Family Meeting Study for End Stage Renal Disease

Study Overview
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Brief Summary
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A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

Detailed Description
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Patients hospitalized at Henry For Hospital who have end stage renal disease will complete baseline questionnaires and be randomized into the experimental or control condition. Patients randomized into the experimental condition will have a single family consultation session before the patient is discharged. A trained, master's level therapist will conduct the family consultation, which will use education, motivational interviewing, and other techniques to help the family engage and support the patient's health needs. Patients in both the experimental and control conditions will complete follow up questionnaires 1 month after discharge. Investigators will conduct chart reviews of outcome data, including readmissions, at 1, 3, and 6 months post-discharge.

Official Title
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Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Behavioral: Family Consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized in inpatient Nephrology Unit at Henry Ford Hospital Has end-stage renal disease Willing and able to contact support person / family member about participating in the study Exclusion Criteria: Persistent Delirium Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Consultation Condition<br>The family consultation will be one, 1-hour session conducted by trained, master's level therapists. The goals of the meetings are: a) Review patient and family understanding of events that caused the hospital admission; b) increase family awareness of the level of cognitive impairment that the patient is experiencing; c) discuss ways the family can get involved and help the patient with their medication and dialysis adherence; d) use motivational interviewing techniques as needed. This will be provided in addition to the usual care that inpatients receive in this unit. | Behavioral: Family Consultation<br>* This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.<br>|
| No Intervention: Treatment as Usual Control Condition<br>Standard of care for the nephrology unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Hospital Readmissions - 1 Month | Were patients readmitted to the hospital within 1 month of their initial discharge? | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Instrumental Social Support | Amount of involvement of support people in terms of disease management. Items modified from the Diabetes Social Support Questionnaire-Family. | Baseline and 1-month follow-up | 
| Change in Medication Adherence | Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale. | Baseline and 1-month follow-up | 
| Change in Depression | Assessed using Patient Health Questionnaire 8 | Baseline and 1-month follow-up | 
| Change in Anxiety | Assessed using Generalized Anxiety Disorder Questionnaire-7 | Baseline and 1-month follow-up | 
| Change in Biological Measures of Health | Based on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality | Baseline, 1, and 3 months | 
| Hospital Readmissions - 3 Months | Were patients readmitted to the hospital within 3 months of their initial discharge? | 3 Months |