Reducing Hospital Readmissions in Patients With Depressive Symptoms (RED-D)
6. mars 2018 oppdatert av: Brian Jack, Boston Medical Center
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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
709
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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The Case Management intervention will continue for 12 weeks post-discharge (from the index admission).
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause readmission rates
Tidsramme: 30 days and 90 days post-discharge from hospital at index admission
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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
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30 days and 90 days post-discharge from hospital at index admission
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All-cause reutilization rates
Tidsramme: 30 & 90 days post discharge from index hospitalization
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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
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30 & 90 days post discharge from index hospitalization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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cost-saving
Tidsramme: 90 & 180 after discharge from index hospitalization
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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.
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90 & 180 after discharge from index hospitalization
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Mental Health Related Quality of Life
Tidsramme: 30 days and 90 days after discharge from index admission
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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.
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30 days and 90 days after discharge from index admission
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2013
Primær fullføring (Faktiske)
1. februar 2018
Studiet fullført (Faktiske)
1. februar 2018
Datoer for studieregistrering
Først innsendt
18. april 2013
Først innsendt som oppfylte QC-kriteriene
23. april 2013
Først lagt ut (Anslag)
26. april 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-31632
- 1R01HS019700 (U.S.A. AHRQ-stipend/kontrakt)
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