Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED

Depression Clinical Trial

— EMASPOT  

Official title:

Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03188861
• Other study ID #: EA1/363/16
• Secondary ID: 0133/17/ST3
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2018
• Source: Charite University, Berlin, Germany
• Contact: Martin Möckel, Prof. Dr.
• Phone: 004930450553472
• Email: martin.moeckel[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac ACSC on transsectoral utilisation of health care services.

Description:

The specific aims of EMASPOT are primarily to determine the prevalence of mental health conditions (MHC) (i.e., symptoms of depression, anxiety, somatoform disorders, and alcohol abuse) in patients with multimorbidity and cardiac ACSC in a prospective cohort study.

The study population comprises patients admitted to an ED in Berlin-Mitte during the study period from 01.06.2017 to 31.05.2018 with cardiac complaints who are admitted to the hospital or discharged from ED. The study focusses especially on older and multimorbid patients. Multimorbidity is defined as the presence of more than two chronic diagnoses.

After having given informed consent patients are enrolled in the study and interviewed by a study nurse. Self-reported symptom burden for depression, anxiety disorders, somatoform disorders, alcohol abuse as well as frequency of utilization of health care services are assessed. Medical data will be abstracted from medical charts and include somatic comorbidities, medication and diagnostic procedures and interventions during hospitalization.

Individual semi-structured interviews will be conducted with 30 patients to assess the treatment expectations and underlying motives for ED-visits, as well as with 30 health care professionals to investigate perceptions of challenges regarding identification and treatment of patients with MHC.

All patients will have a 6-months follow-up after discharge from the ED. The follow-up is conducted either by telephone calls, e-mail or via mail. The follow-up data will include mental health conditions as assessed at baseline, frequency of utilization of health care services and health-related quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: April 30, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting to one of the EDs in Berlin-Mitte due to cardiac complaints (acute heart failure, angina pectoris, dyspnea, arrhythmias)

• Age 50 and older

Exclusion Criteria:

• Age 49 and younger

• Inability to give written informed consent (cognitive impairment, legal guardianship)

• Insufficient language skills to complete the questionnaire in one of the provided languages (German, English, Russian, Turkish)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Anxiety
• Depression
• Disease
• Somatoform Disorders

Locations

Country	Name	City	State
Germany	Division of Emergency Medicine, Charité University Hospital	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health conditions	Proportion of patients with a high self-reported symptom burden for at least one of four mental conditions: depression, anxiety disorders, somatoform disorders, alcohol abuse	Baseline
Secondary	Prevalence of mental disorders	Prevalence of mental disorders as assessed by structured clinical interview	Baseline
Secondary	Health outcomes	Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)	6-months follow-up
Secondary	Utilization of health care systems	Frequency of health care system utilization before ED visit	Baseline
Secondary	Utilization of health care systems	Frequency of health care system utilization after ED visit	6-months follow-up
Secondary	Expectations towards ED-care, semi-structured qualitative interviews	Patient (n˜30) and providers (n˜30) expectations towards ED-care and psychological care, assessed in a qualitative interview and categorized on the basis of qualitative methods	Baseline

External Links

•   project web page