This trial is active, not recruiting.

Conditions primary health care, aged, clinical information
Treatment patient overview document
Sponsor University of Wisconsin, Madison
Start date May 2011
End date January 2013
Trial size 2304 participants
Trial identifier NCT01326637, 2010-0447, R18HS017899


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.


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research

Primary Outcomes

Number and types of problems discussed during visit
time frame: 04/12

Secondary Outcomes

Resource utilization
time frame: 04/12

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly
Principal investigator Ben-Tzion Karsh, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.