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

NCT01078532 | Completed

• 1 other identifier: HS018167
• Study Type: interventional
• Target: 1,815
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk

Keywords

medically complex diseases that increase cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• improved targeted chronic disease outcomes

  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.

  1 year

Secondary Outcomes (2)

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

  1 year

• rates of adherence to diagnostic and therapeutic recommendations

  1 year

Study Arms (2)

SMART PHR

EXPERIMENTAL

Patients receive the active PHR

Other: SMART PHR

Passive PHR

OTHER

Usual PHR Care

Other: usual care

Interventions

SMART PHR OTHER

Patient receives an active PHR

SMART PHR

usual care OTHER

Usual passive PHR

Passive PHR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UPMC Primary Care practices

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 25243350 DERIVED

Study Officials

• Mark S Roberts, MD, MPP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2010
• First Posted: March 2, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)