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DepressionRED-DNCT01840826

Reducing Hospital Readmissions in Patients With Depressive Symptoms

A study testing RED-D Care Management in people with Depression, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
RED-D Care Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
709 participants
Where
1 siteUnited States
Study dates
Feb 2013to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: 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.

Conditions
Depression
Being tested
RED-D Care Management
Keywords
Rehospitalization, Reutilization, Depressive Symptoms, Pharmacotherapy, Cognitive Therapy, Self-help, Complementary Therapies
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RED-D Care ManagementOther

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

Study groups in NCT01840826
Study groupRoleWhat they receive
RED-D Care ManagementExperimentalPatients 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.
Receives: Other: RED-D Care Management
RED and Behavioral Health ReferralNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days and 90 days post-discharge from hospital at index admission

  2. 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

    Measured: 30 & 90 days post discharge from index hospitalization

Secondary outcomes (2)

  1. 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.

    Measured: 90 & 180 after discharge from index hospitalization

  2. 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.

    Measured: 30 days and 90 days after discharge from index admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
709 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01840826
Sponsor's protocol ID
H-31632
Other IDs
1R01HS019700
Acronym
RED-D
Status last verified
Mar 2018
First submitted
18 Apr 2013
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 20577971

  • 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/

    PubMed 21249944

  • 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/

    PubMed 21249814

  • 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.

    PubMed 19502567

  • 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.

    PubMed 35606137

Questions about this trial

What is this clinical trial studying?

A study testing RED-D Care Management in people with Depression, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause readmission rates (time frame: 30 days and 90 days post-discharge from hospital at index admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01840826, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.

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