Quality of Life Clinical Trial
Official title:
Functional Assessment Screening Patient Reported Information
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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