Care Transitions for Patients With Depression

NCT03056183 | Withdrawn

• 1 other identifier: Pro00045116
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  365 days

Secondary Outcomes (1)

• Depression Surveys

  365 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: Depression Care Transitions (DCT)

Control Group - Standard of Care

NO INTERVENTION

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

Interventions

Depression Care Transitions (DCT) BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Waguih IsHak, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Education and Research

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 17, 2017
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share