Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention

Cancer Clinical Trial

— iCare  

Official title:

Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575791
• Other study ID #: EA1/292/20
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases, Obstructive
• Postoperative Complications
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin	Berlin-Steglitz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (24)

Birkelbach O, Morgeli R, Balzer F, Olbert M, Treskatsch S, Kiefmann R, Muller-Werdan U, Reisshauer A, Schwedtke C, Neuner B, Spies C. [Why and How Should I Assess Frailty? A Guide for the Preoperative Anesthesia Clinic]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2017 Nov;52(11-12):765-776. doi: 10.1055/s-0043-104682. Epub 2017 Nov 20. German. — View Citation

Birkelbach O, Morgeli R, Spies C, Olbert M, Weiss B, Brauner M, Neuner B, Francis RCE, Treskatsch S, Balzer F. Routine frailty assessment predicts postoperative complications in elderly patients across surgical disciplines - a retrospective observational study. BMC Anesthesiol. 2019 Nov 7;19(1):204. doi: 10.1186/s12871-019-0880-x. — View Citation

Brumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000. doi: 10.1111/j.1532-5415.2007.01234.x. — View Citation

Cancer Control: Knowledge into Action: WHO Guide for Effective Programmes: Module 5: Palliative Care. Geneva: World Health Organization; 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK195248/ — View Citation

Chan R, Ueno R, Afroz A, Billah B, Tiruvoipati R, Subramaniam A. Association between frailty and clinical outcomes in surgical patients admitted to intensive care units: a systematic review and meta-analysis. Br J Anaesth. 2022 Feb;128(2):258-271. doi: 10.1016/j.bja.2021.11.018. Epub 2021 Dec 17. — View Citation

de Heer G, Saugel B, Sensen B, Rubsteck C, Pinnschmidt HO, Kluge S. Advance Directives and Powers of Attorney in Intensive Care Patients. Dtsch Arztebl Int. 2017 Jun 5;114(21):363-370. doi: 10.3238/arztebl.2017.0363. — View Citation

Hadler RA, Fatuzzo M, Sahota G, Neuman MD. Perioperative Management of Do-Not-Resuscitate Orders at a Large Academic Health System. JAMA Surg. 2021 Dec 1;156(12):1175-1177. doi: 10.1001/jamasurg.2021.4135. — View Citation

Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2. — View Citation

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Leder N, Schwarzkopf D, Reinhart K, Witte OW, Pfeifer R, Hartog CS. The Validity of Advance Directives in Acute Situations. Dtsch Arztebl Int. 2015 Oct 23;112(43):723-9. doi: 10.3238/arztebl.2015.0723. — View Citation

Ma J, Chi S, Buettner B, Pollard K, Muir M, Kolekar C, Al-Hammadi N, Chen L, Kollef M, Dans M. Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial. Crit Care Med. 2019 Dec;47(12):1707-1715. doi: 10.1097/CCM.0000000000004016. — View Citation

Maltoni M, Scarpi E, Dall'Agata M, Zagonel V, Berte R, Ferrari D, Broglia CM, Bortolussi R, Trentin L, Valgiusti M, Pini S, Farolfi A, Casadei Gardini A, Nanni O, Amadori D; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial. Eur J Cancer. 2016 Sep;65:61-8. doi: 10.1016/j.ejca.2016.06.007. Epub 2016 Jul 26. — View Citation

Morgeli R, Wollersheim T, Spies C, Balzer F, Koch S, Treskatsch S. [How to Reduce the Rate of Postoperative Complications in Frail Patients?]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2017 Nov;52(11-12):785-797. doi: 10.1055/s-0043-104685. Epub 2017 Nov 20. German. — View Citation

Pfirstinger J, Kattner D, Edinger M, Andreesen R, Vogelhuber M. The impact of a tumor diagnosis on patients' attitudes toward advance directives. Oncology. 2014;87(4):246-56. doi: 10.1159/000363508. Epub 2014 Aug 15. — View Citation

Scally CP, Robinson K, Blumenthaler AN, Bruera E, Badgwell BD. Identifying Core Principles of Palliative Care Consultation in Surgical Patients and Potential Knowledge Gaps for Surgeons. J Am Coll Surg. 2020 Jul;231(1):179-185. doi: 10.1016/j.jamcollsurg.2020.03.036. Epub 2020 Apr 18. — View Citation

Schoffner M, Schmidt KW, Benzenhofer U, Sahm S. [Living wills under close scrutiny: Medical consultation is indispensable]. Dtsch Med Wochenschr. 2012 Mar;137(10):487-90. doi: 10.1055/s-0031-1298998. Epub 2012 Feb 28. German. — View Citation

Siouta N, Heylen A, Aertgeerts B, Clement P, Van Cleemput J, Janssens W, Menten J. Early integrated palliative care in chronic heart failure and chronic obstructive pulmonary disease: protocol of a feasibility before-after intervention study. Pilot Feasibility Stud. 2019 Feb 21;5:31. doi: 10.1186/s40814-019-0420-y. eCollection 2019. — View Citation

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. — View Citation

Urman RD, Gross CS, Sadovnikoff N, Bader AM. Improving Preoperative Completion of Advanced Care Planning Documents in Patients With Expected Postoperative Intensive Care Unit Stay. A A Pract. 2019 Jun 15;12(11):455-458. doi: 10.1213/XAA.0000000000000993. — View Citation

Vanbutsele G, Pardon K, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Cocquyt V, Geboes K, Deliens L. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol. 2018 Mar;19(3):394-404. doi: 10.1016/S1470-2045(18)30060-3. Epub 2018 Feb 3. — View Citation

Vanbutsele G, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Naert E, De Man M, Geboes K, Deliens L, Pardon K. The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial. Eur J Cancer. 2020 Jan;124:186-193. doi: 10.1016/j.ejca.2019.11.009. Epub 2019 Dec 5. — View Citation

Yefimova M, Aslakson RA, Yang L, Garcia A, Boothroyd D, Gale RC, Giannitrapani K, Morris AM, Johanning JM, Shreve S, Wachterman MW, Lorenz KA. Palliative Care and End-of-Life Outcomes Following High-risk Surgery. JAMA Surg. 2020 Feb 1;155(2):138-146. doi: 10.1001/jamasurg.2019.5083. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

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