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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT03188861
Collaborator
German Federal Ministry of Education and Research (Other)
650
1
22.9
28.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Systematic Screening for Comorbid Psychological Conditions in Cardiac Ambulatory Care Sensitive Conditions (ACSC) Patients With Multimorbidity in the Emergency Departments (ED)
    Actual Study Start Date :
    Jun 1, 2017
    Anticipated Primary Completion Date :
    Aug 31, 2018
    Anticipated Study Completion Date :
    Apr 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Mental health conditions [Baseline]

      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

    Secondary Outcome Measures

    1. Prevalence of mental disorders [Baseline]

      Prevalence of mental disorders as assessed by structured clinical interview

    2. Health outcomes [6-months follow-up]

      Patient-reported health outcomes after 6 months ((Mental health conditions: Depression, anxiety, somatoform symptoms, alcohol abuse) and Quality of life)

    3. Utilization of health care systems [Baseline]

      Frequency of health care system utilization before ED visit

    4. Utilization of health care systems [6-months follow-up]

      Frequency of health care system utilization after ED visit

    5. Expectations towards ED-care, semi-structured qualitative interviews [Baseline]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Emergency Medicine, Charité University Hospital Berlin Germany

    Sponsors and Collaborators

    • Charite University, Berlin, Germany
    • German Federal Ministry of Education and Research

    Investigators

    • Principal Investigator: Martin Möckel, Prof. Dr., Division of Emergency Medicine, Charité University Hospital Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Martin Moeckel, Prof. Dr., Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03188861
    Other Study ID Numbers:
    • EA1/363/16
    • 0133/17/ST3
    First Posted:
    Jun 16, 2017
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Martin Moeckel, Prof. Dr., Charite University, Berlin, Germany
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2018