- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360057
The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene
The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene: A Feasibility Study
Study Overview
Detailed 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:
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Cancer Therapy & Research Center at UTHSCSA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Hand Hygiene education
|
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.
Other Names:
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene
Time Frame: At treatment completion, an average of 4-6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patti G Grota, University of Texas Health at San Antonio
- Principal Investigator: Tony Eng, MD, University of Texas Health at San Antonio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC20160369H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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