Hand DisinfectionNCT04360057
The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene
A study testing PMD and PMDPlus in people with Hand Disinfection, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 3 to 85 years
- Conditions the study is for
- Hand Disinfection
- What is being tested?
- PMD and PMDPlus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Unable to understand instructions given by physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene: A Feasibility Study
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.
Read the 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.
- Conditions
- Hand Disinfection
- Being tested
- PMD, PMDPlus
- Keywords
- Motivation, hand hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMDOther
Also called Patient Motivational Dialogue
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.
PMDPlusOther
Also called Patient Motivational Dialogue Plus
A script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits
| Study group | Role | What they receive |
|---|---|---|
| Hand Hygiene education | Other | Not described Receives: Other: PMD; Other: PMDPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At treatment completion, an average of 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2016
- Primary completion30 May 2017
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DisinfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be included from two oncology clinics, one in radiation oncology and one in chemotherapy oncology
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patti G Grota, Principal investigator, University of Texas Health at San AntonioTony Eng, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360057
- Sponsor's protocol ID
- HSC20160369H
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04360057
- Acronym / sponsor ID
- HSC20160369H
- Conditions
- Hand Disinfection
- Keywords
- Motivation, hand hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be included from two oncology clinics, one in radiation oncology and one in chemotherapy oncology
| Arm | Type | Receives |
|---|---|---|
| Hand Hygiene education | Other | Other: PMD, Other: PMDPlus |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Unable to understand instructions given by physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMDAlso: Patient Motivational DialogueA script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit. | Other | Hand Hygiene education |
| PMDPlusAlso: Patient Motivational Dialogue PlusA script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits | Other | Hand Hygiene education |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Hand Disinfection
Recruiting
Effectiveness of VR on the Sustainability of Hand Hygiene Compliance: School-based RCT With 10-month Follow-up
Hand, Hygiene Practices and Knowledge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patti G Grota principal investigator
University of Texas Health at San Antonio
Tony Eng, MD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMD and PMDPlus in people with Hand Disinfection, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.