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Completed Not applicable Interventional Accepts healthy volunteers

Functional Assessment Screening Patient Reported Information

ClinicalTrials.gov ID: NCT01669564

Public ClinicalTrials.gov record NCT01669564. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01669564
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Pittsburgh
Other
Enrollment
666 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2013
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015
Last update posted
Dec 1, 2015

2013 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
General Internal Medicine Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01669564, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 1, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01669564 live on ClinicalTrials.gov.

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