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Patient Centered Evaluation of Computerized Patient Records System

Patient Centered Evaluation of Computerized Patient Records System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00935584
Acronym
PACECPRS
Enrollment
151
Registered
2009-07-09
Start date
2010-05-31
Completion date
2013-04-30
Last updated
2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Medical Records

Keywords

Communication, Doctor-patient relations, medical informatics, patient-centered care, medical records systems, computerized

Brief summary

The VHA is a leader in electronic medical records (EMR) use for patient care. It is believed that EMR use by doctors will improve patient-centeredness of visits, and improve clinical care. The proposed study will determine how doctors should use the EMR during patient consultations. We will also develop a training program to improve doctors ability to communicate with patients while using EMR.

Detailed description

Anticipated Impact on Veterans Healthcare: Health information technology (HIT), including electronic medical records (EMR) has the potential to improve the quality and safety of ambulatory care. The VHA is a leader in EMR implementation. It is believed that EMR use by physicians will improve patient-centeredness of visits, and healthcare outcomes. The proposed clinical trial addresses the need for rigorous research on EMR use, patient-centered care, and relevant health outcomes. Both physician-patient communication and EMR use are cross-cutting clinical issues with broad implications for patient care within the VHA. Consequently, the proposed project is directly related to the VHA's mission to use HIT to improve the quality health care for veteran patients. BACKGROUND/RATIONALE EMRs can potentially improve quality and safety of ambulatory care. However, little research systematically documents the effect of EMRs on patient-centered care. Studies of the EMR's effect on patient-provider communication have been observational and had small sample sizes. Overall, these studies reported varied success regarding providers integrating the EMR into office visits, and suggest that further research is needed to evaluate the effectiveness of training providers in patient-centered communication and EMR use. OBJECTIVES The PACE aims were to study how EMR use affects patient-provider communication behaviors, and patient-centered care and related health outcomes; to develop a unique provider training program tailored to patient-centered EMR use; and to evaluate the effect of the training intervention on patient-provider communication, patient-centered care, and provider EMR use. METHODS The study used a quasi-experimental (pre-post intervention design) carried out in three phases: 1. Pre-intervention: A pre-intervention patient-provider visit was conducted for each patient-provider pair. Visits were video recorded and reviewed for verbal and nonverbal patient-provider communication. MORAE software was used to record provider-EMR interaction data, including page views, navigation, and mouse clicks. Data were collected for related outcomes (patient and provider satisfaction). 2. Training: Findings from pre-intervention data guided development of a multifaceted provider training intervention promoting patient-centered EMR appropriation. The training intervention was delivered via a full day training workshop and individual feedback sessions. 3. Post-intervention: A second round of visits was conducted with the same patient-provider pairs and similar data were collected as in pre-intervention. Within group analyses (pre-post) were used to test whether the training intervention resulted in significant improvements in (a) patient-centered EMR use and (b) related outcomes (patient and provider satisfaction). IMPACT PACE findings emphasize the need to address EMR usability by the VHA hi2 (Health Informatics Initiative) and iEHR team.

Interventions

BEHAVIORALPhysician training in patient-centered emr use

This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (age\>18) male and female patients from participating study providers' practices who have an established a doctor-patient relationship with their provider and require a minimum of 2 primary care clinic visits/year based on historical clinic data.

Exclusion criteria

* Patients with significant communication disability (severe speech and hearing impairment, severe dementia, or a mental health condition resulting in a non-communicative patient); * patients are considered mentally incompetent to provide informed written consent; * a life expectancy of less than 1 year.

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time. Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported.
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time. Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported.
Change in Patient EngagementBaseline clinic visit and post-intervention clinic visit (over a period of 1 year)Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.
Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.
Change in Total Number of EMR Mouse Click Per Visit (Median/Range)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.
Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
Change in EMR Mouse Click Per Minute Per Visit (Median/Range)Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.

Countries

United States

Participant flow

Recruitment details

The study recruited 23 primary care providers from VA San Diego and its community based outpatient clinics. For each provider we enrolled approximately 6 patients from their out-patient practice. A total of 23 physicians and 126 patients were included in the final analysis.

Participants by arm

ArmCount
PACE Study Patients
The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases. Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills.
126
PACE Study Providers
23 providers participated in the study. However, final analysis was based on 126 clinic visits.
23
Total149

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath30
Overall StudyLost to Follow-up80
Overall StudyNo show90
Overall StudyPatient changed provider30
Overall StudyProvider dropped out of study144
Overall StudyRelocated30
Overall StudyWithdrawal by Subject90

Baseline characteristics

CharacteristicPACE Study PatientsPACE Study ProvidersTotal
Age, Continuous60.5 years
STANDARD_DEVIATION 13.4
NA yearsNA years
Region of Enrollment
United States
126 participants23 participants149 participants
Sex: Female, Male
Female
4 Participants17 Participants21 Participants
Sex: Female, Male
Male
122 Participants6 Participants128 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.

ArmMeasureValue (MEAN)Dispersion
PACE StudyChange in EMR Mouse Click Per Minute Per Visit (Mean/SD)-0.089 EMR mouse clicks per minute per visitStandard Deviation 3.11
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: <0.05Mixed Models Analysis
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: <0.05Wilcoxon signed rank test
Primary

Change in EMR Mouse Click Per Minute Per Visit (Median/Range)

For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.

ArmMeasureValue (MEDIAN)
PACE StudyChange in EMR Mouse Click Per Minute Per Visit (Median/Range)0.005 EMR mouse clicks per minute per visit
Primary

Change in Patient Engagement

Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=72 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=125) using all available data.

ArmMeasureGroupValue (MEAN)Dispersion
PACE StudyChange in Patient EngagementTime spent on patient and companion2.9 percentage of total visit timeStandard Deviation 15.2
PACE StudyChange in Patient EngagementTime spent on physical exam-1.4 percentage of total visit timeStandard Deviation 14.7
PACE StudyChange in Patient EngagementTime spent on EMR-1.6 percentage of total visit timeStandard Deviation 16.6
Comparison: The null hypothesis is that there is no significant change in patient engagement from pre to post visit.p-value: >0.05Mixed Models Analysis
Comparison: The null hypothesis is that there is no significant change in patient engagement from pre to post visit.p-value: >0.05Wilcoxon signed rank test
Primary

Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)

Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time. Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.

ArmMeasureGroupValue (MEAN)Dispersion
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Patient satisfaction/visit-0.033 units on a scaleStandard Deviation 0.454
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Patient satisfacton/clinical skill0.032 units on a scaleStandard Deviation 0.69
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Patient satisfaction/interpersonal skill-0.018 units on a scaleStandard Deviation 0.386
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Provider satisfaction/physician-patient relation0.077 units on a scaleStandard Deviation 0.538
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Provider satisfaction/patient's cooperation0.0101 units on a scaleStandard Deviation 0.869
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Provider satisfaction/data collection0.095 units on a scaleStandard Deviation 0.686
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)Provider satisfaction/use of time-0.035 units on a scaleStandard Deviation 0.827
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: >0.05Mixed Models Analysis
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: >0.05Wilcoxon signed rank test
Primary

Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)

Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time. Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.

ArmMeasureGroupValue (MEDIAN)
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Patient satisfaction/visit0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Patient satisfaction/clinic skill0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Patient satisfaction/interpersonal skill0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Provider satisfaction/physician-patient relation0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Provider satisfaction/patient's cooperation0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Provider satisfaction/data collection0 units on a scale
PACE StudyChange in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)Provider satisfaction/use of time0 units on a scale
Comparison: The null hypothesis is that there is no significant change in outcome from pre to post visit.p-value: >0.05Mixed Models Analysis
Comparison: The null hypothesis is that there is no significant change in outcome from pre to post visit.p-value: >0.05Wicoxon signed rank test
Primary

Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)

For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (n= 60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.

ArmMeasureValue (MEAN)Dispersion
PACE StudyChange in Total Number of EMR Mouse Click Per Visit (Mean/SD)-1.22 EMR mouse clicks per visitStandard Deviation 155
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: <0.05Mixed Models Analysis
Comparison: The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.p-value: <0.05Wilcoxon signed rank test
Primary

Change in Total Number of EMR Mouse Click Per Visit (Median/Range)

For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Population: Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.

ArmMeasureValue (MEDIAN)
PACE StudyChange in Total Number of EMR Mouse Click Per Visit (Median/Range)-2 EMR mouse clicks per visit
Comparison: The null hypothesis is that there is no significant change in outcome from pre to post visit.p-value: <0.05Mixed Models Analysis
Comparison: The null hypothesis is that there is no significant change in outcome from pre to post visit.p-value: <0.05Wilcoxon signed rank test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026