Primary Health CareSAFE-CNCT01326637
Human Factors Intervention to Reduce Risk in Primary Care of the Elderly
A study testing Patient Overview Document in people with Primary Health Care and Aged, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Primary Health Care, Aged, Clinical Information
- What is being tested?
- Patient Overview Document
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,332 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Must be greater than or equal to 65 years of age
- Must be patients of participating physicians
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53705
About this study
Official title: A 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.
Read more
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
- Conditions
- Primary Health Care, Aged, Clinical Information
- Being tested
- Patient Overview Document
- Keywords
- primary health care, aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Overview DocumentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Received the intervention: previsit planning phone call with filled out patient overview document \& clinician huddle Receives: Other: Patient Overview Document |
| observation | No intervention | Received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of problems discussed during visit
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.
Measured: 04/12
Secondary outcomes (1)
Resource utilization
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.
Measured: 04/12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben-Tzion Karsh, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326637
- Sponsor's protocol ID
- 2010-0447
- Other IDs
- R18HS017899
- Acronym
- SAFE-C
- Status last verified
- Feb 2019
- First submitted
- 23 Mar 2011
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly
- ClinicalTrials.gov ID
- NCT01326637
- Acronym / sponsor ID
- SAFE-C / 2010-0447
- Conditions
- Primary Health Care, Aged, Clinical Information
- Keywords
- primary health care, aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,332 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Patient Overview DocumentReceived the intervention: previsit planning phone call with filled out patient overview document \& clinician huddle |
| observation | No intervention | –Received usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Must be greater than or equal to 65 years of age
- Must be patients of participating physicians
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Overview DocumentThe 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. | Other | intervention |
Primary outcome
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.
1 secondary outcome
Resource utilization
Time frame: 04/12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben-Tzion Karsh, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Overview Document in people with Primary Health Care and Aged, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and types of problems discussed during visit (time frame: 04/12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.