NCT04581369: CMH

Cirrhosis Medical Home

Completed NA Results posted Last updated 17 July 2024

What this trial tests

NA trial testing Care Coordinator Intervention for Direct Intervention Group in Cirrhosis, Liver in 44 participants. Completed in 31 May 2023.

Timeline

17 September 2020

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	health services research
Enrollment	44
Start date	17 September 2020
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Care Coordinator Intervention for Direct Intervention Group
• Care Coordinator Intervention for Standard of Care Group
• Caregiver Intervention

Conditions studied

• Cirrhosis, Liver — all drugs for Cirrhosis, Liver →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Enrollment Rate Primary · Time of Enrollment

The proportion of screened patients eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics.

Group	Value	95% CI
Direct Intervention	20
Standard of Care	20

Number of Participants Who Dropped Out or Are Lost to Follow-up Primary · At drop out date or lost to follow-up date, which every comes first an average of 6 months

This is the proportion of enrolled participants (patients) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics.

Group	Value	95% CI
Direct Intervention	3
Standard of Care	7

Number of Participants With Complete Data Primary · Through study completion, an average of 6 months

Completeness of the data collection for enrolled subjects and reasons for incomplete data will be recorded. This is an internal assessment relating not to participants but to department specific metrics.

Group	Value	95% CI
Direct Intervention	4
Standard of Care	4
Caregiver	4

Acute Health Care Utilization Secondary · 6 months

This is an assessment of patient use of health care resources, including hospitalizations and Emergency room visits. For the patient only, data will be gathered from the patient and medical record relating to the participant's emergency room visits and hospital admissions/inpatient stays during the course of their enrollment in the study.

Group	Value	95% CI
Direct Intervention	17
Standard of Care	18
Caregiver	0

Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) Secondary · measure was completed at enrollment by patients only

Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.

Group	Value	95% CI
Direct Intervention	56	± 0.7
Standard of Care	58	± 0.7

Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) Secondary · measure was completed at 3 months by patients only

Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.

Group	Value	95% CI
Direct Intervention	84	± 0.8
Standard of Care	88	± 0.4

Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) Secondary · measure was completed at 6 months by patients only

Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.

Group	Value	95% CI
Direct Intervention	102	± 0.5
Standard of Care	100	± 0.7

Depression Symptoms Secondary · measure was completed at initial enrollment by patients only

Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.

Group	Value	95% CI
Direct Intervention	11	± 0.044
Standard of Care	14	± 0.11

Depression Symptoms Secondary · measure was completed at 3 months by patients only

Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.

Group	Value	95% CI
Direct Intervention	14	± 0.15
Standard of Care	14	± 0.11

Depression Symptoms Secondary · measure was completed at 6 months by patients only

Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.

Group	Value	95% CI
Direct Intervention	12	± 0.2
Standard of Care	18	± 0.18

Anxiety Symptoms Secondary · measure was completed at initial enrollment by patients only

Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.

Group	Value	95% CI
Direct Intervention	7	± 0.11
Standard of Care	9	± 0.11

Anxiety Symptoms Secondary · measure was completed at 3 months by patients only

Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.

Group	Value	95% CI
Direct Intervention	14	± 0.11
Standard of Care	14	± 0.15

Sponsor's own description

To address the health care system's lack of care coordination, the Institute of Medicine and Centers for Medicare and Medicaid Services recommend the development of collaborative care models (CCM) in a wide range of clinical settings. CCMs are intended to provide coordinated, personalized care pragmatically using care coordinators. CCMs have successfully improved care in multiple patient populations, ranging from frail older adults to depression. In contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of CCM in this medically complex and vulnerable population. At Indiana University, researchers have over 20 years of experience in developing, testing, and implementing CCMs successfully for patients living with dementia or depression. Building on these successes, we have customized the CCM to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the Cirrhosis Medical Home.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Cirrhosis Medical Home: A Pilot Randomized Trial of a Collaborative Care Model for Patients With Decompensated Cirrhosis.
   Orman ES, Desai AP, Kuchana SK, Campbell N, et al · · 2026 · PMID 41778640 · DOI 10.14309/ctg.0000000000001013