The Impact of Patient Motivational Dialogue (PMD) on Pati... | NCT04360057

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

NCT04360057

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Hand Disinfection

Interventions

PMD
PMDPlus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

Mar 13, 2018Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hand Hygiene education	Other		Other: PMD Other: PMDPlus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PMD	Other	A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.	Hand Hygiene education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patti G Grota	University of Texas Health at San Antonio	Principal Investigator
Tony Eng, MD	University of Texas Health at San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Therapy & Research Center at UTHSCSA		San Antonio	Texas	78229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided