Evaluating the Implementation of Evidence-Based Kidney Nutrition Practice Guidelines: The AUGmeNt Study Protocol

NCT05032417 | Unknown

• 1 other identifier: 19-156
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence-Based Nutrition Practice Guidelines (EBNPGs) inform registered dietitian nutritionist (RDN) care for patients with chronic kidney disease grade 5 treated by dialysis (CKD G5D); however, there has been little evaluation of best practices for implementing EBNPGs. In this effectiveness-implementation hybrid study with a quasi-experimental design, United States RDNs in hemodialysis clinics will document initial and follow-up nutrition care for patients with CKD G5D using the Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII) before and after being randomly assigned to a training model: 1) EBNPG knowledge training, or 2) EBNPG knowledge training plus an implementation toolkit. Aims of the study include examining congruence of RDN documentation of nutrition care with the EBNPG; describing common RDN-reported EBNPG acceptability, adoption and adaptation issues; and determining the feasibility of estimating the impact of RDN care on nutrition-related patient outcomes. The AUGmeNt study can inform effective development and implementation of future EBNPGs.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Congruence with the evidence-based nutrition practice guideline

  Total evidence-based nutrition practice guideline (EBNPG) congruence score is calculated by comparing standardized terms in registered dietitian nutritionist (RDN) documentation of nutrition care across 6 components (evidence, diagnosis, etiology, intervention, goal, and outcome) to standardized terms that would be expected, if the RDN was providing care congruent with recommendations. Scores are assigned in units of 0.5 and range from 0-6. Term matching is determined using natural language processing methods. Score = 0-2.0 (not congruent) if the terms match in one or two components, but not in other components. Score=2.5-3.5 (partially congruent) if the terms match in three or four components, but not in other components. Score = 4.0-5.5 (congruent) if the terms match in five or six components but are missing some aspects of one of the components. Score = 6.0 (fully congruent) if the terms match across all required aspects of all six components.

  3 months

Secondary Outcomes (1)

• acceptability

  1 year

Study Arms (2)

EBNPG knowledge-focused training (knowledge-only group)

ACTIVE COMPARATOR

The knowledge-focused training includes didactic information about the content of the EBNPG related to nutrition care for individuals on dialysis. This training contains information that is typically shared with RDNs when an EBNPG is released, and in this instance, includes a free webinar developed by the Academy and NKF that provides an overview of EBNPGs, as well as a presentation of the specific EBNPG developed.

Other: implementation of evidence-based nutrition practice guidelines

EBNPG knowledge-focused training plus an implementation toolkit (comprehensive group)

EXPERIMENTAL

The comprehensive training includes the knowledge-focused training, plus access to the EBNPG virtual implementation toolkit. Due to the depth and breadth of the CKD EBNPG, which includes over 70 recommendations, consensus building discussions were conducted with key stakeholders, such as leadership from national dialysis companies and the Evidence Analysis Center guideline developers, to select five recommendations for patients on dialysis as the primary implementation focus for this project.

Other: implementation of evidence-based nutrition practice guidelines

Interventions

implementation of evidence-based nutrition practice guidelines OTHER

The comprehensive training includes the knowledge-focused training, plus access to the EBNPG virtual implementation toolkit. Due to the depth and breadth of the CKD EBNPG, which includes over 70 recommendations, consensus building discussions were conducted with key stakeholders, such as leadership from national dialysis companies and the Evidence Analysis Center guideline developers, to select five recommendations for patients on dialysis as the primary implementation focus for this project.

EBNPG knowledge-focused training (knowledge-only group); EBNPG knowledge-focused training plus an implementation toolkit (comprehensive group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years,
• residing in the United States,
• a referral diagnosis of CKD G5D,
• will receive care at the facility for at least six months,
• stable as defined by CMS - Conditions for Coverage for ESRD Facilities Regulation V52029 applied per the RDNs' clinical judgement or facility policy

You may not qualify if:

• patients without a CKD G5D diagnosis
• prisoners
• pregnant women,

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead
• Davita Clinical Research: collaborator
• Fresenius AG: collaborator

Study Sites (1)

DaVita Renal Center New Lenox

New Lenox, Illinois, 60451, United States

Location

MeSH Terms

Conditions

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 Design

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

Model Details: The AUGmeNt study is a hybrid effectiveness-implementation study, in that there are a priori plans to test an EBNPG implementation strategy and examine the clinical effectiveness of care congruent with EBNPG.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 2, 2021
• Study Start: September 17, 2019
• Primary Completion: January 10, 2023
• Study Completion: August 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)