SmokingNCT01080183
Functional Assessment Screening Tablets - Patient Reported Measures
A study testing Patient feedback form in people with Smoking, run by University of Pittsburgh at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Patient feedback form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
- patients of physician's who have consented to participate.
Who cannot join
- age less than 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Internal Medicine Oakland
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Smoking
- Being tested
- Patient feedback form
- Keywords
- Health-related quality of life, physical activity
- Medical subject headings
- Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient feedback formOther
patients receive a report that feeds back their patient reported measures to them prior to their clinical visit
| Study group | Role | What they receive |
|---|---|---|
| Feedback form | Experimental | patients receive feedback regarding their prms in addition to doctor receiving report Receives: Other: Patient feedback form |
| usual care | No intervention | patients do not receive feedback form prior to the encounter, clinicians continue to receive patient reported measures prior to the appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doctor Patient Communication
the doctor patient and encounter will be queried for communication regarding the patient reported measures
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- RAND
- Responsible party
- Principal investigator, Rachel Hess, University of Pittsburgh
- Investigators
- Rachel Hess, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080183
- Sponsor's protocol ID
- PRO09080140
- Status last verified
- Jan 2016
- First submitted
- 27 Feb 2010
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment Screening Tablets - Patient Reported Measures Translating Research Into Practice Pilot
- ClinicalTrials.gov ID
- NCT01080183
- Acronym / sponsor ID
- PRO09080140
- Conditions
- Smoking
- Keywords
- Health-related quality of life, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- RAND
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback form | Experimental | Other: Patient feedback formpatients receive feedback regarding their prms in addition to doctor receiving report |
| usual care | No intervention | –patients do not receive feedback form prior to the encounter, clinicians continue to receive patient reported measures prior to the appointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
- patients of physician's who have consented to participate.
Key exclusion criteria (1 listed)
- age less than 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient feedback formpatients receive a report that feeds back their patient reported measures to them prior to their clinical visit | Other | Feedback form |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
Related trials for Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Hess, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient feedback form in people with Smoking, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.