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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03149146
Other study ID # MU
Secondary ID
Status Completed
Phase N/A
First received May 8, 2017
Last updated October 24, 2017
Start date March 13, 2017
Est. completion date October 5, 2017

Study information

Verified date October 2017
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date October 5, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical Decision Making (CDM) Workshop
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) Workbook
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.

Locations

Country Name City State
Myanmar University of Medical Technology Yangon Insein

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University University of Medical Technology (Yangon) Myanmar

Country where clinical trial is conducted

Myanmar, 

References & Publications (2)

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. — View Citation

Wainwright 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (before intervention)
Primary 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. Immediate post-Intervention
Primary 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. One-month post-Intervention
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