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Completed

NCT Number: NCT01840826

Reducing Hospital Readmissions in 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RED-D Care Management

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Reducing Hospital Readmission Among Medical Patients With Depressive Symptoms

Acronym: RED-D

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2013
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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