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

NCT01744015 | Withdrawn

• 2 other identifiers: 6291965WalshU1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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)

Conditions

Mechanical Low Back Pain

Keywords

Low back pain

Outcome Measures

Primary Outcomes (1)

• Care Seeking Behavior (recurrence of back pain) at 1 year

  Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year

  1 year status post discharge from formal physical therapy care

Secondary Outcomes (1)

• Oswestry Disability Index

  participants will be followed for the duration of the treatment which is on average 4 weeks

Other Outcomes (1)

• Numeric Pain Rating Scale

  participants will be followed for the duration of the treatment which is on average 4 weeks

Study Arms (2)

Patient Decision Making Tool

EXPERIMENTAL

Patients will be given an opportunity to use a decision making tool to assist in decision making of their care

Behavioral: Patient Decision Making tool

Standard of care

ACTIVE COMPARATOR

Control group consisting of normal care

Other: Standard of care

Interventions

Patient Decision Making tool BEHAVIORAL

The experimental group will consist of typical care from the physical therapist (as with the control group) with the addition of the patient decision support tool and information dissemination. The process of information dissemination for informed decision making. Based on the literature, we have deemed three points of informational contact as necessary to improve informed decision making. We plan to inform patients through the use of a) pre-material, b) dialogue, and c) reinforcement means.

Patient Decision Making Tool

Standard of care OTHER

A control group will receive typical care from the physical therapist. Typical care includes physical therapist directed care of patients with low back pain, using standardized treatment algorithms (guideline oriented) for referral to physicians during cases of concern. In this model, a physician is consulted when the physical therapists feel it is necessary; or when directly requested by a patient. Physician consult is not normally provided as an option for the control group, unless evidence exists within the examination to suggest the need from a mutually agreed upon examination scheme including identification of red flags between the PT and physician. In the current model, because most of patients seen are diagnosed with non-specific LBP and do not require imaging or prescriptive medications, a majority are treated actively by the physical therapists-only during the initial visit.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older with mechanically producible LBP

Sponsors & Collaborators

• Walsh University: lead
• Proaxis Therapy: collaborator

Study Sites (1)

Proaxis Physical Therapy

Greenville, South Carolina, 29602, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chad E Cook, phd

  Walsh U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2012
• First Posted: December 6, 2012
• Study Start: April 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 10, 2013

Record last verified: 2012-12

Locations

US (1)