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

NCT ID: NCT01078532

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1815 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

SMART PHR

Patients receive the active PHR

Group Type: EXPERIMENTAL

SMART PHR

Intervention Type: OTHER

Patient receives an active PHR

Passive PHR

Usual PHR Care

Group Type: OTHER

usual care

Intervention Type: OTHER

Usual passive PHR

Interventions

SMART PHR

Patient receives an active PHR

Intervention Type: OTHER

usual care

Usual passive PHR

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S Roberts, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Primary Care practices

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25243350 (View on PubMed)

Other Identifiers

HS018167

Identifier Type: -

Identifier Source: org_study_id