Functional Assessment Screening Patient Reported Information

NCT01669564 | Completed DMC

• 1 other identifier: 1R18HS018932-01A1
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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).

Conditions

Quality of Life; Tobacco Use Cessation; Physical Activity

Keywords

Quality of Life; Tobacco Use Cessation; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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.

  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.

  One year

Study Arms (4)

Activated Patients

ACTIVE COMPARATOR

Will use HIT patient feedback to activate patients.

Other: Will use HIT patient feedback to activate patients.

Control patients

OTHER

Patients will not receive HIT patient feedback.

Other: Patients will not receive HIT patient feedback.

Intervention Physicians

OTHER

Will use HIT patient feedback to activate patients.

Other: Will use HIT patient feedback to activate patients.

Control Physicians

OTHER

Patients will not receive HIT patient feedback.

Other: Patients will not receive HIT patient feedback.

Interventions

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.

Activated Patients; Intervention Physicians

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.

Control Physicians; Control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

General Internal Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Motor Activity

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Hess Rachel, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 21, 2012
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

US (1)