跳至主要内容
临床试验/NCT01669564
NCT01669564
已完成
不适用

Functional Assessment Screening Patient Reported Information

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 666 人2013年2月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Quality of Life
发起方
University of Pittsburgh
入组人数
666
试验地点
1
主要终点
Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group.
状态
已完成
最后更新
10年前

概览

简要总结

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).

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2013年2月
结束日期
2015年8月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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))

排除标准

  • 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.

结局指标

主要结局

Aim 1 Primary outcome: Patient report of differences in the rates of initiation of discussions of PRI in the intervention vs. control group.

时间窗: 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.

时间窗: 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.

次要结局

  • 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)
  • 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)

研究点 (1)

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