search
Back to results

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

Primary Purpose

Chronic Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
implementation of evidence-based nutrition practice guidelines
Sponsored by
Academy of Nutrition and Dietetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient inclusion criteria:

  • 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

Patient: Exclusion criteria include:

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

Sites / Locations

  • DaVita Renal Center New Lenox

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EBNPG knowledge-focused training (knowledge-only group)

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

acceptability
RDN perceived acceptability of guideline recommendations.

Full Information

First Posted
August 12, 2021
Last Updated
January 30, 2023
Sponsor
Academy of Nutrition and Dietetics
Collaborators
Davita Clinical Research, Fresenius AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05032417
Brief Title
Evaluating the Implementation of Evidence-Based Kidney Nutrition Practice Guidelines: The AUGmeNt Study Protocol
Acronym
AUGmeNt
Official Title
Evaluating the Implementation of Evidence-Based Kidney Nutrition Practice Guidelines: The AUGmeNt Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Academy of Nutrition and Dietetics
Collaborators
Davita Clinical Research, Fresenius AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Implementation and effectiveness aims will be assessed using a quasi-experimental design. RDNs will document initial and follow-up nutrition care for a randomly selected subset of their patients for three months, and then be randomly assigned to one of two EBNPG training models (a knowledge-focused training or a comprehensive training). RDNs will then document initial and follow-up nutrition care for a different randomly selected subset of their patients for three months. Additional information about RDN and clinic characteristics, changes in RDN knowledge, and RDN experience with EBNPG implementation will be collected via an RDN survey. Deidentified patient nutrition care information is collected into the Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII) registry based on guidance from the Office for Human Research Protections Guidance on Research Involving Coded Private Information or Specimens. To meet the standards for registry research, the protocol ensures the identities of the individuals whose data are collected are protected from disclosure to the investigators, and clinical data are not obtained through research interventions or interactions with patients. RDNs will review a consent document before voluntarily agreeing to complete study surveys. 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 by the Academy. 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. Several criteria were used to select the recommendations that were included, with preference being given to recommendations that: 1) changed substantially from those in previous kidney nutrition guidelines (2010 CKD EBNPGs or the 2000 KDOQI guidelines) meaning that implementation efforts would likely be required; 2) included clear action statements for the RDN; and 3) were supported by strong evidence. An expert advisory group, consisting of renal nutrition researchers, clinicians, and patient advocates, reviewed the selected five CKD G5D recommendations and completed a formative survey to identify potential barriers and facilitators to implementation at several levels (patient, RDN, medical provider, clinic, and company). Identified barriers varied by recommendation and included: RDN knowledge gap, time, and buy-in; patient knowledge gap, time, buy-in, finances, and insurance coverage; electronic health record set-up; medical provider buy-in; existing clinical protocols; and administrative support. The survey results and additional input from the advisory group were used to compile a list of potential barriers, and of facilitators to overcome those barriers, for each of the five selected recommendations. This formative work was used to develop an implementation toolkit, including a virtual, asynchronous training on implementation science and quality improvement principles, a recommendation-specific resource list, and peer support. The primary objectives of the implementation science and quality improvement training are to provide the comprehensive training group with increased understanding of the complexity of their work environment, strategies to build buy-in from leadership and stakeholders, strategies to encourage operationalization of recommendations in daily practice, and methods to monitor and revise their implementation approaches. The implementation strategies were adapted from the Normalization Process Theory, which is an action theory that focuses on what people do, rather than beliefs and attitudes, and from quality improvement resources developed by the Institute for Healthcare Improvement. The implementation training concludes with a case study demonstrating the implementation of one CKD recommendation by an RDN. A final component of the implementation toolkit is an online community portal to facilitate ongoing peer-to-peer and RDN-to-research team discussion of implementation strategies. Study procedures will occur in four phases. In phase 1, prior to the start of data collection, RDNs will receive virtual training on the use and application of key Academy research tools for the study, including the Nutrition Care Process and Terminology (NCP/T), Evidence Analysis Library, and ANDHII. ANDHII infrastructure facilitates collection of nutrition care documentation using NCP/T. RDNs select appropriate NCPT from a dropdown list to document their activities for each section of the NCP (assessment, intervention, diagnosis and monitoring/evaluation). During phase 2, each participating RDN will use the NCP/T to document initial and follow-up nutrition care provided to 12 patients on dialysis (one new patient per week), along with patient outcomes, in ANDHII for a three-month period. To decide which patients to enter into ANDHII, RDNs will initially screen patients for eligibility. If a patient is eligible for the study, RDNs will use an online random number generating tool (www.random.org) to determine if the patient record should be entered into ANDHII. This random entry process is used to minimize the chances that RDNs will allow conscious or unconscious bias to dictate the patients that they select for entry into ANDHII. RDNs will use the "True Random Number Generator" to select a number between 0 and 1, with a "1" indicating that the patient should be entered into ANDHII and a "0" indicating that the patient should not be entered. RDNs will complete this process for every eligible patient until one patient per week is selected for entry into ANDHII. The RDN will then document follow-up visits for each patient previously added to ANDHII until the end of the three-month phase 2 period. For each patient encounter, RDNs will record de-identified patient sociodemographic characteristics and parameters from the NCP (nutrition assessment/reassessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation) to document the nutrition care that was provided. In phase 3, RDNs will complete one of two midpoint training models, to which they will be randomly assigned in blocks of six: 1) EBNPG knowledge-focused training (knowledge-only group), or 2) EBNPG knowledge-focused training plus an implementation toolkit providing detailed support for five specific recommendations from the EBNPG (comprehensive group). After completing the trainings, during phase 4, each RDN will use the NCP/T to document initial and follow-up nutrition care and patient outcomes for a different group of 12 patients on dialysis (one patient per week) into ANDHII for a three-month period, following the same patient selection and documentation procedures outlined for phase 2. In addition to documenting patient nutrition care into ANDHII, RDNs will be surveyed several times during the study. In phase 1, surveys created by the study team will assess NCP/T-, EAL-, and ANDHII-related knowledge, before and after the virtual trainings; feasibility and acceptability of the baseline trainings; and RDN professional qualifications and experience and characteristics of the hemodialysis clinic(s) where they work. Surveys conducted before and after the midpoint training (phase 3) will assess knowledge of the EBNPG and the feasibility and accessibility of the midpoint trainings. About one week post-training, all RDNs will also be asked to complete an implementation survey to evaluate RDN perceived acceptability and anticipated adoption of the EBNPG recommendations. Finally, RDN surveys conducted at the end of the study (after phase 4) will assess the feasibility and acceptability of documenting nutrition care using ANDHII and perceived acceptability, adoption, and ad hoc adaptation of the EBNPG. The comprehensive group will also be asked to provide feedback on the implementation tools. The implementation surveys were created based on implementation literature and reviewed for content and face validity by renal nutrition clinicians, researchers, and patient advocates that serve on an advisory group for the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBNPG knowledge-focused training (knowledge-only group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EBNPG knowledge-focused training plus an implementation toolkit (comprehensive group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
implementation of evidence-based nutrition practice guidelines
Intervention Description
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.
Primary Outcome Measure Information:
Title
Congruence with the evidence-based nutrition practice guideline
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
acceptability
Description
RDN perceived acceptability of guideline recommendations.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient inclusion criteria: 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 Patient: Exclusion criteria include: patients without a CKD G5D diagnosis prisoners pregnant women,
Facility Information:
Facility Name
DaVita Renal Center New Lenox
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs