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Acid Suppressive Therapy - Review of Appropriateness (ASTRA)

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ClinicalTrials.gov Identifier: NCT02259270
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Acid suppressive therapy (AST) is used in a variety of indications in prevention and treatment of gastric acid related disorders. In recent years, an increase in the use of acid suppressive therapy has been documented. It has generally been accepted that these agents are effective and safe. However, very recently, reports describing hypomagnesaemia, hypocalcemia, vitamin B12 deficiency and enteric infections, were published.

The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness of initiation of AST and the appropriateness of continuation of AST at discharge in a subset of the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of inappropriate AST during hospitalisation will be calculated from these data.

The primary endpoint is defined as the number of patients on long-term ambulatory AST after initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at the level of initiation during hospitalization and at discharge (appropriate continuation); also the impact on the hospital budget (lump sum budget) will be calculated, and potential cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcare payer perspective for a period of 1, 3, 6 and 12 months.


Condition or disease Intervention/treatment
Appropriate Startup of Acid Suppressive Therapy Other: Record review Other: AST-history

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Acid Suppressive Therapy - Review of Appropriateness
Study Start Date : August 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Group/Cohort Intervention/treatment
ASTRA-1

All patients discharged from the participating hospitals between July 2012 and July 2013.

Determination of long term use of AST before, during and after hospitalisation based on dispensing data, no record review.

Other: AST-history
Checking history (period and number) of ambulatory dispensed AST from 1 year before till 1 year after hospitalisation. No intervention with patient or physician. No effect on outcome.

ASTRA-2
Random selected subset of patients in ASTRA-1 with startup of AST in the hospital and AST at discharge. Record review for appropriateness of indication of startup of AST.
Other: Record review
Record review. No intervention with patient or physician. No effect on outcome.




Primary Outcome Measures :
  1. Incidence of long term ambulatory treatment with AST. [ Time Frame: 1 year after discharge ]
    The goal of this study is to evaluate how many cases of long-term ambulatory treatment with AST are initiated during hospital stay (= ASTRA-1). Period from 1 year before till 1 year after hospitalisation is assessed.


Secondary Outcome Measures :
  1. Appropriateness of startup of AST. [ Time Frame: Period of hospitalisation (average of 9 days) ]
    The goal of this study is to assess the appropriateness of initiation of AST and the appropriateness of continuation of AST at discharge in a subset of the hospitalized patient population (= ASTRA-2).

  2. Pharmacoeconomic impact from healthcarepayer perspective [ Time Frame: One year after hospitalisation ]
    The goal of this study is to calculate the pharmacoeconomic impact of inappropriate AST during hospitalisation. Also the impact on the hospital budget (lump sum budget) will be calculated, and potential cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcarepayer perspective for a period of 1, 3, 6 and 12 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Part 1: All adult patients discharged from the participating hospitals in the period July 2012 - July 2013.

Part 2: Subset of Part 1 - random selection of 600 patients with startup of AST in the hospital and AST on date of discharge.

Criteria

Inclusion Criteria:

  • Discharged from participating hospitals from July 2012 till July 2013.
  • Specific for part 2: startup of AST in hospital and AST on time of discharge

Exclusion Criteria:

  • Deceased at discharge
  • Critically ill patients
  • Younger then 18 years old at time of discharge
  • Requested by treating physician (negative consent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259270


Locations
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Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Thomas De Rijdt, PharmD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02259270     History of Changes
Other Study ID Numbers: S55785
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: August 2014
Keywords provided by Universitaire Ziekenhuizen Leuven:
Acid suppressive therapy
Appropriateness
Long term treatment
Risk factors
Hospitalisation
Non-critically ill
Adult