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Health IT Generated PROs to Improve Outcomes in Cirrhosis

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ClinicalTrials.gov Identifier: NCT03564626
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE June 22, 2018
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
Avoidable readmissions [ Time Frame: 30 days ]
Study the proportion of avoidable readmissions between groups and between centers
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03564626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • All readmissions [ Time Frame: 30 days ]
    All readmissions that occur between groups and between centers
  • Readmissions related to hepatic encephalopathy [ Time Frame: 30 days ]
    All hepatic encephalopathy-related readmissions that occur between groups and between centers
  • Readmissions related to ascites and anasarca [ Time Frame: 30 days ]
    All ascites/anasarca-related readmissions that occur between groups and between centers
  • Readmissions related to infections [ Time Frame: 30 days ]
    All infection-related readmissions that occur between groups and between centers
  • Opinions of patients and caregivers regarding App [ Time Frame: 30 days ]
    Determine usability for patients and caregivers regarding the App, measured by a 0-10 Likert scale with 10 indicating greatest usability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health IT Generated PROs to Improve Outcomes in Cirrhosis
Official Title  ICMJE Health IT Generated PROs to Improve Outcomes in Cirrhosis
Brief Summary SPECIFIC AIM 1: To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care.
Detailed Description Cirrhosis affects more than 6 million US patients and is a major burden on patients, caregivers and the healthcare system. Patients with cirrhosis are prone to clinical and psycho-social issues that may predict hospitalization, re-hospitalizations and death. Important patient-reported outcomes (PRO) such as impaired daily functioning, sleep, cognition and pain are widely prevalent in patients with cirrhosis. These changes can independently impact hospitalizations, re-hospitalizations and death in cirrhotic patients. The investigators have studied the impact of these PRO using traditional and computerized scales such as PROMIS (Patient-reported outcomes measurement information system). With the increasing spread of health-related electronic devices, the relevance of health IT in the management of chronic diseases such as cirrhosis is paramount. The team has already developed and used several health IT advances to educate patients and their caregivers in inpatient and outpatient settings. These tools are Patient Buddy to define patients regarding factor preventing readmission, and EncephalApp Stroop to detect cognitive dysfunction in cirrhosis. As part of a funded AHRQ R21, PatientBuddy, which has undergone multiple refinements in response to feedback from patients, caregivers and administering staff, is being used by the study team to prevent readmissions to Virginia Commonwealth University Medical Center (VCU). However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is an important step towards improvement in cirrhosis-related outcomes. In addition, PROs that are elicited and monitored when the patients are outside the hospital will advance the field by making them integral parts of clinical management.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cirrhosis
Intervention  ICMJE
  • Other: Health-IT Only
    • Training patient and caregiver on Patient Buddy and EncephalApp
    • Counseling regarding readmission
    • Daily contact through app
    • Standard of care counseling regarding readmission and discharge instructions
    • Follow up phone calls and visits per standard of care or as necessitated by app
  • Other: Health-IT + Scheduled Follow Up
    • Training patient and caregiver on Patient Buddy and EncephalApp
    • Counseling regarding readmission
    • Daily contact through app
    • Standard of care counseling regarding readmission and discharge instructions
    • Follow up phone calls at Week 1 and Week 3
    • In-person follow up visits at Week 2 and Week 4
Study Arms  ICMJE
  • No Intervention: Control Group
    Standard of care counseling and discharge instructions per local hospital policy. Standard of care follow up phone calls and visits at baseline and at 30 days. Follow-up will be for 30 days
  • Experimental: Health IT only
    Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline and at 30 days.Follow-up will be for 30 days
    Intervention: Other: Health-IT Only
  • Experimental: Health IT + Scheduled Follow Up
    Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline, scheduled at 15 days and at 30 days. In addition, scheduled phone calls will be performed at days 7 and 21.Follow-up will be for 30 days
    Intervention: Other: Health-IT + Scheduled Follow Up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 20, 2022
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Patient Inclusion Criteria:

  • Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
  • Adult caregiver and the patient living in the same house
  • Able to complete the Patient Buddy training and evaluation
  • Discharged home from the hospital
  • Discharge hospital as primary hospital base

Caregiver Inclusion Criteria:

  • Living in same dwelling as patient for the last ≥1 year
  • Able to complete the Patient Buddy training and evaluation
  • Familiar with the patient's routine

Patient Exclusion Criteria:

  • Elective hospitalization
  • Lack of an adult caregiver
  • Active alcohol/substance abuse within 1 month of the hospitalization
  • Unable to perform training or give consent
  • Patients discharged to hospice, nursing home or extended care facilities

Caregiver Exclusion Criteria

  • Unable or unwilling to train or adhere to study guidelines
  • Unfamiliar with the patient routines
  • Not in the same house as the patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jasmohan S Bajaj, MD 8046755021 jsbajaj@vcu.edu
Contact: Melanie B White, RN 8048289780 mbwhite@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03564626
Other Study ID Numbers  ICMJE HM20003950 multisite extension
1R01HS025412-01A1 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Jasmohan S Bajaj, MD VCU Medical Center
PRS Account Virginia Commonwealth University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP