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NCT01326637 · ClinicalTrials.gov registry record · NA

Human Factors Intervention to Reduce Risk in Primary Care of the Elderly

A NA study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
2,332
Enrollment target

NCT01326637: Completed NA study, sponsored by University of Wisconsin, Madison.

NCT01326637 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 2,332 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01326637, a NA study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
2,332 participants
Enrollment target

Study Summary

Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encounters with elderly patients. This puts primary care physicians at risk of higher mental workload and poor decision making which can affect the quality and safety of care delivered to patients. Elderly patients are at particular risk because they are more likely to have more comorbidities, medications, and cognitive impairments. Dr. Karsh and his research team will test an intervention to improve the performance of primary care physicians and, thus the safety of primary care of the elderly. The investigators will use a randomized experiment, with random assignment at the level of patient, to test and evaluate the intervention. The evaluation will involve 4 primary care clinics, with 4 primary care physicians per clinic. The investigators will collect data from 768 patient visits pre-intervention and 1536 patient visits during the intervention. Intervention patients will be randomly assigned to the intervention or care as usual. The Intervention has two components: Pre-visit care coordination: * 5-7 days prior to a study patient's appointment with his/her doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information about the patient using a data collection form the investigators call a Patient Overview Document or POD. * The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging studies, etc., that will be needed by the physician are available to the doctor. Team Meeting: On the day of the patient's appointment and prior to the beginning of the clinic session, the nurse/MA will meet briefly with the doctor to jointly review the POD. Hypotheses: H1. Primary Care Physician (PCP): The intervention will

Primary Outcome

There are no outcome measures for individual patients. We will review the dictated clinic note for each study patient visit in order to * Make a list of the all problems (e.g., hypertension, asthma, annual influenza vaccination, etc.) that are discussed in the clinic note; * Record the number of problems that the patient and doctor discussed. We will compare the number of problems and the kind of problems found in the intervention patient group with the number and kind of problems found in th

Interventions

  • OTHER Patient Overview Document

Trial Details

FieldValue
Enrollment Target 2,332 participants
Start Date 2011-05
Est. Completion 2017-12-21
Phase NA
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01326637 record still lists

NCT01326637 is an interventional study that assigns participants to a tested intervention. Its 2,332 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% higher).

The record links to 0 conditions, and to 1 intervention - of which Patient Overview Document is the first listed.

NCT01326637 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01326637 about?

NCT01326637 is a clinical study titled "Human Factors Intervention to Reduce Risk in Primary Care of the Elderly". Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encoun...

What is the current status of trial NCT01326637?

This trial is currently completed. It is a NA study. The enrollment target is 2,332 participants. The study started on 2011-05. Estimated completion is 2017-12-21.

What interventions are being tested in trial NCT01326637?

The interventions under investigation include: Patient Overview Document (OTHER).

Who is sponsoring clinical trial NCT01326637?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01326637's enrollment target sits among peer trials

2,332 46th of 2000 higher than 1,955 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01326637, the US trial registry maintained by the National Library of Medicine. NCT01326637 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.