Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention (iCare)

February 13, 2023 updated by: Sascha Treskatsch, Charite University, Berlin, Germany

Advances in medicine have led to an increased life expectancy even with complex disease courses of malignant diseases.

This leads to frequent critical situations for patients and high risk surgical interventions. The majority of patients and their practitioners are not prepared for the consequences of a complex and possibly fatal course.

Palliative medicine makes it possible to anticipate the further course of the disease. As a result, palliative medicine has become increasingly important. The beginning of palliative medical interventions has extended from accompaniment limited to the dying phase to earlier phases of the disease.

An early integration of palliative medicine showed a positive effect on the quality of life, the degree of depression and survival in patients suffering from cancer, for example. Furthermore, patients were more able to accept a change in therapy goal at the end of life. Similar results were shown for patients with a non-malignant severe disease such as COPD or heart failure.

What needs further investigating is how to adequately screen and identify the patient populations who could benefit from early palliative care, so that they are prepared for potentially critical and life-threatening situations.

The investigator's objective is therefore whether the Anesthesiology Outpatient Clinic is a suitable screening location for initiating early integrated palliative care for patients with a serious, life-shortening illness and a high perioperative risk.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • Germany
    • Berlin
      • Berlin-Steglitz, Berlin, Germany, 12203
        • Recruiting
        • Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin

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

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants will be selected out of the population consulted at the anesthesiology outpatient clinic of the University hospital Berlin - Charite.

Description

Inclusion Criteria:

  • over 18 years
  • one elective operation with medium or high cardiac risk

And in addition at least one of the following criteria:

  • serious comorbidity pulmonary: Emphysema and / or COPD >= 2 after GOLD cardiac: NYHA > = 2
  • and / or a metastatic malignancy
  • ASA physical status classification >= 3 and pre-frail or frail

Exclusion Criteria:

  • legal care
  • Emergency operation
  • any reasons which contradict inclusion in studies , e.g. cognitive deficit and lack of language skills
  • Pregnant / breastfeeding women

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of the preoperative palliative counseling offer
Time Frame: through study completion, an average of 1 year
Percentage of patients who accept the palliative counseling offer in relation to the total number of patients identified in the screening of the anesthesia outpatient clinic
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance planning documents
Time Frame: through study completion, an average of 1 year
Percentage of patients who, as a result of the palliative medical consultation offer, create or want to create a living will or power of attorney
through study completion, an average of 1 year
Postoperative palliative counseling
Time Frame: through study completion, an average of 1 year
Percentage of patients who would like further palliative medical advice postoperatively
through study completion, an average of 1 year
Acceptance of the preoperative palliative counseling offer depending on the underlying disease
Time Frame: through study completion, an average of 1 year
Percentage of patients with and without a malignant disease who accept the counseling offer
through study completion, an average of 1 year
Therapy target decision-making situations
Time Frame: through study completion, an average of 1 year
Percentage of patients in whom a decision to limit therapy occurs in the postoperative course
through study completion, an average of 1 year
Gender difference
Time Frame: through study completion, an average of 1 year
Percentage of female patients who accept the counseling offer in relation to male patients
through study completion, an average of 1 year
Therapy goal decisions postoperatively
Time Frame: through study completion, an average of 1 year
Percentage of patients who do not accept the offer of counseling and who have difficult therapy goal decisions postoperatively
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2022

Primary Completion (ANTICIPATED)

November 30, 2023

Study Completion (ANTICIPATED)

November 30, 2023

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (ACTUAL)

October 12, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/292/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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