Electronic Medical RecordsPACECPRSNCT00935584

Patient Centered Evaluation of Computerized Patient Records System

A study testing Physician training in patient-centered emr use in people with Electronic Medical Records, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Electronic Medical Records
What is being tested?: Physician training in patient-centered emr use
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 1 siteUnited States
Study dates: May 2010to Apr 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego
San Diego, California, 92161

Other trials in United States

About this study

Read the 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:

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).
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.
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.

Conditions: Electronic Medical Records
Being tested: Physician training in patient-centered emr use
Keywords: Communication, Doctor-patient relations, medical informatics, patient-centered care, medical records systems, computerized
Medical subject headings: Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physician training in patient-centered emr useBehavioural
Also called Educational Workshop
This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.

Study groups in NCT00935584
Study group	Role	What they receive
PACE Study	Other	The study utilized a quasi-experimental pre-post intervention design. The intervention provided was physician education to improve EMR use and communication. Physician training in patient-centered EMR use was developed. The conceptual model of "patient-centered communication" will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills. Receives: Behavioral: Physician training in patient-centered emr use

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
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.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
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.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
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.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
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.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)
Measured: 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)
For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.
Measured: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Apr 2013

First posted9 Jul 2009 (estimated)
Study startMay 2010
Primary completionFeb 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Electronic Medical RecordsStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00935584
Sponsor's protocol ID: IIR 07-196
Acronym: PACECPRS
Status last verified: Oct 2015
First submitted: 7 Jul 2009
Last updated: 6 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Centered Evaluation of Computerized Patient Records System
ClinicalTrials.gov ID: NCT00935584
Acronym / sponsor ID: PACECPRS / IIR 07-196
Conditions: Electronic Medical Records
Keywords: Communication, Doctor-patient relations, medical informatics, patient-centered care, medical records systems, computerized
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: May 2010
Primary completion: Feb 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 9 Jul 2009 (estimated)
Results: Posted 6 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

METHODS

The study used a quasi-experimental (pre-post intervention design) carried out in three phases:

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).
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.
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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PACE Study	Other	Behavioral: Physician training in patient-centered emr useThe study utilized a quasi-experimental pre-post intervention design. The intervention provided was physician education to improve EMR use and communication. Physician training in patient-centered EMR use was developed. The conceptual model of "patient-centered communication" will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (3 listed)

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.

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
Physician training in patient-centered emr useAlso: Educational WorkshopThis intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.	Behavioural	PACE Study

Primary outcome

Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
Time frame: 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)
Time frame: 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 Engagement
Time frame: Baseline 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

Results and safety

Results posted to the registry on 6 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PACE Study Patients	126	77
PACE Study Providers	23	19

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

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year). Mean (Standard Deviation). Unit: units on a scale

Measure	PACE Study n = 126
Patient satisfaction/visit	-0.033 (0.454)
Patient satisfacton/clinical skill	0.032 (0.69)
Patient satisfaction/interpersonal skill	-0.018 (0.386)
Provider satisfaction/physician-patient relation	0.077 (0.538)
Provider satisfaction/patient's cooperation	0.0101 (0.869)
Provider satisfaction/data collection	0.095 (0.686)
Provider satisfaction/use of time	-0.035 (0.827)

PACE Study: p >0.05, Mixed Models Analysis
PACE Study: p >0.05, Wilcoxon signed rank test

Population analysed: 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.

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

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year). Median (Full Range). Unit: units on a scale

Measure	PACE Study n = 126
Patient satisfaction/visit	0 (-1.44 to 1.38)
Patient satisfaction/clinic skill	0 (-2.33 to 3.33)
Patient satisfaction/interpersonal skill	0 (-2 to 1.33)
Provider satisfaction/physician-patient relation	0 (-1.75 to 2)
Provider satisfaction/patient's cooperation	0 (-1.67 to 3)
Provider satisfaction/data collection	0 (-1.67 to 2)
Provider satisfaction/use of time	0 (-3 to 1.67)

PACE Study: p >0.05, Mixed Models Analysis
PACE Study: p >0.05, Wicoxon signed rank test

Primary outcome: Change in Patient Engagement

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year). Mean (Standard Deviation). Unit: percentage of total visit time

Measure	PACE Study n = 125
Time spent on patient and companion	2.9 (15.2)
Time spent on physical exam	-1.4 (14.7)
Time spent on EMR	-1.6 (16.6)

PACE Study: p >0.05, Mixed Models Analysis
PACE Study: p >0.05, Wilcoxon signed rank test

Population analysed: 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.

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

Time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year). Mean (Standard Deviation). Unit: EMR mouse clicks per visit

Measure	PACE Study n = 126
Value	-1.22 (155)

PACE Study: p <0.05, Mixed Models Analysis
PACE Study: p <0.05, Wilcoxon signed rank test

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PACE Study	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Study limitations include inability to capture EHR activity outside the visit, study only primary care providers at a single organization (VA) and only one EHR system, this limits generalizability of the findings to other setting.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Zia Agha, MD MS principal investigator

VA San Diego Healthcare System, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physician training in patient-centered emr use in people with Electronic Medical Records, run by VA Office of Research and Development 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 1 inclusion and 3 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 6 Nov 2015. 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?

Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD) (time frame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00935584.

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 6 Nov 2015.