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Human Factors Intervention to Reduce Risk in Primary Care of the Elderly (SAFE-C)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326637
First Posted: March 31, 2011
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose

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 increase situation awareness, reduce PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will also improve.

H2. Patient: The intervention will improve patients' perceptions of their visits on a variety of AHRQ CAHPS measures, such as physician knowledge of patient history.

H3. Patient: The intervention will not impact the number or types of problems addressed during the visit.

H4. Clinic: The intervention will not affect visit RVUs


Condition Intervention
Primary Health Care Aged Clinical Information Other: Patient Overview Document

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Number and types of problems discussed during visit [ Time Frame: 04/12 ]

    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 the care-as-usual group.



Secondary Outcome Measures:
  • Resource utilization [ Time Frame: 04/12 ]
    There are no outcome measures for individual patients. We will look at the resource utilization (RVUs) during care-as-usual visits compared to resource utilization during intervention visits. To assess resource utilization, we will collect E&M/CPT codes for each study visit and calculate the RVUs. A study patient is seen only once.


Estimated Enrollment: 2304
Study Start Date: May 2011
Estimated Study Completion Date: July 2016
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Patient Overview Document

    The Intervention has two components:

    1. Pre-visit care coordination:

      • 5-7 days prior to a study patient's appointment with the doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information using a data collection form we call a Patient Overview Document or POD. The purpose of the POD is to comprehensively inform the doctor about the patient before the doctor enters the exam room.
      • The nurse/MA will ensure that lab results, consultant reports, ER reports, imaging studies, etc., needed by the physician during the patient's visit, are available to the doctor in their usual place.
    2. Team Meeting:

    On the day of the patient's appointment, prior to the beginning of the clinic session, the nurse/MA and doctor will jointly review the POD.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be greater than or equal to 65 years of age
  • Must be patients of participating physicians

Exclusion Criteria:

  • Cannot speak English
  • Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf
  Contacts and Locations
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): NCT01326637


Locations
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Ben-Tzion Karsh, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01326637     History of Changes
Other Study ID Numbers: 2010-0447
R18HS017899 ( U.S. AHRQ Grant/Contract )
First Submitted: March 23, 2011
First Posted: March 31, 2011
Last Update Posted: October 5, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
primary health care
aged