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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01078532
First received: February 27, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1815
Study Start Date: April 2010
Study Completion Date: September 2012
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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078532

Locations
United States, Pennsylvania
UPMC Primary Care practices
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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: May 20, 2014
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 August 20, 2014