- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01326637
Human Factors Intervention to Reduce Risk in Primary Care of the Elderly (SAFE-C)
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.
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin, Madison
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: intervention
Received the intervention: previsit planning phone call with filled out patient overview document & clinician huddle
|
The Intervention has two components:
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. |
|
Ingen indgriben: observation
Received usual care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number and types of problems discussed during visit
Tidsramme: 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
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. |
04/12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Resource utilization
Tidsramme: 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.
|
04/12
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ben-Tzion Karsh, PhD, University of Wisconsin, Madison
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2010-0447
- R18HS017899 (U.S.A. AHRQ bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Patient Overview Document
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