VIDEO-KD: Improving Medical Decision Making for Older Patients With End Stage Renal Disease
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation [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
- Change in ACP Engagement [baseline, 12 months]
4 investigator designed questions about actions patient has taken with regards to ACP
- Change in ACP Preferences [Baseline, 12 months]
survey assessment
- Change in ACP Conversations [Baseline, 12 months]
3 investigator designed questions about conversations with family/friends about ACP
- Change in Kidney Disease (KD) Specific Quality of Life (QOL) [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.
- Change in Health Related Quality of Life (QoL) [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'.
- Change in Decisional Conflict [Baseline, 12 months]
We will measure decisional conflict using the decisional conflict scale (DCS), which attempts to measure decisional uncertainty.
- Acceptability of video intervention [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.
- Change in CKD Care Preferences [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.
- Healthcare Costs [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
Criteria
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Patients age ≥70 are eligible if they have EITHER Advanced CKD defined as at least two eGFR values ≤ 20 ml/min/1.73m2, separated by at least 90 days OR Have less than a one-year prognosis, defined by the nephrologist answering "NO" to the Surprise Question
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Patients age 65-69 are eligible if they have BOTH Advanced CKD defined as at least two eGFR values ≤ 20 ml/min/1.73m2, separated by at least 90 days AND Have less than a one-year prognosis, defined by the nephrologist answering "NO" to the Surprise Question
Exclusion Criteria:
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listed for kidney transplantation or previous transplant recipient
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already on or previously on dialysis (including emergent dialysis)
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new patient visit
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visually impaired beyond 20/200 corrected
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psychological state not appropriate for ACP discussions as determined by the primary nephrologist
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cognitive impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94034-1290 |
| 2 | Stanford University | Palo Alto | California | United States | 94034 |
| 3 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115-6110 |
| 4 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02118-2908 |
| 5 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 6 | Renal and Transplant Associates of New England, PC | Springfield | Massachusetts | United States | 01107-1381 |
| 7 | The University of New Mexico Health Sciences Center | Albuquerque | New Mexico | United States | 87131-0001 |
| 8 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-6205 |
| 9 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213-2303 |
| 10 | University of Washington | Seattle | Washington | United States | 98195-9472 |
Sponsors and Collaborators
- Boston Medical Center
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Michael Paasche-Orlow, MD, MPH, Boston Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-39981
- 1R01AG066892