Family Meeting Study for End Stage Renal Disease

Not Applicable

Completed

• Conditions: End-stage Renal Disease
• Interventions: Behavioral: Family Consultation

• Registration Number: NCT02504021
• Lead Sponsor: Mark A. Lumley

Brief 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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-18
• Study First Posted: 2015-07-21
• Primary Completion: 2016-05
• Study Completion: 2016-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Consultation Condition	Family Consultation	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.

Primary Outcome Measures

Name	Time	Method
Early Hospital Readmissions - 1 Month	1 Month	Were patients readmitted to the hospital within 1 month of their initial discharge?

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States