Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR) (SMART PHR)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Risk |
Other: SMART PHR Other: usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART PHR) |
- improved targeted chronic disease outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- change in value in these outcome measures (lipid levels, blood pressure, and A1c levels) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- rates of adherence to diagnostic and therapeutic recommendations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1815 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SMART PHR
Patients receive the active PHR
|
Other: SMART PHR
Patient receives an active PHR
|
|
Passive PHR
Usual PHR Care
|
Other: usual care
Usual passive PHR
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Pennsylvania | |
| UPMC Primary Care practices | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Mark S Roberts, MD, MPP | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01078532 History of Changes |
| Other Study ID Numbers: | HS018167 |
| Study First Received: | February 27, 2010 |
| Last Updated: | September 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
medically complex diseases that increase cardiovascular risk |
ClinicalTrials.gov processed this record on June 18, 2013