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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Other: RED-D Care Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||709 participants|
|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|
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.
- 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
- 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
- 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.
- 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.
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
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Brian W Jack, MD||Boston University|