Reducing Hospital Readmissions in Patients With Depressive Symptoms

NCT ID: NCT01840826

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

709 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RED-D Care Management

Intervention Type OTHER

The Case Management intervention will continue for 12 weeks post-discharge (from the index admission).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RED-D Care Management

The Case Management intervention will continue for 12 weeks post-discharge (from the index admission).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian Jack

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian W Jack, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20577971 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 21249944 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 21249814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19502567 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35606137 (View on PubMed)

Related Links

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Other Identifiers

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1R01HS019700

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

H-31632

Identifier Type: -

Identifier Source: org_study_id

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