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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01078532
First received: February 27, 2010
Last updated: September 9, 2011
Last verified: September 2011

February 27, 2010
September 9, 2011
April 2010
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01078532 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)
Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Cardiovascular Risk
  • Other: SMART PHR
    Patient receives an active PHR
  • Other: usual care
    Usual passive PHR
  • Experimental: SMART PHR
    Patients receive the active PHR
    Intervention: Other: SMART PHR
  • Passive PHR
    Usual PHR Care
    Intervention: Other: usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1815
September 2012
July 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01078532
HS018167
No
University of Pittsburgh
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Mark S Roberts, MD, MPP University of Pittsburgh
University of Pittsburgh
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP