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Clinical Trials/NCT07283653
NCT07283653
Recruiting
Not Applicable

Dissemination and Implementation of DIGEST™ as an Evidence-based Measurement Tool for Dysphagia: A Randomized Implementation Trial

M.D. Anderson Cancer Center1 site in 1 country85 target enrollmentStarted: June 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
85
Locations
1
Primary Endpoint
Adoption of DIGEST in routine clinical documentation for oncology MBS studies

Overview

Brief Summary

To improve swallowing outcomes in cancer through clinical implementation of the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST™) as an evidence-based practice (EBP) tool to grade pharyngeal dysphagia (difficulty swallowing) as a toxicity of cancer.

Detailed Description

Primary Objective Assess the impact of implementation strategies on clinical adoption (reach) of DIGEST for oncology MBS studies.

Secondary Objective Assess the impact of implementation strategies on the fidelity (reliability) of DIGEST adoption for oncology MBS studies

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A hospital or clinic affiliated with the Veteran's Affairs system, University of Wisconsin system, or Ohio State University system.
  • A minimum average of 10 Modified Barium Swallow (MBS) procedures per month in oncology patients in preceding year.
  • MBS imaging files are recorded and archived as a routine procedure (and accessible to researchers).

Exclusion Criteria

  • Not provided

Arms & Interventions

Control Arm 1

Experimental

The control arm will receive no active implementation strategy.

Intervention: No intervention (Other)

Training Arm 2

Experimental

Represents a low intensity implementation strategy solely using the DIGEST training program as the intervention.

Intervention: DIGEST Training Program (Other)

Training + Practice Facilitation Arm 3

Experimental

Represents a higher intensity strategy using the same training program plus practice facilitation.

Intervention: DIGEST Training + Practice Facilitation (Other)

Outcomes

Primary Outcomes

Adoption of DIGEST in routine clinical documentation for oncology MBS studies

Time Frame: Through study completion; an average of 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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