Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02558049
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2015-09-17
Brief Title:
Should I Continue Taking My Acid Reflux Medication Development and Pilot Testing of a Patient Decision Aid
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Should I Continue Taking My Acid Reflux Medication Development and Pilot Testing of a Patient Decision Aid
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BACKGROUND Proton pump inhibitors PPIs treat problems such as gastroesophageal reflux disease GERD In many patients with mild or moderate GERD PPIs should be used for 1-2 months but are often continued longer unnecessarily This is a problem because PPIs may cause harm when used long-term PPI use is associated with severe C difficile infections fractures and pneumonia Canadas public drug programs spent 247 million on PPIs in 2012 not including Quebec or PEI Due to concerns with long-term PPI use patients may face the decision to continue their PPI use a lower dose or stop and use on-demand only when symptoms return This decision should be made collaboratively between patients and clinicians though patients tend to have a poor understanding of when reducing a drug is appropriate Using a lower dose or using on-demand may be viewed as difficult because of the chance of symptoms returning Patient decision aids PDAs inform patients on benefits and risks of treatment options and improve ability to make informed decisions and clarify values OBJECTIVES Develop a PDA to help patients with the decision to continue PPI or stop and use on-demanduse a lower dose Evaluate whether 1 the PDA changes patient preference to continue or stop and use on-demanduse a lower dose of PPI 2 the PDA improves patient knowledge and realistic expectations 3 patients and pharmacists feel they made a shared decision 4 there is a change in PPI prescribing 8 weeks post-PDA and 5 patients choices match up with their values METHODOLOGY The PDA will be developed by a team of doctors pharmacists and patients It will be delivered during a visit with a pharmacist Patients n54 will indicate which choice they prefer continue PPIstop or use lower dose before and after going through the PDA We will use Mcnemars test to compare the number of patients preferring to continue their PPI before and after We will evaluate whether there is a difference in knowledge test scores and expectations test scores before and after the PDA After the PDA we will ask patients and pharmacists to rate the extent to which shared decision making occurred and measure the agreement Valueschoice congruence will be evaluated using logistic regression Eight weeks after patients have received the PDA we will look at whether there is any reduction in PPI use
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None