Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention

Recruiting

• Conditions: Cancer; Chronic Obstructive Pulmonary Disease; Postoperative Complications; Heart Failure

• Registration Number: NCT05575791
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Study Start: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptance of the preoperative palliative counseling offer	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

Secondary Outcome Measures

Name	Time	Method
Therapy target decision-making situations	through study completion, an average of 1 year	Percentage of patients in whom a decision to limit therapy occurs in the postoperative course
Therapy goal decisions postoperatively	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
Advance planning documents	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
Postoperative palliative counseling	through study completion, an average of 1 year	Percentage of patients who would like further palliative medical advice postoperatively
Acceptance of the preoperative palliative counseling offer depending on the underlying disease	through study completion, an average of 1 year	Percentage of patients with and without a malignant disease who accept the counseling offer
Gender difference	through study completion, an average of 1 year	Percentage of female patients who accept the counseling offer in relation to male patients

Trial Locations

Locations (1)

Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin; 🇩🇪 Berlin-Steglitz, Berlin, Germany