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NCT Number: NCT01326637

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 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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Overview Document

Other

The Intervention has two components:

  • 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.
  • 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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: SAFE-C

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Mar 31, 2011
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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