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

5 april 2013 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

264

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02118
        • Boston Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Andra namn:
  • TLC-C
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Acute Hospital Care Utilization
Tidsram: 3 months
3 months
Acute Hospital Care Utilization
Tidsram: 6 months
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient Quality of Life
Tidsram: 3 months
3 months
Ambulatory Appointment Show Rate
Tidsram: 3 months
3 months
Patient Quality of Life
Tidsram: 6 months
6 months
Patient Satisfaction
Tidsram: 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
Tidsram: 6 months
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Brian Jack, MD, Boston Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2008

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

1 april 2013

Studieregistreringsdatum

Först inskickad

29 juni 2011

Först inskickad som uppfyllde QC-kriterierna

20 oktober 2011

Första postat (Uppskatta)

24 oktober 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 april 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 april 2013

Senast verifierad

1 april 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H-27747

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