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Withdrawn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
About this trial
This is an interventional treatment trial for Depression
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.
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
NCT ID
NCT03056183
First Posted
February 14, 2017
Last Updated
July 27, 2019
Sponsor
Cedars-Sinai Medical Center
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
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Care Transitions for Patients With Depression
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