- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080183
Functional Assessment Screening Tablets - Patient Reported Measures
January 13, 2016 updated by: Rachel Hess, University of Pittsburgh
Functional Assessment Screening Tablets - Patient Reported Measures Translating Research Into Practice Pilot
The team's ultimate goal is to improve health care quality and effectiveness and support patient-centered care.
In this project, we, the investigators, will test whether providing patients with guideline based-recommendations regarding tobacco use, physical activity and mental and physical health-related quality of life (patient reported measures: PRMs) using health information technology increases doctor-patient discussions regarding these topics and results in improvements in PRMs.
We will randomize physicians in a single general internal medicine practice.
Patients seeing intervention physicians will receive guideline-based recommendations regarding PRMs, those seeing control physicians will not.
We will compare differences in doctor-patient discussions regarding PRMs between the intervention and control groups.
The successful completion of this project will provide evidence the effectiveness of involving patients in their care through the use guideline-based feedback.
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- General Internal Medicine Oakland
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
- patients of physician's who have consented to participate.
Exclusion Criteria:
- age less than 18.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback form
patients receive feedback regarding their prms in addition to doctor receiving report
|
patients receive a report that feeds back their patient reported measures to them prior to their clinical visit
|
|
No Intervention: usual care
patients do not receive feedback form prior to the encounter, clinicians continue to receive patient reported measures prior to the appointment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Doctor Patient Communication
Time Frame: The doctor and patient pair will complete a one time survey within two weeks of the doctor patient encounter. Audiotaping of the encounter will occur once at the time of encounter.
|
the doctor patient and encounter will be queried for communication regarding the patient reported measures
|
The doctor and patient pair will complete a one time survey within two weeks of the doctor patient encounter. Audiotaping of the encounter will occur once at the time of encounter.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel Hess, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
February 27, 2010
First Submitted That Met QC Criteria
March 2, 2010
First Posted (Estimate)
March 3, 2010
Study Record Updates
Last Update Posted (Estimate)
January 15, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- PRO09080140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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