Clinical trial NCT01669564: Functional Assessment Screening Patient Reported Information
Official title: Functional Assessment Screening Patient Reported Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Tobacco Use Cessation
Physical Activity
Keywords: Quality of Life
Tobacco Use Cessation
Physical Activity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-08-21
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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,
* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group.
timeFrame: One year
measure: Aim 2 Primary outcome: number of smoking quit attempts, physical activity, and mental HRQoL at six- and twelve-months.
timeFrame: One year
Secondary outcomes:
measure: 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.
timeFrame: One year
measure: Aim 2 Secondary outcome: percentage of patients being non-smokers, percentage of patients being adequately physically active, and mental HRQoL at twelve months.
timeFrame: One year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: General Internal Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hess Rachel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: