Clinical trial NCT00935584: Patient Centered Evaluation of Computerized Patient Records System
Official title: Patient Centered Evaluation of Computerized Patient Records System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Medical Records
Keywords: Communication
Doctor-patient relations
medical informatics
patient-centered care
medical records systems, computerized
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-07-09
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in Patient Engagement
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in Total Number of EMR Mouse Click Per Visit (Median/Range)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
measure: Change in EMR Mouse Click Per Minute Per Visit (Median/Range)
timeFrame: Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Zia Agha, MD MS
role: PRINCIPAL_INVESTIGATOR
References: