Improving Medical Decision Making for Older Patients With End Stage Renal Disease

Palliative Care Clinical Trial

— VIDEO-KD  

Official title:

Improving Medical Decision Making for Older Patients With End Stage Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347629
• Other study ID #: H-39981
• Secondary ID: 1R01AG066892
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Tufts Medical Center
• Contact: Michael Paasche-Orlow, MD MPH
• Phone: 617-636-1029
• Email: michael.paasche-orlow[@]tuftsmedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.

Description:

The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet. The video will be shared with their nephrologist. The patient will have a copy of the video to take with them and share with their loved ones.

Patients will answer survey questions about their preferences, knowledge, decisional conflict, and ACP engagement. They will be surveyed every two months for one year or death (if they die before one year).

Potential participants will be recruited from 10 nephrology clinics: Massachusetts General Hospital (n=75), Brigham and Women's Hospital (n=75), University of Pittsburgh (n=75), University of Pennsylvania, Stanford University, Palo Alto Veterans Institute for Research, University of Washington, Renal & Transplant Associates of New England, University of New Mexico and Boston Medical Center.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients age =70 are eligible if they have EITHER Advanced CKD defined as ONE eGFR value = 30 ml/min/1.73m2 in the past 12 months NOT determined to be a result of AKI OR Have a diagnosis of CKD and less than a two-year prognosis from any cause, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")

• Patients age 65-69 are eligible if they have BOTH Advanced CKD defined as ONE eGFR value = 30 ml/min/1.73m2 NOT determined to be a result of AKI AND Have less than a two-year prognosis, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")

• Patients who have not had a nephrology visit in the past 12 months can be recruited from non-Nephrology Clinics per the above eligibility criteria

Exclusion Criteria:

• listed for kidney transplantation or previous transplant recipient

• already on or previously on dialysis (including emergent dialysis)

• new patient visit

• visually impaired beyond 20/200 corrected

• psychological state not appropriate for ACP discussions as determined by the primary nephrologist

• cognitive impairment

Related Conditions & MeSH terms

• Decision Aids
• Kidney Diseases
• Kidney Failure, Chronic
• Palliative Care
• Renal Disease, End Stage

Intervention

Behavioral:
• Advance Care Planning Video Decision Aid
The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.

Locations

Country	Name	City	State
United States	The University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Stanford University	Palo Alto	California
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation	Documentation in the electronic health record reflecting an ACP conversation (any of the following: completion of advance directive or physician order for life sustaining treatment (POLST); code status documentation; provider note reflecting ACP discussion).	Baseline, 12 months
Secondary	Change in ACP Engagement	4 investigator designed questions about actions patient has taken with regards to ACP	baseline, 12 months
Secondary	Change in ACP Preferences	survey assessment	Baseline, 12 months
Secondary	Change in ACP Conversations	3 investigator designed questions about conversations with family/friends about ACP	Baseline, 12 months
Secondary	Change in Kidney Disease (KD) Specific Quality of Life (QOL)	KD-QOL is a validated instrument to assess QOL that includes 36 questions with response options in likert scale format. The outcome measure is the difference in averaged scores between baseline and 12 months; It is calculated as (Score at visit 2 - Score at visit 1).; QOL is assessed by three components; physical health score, mental health score and kidney disease health score. Physical health score, mental health score and kidney disease health score are averaged scores of sub-scales. The range of each score and each sub-scale are 0 - 100, and higher values indicate better QOL status.	Baseline, 12 months
Secondary	Change in Health Related Quality of Life (QoL)	Health related quality of life will be assessed using a validated instrument EuroQol-5D (EQ-5D) which has two components. There is a descriptive system with 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. the other component is a visual analogue scale (VAS) that records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.	Baseline, 12 months
Secondary	Change in Decisional Conflict	We will measure decisional conflict using the decisional conflict scale (DCS), which attempts to measure decisional uncertainty.	Baseline, 12 months
Secondary	Acceptability of video intervention	For those patients randomized to the video intervention, we will measure, via survey, acceptability of the decision aid using a modified version of the validated Yorkshire Dialysis Decision Aid Usefulness Scale. We will also ask questions regarding comfort viewing the video, which we have validated in our prior work.	Baseline
Secondary	Change in CKD Care Preferences	All patients will be asked their preferences for kidney failure care at baseline. We will then assess their follow-up preferences by chart review in the electronic medical record.	Baseline, 12 months
Secondary	Healthcare Costs	We will identify the major components of healthcare services used, including inpatient, pharmacy, outpatient, emergency department and dialysis. We will also examine utilization by subgroups with comorbidity of diabetes, heart failure and cardiovascular disease. We will use Medicare claims data to obtain the associated costs, including payments by Medicare and secondary payers (e.g., out-of-pocket payments).	Baseline, 12 months