Family Meeting Study for End Stage Renal Disease

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504021
• Other study ID #: HFHS IRB 9714
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: September 18, 2017
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Family Consultation
This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Mark A. Lumley	Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Hospital Readmissions - 1 Month	Were patients readmitted to the hospital within 1 month of their initial discharge?	1 Month
Secondary	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
Secondary	Change in Medication Adherence	Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.	Baseline and 1-month follow-up
Secondary	Change in Depression	Assessed using Patient Health Questionnaire 8	Baseline and 1-month follow-up
Secondary	Change in Anxiety	Assessed using Generalized Anxiety Disorder Questionnaire-7	Baseline and 1-month follow-up
Secondary	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
Secondary	Hospital Readmissions - 3 Months	Were patients readmitted to the hospital within 3 months of their initial discharge?	3 Months