Condition category
Not Applicable
Date applied
27/06/2011
Date assigned
06/07/2011
Last edited
19/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intensive care medicine often enables the survival of older critically ill patients. However, relatively little is known about the long-term outcomes following treatment in the intensive care unit (ICU). Survival alone is not the only important outcome following an ICU stay. Stress experienced in the ICU and the severity of illness or injury can have long-term consequences. Over the long term, discomfort experienced in the ICU and stressful memories of an ICU stay can lead to anxiety, depression, and impaired quality of life. Until now, few studies have examined the long-term outcomes after ICU admission in older critically ill patients. Pain, anxiety and agitation are important stress factors for many critically ill patients and can have consequences for quality of life, but they have rarely been studied in older critically ill patients in the ICU. This study examines the relationship between the ICU stay and pain, anxiety and agitation in older critically ill patients, and addresses whether experiences in the ICU can cause more serious chronic conditions after discharge from the hospital.

Who can participate?
Critically ill patients aged 65 and over who have had an ICU stay of at least 48 hours, and a sample of people aged 65 and over who have not been admitted to an ICU for the last 15 years.

What does the study involve?
Patients are followed up one year after their discharge from the hospital. Their pain experiences, levels of anxiety and agitation, quality of life, and use of the health care system are assessed in order to detect relationships between these outcomes and their ICU experiences. Data is collected at the following intervals: during their ICU stay, and 1 week, 6 and 12 months after hospital discharge. Similar data is also collected from a sample of older people who have not been admitted to an ICU for the last 15 years.

What are the possible benefits and risks of participating?
No risks to the participants are anticipated. During the interview, the participants are confronted with memories and experiences of the ICU, which may be upsetting. If this is the case, the interview is stopped. The participants are offered professional support, for example medical and/or psychological care, information, etc. It is also possible that remembering unpleasant experiences can be an important step towards coming to terms with their stay on the ICU. Therefore, the interviews are geared to the needs and abilities of the participants, who are thoroughly informed that they may interrupt the interview or stop it altogether.

Where is the study run from?
The study is conducted in the interdisciplinary ICU of a Swiss university hospital, as well as at 12 follow-up clinics

When is the study starting and how long is it expected to run for?
December 2008 to April 2011

Who is funding the study?
University Hospital of Bern and the Swiss Red Cross (Switzerland)

Who is the main contact?
Marie-Madlen Jeitziner

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marie-Madlen Jeitziner

ORCID ID

Contact details

University Hospital Bern (Inselspital)
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Long-term consequences of pain, anxiety and agitation in older, critically ill patients after a stay on an intensive care unit - a prospective, observational study

Acronym

Study hypothesis

Modern methods in intensive care medicine often enable the survival of older critically ill patients. The short-term outcomes for patients treated in intensive care units (ICUs), such as survival to hospital discharge, are well documented. However, relatively little is known about subsequent long-term outcomes. Pain, anxiety and agitation are important stress factors for many critically ill patients. There are very few studies concerned with pain, anxiety and agitation and the consequences in older critically ill patients. The overall aim of this study is to identify how an ICU stay influences an older person’s experiences later in life. More specificly, this study has the following objectives:
1. To explore the relationship between pain, anxiety and agitation during ICU stays and experiences of the same symptoms in later life
2. To explore the associations between pain, anxiety and agitation experienced during ICU stays and their effect on subsequent health-related quality of life, use of the health care system (readmissions, doctor visits, rehabilitation, medication use), living situation, and survival after discharge and at 6 and 12 months of follow-up

Ethics approval

Cantonal Ethics Commission of Bern (Kantonale Ethischen Kommission Bern), 01/09/2008, Ref. Nr. KEK-BE: 128/08

Study design

Prospective observational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

ICU patients

Intervention

1. Background data will be gathered via medical records and questionnaires
2. Medical and nursing staff will gather daily routine data regarding pain, anxiety, and agitation, along with any other information relevant to usual care in the ICU
3. Collection of data concerning pain, anxiety and agitation will be carried out by the staff who regularly care for the patients
4. For this study these caregivers have received special training
5. Data about the outcome indicators will be collected using questionnaires 1 week, 6 months and 12 months after discharge. It should be emphasized that participants in the ICU group will be asked one week after discharge to make an assessment of both their current HR-QOL and their HR-QOL, pain, anxiety and agitation intensity, before admission to the ICU
6. One week after ICU discharge, patients in the ICU group will be contacted and interviewed
7. The interviews will be carried out only if the patients are physically and psychologically fit to be interviewed
8. If necessary, help will be provided in filling out the questionnaire
9. All data will be collected using face-to-face (baseline) and telephone (follow-up) interviews and will be collected by 4 trained interviewers
10. The baseline interviews with all critically ill patients will take place in the hospital
11. All other interviews for both groups will take place by telephone
12. The SF-36 and HADS-D will be mailed to all participants. In order for them to prepare themselves for the interview, both groups will be informed of the general nature of the questions ahead of time
13. Because unanswered questions would affect the evaluation of the questionnaires, an interviewer will check to ensure that all questions have been answered, and follow up in cases where information is lacking. If questionnaires are not returned, reminders will be sent to the participants.
14. Data will be collected at the following intervals: during ICU, 1 week, 6 and 12 months after hospital discharge

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain, anxiety and agitation during an ICU stay
2. During the ICU stay, pain, anxiety and agitation will be measured in the ICU group
3. In patients unable to verbally express themselves, pain intensity will be measured using a behavioural pain scale employing three behavioural parameters:
3.1. Mimic
3.2. Body movement
3.3. Muscle tone
4. The intensity of the behavioural parameters will be assessed on the basis of a four-point Likert scale: each characteristic will be rated as weak or absent, moderately severe, severe, or very severe
5. Anxiety will be assessed using a numeric rating scale (0-10) (0=no anxiety to 10=worst possible anxiety)
6. Agitation during the ICU stay will be measured using the German version of the Richmond Agitation-Sedation Scale (RASS), which has 10 levels, ranging from -5: unarousable (no response) to +4: combative (danger to staff)
6. This scale has proven reliable for the assessment of critically ill patients in the ICU, with strong interrater reliability and criterion, construct, and face validity
7. The Confusion Assessment Method for the ICU (CAM-ICU) will be used to assess delirium in the ICU, as well as general cognitive abilities, focusing on the following factors: 7.1. Acute onset or fluctuating course
7.2. Inattention
7.3. Disorganized thinking
7.4. Altered level of consciousness

After discharge:
1. In line with the study aims, the following outcome indicators will be measured in both the ICU group and the comparison group:
1.1. Pain, anxiety and agitation
1.2. HRQOL
1.3. Use of the health care system (readmissions, general practitioner visits, rehabilitation, length of hospital stay), medication use, living situation and survival
2. Pain intensity will be measured with a numeric scale (NRS) (0=no pain to 10=worst possible pain), and pain frequency with a Likert-type scale (never, seldom, occasionally, often, always)
3. Anxiety will be assessed using a numeric rating scale (0-10) and the Hospital Anxiety and Depression Scale (HADS-D), which uses two subscales, an anxiety scale (HADS-A) and a depression scale (HADS-D)
4. Agitation will be measured using the Confusion Assessment Method (CAM)
5. The German or French Short Form of the Confusion Assessment Method (CAM), including a telephone version for the 6- and 12-month follow-ups, will be used for all participants
6. Health-related quality of life (HR-QOL) will be assessed using the component scores of the Short Form 36 Health Survey (SF-36). As a comprehensive, generic, 36-item instrument, the SF-36 concentrates on the subjective evaluation of health:
6.1. Physical function
6.2. Physical role function
6.3. Bodily pain
6.4. General health perceptions
6.5. Vitality
6.6. Social role function
6.7. Emotional role function
6.8. Mental health
7. The items vary from yes/no questions to hose offering 6 levels of choice
8. All subscales have been adapted to yield assessment values between 0 and 100

Secondary outcome measures

1. Use of the health care system (readmissions, general practitioner visits, rehabilitation, length of hospital stay)
2. Medication use
3. Living situation and survival

Overall trial start date

01/12/2008

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Minimum age of 65 years
2. Have had an ICU stay of at least 48 hours (ICU group) or no stay for the last 15 years (comparison group)
3. Be able to speak and read either German or French, and live in Switzerland

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

150 ICU patients and 150 persons for the comparison group

Participant exclusion criteria

1. Temporary tracheostomies
2. Chronic mechanical ventilation
3. Illness-related cognitive impairment (dementia)
4. Psychotic illnesses including delusions and changes in mental state
5. Potentially terminal illnesses such as lung or heart diseases and cancer

Recruitment start date

01/12/2008

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Bern (Inselspital)
Bern
3010
Switzerland

Sponsor information

Organisation

University Hospital Bern (Switzerland)

Sponsor details

c/o Ms Marie-Madlen Jeitziner
Hochschulstrasse 4
Bern
CH-3012
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.cvrc.dkf.unibe.ch/content/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Bern (Direktion Pflege / MTT) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Red Cross (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21888641

Publication citations

  1. Protocol

    Jeitziner MM, Hantikainen V, Conca A, Hamers JP, Long-term consequences of an intensive care unit stay in older critically ill patients: design of a longitudinal study., BMC Geriatr, 2011, 11, 52, doi: 10.1186/1471-2318-11-52.

Additional files

Editorial Notes

19/02/2016: Plain English summary added.