NCT00935584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 6, 2015

Completed
Last Updated

November 6, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

July 7, 2009

Results QC Date

January 31, 2014

Last Update Submit

October 7, 2015

Conditions

Keywords

CommunicationDoctor-patient relationsmedical informaticspatient-centered caremedical records systems, computerized

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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)

    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.

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

Study Arms (1)

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.

Behavioral: Physician training in patient-centered emr use

Interventions

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

Also known as: Educational Workshop
PACE Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Zia Agha
Organization
VA san Diego Healthcare System

Study Officials

  • Zia Agha, MD MS

    VA San Diego Healthcare System, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

May 1, 2010

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

November 6, 2015

Results First Posted

November 6, 2015

Record last verified: 2015-10

Locations