Improving Medical Decision Making for Older Patients With End Stage Renal Disease (VIDEO-KD)

• ClinicalTrials.gov Identifier: NCT04347629
• Recruitment Status: Recruiting
• First Posted: April 15, 2020
• Last Update Posted: February 20, 2024
• Sponsor: Tufts Medical Center
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Tufts Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Renal Disease, End Stage; Palliative Care; Decision Aids	Behavioral: Advance Care Planning Video Decision Aid	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Medical Decision Making for Older Patients With End Stage Renal Disease
• Actual Study Start Date: June 21, 2021
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care; Usual clinical care
Experimental: Video Decision Aid; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation [ Time Frame: Baseline, 12 months ]
   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).

Secondary Outcome Measures :

1. Change in ACP Engagement [ Time Frame: baseline, 12 months ]
   4 investigator designed questions about actions patient has taken with regards to ACP
2. Change in ACP Preferences [ Time Frame: Baseline, 12 months ]
   survey assessment
3. Change in ACP Conversations [ Time Frame: Baseline, 12 months ]
   3 investigator designed questions about conversations with family/friends about ACP
4. Change in Kidney Disease (KD) Specific Quality of Life (QOL) [ Time Frame: Baseline, 12 months ]

   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.

5. Change in Health Related Quality of Life (QoL) [ Time Frame: Baseline, 12 months ]
   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'.
6. Change in Decisional Conflict [ Time Frame: Baseline, 12 months ]
   We will measure decisional conflict using the decisional conflict scale (DCS), which attempts to measure decisional uncertainty.
7. Acceptability of video intervention [ Time Frame: Baseline ]
   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.
8. Change in CKD Care Preferences [ Time Frame: Baseline, 12 months ]
   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.
9. Healthcare Costs [ Time Frame: Baseline, 12 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Michael Paasche-Orlow, MD MPH; 617-636-1029; michael.paasche-orlow@tuftsmedicine.org

Locations

United States, California

VA Palo Alto Health Care System; Recruiting

Palo Alto, California, United States, 94034-1290

Contact: Manjula Tamura 650-493-5000 ext 63251 mktamura@stanford.edu

Stanford University; Recruiting

Palo Alto, California, United States, 94034

Contact: Yulissa Rodriguez 650-272-1628 yulissa@stanford.edu

United States, Massachusetts

Brigham & Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115-6110

Contact: Ernest Mandel, MD 617-525-6496 emandel@bwh.harvard.edu

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02118-2908

Contact: Angelo Volandes, MD 917-612-9762 avolandes@partners.org

Boston Medical Center; Recruiting

Boston, Massachusetts, United States, 02118

Contact: Lori Henault, MPH 617-414-6935 lori.henault@bmc.org

Principal Investigator: Sushrut Waikar, MD

Renal and Transplant Associates of New England, PC; Recruiting

Springfield, Massachusetts, United States, 01107-1381

Contact: Joy Whitbeck 413-731-1008 ext 700 jwhitbeck@rtane.org

United States, New Mexico

The University of New Mexico Health Sciences Center; Recruiting

Albuquerque, New Mexico, United States, 87131-0001

Contact: Mark L. Unruh, MD 505-272-6314 mlunruh@salud.unm.edu

United States, Pennsylvania

University of Pennsylvania; Active, not recruiting

Philadelphia, Pennsylvania, United States, 19104-6205

University of Pittsburgh; Withdrawn

Pittsburgh, Pennsylvania, United States, 15213-2303

United States, Washington

University of Washington; Recruiting

Seattle, Washington, United States, 98195-9472

Contact: Taryn Oestreich 206-277-4376 taryno@uw.edu

Sponsors and Collaborators

Tufts Medical Center

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Michael Paasche-Orlow, MD, MPH; Tufts Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eneanya ND, Lakin JR, Paasche-Orlow MK, Lindvall C, Moseley ET, Henault L, Hanchate AD, Mandel EI, Wong SPY, Zupanc SN, Davis AD, El-Jawahri A, Quintiliani LM, Chang Y, Waikar SS, Bansal AD, Schell JO, Lundquist AL, Tamura MK, Yu MK, Unruh ML, Argyropoulos C, Germain MJ, Volandes A. Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial. BMJ Open. 2022 Apr 8;12(4):e059313. doi: 10.1136/bmjopen-2021-059313.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT04347629
• Other Study ID Numbers: H-39981; 1R01AG066892 ( U.S. NIH Grant/Contract )
• First Posted: April 15, 2020
• Last Update Posted: February 20, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The phenotypic data associated with enrolled participants will be shared by depositing these data in the Open Science Framework data repository. Additional data documentation and de-identified IPD including demographics, diagnoses, and outcomes will be deposited. Resources such as study protocols and statistical analysis codes will also be made available.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Outcome data will be deposited into Open Science Framework repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. Data will remain available for a period of 5 years.
• Access Criteria: Data and supporting information will be shared with investigators working in accordance to guidelines set by the data repository. Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be made available to investigators through the Open Science Framework data repository.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tufts Medical Center:

video decision aid; video declaration; aging population

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes