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Completed

NCT Number: NCT01078532

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Primary Care practices

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SMART PHR

Other

Patient receives an active PHR

Usual Care

Other

Usual passive PHR

Primary outcomes

  1. improved targeted chronic disease outcomes

    Time frame: 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 outcomes

  1. change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)

    Time frame: 1 year

  2. rates of adherence to diagnostic and therapeutic recommendations

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: SMART PHR

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2010
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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