Acute Respiratory Distress Syndrome (ARDS)DACAPONCT02637011
Surviving ARDS: The Influence of Quality of Care and Individual Patient Characteristics on Quality of Life
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by University Hospital Regensburg at 3 sites in Germany.
Trial summary
The purpose of the DACAPO study ("Surviving ARDS: the influence of quality of care and individual patient characteristics on quality of life") is to investigate the role of quality of care and individual patient characteristics on quality of life and return to work in survivors of ARDS (acute respiratory distress… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 2,000 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2014to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected of patients with ARDS treated at intensive care units of the participating hospitals. Participating hospitals are members of the ARDS Network Germany or other hospitals which agreed to take part in the study.
Who may be able to join
- ARDS according to the criteria of the Berlin-Definition:
- Acute onset within one week, ii) bilateral pulmonary infiltrates (chest imaging), iii) respiratory failure not fully explained by cardiac failure or fluid overload.
- informed consent provided by the patient or the legal guardian
- 18 years old or older
Who cannot join
- no ARDS
- no informed consent provided by the patient or the legal guardian
- younger than 18 years
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Universitätsmedizin Charite
Berlin, State of Berlin, 10117
Steffen Weber-Carstens, PhD, ++49-30-450651055, steffen.weber-carstens@charite.de
Anton Goldmann, Dr, ++49-30-4500, anton.goldmann@charite.de
- Recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
Lars-Olav Harnisch, Dr., +49551/39-13328, lars-olav.harnisch@med.uni-goettingen.de
Michael Quintel, Prof. Dr., +49551/39-13328, mquintel@med.uni-goettingen.de
- Recruiting
Klinik für Intensivmedizin
Hamburg, 20246
Stefan Kluge, Prof.Dr., 49-(0)40-7410-57010, s.kluge@uke.de
About this study
Official title: Influence of Quality of Care and Individual Patient Characteristics on Quality of Life/ Return to Work in Survivors of the Acute Respiratory Distress Syndrome (ARDS): Prospective, Observational, Multi-centre Cohort Study
The purpose of the DACAPO study ("Surviving ARDS: the influence of quality of care and individual patient characteristics on quality of life") is to investigate the role of quality of care and individual patient characteristics on quality of life and return to work in survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher quality of care is associated with better health-related quality of life and a higher rate of return to work among survivors.
A prospective, observational, multi-centre patient cohort study is performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. Quality of care will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (health related quality of life and return to work) will be gathered by self-report questionnaires. Further data assessment includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of quality of care and individual patient characteristics on outcomes, taking the cluster structure of the data into account.
Read the detailed description
Design Patients will be included in the study at the beginning of ICU stay in a participating hospital (t0) and survivors will be followed over a period of 12 months after discharge from ICU. If patients have been treated before in a referring hospital, a retrospective assessment of their health status during their stay in this hospital and during inter-hospital transport will be performed. Four follow-up measurements (at discharge from ICU as well as 3, 6 and 12 months after discharge) will be performed on individual patient level.
Sample \& Recruitment Hospitals of the "ARDS Network Germany" and other hospitals which provide care for patients with ARDS were invited to participate in the study.
It is envisaged to screen 2600 patients for the presence of ARDS and to include 2400 patients as members of the source population. An in-hospital mortality rate of 30% is assumed; therefore, we expect to analyze a study population of 1500 patients at t1 (discharge from ICU). For each follow-up-assessment (t2-t4: 3 months, 6 months, 12 months after discharge), loss-to-follow-up rates due to death, withdrawal of consent or other reasons are estimated to be about 10%, resulting in slightly more than 1000 patients at 12-months-follow-up.
Measurements The main predictor is quality of care provided in the ICUs of the participating hospitals. The following main indicators were chosen: qualification of physicians, implementation of routine daily multiprofessional ward rounds with documentation of daily therapy goals, number of ventilated patients per, and membership of the hospital in the "ARDS Network Germany". All quality indicators will be assessed by questionnaire at the institutional level.
Main outcome measures of the DACAPO study are HRQoL and return to work among survivors of ARDS (see study outcomes).
Moderating variables are gender, socio-economic status, prevalent and incident psychopathological symptoms (PHQ-D, PTSS-14) and the availability of social support (F-SozU K-14).
Additional variables comprise general medical ICU parameters (e.g. comorbidity, prognostic scores (SAPS (Simplified Acute Physiology Score) II, SAPS III ) and an organ dysfunction score (SOFA (Sequential Organ Failure Assessment score)) and parameters relating to ARDS (e.g. cause and severity) and its treatment (e.g. ventilation parameters, use of supportive care measures, critical events (hypoglycaemia, hypoxia)) as well as socio-demographic and psycho-social characteristics.
Additionally, costs will be assessed as direct costs in terms of treatment costs at the ICU.
Data Sources and Data Collection Patients's general medical characteristics and medical data relating to ARDS and its treatment will be assessed during ICU stay and gathered through electronic case report forms (eCRFs). Data on the direct costs of treating patients with ARDS in the ICU will be gathered from hospital records. A 12-months mortality follow-up will be performed. Local municipal population registries will be contacted to obtain data on mortality at the patient level.
At baseline, caregivers will provide proxy report of patients' socio-demographic data, at follow-ups (discharge from ICU, 3 months, 6 months, 12 months), patients themselves will complete self-report questionnaires on socio-demographic and psycho-social characteristics as well as on the main outcome measures.
Data on indicators of quality of care will be assessed through questionnaires administered to the directors of the hospitals/ICUs.
Data Management The open source software OpenClinica, version 3.1, will be used for electronic data collection and data management. eCRFs will be used for data entry. A continuous assessment of data quality will be performed by exporting data sets to statistical packages to run further error and plausibility checks. Data from paper-pencil-questionnaires completed by patients will be entered into the database twice in order to ensure high data quality.
Statistical Analysis A linear multilevel regression model will be fitted both for the physical and the mental component summary score of the SF-12. A non-parametric multilevel regression model will be used for the outcome "return to work". The modelling procedure will be applied to each of the operationalizations of the predictor "quality of care".
All analyses will be carried out using SAS 9.4 software and STATA version 12 software.
- Keywords
- acute respiratory distress syndrome, intensive care medicine, critical illness, long-term outcomes, quality of life, return to work, quality of care
- Medical subject headings
- Respiratory Distress Syndrome, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12)
change from baseline (discharge from the ICU) to 3 months, 6 months and 12 months, respectively.
Measured: 3 months, 6 months, 12 months after discharge from the ICU
Secondary outcomes (1)
return to work
Assessment by questionnaire
Measured: 3 months, 6 months, 12 months after discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg
- Responsible party
- Principal investigator, Prof. Dr. Thomas Bein M.A., University Hospital Regensburg
- Investigators
- Thomas Bein, Prof. Dr., Principal investigator, University Hospital Regensburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637011
- Sponsor's protocol ID
- 01GY1340
- Acronym
- DACAPO
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blecha S, Zeman F, Rohr M, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Apfelbacher C, Bein T; DACAPO study group. Association of analgosedation with psychiatric symptoms and health-related quality of life in ARDS survivors: Post hoc analyses of the DACAPO study. PLoS One. 2022 Oct 21;17(10):e0275743. doi: 10.1371/journal.pone.0275743. eCollection 2022.
PubMed 36269731Apfelbacher C, Brandstetter S, Blecha S, Dodoo-Schittko F, Brandl M, Karagiannidis C, Quintel M, Kluge S, Putensen C, Bercker S, Ellger B, Kirschning T, Arndt C, Meybohm P, Weber-Carstens S; DACAPO study group; Bein T. Influence of quality of intensive care on quality of life/return to work in survivors of the acute respiratory distress syndrome: prospective observational patient cohort study (DACAPO). BMC Public Health. 2020 Jun 5;20(1):861. doi: 10.1186/s12889-020-08943-8.
PubMed 32503583Blecha S, Brandl M, Zeman F, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. Tracheostomy in patients with acute respiratory distress syndrome is not related to quality of life, symptoms of psychiatric disorders or return-to-work: the prospective DACAPO cohort study. Ann Intensive Care. 2020 May 6;10(1):52. doi: 10.1186/s13613-020-00671-x.
PubMed 32377963Blecha S, Brandstetter S, Dodoo-Schittko F, Brandl M, Graf BM, Bein T, Apfelbacher C. Acceptability of a German multicentre healthcare research study: a survey of research personnels' attitudes, experiences and work load. BMJ Open. 2018 Sep 24;8(9):e023166. doi: 10.1136/bmjopen-2018-023166.
PubMed 30249633Dodoo-Schittko F, Brandstetter S, Brandl M, Blecha S, Quintel M, Weber-Carstens S, Kluge S, Kirschning T, Muders T, Bercker S, Ellger B, Arndt C, Meybohm P, Adamzik M, Goldmann A, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. German-wide prospective DACAPO cohort of survivors of the acute respiratory distress syndrome (ARDS): a cohort profile. BMJ Open. 2018 Apr 4;8(4):e019342. doi: 10.1136/bmjopen-2017-019342.
PubMed 29622574Blecha S, Dodoo-Schittko F, Brandstetter S, Brandl M, Dittmar M, Graf BM, Karagiannidis C, Apfelbacher C, Bein T; DACAPO Study Group. Quality of inter-hospital transportation in 431 transport survivor patients suffering from acute respiratory distress syndrome referred to specialist centers. Ann Intensive Care. 2018 Jan 15;8(1):5. doi: 10.1186/s13613-018-0357-y.
PubMed 29335831
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Quality of Care and Individual Patient Characteristics on Quality of Life/ Return to Work in Survivors of the Acute Respiratory Distress Syndrome (ARDS): Prospective, Observational, Multi-centre Cohort Study
- ClinicalTrials.gov ID
- NCT02637011
- Acronym / sponsor ID
- DACAPO / 01GY1340
- Keywords
- acute respiratory distress syndrome, intensive care medicine, critical illness, long-term outcomes, quality of life, return to work, quality of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- University of Regensburg
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the DACAPO study ("Surviving ARDS: the influence of quality of care and individual patient characteristics on quality of life") is to investigate the role of quality of care and individual patient characteristics on quality of life and return to work in survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher quality of care is associated with better health-related quality of life and a higher rate of return to work among survivors.
A prospective, observational, multi-centre patient cohort study is performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. Quality of care will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (health related quality of life and return to work) will be gathered by self-report questionnaires. Further data assessment includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of quality of care and individual patient characteristics on outcomes, taking the cluster structure of the data into account.
Detailed description
Design Patients will be included in the study at the beginning of ICU stay in a participating hospital (t0) and survivors will be followed over a period of 12 months after discharge from ICU. If patients have been treated before in a referring hospital, a retrospective assessment of their health status during their stay in this hospital and during inter-hospital transport will be performed. Four follow-up measurements (at discharge from ICU as well as 3, 6 and 12 months after discharge) will be performed on individual patient level.
Sample \& Recruitment Hospitals of the "ARDS Network Germany" and other hospitals which provide care for patients with ARDS were invited to participate in the study.
It is envisaged to screen 2600 patients for the presence of ARDS and to include 2400 patients as members of the source population. An in-hospital mortality rate of 30% is assumed; therefore, we expect to analyze a study population of 1500 patients at t1 (discharge from ICU). For each follow-up-assessment (t2-t4: 3 months, 6 months, 12 months after discharge), loss-to-follow-up rates due to death, withdrawal of consent or other reasons are estimated to be about 10%, resulting in slightly more than 1000 patients at 12-months-follow-up.
Measurements The main predictor is quality of care provided in the ICUs of the participating hospitals. The following main indicators were chosen: qualification of physicians, implementation of routine daily multiprofessional ward rounds with documentation of daily therapy goals, number of ventilated patients per, and membership of the hospital in the "ARDS Network Germany". All quality indicators will be assessed by questionnaire at the institutional level.
Main outcome measures of the DACAPO study are HRQoL and return to work among survivors of ARDS (see study outcomes).
Moderating variables are gender, socio-economic status, prevalent and incident psychopathological symptoms (PHQ-D, PTSS-14) and the availability of social support (F-SozU K-14).
Additional variables comprise general medical ICU parameters (e.g. comorbidity, prognostic scores (SAPS (Simplified Acute Physiology Score) II, SAPS III ) and an organ dysfunction score (SOFA (Sequential Organ Failure Assessment score)) and parameters relating to ARDS (e.g. cause and severity) and its treatment (e.g. ventilation parameters, use of supportive care measures, critical events (hypoglycaemia, hypoxia)) as well as socio-demographic and psycho-social characteristics.
Additionally, costs will be assessed as direct costs in terms of treatment costs at the ICU.
Data Sources and Data Collection Patients's general medical characteristics and medical data relating to ARDS and its treatment will be assessed during ICU stay and gathered through electronic case report forms (eCRFs). Data on the direct costs of treating patients with ARDS in the ICU will be gathered from hospital records. A 12-months mortality follow-up will be performed. Local municipal population registries will be contacted to obtain data on mortality at the patient level.
At baseline, caregivers will provide proxy report of patients' socio-demographic data, at follow-ups (discharge from ICU, 3 months, 6 months, 12 months), patients themselves will complete self-report questionnaires on socio-demographic and psycho-social characteristics as well as on the main outcome measures.
Data on indicators of quality of care will be assessed through questionnaires administered to the directors of the hospitals/ICUs.
Data Management The open source software OpenClinica, version 3.1, will be used for electronic data collection and data management. eCRFs will be used for data entry. A continuous assessment of data quality will be performed by exporting data sets to statistical packages to run further error and plausibility checks. Data from paper-pencil-questionnaires completed by patients will be entered into the database twice in order to ensure high data quality.
Statistical Analysis A linear multilevel regression model will be fitted both for the physical and the mental component summary score of the SF-12. A non-parametric multilevel regression model will be used for the outcome "return to work". The modelling procedure will be applied to each of the operationalizations of the predictor "quality of care".
All analyses will be carried out using SAS 9.4 software and STATA version 12 software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected of patients with ARDS treated at intensive care units of the participating hospitals. Participating hospitals are members of the ARDS Network Germany or other hospitals which agreed to take part in the study.
Key inclusion criteria (4 listed)
- ARDS according to the criteria of the Berlin-Definition:
- informed consent provided by the patient or the legal guardian
- 18 years old or older
Key exclusion criteria (3 listed)
- no ARDS
- no informed consent provided by the patient or the legal guardian
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12)
Time frame: 3 months, 6 months, 12 months after discharge from the ICU
change from baseline (discharge from the ICU) to 3 months, 6 months and 12 months, respectively.
1 secondary outcome
return to work
Time frame: 3 months, 6 months, 12 months after discharge from the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 36269731Blecha S, Zeman F, Rohr M, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Apfelbacher C, Bein T; DACAPO study group. Association of analgosedation with psychiatric symptoms and health-related quality of life in ARDS survivors: Post hoc analyses of the DACAPO study. PLoS One. 2022 Oct 21;17(10):e0275743. doi: 10.1371/journal.pone.0275743. eCollection 2022.
- Derived from this study: PubMed 32503583Apfelbacher C, Brandstetter S, Blecha S, Dodoo-Schittko F, Brandl M, Karagiannidis C, Quintel M, Kluge S, Putensen C, Bercker S, Ellger B, Kirschning T, Arndt C, Meybohm P, Weber-Carstens S; DACAPO study group; Bein T. Influence of quality of intensive care on quality of life/return to work in survivors of the acute respiratory distress syndrome: prospective observational patient cohort study (DACAPO). BMC Public Health. 2020 Jun 5;20(1):861. doi: 10.1186/s12889-020-08943-8.
- Derived from this study: PubMed 32377963Blecha S, Brandl M, Zeman F, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. Tracheostomy in patients with acute respiratory distress syndrome is not related to quality of life, symptoms of psychiatric disorders or return-to-work: the prospective DACAPO cohort study. Ann Intensive Care. 2020 May 6;10(1):52. doi: 10.1186/s13613-020-00671-x.
- Derived from this study: PubMed 30249633Blecha S, Brandstetter S, Dodoo-Schittko F, Brandl M, Graf BM, Bein T, Apfelbacher C. Acceptability of a German multicentre healthcare research study: a survey of research personnels' attitudes, experiences and work load. BMJ Open. 2018 Sep 24;8(9):e023166. doi: 10.1136/bmjopen-2018-023166.
- Derived from this study: PubMed 29622574Dodoo-Schittko F, Brandstetter S, Brandl M, Blecha S, Quintel M, Weber-Carstens S, Kluge S, Kirschning T, Muders T, Bercker S, Ellger B, Arndt C, Meybohm P, Adamzik M, Goldmann A, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. German-wide prospective DACAPO cohort of survivors of the acute respiratory distress syndrome (ARDS): a cohort profile. BMJ Open. 2018 Apr 4;8(4):e019342. doi: 10.1136/bmjopen-2017-019342.
- Derived from this study: PubMed 29335831Blecha S, Dodoo-Schittko F, Brandstetter S, Brandl M, Dittmar M, Graf BM, Karagiannidis C, Apfelbacher C, Bein T; DACAPO Study Group. Quality of inter-hospital transportation in 431 transport survivor patients suffering from acute respiratory distress syndrome referred to specialist centers. Ann Intensive Care. 2018 Jan 15;8(1):5. doi: 10.1186/s13613-018-0357-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bein, Prof. Dr. principal investigator
University Hospital Regensburg, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by University Hospital Regensburg at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Bein, Prof. Dr. (++49-941-944-0, thomas.bein@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12) (time frame: 3 months, 6 months, 12 months after discharge from the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637011, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.