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

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University of Pittsburgh

Status

Completed

Conditions

Cardiovascular Risk

Treatments

Other: SMART PHR
Other: usual care

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01078532
HS018167

Details and patient eligibility

About

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.

Enrollment

1,815 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,815 participants in 2 patient groups

SMART PHR
Experimental group
Description:
Patients receive the active PHR
Treatment:
Other: SMART PHR
Passive PHR
Other group
Description:
Usual PHR Care
Treatment:
Other: usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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