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

Reducing Hospital Readmission Among Medical Patients With Depressive Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: RED-D Care Management

• Study Type: Interventional
• Enrollment (Actual): 709
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause readmission rates	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	30 days and 90 days post-discharge from hospital at index admission
All-cause reutilization rates	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	30 & 90 days post discharge from index hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost-saving	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.	90 & 180 after discharge from index hospitalization
Mental Health Related Quality of Life	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.	30 days and 90 days after discharge from index admission

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

General Publications

• Mitchell SE, Paasche-Orlow MK, Forsythe SR, Chetty VK, O'Donnell JK, Greenwald JL, Culpepper L, Jack BW. Post-discharge hospital utilization among adult medical inpatients with depressive symptoms. J Hosp Med. 2010 Sep;5(7):378-84. doi: 10.1002/jhm.673.
• Jack B, Greenwald J, Forsythe S, O'Donnell J, Johnson A, Schipelliti L, Goodwin M, Burniske GM, Hesko C, Paasche-Orlow M, Manasseh C, Anthony D, Martin S, Hollister L, Jack M, Jhaveri V, Casey K, Chetty VK. Developing the Tools to Administer a Comprehensive Hospital Discharge Program: The ReEngineered Discharge (RED) Program. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 3: Performance and Tools). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43688/
• Anthony D, Chetty VK, Kartha A, McKenna K, DePaoli MR, Jack B. Re-engineering the Hospital Discharge: An Example of a Multifaceted Process Evaluation. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20484/
• Clancy CM. Reengineering hospital discharge: a protocol to improve patient safety, reduce costs, and boost patient satisfaction. Am J Med Qual. 2009 Jul-Aug;24(4):344-6. doi: 10.1177/1062860609338131. Epub 2009 Jun 5. No abstract available.
• Mitchell SE, Reichert M, Howard JM, Krizman K, Bragg A, Huffaker M, Parker K, Cawley M, Roberts HW, Sung Y, Brown J, Culpepper L, Cabral HJ, Jack BW. Reducing Readmission of Hospitalized Patients With Depressive Symptoms: A Randomized Trial. Ann Fam Med. 2022 May-Jun;20(3):246-254. doi: 10.1370/afm.2801.

Helpful Links

• Project RED Website Homepage

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Self-help; Complementary Therapies; Pharmacotherapy; Cognitive Therapy; Depressive Symptoms; Rehospitalization; Reutilization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: H-31632; 1R01HS019700 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No