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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

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Other: Health-IT Only Other: Health-IT + Scheduled Follow Up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Health IT Generated PROs to Improve Outcomes in Cirrhosis
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Avoidable readmissions [ Time Frame: 30 days ]
    Study the proportion of avoidable readmissions between groups and between centers


Secondary Outcome Measures :
  1. All readmissions [ Time Frame: 30 days ]
    All readmissions that occur between groups and between centers

  2. Readmissions related to hepatic encephalopathy [ Time Frame: 30 days ]
    All hepatic encephalopathy-related readmissions that occur between groups and between centers

  3. Readmissions related to ascites and anasarca [ Time Frame: 30 days ]
    All ascites/anasarca-related readmissions that occur between groups and between centers

  4. Readmissions related to infections [ Time Frame: 30 days ]
    All infection-related readmissions that occur between groups and between centers

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564626


Contacts
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Contact: Jasmohan S Bajaj, MD 8046755021 jsbajaj@vcu.edu
Contact: Melanie B White, RN 8048289780 mbwhite@vcu.edu

Locations
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United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Amy Olofson    507-284-2511    olofson.amy@mayo.edu   
Principal Investigator: Patrick Kamath, MD         
United States, Virginia
Hunter Holmes McGuire VA Medical Center Not yet recruiting
Richmond, Virginia, United States, 23249
Contact: Jasmohan Bajaj, MD    804-675-5021    jasmohan.bajaj@vcuhealth.org   
Contact: Edith A Gavis, RN    804 675 5584    edith.gavis@va.gov   
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Melanie B White, BSN, RN    804-828-9780    mbwhite@vcu.edu   
Contact: Jasmohan S Bajaj, MD, MSc    804 675 5802    jsbajaj@vcu.edu   
Principal Investigator: Jasmohan S Bajaj, MD, MSc         
Sponsors and Collaborators
Virginia Commonwealth University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Jasmohan S Bajaj, MD VCU Medical Center

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03564626     History of Changes
Other Study ID Numbers: HM20003950 multisite extension
1R01HS025412-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases