Family Meeting Study for End Stage Renal Disease

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

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Behavioral: Family Consultation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Consultation Condition; 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; This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.
No Intervention: Treatment as Usual Control Condition; Standard of care for the nephrology unit.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mark A. Lumley
• Collaborators: Henry Ford Health System
• Investigators: Principal Investigator: Mark W Ketterer, Ph.D., Henry Ford Health Systems

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 18, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: HFHS IRB 9714