search
Back to results

Family Meeting Study for End Stage Renal Disease

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Consultation
Sponsored by
Mark A. Lumley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family Consultation Condition

Treatment as Usual Control Condition

Arm Description

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.

Standard of care for the nephrology unit.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Change in Medication Adherence
Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.
Change in Depression
Assessed using Patient Health Questionnaire 8
Change in Anxiety
Assessed using Generalized Anxiety Disorder Questionnaire-7
Change in Biological Measures of Health
Based on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality
Hospital Readmissions - 3 Months
Were patients readmitted to the hospital within 3 months of their initial discharge?

Full Information

First Posted
July 14, 2015
Last Updated
September 18, 2017
Sponsor
Mark A. Lumley
Collaborators
Henry Ford Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT02504021
Brief Title
Family Meeting Study for End Stage Renal Disease
Official Title
Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark A. Lumley
Collaborators
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Consultation Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual Control Condition
Arm Type
No Intervention
Arm Description
Standard of care for the nephrology unit.
Intervention Type
Behavioral
Intervention Name(s)
Family Consultation
Intervention Description
This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.
Primary Outcome Measure Information:
Title
Early Hospital Readmissions - 1 Month
Description
Were patients readmitted to the hospital within 1 month of their initial discharge?
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Change in Instrumental Social Support
Description
Amount of involvement of support people in terms of disease management. Items modified from the Diabetes Social Support Questionnaire-Family.
Time Frame
Baseline and 1-month follow-up
Title
Change in Medication Adherence
Description
Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.
Time Frame
Baseline and 1-month follow-up
Title
Change in Depression
Description
Assessed using Patient Health Questionnaire 8
Time Frame
Baseline and 1-month follow-up
Title
Change in Anxiety
Description
Assessed using Generalized Anxiety Disorder Questionnaire-7
Time Frame
Baseline and 1-month follow-up
Title
Change in Biological Measures of Health
Description
Based on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality
Time Frame
Baseline, 1, and 3 months
Title
Hospital Readmissions - 3 Months
Description
Were patients readmitted to the hospital within 3 months of their initial discharge?
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Ketterer, Ph.D.
Organizational Affiliation
Henry Ford Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Family Meeting Study for End Stage Renal Disease

We'll reach out to this number within 24 hrs