Quality of LifeFAST-PRINCT01669564
Functional Assessment Screening Patient Reported Information
A study testing Will use HIT patient feedback to activate patients. and Patients will not receive HIT patient feedback. in people with Quality of Life and Tobacco Use Cessation, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Tobacco Use Cessation, Physical Activity
- What is being tested?
- Will use HIT patient feedback to activate patients. and Patients will not receive HIT patient feedback.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians will be eligible to participate if:
- They see patients in the GIMO practice and
- They consent to participate in FAST-PRI.
- Patients will be eligible to participate if:
- They are 18 years or older,
- Complete a FAST questionnaire at that visit,
Show all 12Show fewer
- Have at least one study-designated PRI (i.e.,
- Tobacco use,
- Physical inactivity, or
- Poor mental HRQoL (MHC≤38))
- Consent to participate, and
- Speak English. FAST is only available in English.
Who cannot join
- Physicians will be ineligible to participate if:
- They are planning to leave the practice during the study period or
- See patients fewer than 4 hours/week.
- Patients will be ineligible to participate if:
- They are planning to relocate during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Internal Medicine
Pittsburgh, Pennsylvania, 15213
About this study
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:
Read more
- 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).
Read the detailed 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.
- Conditions
- Quality of Life, Tobacco Use Cessation, Physical Activity
- Being tested
- Will use HIT patient feedback to activate patients., Patients will not receive HIT patient feedback.
- Keywords
- Quality of Life, Tobacco Use Cessation, Physical Activity
- Medical subject headings
- Tobacco Use Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Will use HIT patient feedback to activate patients.Other
After completing the FAST, GIMO patients seeing a participating provider will receive(or not receive)HIT patient feedback, based on their providers' study group assignment. Feedback for each PRI will be personalized based on the medical history, family history, and other PRI reported on the FAST. A discussion of potential treatment options will be presented along with possible general referral resources. The patient will be encouraged to discuss the PRI with his or her physician.
Patients will be provided with a list of resources, customized to their study-designated PRI, that includes ongoing programs available both in the community and GIMO to help them with behavior change and mental HRQoL.
Patients will not receive HIT patient feedback.Other
After completing the FAST (standard of care in GIMO) GIMO patients seeing a participating provider will receive (or not receive) HIT patient feedback, based on their providers' study group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Activated Patients | Active comparator | Will use HIT patient feedback to activate patients. Receives: Other: Will use HIT patient feedback to activate patients. |
| Control patients | Other | Patients will not receive HIT patient feedback. Receives: Other: Patients will not receive HIT patient feedback. |
| Intervention Physicians | Other | Will use HIT patient feedback to activate patients. Receives: Other: Will use HIT patient feedback to activate patients. |
| Control Physicians | Other | Patients will not receive HIT patient feedback. Receives: Other: Patients will not receive HIT patient feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group.
The investigators will survey patients and physicians and abstract referral data from the electronic medical record (EMR).
Measured: One year
Aim 2 Primary outcome: number of smoking quit attempts, physical activity, and mental HRQoL at six- and twelve-months.
Patient participants will be contacted and asked to report smoking quit attempts, physical activity using the Modified Activity Questionnaire, physical activity lapses, and HRQoL using the RAND-36.
Smoking quit attempts will be measured using questions modified from the Tobacco Use Supplement to the Current Population Survey, National Health and Nutrition Examination Survey, and the National Health Interview Survey.
Measured: One year
Secondary outcomes (2)
Aim 1 Secondary outcomes include patient-report of the occurrence of discussion and helpfulness of the discussion and physician reports of initiation, occurrence, and helpfulness of the discussion.
After each clinical encounter, a participating patient will be asked to complete a brief questionnaire immediately after the encounter. The questionnaire ascertains if the PRI (i.e., physical activity, tobacco use, or mental HRQoL) were discussed during the doctor-patient encounter, who initiated the discussion, and how useful the patient found the discussion (1: not at all useful to 5: very useful, 0: not discussed).
Measured: One year
Aim 2 Secondary outcome: percentage of patients being non-smokers, percentage of patients being adequately physically active, and mental HRQoL at twelve months.
At the end of the intervention period, physician level data examining percentage of the panel with improvement of the PRI will be examined. The investigators will electronically abstract data from the FAST and EpicCare EMRs regarding each study-designated PRI, physician study group assignment, referrals, and number of visits over the study period in a de-identified manner. In this way, the investigators will be able to compare the impact of the HIT patient feedback intervention across GIMO.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- None (open label)
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Hess Rachel, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669564
- Sponsor's protocol ID
- 1R18HS018932-01A1
- Acronym
- FAST-PRI
- Status last verified
- Dec 2015
- First submitted
- 14 Aug 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment Screening Patient Reported Information
- ClinicalTrials.gov ID
- NCT01669564
- Acronym / sponsor ID
- FAST-PRI / 1R18HS018932-01A1
- Conditions
- Quality of Life, Tobacco Use Cessation, Physical Activity
- Keywords
- Quality of Life, Tobacco Use Cessation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Aug 2012 (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.
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).
Detailed 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Activated Patients | Active comparator | Other: Will use HIT patient feedback to activate patients.Will use HIT patient feedback to activate patients. |
| Control patients | Other | Other: Patients will not receive HIT patient feedback.Patients will not receive HIT patient feedback. |
| Intervention Physicians | Other | Other: Will use HIT patient feedback to activate patients.Will use HIT patient feedback to activate patients. |
| Control Physicians | Other | Other: Patients will not receive HIT patient feedback.Patients will not receive HIT patient feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- They see patients in the GIMO practice and
- They consent to participate in FAST-PRI.
- They are 18 years or older,
- Complete a FAST questionnaire at that visit,
- Have at least one study-designated PRI (i.e.,
Key exclusion criteria (5 listed)
- They are planning to leave the practice during the study period or
- See patients fewer than 4 hours/week.
- They are planning to relocate during the study period.
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 |
|---|---|---|
| Will use HIT patient feedback to activate patients.After completing the FAST, GIMO patients seeing a participating provider will receive(or not receive)HIT patient feedback, based on their providers' study group assignment. Feedback for each PRI will be personalized based on the medical history, family history, and other PRI reported on the FAST. A discussion of potential treatment options will be presented along with possible general referral resources. The patient will be encouraged to discuss the PRI with his or her physician. Patients will be provided with a list of resources, customized to their study-designated PRI, that includes ongoing programs available both in the community and GIMO to help them with behavior change and mental HRQoL. | Other | Activated Patients, Intervention Physicians |
| Patients will not receive HIT patient feedback.After completing the FAST (standard of care in GIMO) GIMO patients seeing a participating provider will receive (or not receive) HIT patient feedback, based on their providers' study group assignment. | Other | Control Physicians, Control patients |
Primary outcome
Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group.
Time frame: One year
The investigators will survey patients and physicians and abstract referral data from the electronic medical record (EMR).
Aim 2 Primary outcome: number of smoking quit attempts, physical activity, and mental HRQoL at six- and twelve-months.
Time frame: One year
Patient participants will be contacted and asked to report smoking quit attempts, physical activity using the Modified Activity Questionnaire, physical activity lapses, and HRQoL using the RAND-36. Smoking quit attempts will be measured using questions modified from the Tobacco Use Supplement to the Current Population Survey, National Health and Nutrition Examination Survey, and the National Health Interview Survey.
2 secondary outcomes
Aim 1 Secondary outcomes include patient-report of the occurrence of discussion and helpfulness of the discussion and physician reports of initiation, occurrence, and helpfulness of the discussion.
Time frame: One year
Aim 2 Secondary outcome: percentage of patients being non-smokers, percentage of patients being adequately physically active, and mental HRQoL at twelve months.
Time frame: One year
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 2 Dec 2015.
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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.
Hess Rachel, MD, MS 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 Will use HIT patient feedback to activate patients. and Patients will not receive HIT patient feedback. in people with Quality of Life and Tobacco Use Cessation, 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 12 inclusion and 5 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 2 Dec 2015. 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?
Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group. (time frame: One year). The study lists 2 primary outcomes in all. 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 2 Dec 2015.