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Care Transitions for Patients With Depression

Primary Purpose

Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Depression Care Transitions (DCT)
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants older than the age of 18, admitted to Cedars-Sinai Medical Center, English speaking, and answers "yes" to either question on the PHQ-2 instrument.

Exclusion Criteria:

  • Participants under the age of 18, non-English speaking, and does not answer "yes" to either question on the PHQ-2 instrument.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment Group

    Control Group - Standard of Care

    Arm Description

    Patients in the Depression Care Transitions intervention will have a Transitional Care Social Worker who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.

    To be followed per standard of care and data from their medical records will be reviewed.

    Outcomes

    Primary Outcome Measures

    Transitional Care
    Patients in the DCT intervention will have a Transitional Care Social Worker (TCSW) who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.

    Secondary Outcome Measures

    Depression Surveys
    All patients who are admitted to CSMC are screened for depression using the PHQ instrument (Kroenke, Spitzer, & Williams, 2001). Patients are asked two questions about frequent occurrence of cardinal depressive symptoms - sadness and anhedonia - and provide yes/no answers to the intake nurse (PHQ-2). If patients answer, "yes" to either question, they are administered the complete PHQ-9 instrument. Per the CSMC depression screening protocol, if patients score >12 on the PHQ-9, a social worker evaluation, and notification of the admitting physician and psychiatry, will take place. The subjects will be identified through the psychiatrist who will discuss the risks and benefits of study participation, and assess the patient's interest in the study.

    Full Information

    First Posted
    February 14, 2017
    Last Updated
    July 27, 2019
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03056183
    Brief Title
    Care Transitions for Patients With Depression
    Official Title
    Care Transitions for Medically Ill Patients With Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    not funded
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim 1: To collect data on a Depression Care Transition (DCT) program's association with self-care behaviors as measured by medication adherence and clinic visit attendance, after discharge. Hypothesis 1: Compared with usual care, patients who receive the DCT intervention will have significantly greater medication adherence and clinic visit attendance, at 30, 90, and 365 days after discharge. Aim 2: To collect data on DCT's association with clinical/health outcomes as measured by depression severity, functional status, and overall physical and mental health, after discharge. Hypothesis 2: Compared with usual care, patients who receive the DCT intervention will have significantly larger improvements in depression severity, functional status, and overall physical & mental health at 30, 90, and 365 days after discharge. Aim 3: To collect data on DCT's association with utilization outcomes as measured by readmissions, length of subsequent hospital stays, and cost of care, after discharge. Hypothesis 3: Compared with usual care, patients who receive the DCT intervention will have significantly lower hospital readmissions, shortened length of subsequent hospital stays and lower cost of care, at 30, 90, and 365 days of discharge. Leading the research team are a psychiatrist (Dr. IsHak - PI) and a hospitalist (Dr. Nuckols - Co-I) with an advanced and well-established track record of health services research/scholarship in the fields of depression, outcome measurement, and economic implications of improving the quality and safety of health care.
    Detailed Description
    This study will contribute to advancing the science of continuity of care delivery for depressed medical inpatients by collecting data on the impact of a modified evidence-based care transition model on clinical/health and utilization outcomes of depression in medically ill inpatients. The study could generate evidence to support the inpatient application of the USPSTF guidelines for screening adults for depression through staff-assisted depression care systems including follow-up and continuity of care. This study will add to the existing outpatient evidence for identification and treatment of depression in improving outcomes (Simon et al., 2001;O'Connor et al., 2013), the crucial aspect of inpatient evidence for depression identification, treatment, and continuity of care/care transitions in improving clinical/health and utilization outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    Patients in the Depression Care Transitions intervention will have a Transitional Care Social Worker who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.
    Arm Title
    Control Group - Standard of Care
    Arm Type
    No Intervention
    Arm Description
    To be followed per standard of care and data from their medical records will be reviewed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Depression Care Transitions (DCT)
    Intervention Description
    DCT Intervention group - Patients in the DCT intervention will have a Transitional Care Social Worker (TCSW) who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.
    Primary Outcome Measure Information:
    Title
    Transitional Care
    Description
    Patients in the DCT intervention will have a Transitional Care Social Worker (TCSW) who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.
    Time Frame
    365 days
    Secondary Outcome Measure Information:
    Title
    Depression Surveys
    Description
    All patients who are admitted to CSMC are screened for depression using the PHQ instrument (Kroenke, Spitzer, & Williams, 2001). Patients are asked two questions about frequent occurrence of cardinal depressive symptoms - sadness and anhedonia - and provide yes/no answers to the intake nurse (PHQ-2). If patients answer, "yes" to either question, they are administered the complete PHQ-9 instrument. Per the CSMC depression screening protocol, if patients score >12 on the PHQ-9, a social worker evaluation, and notification of the admitting physician and psychiatry, will take place. The subjects will be identified through the psychiatrist who will discuss the risks and benefits of study participation, and assess the patient's interest in the study.
    Time Frame
    365 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants older than the age of 18, admitted to Cedars-Sinai Medical Center, English speaking, and answers "yes" to either question on the PHQ-2 instrument. Exclusion Criteria: Participants under the age of 18, non-English speaking, and does not answer "yes" to either question on the PHQ-2 instrument.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Waguih IsHak, MD
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Care Transitions for Patients With Depression

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