Patient Centered Evaluation of Computerized Patient Records System

Electronic Medical Records Clinical Trial

— PACECPRS  

Official title:

Patient Centered Evaluation of Computerized Patient Records System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935584
• Other study ID #: IIR 07-196
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: October 7, 2015
• Start date: May 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. We will also develop a training program to improve doctors ability to communicate with patients while using EMR.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Electronic Medical Records

Intervention

Behavioral:
• Physician training in patient-centered emr use
This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No
Primary	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)	No
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.	Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)	No