Patient Centered Evaluation of Computerized Patient Records System (PACECPRS)

• ClinicalTrials.gov Identifier: NCT00935584
• Recruitment Status: Completed
• First Posted: July 9, 2009
• Results First Posted: November 6, 2015
• Last Update Posted: November 6, 2015
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Electronic Medical Records	Behavioral: Physician training in patient-centered emr use	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Patient Centered Evaluation of Computerized Patient Records System
• Study Start Date: May 2010
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm

Intervention/treatment

PACE Study; 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; This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.; Other Name: Educational Workshop

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

3. 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.
4. 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.
5. 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.
6. 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) ]
7. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

VA San Diego Healthcare System, San Diego

San Diego, California, United States, 92161

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Zia Agha, MD MS; VA San Diego Healthcare System, San Diego

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00935584
• Other Study ID Numbers: IIR 07-196
• First Posted: July 9, 2009
• Results First Posted: November 6, 2015
• Last Update Posted: November 6, 2015
• Last Verified: October 2015

Keywords provided by VA Office of Research and Development:

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