A survey to check knowledge, awareness, attitude and practice among doctors while prescribing antacids in acidity
- Conditions
- Acidic Peptic Disease
- Registration Number
- CTRI/2020/12/030056
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
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Study Title
A prospective, cross-sectional, multicenter, observational, questionnaire-based survey to assess the Knowledge, Awareness, Attitude and Practice of physicians while prescribing proton pump inhibitor (PPI) drugs for AcidPeptic Disease.
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StudyObjective
- The main objective of the survey is to access and map the knowledge, awareness, attitude and practice of physicians while prescribing PPI for Acid Peptic Disease.
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Study Design
- Prospective, Cross Sectional,multicenter, Observational Survey
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Study Phase
Not applicable
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Study Endpoints
- To enumerate the demographics of the physicians prescribing PPI’s for treatment of APD.
- To enumerate the PPI patient demographics and disposition at physician’s practice.
- To enumerate the patient co-morbidities and their effects on PPI prescription at physician’s practice.
- To identify the diagnostic workup nature followed by the physician at practice before PPI prescription and compare it with current practice guidelines recommended.
- To enumerate the concomitant medications utilized by APD patients at physician’s practice.
- To characterize the role of concomitant medications in the physician’s decision of prescribing PPI to APD patients.
- To enumerate other Antacids prescribed to APD patients along with PPI’s at physician’s practice.
- To enumerate the duration of PPI administration to patient and patient follow-up practices at physician’s practice.
- To enumerate the clinical knowledge and awareness of physician while choosing PPI as treatment for APD patients.
- To enumerate the PPI prescription choice, dosage and duration at physician’s practice.
- To present the physician’s perception of different PPI’s efficacy and the reasons thereof.
- To enumerate the factors effecting the dosage modification and substitution of PPI’s at physician’s practice.
- To enumerate the patient PPI self-medication pattern observed at physician’s practice.
- To enumerate the overall satisfaction of patients who are treated with PPI’s at physician’s practice as reported based on physician’s experience.
- To enumerate the perception of the physicians on the PPI effecting the efficacy or safety of the core prescription (the drugs given to treat the other chronic conditions like Diabetes, Heart Disease, Kidney disease, Lung disease, etc)
- To enumerate the Physician’s perception on the important patient satisfaction attributes for a PPI.
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Study population
For Quantitative -upto 270doctors treating APD
For Qualitative – upto 40 doctors treating APD.
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Study Procedure
This survey will be conducted as a cross-sectional observational study on practicing physicians. The physicians (doctors treating APD) will be selected randomly from all over India for participation in the survey. A questionnaire will be designed on web-based forms and the link generated will be shared on WhatsApp groups or Emails to selected physicians (doctors treating APD) by CRO representative. The selected physicians (doctors treating APD)(participants) will be asked to fill the questionnaire after giving their consent via the weblink by clicking the “Agree to Participate†option. The Participants will be assured of the confidentiality of their information, and that it would be used only for the purpose of this study. All the participants will be asked to only fill the questionnaire once to avoid duplication of data and that their participation in the study will be entirely on voluntary basis. The responses from the online version of the questionnaire will be retrieved automatically and data used for this study will be collected and processed on SAS 9.X and statistically analyzed using descriptive statistics.
A structured questionnaire will be used based on the variables of interest and guided by the study specific objectives. The questionnaire will consist of questions assessing demographics of physician, knowledge, awareness, attitude, practice toward usage of PPI. The questionnaire comprises of three sections, the first section to provide information to the participants about the title of the study and to obtain their consent for participation, the second section to reveal the sociodemographic details of participants and the third section has a set of questions.
The time spent for the completion of the questionnaire will be approximately 10–20 min
The cross-sectional survey will also comprise of qualitative assessment through interview questions which are to be answered by approx. 30 - 40 physicians(doctors treating APD). The interview questions will be asked by a representative appointed by the principal investigator and the responses will be noted down for evaluation. The time required for completion of the interview would be approximately 30 min.
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Study Selection criteria
Inclusion Criteria:
Physicians (doctors treating APD)meeting with following criteria will be included in the study:
1. Doctors registered with Medical Council of Indiaand having MBBS Degree and above
2. Doctors having a minimum of 5 years’ experience in clinical practice.
3. Doctors treating Acid Peptic Disease patients.
4. Doctors prescribing proton pump inhibitor (PPI) drugs
5. Doctors who are willing to voluntarily participate in the survey and provide the consent.
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Study Duration
The Study is planned to be conducted between 1st Nov 2020 to 31st Jan 2021.
The study is planned to be completed within 3months.
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Statistical Analysis
Absolute (n) and relative frequencies (%) will be presented for qualitative variables and mean (±SD) will used for continuous variables. Normal distribution will be assessed by the Kolmogorov–Smirnov test. For Comparisons between groups if applicable, Student’s t-test or Mann–Whitney U test will be used according to variable distribution. Chi-squared test will be used for categorical variables. One-way analysis of variance (ANOVA) or Kruskal-Wallis will be used to compare more than two groups if applicable according to variable distribution. Statistical analysis will be performed using the SAS 9.X. Statistical significance was defined as p-value < 0.05.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 310
- Physicians (doctors treating APD)meeting with following criteria will be included in the study: 1.
- Doctors registered with Medical Council of India and having MBBS Degree and above 2.
- Doctors having a minimum of 5 years’ experience in clinical practice.
- Doctors treating Acid Peptic Disease patients.
- Doctors prescribing proton pump inhibitor (PPI) drugs 5.
- Doctors who are willing to voluntarily participate in the survey and provide the consent.
NOT APPLICABLE.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Enumerate the below mentioned outcomes in treatment of APD: At baseline 0 DAY 5) Clinical knowledge an d Awareness of Physicians At baseline 0 DAY 2) patient co-morbidities and their effects At baseline 0 DAY 4) Duration of PPI administration. At baseline 0 DAY 1) Demographics of Physicians At baseline 0 DAY 3) Role of Concomitant Medications At baseline 0 DAY
- Secondary Outcome Measures
Name Time Method 1) PPI prescription choice, dosage and duration 2) physician’s perception of different PPI’s efficacy
Trial Locations
- Locations (1)
Dr. Reddys Laboratories Ltd.
🇮🇳Hyderabad, TELANGANA, India
Dr. Reddys Laboratories Ltd.🇮🇳Hyderabad, TELANGANA, IndiaDr Kranthi Kiran PebbiliPrincipal investigator9999536367kranthikiranpebbili@drreddys.com