NCT01080183

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

February 27, 2010

Last Update Submit

January 13, 2016

Conditions

Keywords

Health-related quality of lifephysical activity

Outcome Measures

Primary Outcomes (1)

  • Doctor Patient Communication

    the doctor patient and encounter will be queried for communication regarding the patient reported measures

    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.

Study Arms (2)

Feedback form

EXPERIMENTAL

patients receive feedback regarding their prms in addition to doctor receiving report

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

Interventions

patients receive a report that feeds back their patient reported measures to them prior to their clinical visit

Feedback form

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physicians who see patients in the University of Pittsburgh General Internal Medicine Practice.
  • patients of physician's who have consented to participate.

You may not qualify if:

  • age less than 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Internal Medicine Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

SmokingMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rachel Hess, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS

Study Record Dates

First Submitted

February 27, 2010

First Posted

March 3, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations