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Clinical Trial Summary

This study will evaluate a new tool, based on our currently implemented "Functional Assessment Screening Tablets (FAST)," and activate patients to partner with their physicians. Completion of this project, FAST-PRI, will provide important information on the effectiveness of using HIT patient feedback to inform and activate patients and promote health behavior change.

Aim 1 Hypotheses: Patients who receive self-management support through HIT patient feedback (intervention) will be more likely than patients who do not receive such feedback (control) to:

- Initiate discussions with their provider regarding study-designated PRI;

- Have discussions with their providers, regardless of the initiator, regarding study-designated PRI; and

- Perceive these discussions of study-designated PRI to be useful. Approach: We will conduct a 12-month randomized controlled trial of HIT patient feedback, clustered at the physician level, in an academic group medical practice. Patients and providers will complete questionnaires regarding discussions of health behaviors and HRQoL at each clinical encounter.

Aim 2 Hypotheses: HIT patient feedback will result in: 1) increased number of smoking quit attempts, 2) increased physical activity, and 3) improved mental HRQoL at six, and twelve months.

Approach: Patient participants will complete questionnaires regarding smoking quit attempts, physical activity, and their mental HRQoL at baseline, six and twelve months.

Aim 3 Hypotheses: For each study-designated PRI, patients who receive HIT patient feedback will: 1) receive more treatment recommendations (e.g., nurse educator, pharmacist, social worker referrals); 2) act on more treatment recommendations; and 3) exhibit improved self-efficacy regarding their ability to make positive lifestyle changes and improve their HRQoL; physicians whose patients receive HIT patient feedback will have higher self-efficacy regarding their ability to influence their patients to make positive lifestyle changes and improve HRQoL. These, in addition to discussions (Aim 1), will mediate the relationship between HIT patient feedback and improvements in study-designated PRI.

Approach: We will survey patients and physicians and abstract referral data from the electronic medical record (EMR).


Clinical Trial Description

The proposed project, Functional Assessment Screening Tablets-Patient Reported Information, has been developed in response to PAR-08-270: Utilizing Health Information Technology to Improve Health Care Quality (R18). Tobacco, physical activity, and poor mental health-related quality of life (HRQoL) are major causes of morbidity and mortality that are not being adequately addressed in the current systems of care. Healthcare providers play an important role in encouraging healthy behaviors and identifying factors that impact patients' HRQoL. Clinicians are most effective in this role when they partner with informed, activated, and engaged patients. The investigators will evaluate a new tool, based our current "Functional Assessment Screening Tablets (FAST)," that is designed to inform and activate patients about their own patient reported information (PRI). The FAST currently uses wirelessly-networked tablet computers to collect PRI while patients wait to see their primary care provider and provides this PRI to providers at the time of the patient's visit. The new health information technology (HIT)-based tool, used in the FAST-PRI intervention and referred to as HIT patient feedback, provides patients with self-management support through immediate, personalized, guideline-based feedback about their health behaviors (tobacco use and physical inactivity) and mental HRQoL and encourages them to take a more active role in their health. Completion of this cluster-randomized controlled trial, FAST-PRI, will provide important information on the effectiveness of using HIT patient feedback to inform and activate patients and promote health behavior change. The investigators will accomplish this through the following three specific aims:

Aim 1. Use HIT patient feedback regarding study-designated PRI (i.e., tobacco use, physical inactivity, and mental HRQoL) to activate patients.

Aim 2. Assess the impact of HIT patient feedback on study-designated PRI. Aim 3. Evaluate potential mediators of the effectiveness of HIT patient feedback on study-designated PRI.

The investigators will conduct a 12-month randomized controlled trial of HIT patient feedback, clustered at the physician level, in an academic group medical practice. Patients and providers will complete questionnaires regarding discussions of health behaviors and HRQoL at each clinical encounter. In addition, patient participants will complete questionnaires regarding smoking quit attempts, physical activity, and their mental HRQoL, as well as self-efficacy and use of interdisciplinary referral at baseline, six and twelve months. The investigators will survey physicians regarding self-efficacy at baseline, 12 and 24 months. Finally, we will abstract referral data from the electronic medical record regarding health behaviors, HRQoL, and referrals. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01669564
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date August 2015

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