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Patient outcomes of rapid testing at the internal medicine outpatient clinic


- candidate number24155
- NTR NumberNTR5782
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mrt-2016
- Secondary IDs15/415  
- Public TitlePatient outcomes of rapid testing at the internal medicine outpatient clinic
- Scientific TitlePatient outcomes of rapid testing at the internal medicine outpatient clinic
- ACRONYMPOORT study
- hypothesisPerforming a standard laboratory package prior to the first visit to the outpatient clinic rather than performing laboratory tests afterwards will lead to a shorter time until the diagnosis has been established.
- Healt Condition(s) or Problem(s) studiedPatient reported outcomes
- Inclusion criteriaall patients who are newly referred to the general internal medicine outpatient clinic
- Exclusion criteriareferrals for suspected thrombosis, cardiovascular diseases, and second opinions
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 15-apr-2016
- planned closingdate15-apr-2017
- Target number of participants400
- Interventionsstandard laboratory package prior to first visit to outpatient clinic
- Primary outcomeprimary diagnostic workup completed in one day
- Secondary outcometotal consultation time, patient satisfaction, physician satisfaction, total number of laboratory tests, total number of laboratory orders, number of imaging tests ordered, accurate diagnosis after primary work up, costs
- TimepointsFollow up at three months after first outpatient clinic visit
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Bram Vrijsen
- CONTACT for SCIENTIFIC QUERIES J. Vis
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)29-apr-2017-EB

Primary outcome NEW:
Time to diagnosis, defined as the time in days from the first visit to the outpatient clinic to the definite establishment of the diagnosis by the treating physician.

Secondary outcomes NEW:
patient satisfaction, physician satisfaction, total number of laboratory tests, total number of laboratory orders, number of imaging tests ordered, accurate diagnosis after primary work up, primary diagnostic workup completed in one day, costs Target number of participants
400.

The original sample size calculation was based on comparing two proportions and led to a desired total sample size of 400 patients (200 in each group).  In our revised endpoint, the interest is in the comparison of full distribution of time to final diagnosis between the two arms as any reduction in the time to final diagnosis is to the benefit of patients. Switching from comparing two proportions to comparing continuous outcomes leads to additional more power to detect differences. Using the same total sample size, the study has an 80% power to detect a week difference in time (a reduction of 57 to 50 days) to arrive at a final diagnosis at an alpha of 0.05, assuming a standard deviation of 25 based on the Wilcoxon-Mann- Whiney test given the expected non-normality of the data.
- RECORD29-mrt-2016 - 29-apr-2017


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