Influence of Patient-Informed Choice in a Novel Treatment Model for LBP

Status Withdrawn

Clinical Trial Summary

1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain.

(We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach)

2. (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)

Clinical Trial Description

The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01744015
Study type	Interventional
Source	Walsh University
Contact
Status	Withdrawn
Phase	N/A
Start date	April 2013
Completion date	July 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.