NCT04360057

Brief Summary

This exploratory cross sectional cohort study will evaluate the feasibility and fidelity of using an innovative strategy, the Patient Motivational Dialogue (PMD)/PMDPlus that will intentionally motivate and encourage the patient toward self-advocacy for their Health Care Professional's (HCP's) hand hygeine (HH) adherence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 14, 2020

Last Update Submit

April 22, 2020

Conditions

Keywords

Motivation, hand hygiene

Outcome Measures

Primary Outcomes (1)

  • The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene

    At the last clinic visit, the PI or research assistant will ask the patient this nominal question: "Have you ever ask your physician or your HCP to clean their hands during your visits here?" If yes, describe the circumstances. If no, describe why not. Verbal responses will be recorded.

    At treatment completion, an average of 4-6 months

Study Arms (1)

Hand Hygiene education

OTHER
Other: PMDOther: PMDPlus

Interventions

PMDOTHER

A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.

Also known as: Patient Motivational Dialogue
Hand Hygiene education
PMDPlusOTHER

A script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits

Also known as: Patient Motivational Dialogue Plus
Hand Hygiene education

Eligibility Criteria

Age3 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English or Spanish speaking
  • Able to understand instructions given by physician
  • Receiving care in radiation oncology clinic and/or chemotherapy clinic at Cancer Therapy Research Center at University of Texas Health Science Center (UTHSCSA)

You may not qualify if:

  • Unable to understand instructions given by physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Patti G Grota

    University of Texas Health at San Antonio

    PRINCIPAL INVESTIGATOR
  • Tony Eng, MD

    University of Texas Health at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Subjects will be included from two oncology clinics, one in radiation oncology and one in chemotherapy oncology
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 24, 2020

Study Start

October 1, 2016

Primary Completion

May 30, 2017

Study Completion

March 13, 2018

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations