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

N/AActive Not RecruitingNCT04347629

Tufts Medical Center456 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

456

Conditions

Renal Disease, End Stage Palliative Care Decision Aids

Interventions

Advance Care Planning Video Decision AidBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University

Palo Alto, California, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, 12 months

Secondary Outcomes

Change in ACP Engagement

4 investigator designed questions about actions patient has taken with regards to ACP

Time frame: baseline, 12 months

Change in ACP Preferences

survey assessment

Time frame: Baseline, 12 months

Change in ACP Conversations

3 investigator designed questions about conversations with family/friends about ACP

Time frame: Baseline, 12 months

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.

Time frame: Baseline, 12 months

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'.

Data from ClinicalTrials.gov

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