Trial Outcomes & Findings for Patient Centered Evaluation of Computerized Patient Records System (NCT NCT00935584)
NCT ID: NCT00935584
Last Updated: 2015-11-06
Results Overview
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.
COMPLETED
NA
151 participants
Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
2015-11-06
Participant Flow
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.
Participant milestones
| Measure |
PACE Study Patients
The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.
126 patients started the study and 77 completed the study.
|
PACE Study Providers
23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
23
|
|
Overall Study
COMPLETED
|
77
|
19
|
|
Overall Study
NOT COMPLETED
|
49
|
4
|
Reasons for withdrawal
| Measure |
PACE Study Patients
The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.
126 patients started the study and 77 completed the study.
|
PACE Study Providers
23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
0
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
0
|
|
Overall Study
No show
|
9
|
0
|
|
Overall Study
Relocated
|
3
|
0
|
|
Overall Study
Patient changed provider
|
3
|
0
|
|
Overall Study
Provider dropped out of study
|
14
|
4
|
Baseline Characteristics
Patient Centered Evaluation of Computerized Patient Records System
Baseline characteristics by cohort
| Measure |
PACE Study Patients
n=126 Participants
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.
|
PACE Study Providers
n=23 Participants
23 providers participated in the study. However, final analysis was based on 126 clinic visits.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
23 participants
n=7 Participants
|
149 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Patient satisfaction/visit
|
-0.033 units on a scale
Standard Deviation 0.454
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Patient satisfacton/clinical skill
|
0.032 units on a scale
Standard Deviation 0.69
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Patient satisfaction/interpersonal skill
|
-0.018 units on a scale
Standard Deviation 0.386
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Provider satisfaction/physician-patient relation
|
0.077 units on a scale
Standard Deviation 0.538
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Provider satisfaction/patient's cooperation
|
0.0101 units on a scale
Standard Deviation 0.869
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Provider satisfaction/data collection
|
0.095 units on a scale
Standard Deviation 0.686
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Provider satisfaction/use of time
|
-0.035 units on a scale
Standard Deviation 0.827
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Patient satisfaction/visit
|
0 units on a scale
Interval -1.44 to 1.38
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Patient satisfaction/clinic skill
|
0 units on a scale
Interval -2.33 to 3.33
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Patient satisfaction/interpersonal skill
|
0 units on a scale
Interval -2.0 to 1.33
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Provider satisfaction/physician-patient relation
|
0 units on a scale
Interval -1.75 to 2.0
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Provider satisfaction/patient's cooperation
|
0 units on a scale
Interval -1.67 to 3.0
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Provider satisfaction/data collection
|
0 units on a scale
Interval -1.67 to 2.0
|
|
Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
Provider satisfaction/use of time
|
0 units on a scale
Interval -3.0 to 1.67
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PACE Study
n=125 Participants
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.
|
|---|---|
|
Change in Patient Engagement
Time spent on patient and companion
|
2.9 percentage of total visit time
Standard Deviation 15.2
|
|
Change in Patient Engagement
Time spent on physical exam
|
-1.4 percentage of total visit time
Standard Deviation 14.7
|
|
Change in Patient Engagement
Time spent on EMR
|
-1.6 percentage of total visit time
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)
|
-1.22 EMR mouse clicks per visit
Standard Deviation 155
|
PRIMARY outcome
Timeframe: 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.
For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in Total Number of EMR Mouse Click Per Visit (Median/Range)
|
-2 EMR mouse clicks per visit
Interval -412.0 to 303.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)
|
-0.089 EMR mouse clicks per minute per visit
Standard Deviation 3.11
|
PRIMARY outcome
Timeframe: 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.
For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.
Outcome measures
| Measure |
PACE Study
n=126 Participants
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.
|
|---|---|
|
Change in EMR Mouse Click Per Minute Per Visit (Median/Range)
|
0.005 EMR mouse clicks per minute per visit
Interval -7.13 to 5.84
|
Adverse Events
PACE Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place