Clinical trial NCT01078532: Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)
Official title: Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART PHR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Keywords: medically complex diseases that increase cardiovascular risk
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-03-02
Enrollment: 1815
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: improved targeted chronic disease outcomes
timeFrame: 1 year
Secondary outcomes:
measure: change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)
timeFrame: 1 year
measure: rates of adherence to diagnostic and therapeutic recommendations
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Primary Care practices
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mark S Roberts, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess R, Fischer GS, Sullivan SM, Dong X, Weimer M, Zeith C, Clark S, Roberts MS. Patterns of response to patient-centered decision support through a personal health record. Telemed J E Health. 2014 Nov;20(11):984-9. doi: 10.1089/tmj.2013.0332. Epub 2014 Sep 22.