Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease

Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.

Time frame: Day 90

Proportion of eligible participants who consent to randomization.

Time frame: 12 months

Proportion of screened participants deemed eligible for randomization.

Time frame: 12 months

Depression scores assessed with the patient health questionnaire (PHQ-9) will be compared between the two vascular access arms. PHQ-9 score range 0-27. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Time frame: 3 and 6 months

The impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.

Time frame: Baseline, Month 3, and Month 6

The impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.

Time frame: 3 and 6 months

This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: no pain, mild pain, moderate pain, severe pain, or pain as bad as it could be.

Time frame: Baseline, Month 3 and Month 6

Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance

This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: no pain, mild pain, moderate pain, severe pain, or pain as bad as it could be.

Time frame: Baseline, 3 and 6 months

Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance

This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: no pain, mild pain, moderate pain, severe pain, or pain as bad as it could be.

Time frame: Baseline, Month 3 and Month 6

Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance

This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: no pain, mild pain, moderate pain, severe pain, or pain as bad as it could be.

Time frame: Baseline, Month 3 and Month 6

Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance

Vascular access questionnaire will be used to assess differences in patient satisfaction with vascular access between the two access interventions using the short-form vascular access questionnaire (SF-VAQ). Mean scores obtained on SF-VAQ will be compared. SF-VAQ score range 4 -20 with higher scores indicating more satisfaction with the vascular access.

Time frame: 3 and 6 months

Population: Number differ form total number of randomized, 1 participant expired, not all questionnaires collected

The level of independence will be evaluated using ADLs. ADL score range 0-30, with higher scores denoting more dependence on other people to perform the usual daily activities.

Time frame: Baseline and 6 months

Population: Patients declined survey

The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people.

Time frame: Baseline, 3 and 6 months

Population: Patients declined survey

The Rapid Assessment of Physical Activity (RAPA) instrument will be used to assess habitual physical activity. RAPA test score ≤ 3 corresponded to a sedentary lifestyle or a very light activity level; values ≥4 indicated a moderate to vigorous active lifestyle.

Time frame: 3 and 6 months

The 4MGS test is a simple screening test and a useful predictor of worsening daily activity in patients with chronic respiratory diseases.

Time frame: Baseline, month 3 and 6

Population: Assessment was added on 2.4.2019 - Subjects could not walk un-assisted

The grip-strength test will be performed twice on each hand for each assessment and the mean of the two results will be used for statistical analyses; a cut-off point \<16 kg in women and \<26 kg in men will define muscle weakness. Changes in grip strength will be compared between the two access interventions. Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer.

Time frame: 3 and 6 months

Population: Subject could not move hand from past stroke; Subject had joint pain; not completed due to distance

Incidence rate of AV access infection between the two AV access strategies. This will include fistula or graft cellulitis, abscess, and/or bacteremia due to AV access infection.

Time frame: 12 months

Rate of AV access primary failure between the two AV access strategies. Primary access failure is defined as permanent failure of the fistula or graft before hemodialysis suitability. This will include inadequate maturation, thrombosis, failure of first and subsequent cannulations, and/or other complications leading to nonfunctional fistula or graft.

Time frame: 6 months

Number of AV access procedures per 100 patient-days between the two AV access strategies. This will include angioplasty, thrombectomy, stent placement, repeat surgery, and/or surgical superficialization.

Time frame: 12 months

Number of AV access procedures per 100 patient-days between the two AV access strategies. This will include angioplasty, thrombectomy, stent placement, repeat surgery, and/or surgical superficialization.

Time frame: 12 months

Rate of AV access secondary failure between the two AV access strategies. Secondary access failure is defined by permanent AV access failure after the fistula or graft met dialysis suitability criteria with subsequent abandonment.

Time frame: 12 months

Will compare the proportion of patients with successful AV access cannulation between the two AV access strategies. Successful cannulation is defined by the use of the AV access as the primary vascular access for hemodialysis (the fistula or graft access has been cannulated with two 16- or 15-gauge needles for ≥3 consecutive dialysis sessions and the dialysis central venous catheter was removed).

Time frame: 6 months