Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)

Not Applicable

Completed

• Conditions: Cardiovascular Risk
• Interventions: Other: SMART PHR; Other: usual care

• Registration Number: NCT01078532
• Lead Sponsor: University of Pittsburgh

Brief Summary

This project seeks to improve health care outcomes in complex patients with cardiovascular disease (CVD) or who are at high risk for developing CVD by promoting patient self-management. This will be accomplished in 4 diverse, large primary care practices through the following 3 aims: (1) develop a patient-specific, active component to an existing electronic PHR directed towards patients with complex illnesses that is designed to reduce the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the effectiveness of passive and active PHRs for improving adherence and clinical outcomes of complex patients in an ambulatory environment, and (3) enumerate the barriers and facilitators to implementation and use of an PHR among providers and patients in an ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine which potential features of an 'active PHR' would be most acceptable and useful to them. To accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR currently is installed and in use. Outcomes to be assessed include improvement in control of risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g., annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction, hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR, along with nurses and physicians at the study sites, and by conducting focus groups of PHR participants, nurses, and physicians to determine the most useful features of the PHR and to barriers and facilitators of use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-27
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Study Start: 2010-04
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1815

Inclusion Criteria

• >=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user

Read More

Exclusion Criteria

• current PHR user life-expectancy of less than 6 months dementia or disability that prevents them from being able to utilize a PHR (such as blindness)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMART PHR	SMART PHR	Patients receive the active PHR
Passive PHR	usual care	Usual PHR Care

Primary Outcome Measures

Name	Time	Method
improved targeted chronic disease outcomes	1 year	blood pressure and low density lipoprotein level (LDL) in all patients, and A1C in patients who have diabetes. For patients on medications requiring monitoring of electrolytes and creatinine, we will look at changes in these parameters as well.

Secondary Outcome Measures

Name	Time	Method
change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)	1 year
rates of adherence to diagnostic and therapeutic recommendations	1 year

Trial Locations

Locations (1)

UPMC Primary Care practices; 🇺🇸 Pittsburgh, Pennsylvania, United States