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Trial record 46 of 130 for:    complementary and alternative medicine AND quality

Reducing Hospital Readmissions in Patients With Depressive Symptoms (RED-D)

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ClinicalTrials.gov Identifier: NCT01840826
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Brian Jack, Boston Medical Center

Brief Summary:
Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who received the RED were 30% less likely than patients receiving usual care to access inpatient or emergency services within 30 days of discharge. In this project, the investigators add a new dimension to RED by integrating screening, referral and treatment for depression into the original RED intervention and determining if this enhanced intervention increases the effectiveness of RED in preventing readmissions and controlling costs in the 180 days after discharge for patients with signs of depression.

Condition or disease Intervention/treatment Phase
Depression Other: RED-D Care Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 709 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Hospital Readmission Among Medical Patients With Depressive Symptoms
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RED-D Care Management
Patients randomized to receive the Intervention work with a RED-D Care Manager post-discharge. The Care Manager meets with the patient in the hospital, prior to discharge, and post-discharge via weekly phone calls. Patients have access to a range of treatment options, overseen by the Care Manager, including: (1) medication; (2) cognitive behavioral therapy (CBT); (3) complementary and alternative medicine (CAM) information and referral; (4) Self-help, such as reading a book, making a change in diet and/or exercise in order to improve mood; (5) active surveillance; and (6) any combination of 1, 2, 3, 4 & 5.
Other: RED-D Care Management
The Case Management intervention will continue for 12 weeks post-discharge (from the index admission).

No Intervention: RED and Behavioral Health Referral
Patients randomized to the "control" group will receive the regular RED intervention, including a follow-up phone call two days post-discharge from the hospital to review and confirm medications, and a referral to behavioral health.



Primary Outcome Measures :
  1. All-cause readmission rates [ Time Frame: 30 days and 90 days post-discharge from hospital at index admission ]
    The primary hypothesis is to test whether the RED intervention plus the collaborative-care approach for depression (RED-D) will reduce the all-cause 30 and 90 day hospital readmission rates for patients who screen positive for depressive symptoms

  2. All-cause reutilization rates [ Time Frame: 30 & 90 days post discharge from index hospitalization ]
    The primary hypothesis is to test whether the RED intervention plus the collaborative-care approach for depression (RED-D) will reduce the all-cause 30 and 90 day hospital utilization rates for patients who screen positive for depressive symptoms


Secondary Outcome Measures :
  1. cost-saving [ Time Frame: 90 & 180 after discharge from index hospitalization ]
    The economic analysis will investigate whether the two interventions are cost saving and whether the RED-D intervention is more cost saving than the RED intervention alone. The principal source of the savings is likely to be from reduced rehospitalizations within the 90 days of study follow-up. Hospital administrative records and insurance company data will be used to gather cost data. Additional costs of the two interventions will be estimated by costing staff time and other resources used. Cost-savings will be estimated by t-test comparisons of the mean costs for the groups; given randomization of patient assignment these will provide unbiased estimates.

  2. Mental Health Related Quality of Life [ Time Frame: 30 days and 90 days after discharge from index admission ]
    The impact of the RED-D Collaborative Care Intervention mental health related quality of life will be ascertained using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Work and Social Adjustment Scale (WSAS) . The investigators will test whether collaborative care for depression can produce a clinically meaningful improvement in mental health related quality of life compared to those patients receiving either usual care or the RED discharge alone.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Admitted to any Boston Medical Center inpatient service or for observation
  • Screen positive for depressive symptoms (Patient Health Questionnaire - 2 >/= 3)
  • Speaks English with health care providers
  • Has access to a telephone
  • Live in the Boston area and don't plan on leaving the Boston area for more than 2 weeks in the next 6 months
  • Screen positive for depressive symptoms (PHQ -9 >/= 10)

Exclusion Criteria:

  • Has plans for inpatient rehabilitation, nursing home, or other institutional settings after discharge.
  • Suicidal precautions
  • Sickle Cell Crisis (SCC)
  • Alcohol and/or drug dependence
  • Diagnosis of Bipolar Disorder, Schizophrenia or other Psychotic Disorder
  • In police custody

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840826


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Brian W Jack, MD Boston University

Additional Information:
Publications:
Responsible Party: Brian Jack, Professor and Chair, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01840826     History of Changes
Other Study ID Numbers: H-31632
1R01HS019700 ( U.S. AHRQ Grant/Contract )
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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 Brian Jack, Boston Medical Center:
Rehospitalization
Reutilization
Depressive Symptoms
Pharmacotherapy
Cognitive Therapy
Self-help
Complementary Therapies

Additional relevant MeSH terms:
Depression
Behavioral Symptoms