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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04360057
Other study ID # HSC20160369H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date March 13, 2018

Study information

Verified date April 2020
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study will be implemented with two volunteer innovation champion physicians, one in radiation oncology and one in the chemotherapy oncology clinic. If other physicians begin to use the PMD/ PMDPlus in their clinics, the initiation will be considered a positive indication of feasibility and fidelity.

New patients will be enrolled in the study starting September 2016 until the sample size reaches 30 patients per clinic (n=60). Each patient will be followed in each clinic visit longitudinal through March 2017 or until discharged from the clinic treatment depending on which comes first. PMD will be administered in the first clinic visit followed by the PMDPlus each visit thereafter to ensure an adequate treatment dose. The PMD is estimated to take about two minutes of the initial clinic visit and the PMDPlus is estimated to take about one minute of the follow-up clinic visit.

The following steps will be taken based on the innovation decision model:

1. The PI will instruct the physicians, or designee in the use of the PMD/PMDPlus. Script cards with the PMD/PMDPlus will be provided to each physician. The physician will be instructed in use of PMD at the initial visit and the PMDPlus every follow-up clinic visit thereafter until discharge from the clinic.

2. A HCP survey will be conducted pre-intervention asking the HCP: "Has a patient or family ever ask you to clean your hands? If yes, the HCP will be asked to describe the situation.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 13, 2018
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 3 Years to 85 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- Unable to understand instructions given by physician

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PMD
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.
PMDPlus
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits

Locations

Country Name City State
United States Cancer Therapy & Research Center at UTHSCSA San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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