Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization

NCT02483039 | Unknown

• 1 other identifier: 004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who are not exposed to the AKI Follow-up Clinic intervention.

Conditions

Acute Kidney Injury; Chronic Kidney Disease

Keywords

Acute kidney injury; Chronic kidney disease; Quality improvement

Outcome Measures

Primary Outcomes (1)

• Proportion with a major adverse kidney event

  Composite of chronic dialysis, chronic kidney disease progression, or death

  1 year after randomization

Secondary Outcomes (18)

• Proportion with a major adverse kidney event

  30, 90, 365 days, and 5 years following randomization

• Proportion deceased

  30, 90, 365 days, and 5 years following randomization

• Proportion who require chronic dialysis

  30, 90, 365 days, and 5 years following randomization

• Proportion with chronic kidney disease progression using CKD-EPI eGFR equation

  30, 90, 365 days, and 5 years following randomization

• Time to major adverse kidney event

  5 years following randomization

Study Arms (2)

AKI Follow-up Clinic

EXPERIMENTAL

Participants randomized to this arm will be referred to the AKI Follow-up Clinic where they will see a nephrologist who will coordinate follow-up care. The target appointment date is within 30 days of hospital discharge. Routine laboratory investigations will be performed at minimum every three months. Additional in-person visits with a nephrologist at the AKI Follow-up Clinic will be determined at the local sites based upon the participant's clinical status. If in-person visits at 12, 24, and/or 36 weeks are not necessary given the patient's clinical status, they may be replaced with a telephone visit

Behavioral: AKI Follow-up Clinic

Usual Care

NO INTERVENTION

Participants randomized to this arm will have a letter outlining their AKI diagnosis mailed to their family physician. Participants may still be referred to a nephrologist by their inpatient or outpatient healthcare provider, but these participants will not have access to the AKI Follow-up Clinic. Rather, they will proceed through the standard local nephrology referral pathway. In addition, all usual care participants will be contacted via telephone by study staff every three months to assess their clinical condition and ensure study engagement. All usual care participants will be offered a nephrologist assessment and/or bloodwork one year after randomization to determine if ongoing nephrology care is indicated based upon the same criteria applied to AKI Follow-up Clinic participants.

Interventions

AKI Follow-up Clinic BEHAVIORAL

Participants randomized to this arm will be referred to the AKI Follow-up Clinic where they will see a nephrologist who will coordinate follow-up care. At the AKI Follow-up Clinic, assessment forms that were developed during the pilot study at St. Michael's Hospital may be used, but this decision will be left to individual sites. Routine laboratory investigations will be performed at minimum every three months.

AKI Follow-up Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 yrs
• Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)

You may not qualify if:

• Kidney transplant recipients
• Outpatient baseline eGFR under 30mL/min/1.73m2 (by CKD-EPI equation); ignore if baseline serum creatinine is unavailable
• Patients discharged from hospital with a persistent requirement for renal replacement therapy
• Clinical diagnosis or suspicion of: glomerulonephritis, vasculitis with kidney involvement, hemolytic-uremic syndrome, polycystic kidney disease, myeloma cast nephropathy
• Pregnancy
• Residence at a nursing home facility (rehabilitation and retirement home patients should not be excluded)
• Palliation as primary goal of care (defined as life expectancy ≤ six months or followed by a palliative care physician)
• Patients with previously established and ongoing nephrology follow-up (defined as ≥ one outpatient appointment with a nephrologist in the previous 12 months)

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• University Health Network, Toronto: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (4)

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (1)

• Robinson C, Hessey E, Nunes S, Dorais M, Chanchlani R, Lacroix J, Jouvet P, Phan V, Zappitelli M. Acute kidney injury in the pediatric intensive care unit: outpatient follow-up. Pediatr Res. 2022 Jan;91(1):209-217. doi: 10.1038/s41390-021-01414-9. Epub 2021 Mar 17.

  PMID: 33731806 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Wald, MDCM, MPH

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 26, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2022
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

CA (4)