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Study of PhoneCare System to Treat Patients With Chronic Diseases (ComplexPt)

5. april 2013 oppdatert av: Boston Medical Center

A Randomized Trial of the PhoneCare System to Improve Ambulatory Care for Patients With Chronic Diseases

The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex Patients (TLC-C) in the care of patients with complex health care needs. These are patients frequently transitioning from inpatient to ambulatory care with multiple chronic diseases that tend to lead to increased health-care utilization and other socio-economic vulnerabilities. The objective is to reduce preventable hospital utilization, improve quality of life, increase satisfaction with ambulatory care, improve disease-specific metrics, and reduce net payer costs.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

TLC-C is a modification of an existing TLC-Multi-Disease system that targets patients with multiple chronic diseases combined with a post-hospital discharge intervention (TLC-RED-Lit). TLC-C uses conversational computer telephony to monitor patients' multiple diseases between their ambulatory care visits. The system works in both routine (patient stable) and exacerbation (patient unstable) modes. The system monitors patients through "virtual visits" and detects and notifies clinicians about important clinical problems to attend to. It also promotes patient self-care (e.g., medication adherence and appointment preparation). In emergent situations the system recommends going to the local Emergency Department (ED). In urgent situations, an alert is sent to the clinician or to his/her coverage provider. Exacerbation mode is used when the patient is discharged from a hospital inpatient service or ED or has worsening symptoms. It concentrates on the exacerbating disease and monitors patient status (improved, stable or deteriorating). Daily contact is maintained until the patient's status improves. Routine mode occurs with the patient at their baseline status and monitors the disease and the patients' self-care behaviors.

The investigators propose to perform a multi-method evaluation study of the patients, the providers, and the practice. This includes a 2-arm randomized clinical trial of TLC-C versus usual care for patients with two or more chronic diseases, at least one previous episode of acute hospital utilization over the last 12 months, and who had been recently discharged from an urban hospital. The randomized clinical trial (RCT) will evaluate the system in 440 patients followed for 6 months.

The primary outcome is acute hospital care utilization (unplanned hospitalizations and ED visits). Secondary outcomes include patient quality of life (EuroQol 5D [EQ-5D]), satisfaction (Clinician and Group Survey [G-CAHPS]), ambulatory appointment show rate and net payer costs. The investigators will explore disease specific metrics (e.g., hemoglobin A1c [HbA1c] or blood pressure). The investigators will perform formative and summative qualitative studies of the implementation of the system, its use and performance over time, and its impact on the patients, providers and the practice as a whole.

Studietype

Intervensjonell

Registrering (Faktiske)

264

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center

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

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • age 18 years or more
  • on one of Boston Medical Center (BMC)'s general medical services with an unscheduled hospitalization
  • has a primary care provider in the BMC General Internal Medicine (GIM) practice or Family Medicine practice or is willing to be assigned a primary care physician (PCP) at BMC GIM or Family Medicine practice upon discharge
  • once discharged, patient is planning to continue his/her primary care at BMC for the next 6 months
  • communicates in English adequately to participate

Exclusion Criteria:

  • patients who are admitted from hospice, nursing home or another institutional setting
  • patients who are in police custody or have a suicide sitter
  • patients who cannot use a telephone unassisted or who do not have regular access to either a land line or cellular telephone for the next 6 months
  • patients unwilling to accept calls to his/her phone for the next 6 months
  • patients currently enrolled in this study or in the RED-Lit trial
  • patients unable to independently consent to participate
  • patients who have sickle cell anemia
  • patients responding positively to the question on the Patient Health Questionnaire (PHQ-9) regarding suicidal ideation

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
Eksperimentell: PhoneCare system
This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.
The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex Patients (TLC-C) in the care of patients with complex health care needs. TLC-C uses conversational computer telephony to monitor patients' multiple diseases between their ambulatory care visits. The system monitors patients through "virtual visits" and detects and notifies clinicians about important clinical problems to attend to. It also promotes patient self-care (e.g., medication adherence and appointment preparation).
Andre navn:
  • TLC-C
Ingen inngripen: Control Group: without PhoneCare System
Subjects in this arm will receive the usual care. Usual care is defined as receiving regular care from their physicians and no additional care or intervention from the study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Acute Hospital Care Utilization
Tidsramme: 3 months
3 months
Acute Hospital Care Utilization
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Quality of Life
Tidsramme: 3 months
3 months
Ambulatory Appointment Show Rate
Tidsramme: 3 months
3 months
Patient Quality of Life
Tidsramme: 6 months
6 months
Patient Satisfaction
Tidsramme: 6 months
A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system.
6 months
Ambulatory Appointment Show Rate
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Brian Jack, MD, Boston Medical Center

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

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

1. september 2008

Primær fullføring (Faktiske)

1. april 2013

Studiet fullført (Faktiske)

1. april 2013

Datoer for studieregistrering

Først innsendt

29. juni 2011

Først innsendt som oppfylte QC-kriteriene

20. oktober 2011

Først lagt ut (Anslag)

24. oktober 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-27747

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