Cognitive ChangeNCT03149146
Improving Clinical Decision Making Skills for Myanmar Physical Therapists by Series of Workshop
A study testing Clinical Decision Making (CDM) Workshop and Clinical Decision Making (CDM) Workbook in people with Cognitive Change, run by Mahidol University at 1 site in Burma.
Trial summary
This study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar physical therapists by series of educational workshops that will introduce them to and guide them through the decision making process by using the CDM workbook. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Clinical Decision Making (CDM) Workshop and Clinical Decision Making (CDM) Workbook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBurma
- Study dates
- 13 Mar 2017to 5 Oct 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently practicing physical therapists with at least two years of clinical experiences.
- Participants have to be available to join all the 4 days of CDM workshop which will be held at the University of Medical Technology (UMT), Yangon, Myanmar.
Who cannot join
- Physical therapists with less than 2 years of clinical experiences.
- Physical therapists who were not educated in Myanmar.
- Physical therapists who are not available to join all 4 days of CDM workshop.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Clinical Decision Making Skills of Physical Therapists in Myanmar By Series of Educational Workshop
This study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar physical therapists by series of educational workshops that will introduce them to and guide them through the decision making process by using the CDM workbook. Participants will be separated into two groups, CDM workshop group and CDM workbook group. There will be three time assessments; one pre-workshop/ workbook and two post-workshop/workbook assessments by using Clinical Decision Making (CDM) assessment worksheet.
Read the detailed description
This study aims to improve the clinical decision making skills of a group of Myanmar Physical therapists by series of educational workshops that will introduce them to and guide them through the decision making process. The hypothesis of the study is the independent variable of CDM education workshop will affect the dependent variable of CDM skills of participants and the direction will be one-tailed.
Regarding my study design with pre-test-post-test for the same subjects design, samples would need 27 samples to see average change in knowledge (CDM knowledge) from pre-test to post-test with the alpha 0.05, power 0.08 and medium effect size of 0.5. However, Researcher will recruit 34 participants to cover 20% of drop out for each group. Altogether 68 participants will be needed.
Participants will be separated into two groups, one workshop and one workbook group. Among all registrants (by initial online announcement of CDM workshop and onsite invitation of CDM workshop -snow ball recruitment ), participants will be randomly assigned to two different group first then principle investigator will inform again them about their group with information sheet and informed consent form to have agreement to join the study from one group. Intervention group will have Clinical Decision Making (CDM) workshop while workbook group will be provided by the Clinical Decision Making (CDM) workbook without attending workshop and onsite interaction.
To conduct the study "Effectiveness of Clinical Decision Making (CDM) workshop in group of Myanmar Physical Therapists" , three preliminary studies have to be done before conducting the main study. Three preliminary studies are 1) Development of Clinical Decision Making (CDM) assessment worksheet, Qualitative Approach (in-depth interview) with 18 physical therapists form Yangon, 2) Validity and Reliability study of Clinical Decision Making (CDM) assessment worksheet and 3) Development of series of Clinical Decision Making (CDM) workshop based on the emerged themes and developed categories to represent the CDM knowledge in Myanmar physical therapists. Study 1 and 3 were done in order to able to develop the protocol of the main study.
Study 4: Effectiveness of Clinical Decision Making (CDM) workshop in group of Myanmar Physical Therapists
Intervention group:
- Clinical Decision Making (CDM) workshops will be presented on four weekdays and will be held in University of Medical Technology, Yangon, Myanmar in 2017.
- Participants will sign an informed consent form describing the benefits and risks of the workshops.
- Participants will be assigned a number. They will put the number on the top of the worksheet to protect their identity.
- A demographic sheet will be given during the workshop registration. This will ask participants their age, gender, years of practice, school attended, places they have practiced, area of practice specialty i.e. Pediatrics, Musculoskeletal etc.
- The workshop will begin with the first assessment approximately 30 minutes.
- During the educational workshop the CDM workbook will be presented and followed by participants as they actively sequence through a typical patient case they have chosen.
- A workbook will be used throughout the workshop which integrates the two clinical practice models: the ICF and Therapeutic Process (TP).
- The workshop will encourage and require group and individual participation and also assist the participants in reflection on their decisions.
- Participants will be assigned into small groups to introduce each other and then introduce to large group.
- Participant will choose a recent patient case and will be guided through the CDM process during the workshop using that case as their example.
- Then discussion will follow guiding the participants through the Therapeutic Process, the ICF and reflecting on choices they made or could make with the patient. During the last half hour of the last session the participants will retake the assessment worksheet.
- The CDM assessment worksheet will be administered one month at the conclusion of the workshop.
- At the time of one month post-CDM workshop assessment, participants will also be asked to reveal the number of patient cases they used CDM workbook to guide their CDM process in their practice to see usefulness of CDM workbook and opportunity to use workbook.
Workbook group:
- Participants will receive Clinical Decision Making (CDM) workbook which will be used to teach the CDM process in the four days CDM workshop.
- Participants will sign an informed consent form describing the benefits and risks of the study.
- Participants will be assigned a number. They will put the number on the top of the worksheet to protect the identity.
- Before receiving CDM workbook, participants will take the first CDM assessment it will take approximately 30 mins.
- A demographic sheet will be given before taking the first CDM assessment. This will ask participants their age, gender, years of practice, school attended, places they have practiced, area of practice specialty i.e. Pediatrics, Musculoskeletal etc.
- After one week, participants will take the second CDM assessment worksheet which is the same time with the immediate post-CDM workshop assessment of the intervention group.
- Then the CDM assessment worksheet will be administered at one month later which is the same time with the one month post-CDM workshop assessment of the intervention group.
- At the time of taking CDM assessment for the last time, participants will be asked to reveal the number of patient cases they used CDM workbook to guide their CDM process in their practice to see usefulness of CDM workbook and opportunity to use workbook.
- Conditions
- Cognitive Change
- Being tested
- Clinical Decision Making (CDM) Workshop, Clinical Decision Making (CDM) Workbook
- Keywords
- Clinical Decision Making, Myanmar Physical therapists, Educational workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Making (CDM) WorkshopOther
Participants will be provided the Clinical Decision Making workbook which will be used as a guideline to practice decision making. A workshop was chosen rather than other methods of presenting the guideline so that participants could receive feedback and guidance from the instructors and from the other participants. Active learning educational environment will be encouraged and the workshop require group and individual participation and also assist the participants in reflection on their decisions.
Clinical Decision Making (CDM) WorkbookOther
Participants are encouraged to read and do exercises which was written in the workbook for a week and they also are asked to recall their recent patient case or use their patient as the example case and answer the questions from the Clinical Decision Making workbook.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Making (CDM) Workshop | Experimental | Series of CDM educational workshop will be conducted for one group of participants and they will be guided the CDM process through the two clinical practice models; Therapeutic process (TP) and International Classification of Functioning, Disability and Health (ICF). Receives: Other: Clinical Decision Making (CDM) Workshop |
| Clinical Decision Making Workbook | Active comparator | Participants will receive Clinical Decision Making (CDM) workbook which will be used to teach the Clinical Decision Making process in the four days workshop. Receives: Other: Clinical Decision Making (CDM) Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Intervention Clinical Decision Making (CDM) Assessment
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
Measured: Baseline (before intervention)
Immediate-post Intervention Clinical Decision Making (CDM) Assessment
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
Measured: Immediate post-Intervention
One month post-Intervention Clinical Decision Making (CDM) Assessment
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
Measured: One-month post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Mar 2017
- Primary completion31 Jul 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medical Technology, Yangon
- Responsible party
- Principal investigator, PHYU HNIN HLAING, Mahidol University
- Investigators
- Phyu H Hlaing, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149146
- Sponsor's protocol ID
- MU
- Status last verified
- Oct 2017
- First submitted
- 8 May 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wainwright SF, Shepard KF, Harman LB, Stephens J. Factors that influence the clinical decision making of novice and experienced physical therapists. Phys Ther. 2011 Jan;91(1):87-101. doi: 10.2522/ptj.20100161. Epub 2010 Dec 2.
PubMed 21127167Wainwright SF, Shepard KF, Harman LB, Stephens J. Novice and experienced physical therapist clinicians: a comparison of how reflection is used to inform the clinical decision-making process. Phys Ther. 2010 Jan;90(1):75-88. doi: 10.2522/ptj.20090077. Epub 2009 Nov 19.
PubMed 19926680
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical Decision Making Skills of Physical Therapists in Myanmar By Series of Educational Workshop
- ClinicalTrials.gov ID
- NCT03149146
- Acronym / sponsor ID
- MU
- Conditions
- Cognitive Change
- Keywords
- Clinical Decision Making, Myanmar Physical therapists, Educational workshop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Medical Technology, Yangon
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 11 May 2017 (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 study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar physical therapists by series of educational workshops that will introduce them to and guide them through the decision making process by using the CDM workbook. Participants will be separated into two groups, CDM workshop group and CDM workbook group. There will be three time assessments; one pre-workshop/ workbook and two post-workshop/workbook assessments by using Clinical Decision Making (CDM) assessment worksheet.
Detailed description
This study aims to improve the clinical decision making skills of a group of Myanmar Physical therapists by series of educational workshops that will introduce them to and guide them through the decision making process. The hypothesis of the study is the independent variable of CDM education workshop will affect the dependent variable of CDM skills of participants and the direction will be one-tailed.
Regarding my study design with pre-test-post-test for the same subjects design, samples would need 27 samples to see average change in knowledge (CDM knowledge) from pre-test to post-test with the alpha 0.05, power 0.08 and medium effect size of 0.5. However, Researcher will recruit 34 participants to cover 20% of drop out for each group. Altogether 68 participants will be needed.
Participants will be separated into two groups, one workshop and one workbook group. Among all registrants (by initial online announcement of CDM workshop and onsite invitation of CDM workshop -snow ball recruitment ), participants will be randomly assigned to two different group first then principle investigator will inform again them about their group with information sheet and informed consent form to have agreement to join the study from one group. Intervention group will have Clinical Decision Making (CDM) workshop while workbook group will be provided by the Clinical Decision Making (CDM) workbook without attending workshop and onsite interaction.
To conduct the study "Effectiveness of Clinical Decision Making (CDM) workshop in group of Myanmar Physical Therapists" , three preliminary studies have to be done before conducting the main study. Three preliminary studies are 1) Development of Clinical Decision Making (CDM) assessment worksheet, Qualitative Approach (in-depth interview) with 18 physical therapists form Yangon, 2) Validity and Reliability study of Clinical Decision Making (CDM) assessment worksheet and 3) Development of series of Clinical Decision Making (CDM) workshop based on the emerged themes and developed categories to represent the CDM knowledge in Myanmar physical therapists. Study 1 and 3 were done in order to able to develop the protocol of the main study.
Study 4: Effectiveness of Clinical Decision Making (CDM) workshop in group of Myanmar Physical Therapists
Intervention group:
- Clinical Decision Making (CDM) workshops will be presented on four weekdays and will be held in University of Medical Technology, Yangon, Myanmar in 2017.
- Participants will sign an informed consent form describing the benefits and risks of the workshops.
- Participants will be assigned a number. They will put the number on the top of the worksheet to protect their identity.
- A demographic sheet will be given during the workshop registration. This will ask participants their age, gender, years of practice, school attended, places they have practiced, area of practice specialty i.e. Pediatrics, Musculoskeletal etc.
- The workshop will begin with the first assessment approximately 30 minutes.
- During the educational workshop the CDM workbook will be presented and followed by participants as they actively sequence through a typical patient case they have chosen.
- A workbook will be used throughout the workshop which integrates the two clinical practice models: the ICF and Therapeutic Process (TP).
- The workshop will encourage and require group and individual participation and also assist the participants in reflection on their decisions.
- Participants will be assigned into small groups to introduce each other and then introduce to large group.
- Participant will choose a recent patient case and will be guided through the CDM process during the workshop using that case as their example.
- Then discussion will follow guiding the participants through the Therapeutic Process, the ICF and reflecting on choices they made or could make with the patient. During the last half hour of the last session the participants will retake the assessment worksheet.
- The CDM assessment worksheet will be administered one month at the conclusion of the workshop.
- At the time of one month post-CDM workshop assessment, participants will also be asked to reveal the number of patient cases they used CDM workbook to guide their CDM process in their practice to see usefulness of CDM workbook and opportunity to use workbook.
Workbook group:
- Participants will receive Clinical Decision Making (CDM) workbook which will be used to teach the CDM process in the four days CDM workshop.
- Participants will sign an informed consent form describing the benefits and risks of the study.
- Participants will be assigned a number. They will put the number on the top of the worksheet to protect the identity.
- Before receiving CDM workbook, participants will take the first CDM assessment it will take approximately 30 mins.
- A demographic sheet will be given before taking the first CDM assessment. This will ask participants their age, gender, years of practice, school attended, places they have practiced, area of practice specialty i.e. Pediatrics, Musculoskeletal etc.
- After one week, participants will take the second CDM assessment worksheet which is the same time with the immediate post-CDM workshop assessment of the intervention group.
- Then the CDM assessment worksheet will be administered at one month later which is the same time with the one month post-CDM workshop assessment of the intervention group.
- At the time of taking CDM assessment for the last time, participants will be asked to reveal the number of patient cases they used CDM workbook to guide their CDM process in their practice to see usefulness of CDM workbook and opportunity to use workbook.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Making (CDM) Workshop | Experimental | Other: Clinical Decision Making (CDM) WorkshopSeries of CDM educational workshop will be conducted for one group of participants and they will be guided the CDM process through the two clinical practice models; Therapeutic process (TP) and International Classification of Functioning, Disability and Health (ICF). |
| Clinical Decision Making Workbook | Active comparator | Other: Clinical Decision Making (CDM) WorkbookParticipants will receive Clinical Decision Making (CDM) workbook which will be used to teach the Clinical Decision Making process in the four days workshop. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Currently practicing physical therapists with at least two years of clinical experiences.
- Participants have to be available to join all the 4 days of CDM workshop which will be held at the University of Medical Technology (UMT), Yangon, Myanmar.
Key exclusion criteria (3 listed)
- Physical therapists with less than 2 years of clinical experiences.
- Physical therapists who were not educated in Myanmar.
- Physical therapists who are not available to join all 4 days of CDM workshop.
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 |
|---|---|---|
| Clinical Decision Making (CDM) WorkshopParticipants will be provided the Clinical Decision Making workbook which will be used as a guideline to practice decision making. A workshop was chosen rather than other methods of presenting the guideline so that participants could receive feedback and guidance from the instructors and from the other participants. Active learning educational environment will be encouraged and the workshop require group and individual participation and also assist the participants in reflection on their decisions. | Other | Clinical Decision Making (CDM) Workshop |
| Clinical Decision Making (CDM) WorkbookParticipants are encouraged to read and do exercises which was written in the workbook for a week and they also are asked to recall their recent patient case or use their patient as the example case and answer the questions from the Clinical Decision Making workbook. | Other | Clinical Decision Making Workbook |
Primary outcome
Pre-Intervention Clinical Decision Making (CDM) Assessment
Time frame: Baseline (before intervention)
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
Immediate-post Intervention Clinical Decision Making (CDM) Assessment
Time frame: Immediate post-Intervention
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
One month post-Intervention Clinical Decision Making (CDM) Assessment
Time frame: One-month post-Intervention
The CDM worksheet represents the knowledge for four main elements of Clinical Decision Making (CDM) process; Health Condition, Examination, Evaluation and Intervention. These four elements represent the sequence of content which will include in the CDM education workshop. The CDM Assessment Worksheet includes three types of question: two categorical measurement level and one open-ended qualitative type of question.
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 25 Oct 2017.
- Background: PubMed 21127167Wainwright SF, Shepard KF, Harman LB, Stephens J. Factors that influence the clinical decision making of novice and experienced physical therapists. Phys Ther. 2011 Jan;91(1):87-101. doi: 10.2522/ptj.20100161. Epub 2010 Dec 2.
- Background: PubMed 19926680Wainwright SF, Shepard KF, Harman LB, Stephens J. Novice and experienced physical therapist clinicians: a comparison of how reflection is used to inform the clinical decision-making process. Phys Ther. 2010 Jan;90(1):75-88. doi: 10.2522/ptj.20090077. Epub 2009 Nov 19.
- Individual participant dataSharing planned: Yes
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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.
Phyu H Hlaing, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Making (CDM) Workshop and Clinical Decision Making (CDM) Workbook in people with Cognitive Change, run by Mahidol University at 1 site in Burma.
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 2 inclusion and 3 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 25 Oct 2017. 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 Burma. 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?
Pre-Intervention Clinical Decision Making (CDM) Assessment (time frame: Baseline (before intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149146, which also lists 2 linked publications.
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 25 Oct 2017.