PICS Clinic Attendance and Recovery Engagement (PICS-CARE)

February 10, 2026 updated by: Claudia Spies, Charite University, Berlin, Germany
To identify relevant factors influencing attendance at appointments at the PICS outpatient clinic after intensive care treatment in order to derive targeted measures to increase the participation rate or send more targeted invitations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This retrospective study examines which factors influence patient attendance at structured follow-up appointments after intensive care treatment in the PICS outpatient clinic at Charité. The focus is on analyzing demographic, clinical, and care-related factors that influence actual participation in follow-up care after intensive care treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Claudia Spies, MD, Prof.
        • Sub-Investigator:
          • Nicolas Paul, MD, Prof.
        • Sub-Investigator:
          • Björn Weiß, MD, Prof.
        • Sub-Investigator:
          • Désirée Boehnke, MD
        • Sub-Investigator:
          • Claudia Denke
        • Sub-Investigator:
          • Frédéric Schwarz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Intensive Care unit patients, who were invited for follow-up care by the PICS outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Description

Inclusion Criteria:

  • Patients who, between January 1, 2021, and December 31, 2025:
  • were invited for follow-up care by the PICS outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
  • were ≥18 years old at the time of the appointment.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intensive care unit patients
Intensive care unit patients, which are invited in the post-intensive care outpatient clinic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Follow-up appointment
Time Frame: 01.01.2021- 31.12.2025
Participation in the first scheduled follow-up appointment at the post-intensive care syndrome (PICS) outpatient clinic (binary: attended vs. did not attend) is measured by medical record review.
01.01.2021- 31.12.2025

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cancellation of a scheduled follow-up appointment.
Time Frame: 01.01.2021- 31.12.2025
Cancellation of a scheduled follow-up appointment is measured by medical record review.
01.01.2021- 31.12.2025
Reasons for canceling a scheduled appointment.
Time Frame: 01.01.2021- 31.12.2025
Reasons for canceling a scheduled appointment is measured by medical record review.
01.01.2021- 31.12.2025
Failure to attend a scheduled follow-up appointment.
Time Frame: 01.01.2021- 31.12.2025
Failure to attend a scheduled follow-up appointment is measured by medical record review.
01.01.2021- 31.12.2025
Death after discharge from the intensive care unit until the first follow-up appointment.
Time Frame: 01.01.2021- 31.12.2025
Death after discharge from the intensive care unit until the first follow-up appointment is measured by medical record review.
01.01.2021- 31.12.2025
Death between the first and second follow-up appointments.
Time Frame: 01.01.2021- 31.12.2025
Death between the first and second follow-up appointments is measured by medical record review.
01.01.2021- 31.12.2025
Scheduling a second follow-up appointment after initial presentation at the outpatient clinic.
Time Frame: 01.01.2021- 31.12.2025
Scheduling a second follow-up appointment after initial presentation at the outpatient clinic is measured by medical record review.
01.01.2021- 31.12.2025
Attendance at the second scheduled follow-up appointment after initial presentation at the outpatient clinic.
Time Frame: 01.01.2021- 31.12.2025
Attendance at the second scheduled follow-up appointment after initial presentation at the outpatient clinic is measured by medical record review.
01.01.2021- 31.12.2025
Scheduling a third follow-up appointment after initial presentation at the outpatient clinic.
Time Frame: 01.01.2021- 31.12.2025
Scheduling a third follow-up appointment after initial presentation at the outpatient clinic is is measured by medical record review.
01.01.2021- 31.12.2025
Attendance at the third scheduled follow-up appointment after initial presentation at the outpatient clinic.
Time Frame: 01.01.2021- 31.12.2025
Attendance at the third scheduled follow-up appointment after initial presentation at the outpatient clinic is measured by medical record review.
01.01.2021- 31.12.2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PICS-CARE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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