self-efficacy is measured by General Perceived Self-Efficacy Scale (GSE).The short-form scale consists of items, and each item scores on a 4-point scale from 1 (not at all true) to 4 (exactly true). Total score ranges from 5-20, where high scores reflect courage and perseverance and coping both with daily hassles and stressful life events Baseline is measured after hospital discharge.	Baseline and 1,2,3,4 and 5 months after baseline
Cognitive Failure Questionnaire	Level of cognitive function is measured by the Cognitive Failure Questionnaire (CFQ). The questionnaire has five responses from "never" (0) to "very often" (4). A lower score indicates better cognition. Baseline is measured after hospital discharge.	Baseline and 1,2,3,4 and 5 months after baseline

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; Diakonhjemmet Hospital
• Investigators: Principal Investigator: Tone Rustøen, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
• 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.
• Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
• 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.
• Schneeweiss S, Wang PS, Avorn J, Glynn RJ. Improved comorbidity adjustment for predicting mortality in Medicare populations. Health Serv Res. 2003 Aug;38(4):1103-20. doi: 10.1111/1475-6773.00165.
• Russell D, Cutrona CE, Rose J, Yurko K. Social and emotional loneliness: an examination of Weiss's typology of loneliness. J Pers Soc Psychol. 1984 Jun;46(6):1313-21. doi: 10.1037//0022-3514.46.6.1313.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Critical Illness; Critical Care; Hope; Intervention study; Critical Care Outcomes; Post-ICU
• Other Study ID Numbers: 542348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No