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Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03443401
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Iowa Physical Therapy Foundation
Information provided by (Responsible Party):
Kory Zimney, University of South Dakota

Brief Summary:
To investigate whether changes in trust between physical therapist and patient correlate to outcomes after receiving physical therapy care. We will be utilizing established questionnaires from the medical literature and one new generated questionnaire.

Condition or disease Intervention/treatment
Trust Chronic Low Back Pain Physical Therapy Procedure: Standard physical therapy care

Detailed Description:
  1. The clinic site staff and physical therapist will fill out facility consent form to participate as a treatment site. The treating physical therapist participant will complete an informed consent form at their clinic site, if willing to participate via phone call with PI. If they consent, they will fill in a demographics form and be given an ID# that will be used for data collection by PI after informed consent received. This will take about 5 minutes.
  2. Front office staff at each physical therapy clinic will provide recruitment letter for each new patient that potentially meets inclusion/exclusion criteria (coming into the clinic with low back that has persisted for greater than 3 month). If patient agrees to participate, they will fill out informed consent and HIPPA form on-line via PsychData link provided to them by clinic staff.
  3. After completing the informed consent process, the patient participant will complete the necessary forms provided in PsychData link prior to the initial visit (Baseline demographics, General Trust in Physician Scale, Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Modified Oswestry Disability Index, Numeric Pain Rating Scale) Completing the forms will take place in the waiting room as they fill out their other normal initial paperwork needed for clinic site. This should take about 10-15 minutes. The forms will be handled electronically as the information is placed in the PI's individual PsychData account. The therapist participants will be blinded to research questionnaires information through the whole research project.
  4. The patient then will receive a normal physical therapy initial evaluation and treatment as directed by the physical therapist based on the patient presentation.
  5. At the conclusion of the initial visit, the patient participant will complete the necessary forms on-line through a second PsychData link (Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Working Alliance Inventory - Short Revised). This should take about 5-10 minutes.
  6. Participant will continue to receive normal physical therapy care as directed by the physical therapist based on patient presentation. The majority of the visits (80%) have to be with the initial physical therapist involved in the care of the patient for that patient participant to be eligible for the study. The patient participant will still be eligible for all the gift cards even if they are eventually excluded due to not seeing the same therapist for 80% of the visits.
  7. At the conclusion of care for the current episode (or at the end of 6 months of continual care by the provider), the patient participant will fill out forms on line to a third PsychData link (Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Working Alliance Inventory - Short Revised, Modified Oswestry Disability Index, Numeric Pain Rating Scale, Global Rate of Change). This should take about 10-15 minutes. If the patient is a no show and does not return for follow up visits, the principle investigator will send follow up letters to try to get final surveys completed.
  8. After the second visit, the treating physical therapist will complete a PT Survey of Patient Connection and Engagement form on the patient via an on-line PyschData link. This will take less than 5 minutes. Treating therapist participant will be notified by PI that patient has consented into the study. This on-line PsychData information will be kept confidential from the patient participant.
  9. At the conclusion of care (or 6 month time period), the physical therapist and clinic site will complete appropriate forms (PT Survey of Patient Connection and Engagement, number of visits, compliance (no show/cancellations), discharge disposition, and Current Procedural Terminology (CPT) billing codes for patients care) and send back to the principle investigator.

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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
Actual Study Start Date : April 8, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patient participants
patients with chronic low back pain receiving standard physical therapy care
Procedure: Standard physical therapy care
standard plan of care delivered to patient with chronic low back within scope of licensure

Physical Therapy clinician participants
Licensed physical therapist that is providing standard physical therapy care for a patient participant
Procedure: Standard physical therapy care
standard plan of care delivered to patient with chronic low back within scope of licensure




Primary Outcome Measures :
  1. Change in Patient Care Assessment Survey [ Time Frame: through study completion, an average of 1 year ]
    Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust.

  2. Change in Wake Forest Scale [ Time Frame: through study completion, an average of 1 year ]
    Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust.

  3. Change in Trust in Physician Scale [ Time Frame: through study completion, an average of 1 year ]
    Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust.

  4. Change in Oswestry Disability Index 2.0 [ Time Frame: through study completion, an average of 1 year ]
    Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability.

  5. Change in Numeric pain rating scale [ Time Frame: through study completion, an average of 1 year ]
    Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating.

  6. Global rate of change [ Time Frame: through study completion, an average of 1 year ]
    Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery.


Secondary Outcome Measures :
  1. General trust in physician scale [ Time Frame: through study completion, an average of 1 year ]
    global trust measurement of patient

  2. Change in Working alliance inventory - short revised [ Time Frame: after initial visit and discontinuation of services, an average of 4-8 weeks. ]
    therapeutic alliance measurement

  3. Change in PT survey of patient connection and engagement [ Time Frame: after 2nd visit and discontinuation of services, an average of 4-8 weeks. ]
    Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care

  4. Number of PT visits [ Time Frame: discontinuation of services, an average of 4-8 weeks. ]
    actual number of visits seen during duration of care

  5. Patient visit compliance [ Time Frame: discontinuation of services, an average of 4-8 weeks. ]
    no show and cancellations of scheduled appointments. A no show will be defined for purposes of this study, as any time a patient does not show for a scheduled visit. A cancellation will be defined as, anytime a patient contacts the clinic site prior to their visit to cancel the visit and does not schedule a subsequent visit to make up for that cancelled visit

  6. Discontinuation disposition [ Time Frame: discontinuation of services, an average of 4-8 weeks. ]
    level of patient at discontinuation of services. 1 = Patient met all goals and current episode discontinued by PT and patient, 2 = Patient met at least one, but not all, goals and current episode discontinued by PT and patient, 3 = Patient did not meet goals and current episode discontinued by PT and patient, 4 = Patient discontinued due to financial constraints with continued care, 5 = Patient self-discharged prior to meeting goals (no show for continued visits), 6 = Patient still receiving care after 6 months from initial visit, 7 = Patient had to be referred out for additional health care from different provider, 8 = Other

  7. CPT codes [ Time Frame: discontinuation of services, an average of 4-8 weeks. ]
    billing information (current procedural terminology - CPT) through course of care. Specific billed codes based on amount and type will be analyzed in relation to outcome variables.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients coming to seek care for chronic low back at outpatient physical therapy clinics
Criteria

Inclusion Criteria:

  • age range 18 years of age or older, able to speak and read English, seeking physical therapy treatment for persistent low back pain of 3 months or greater. Being treated by a PT participant in the study

Exclusion Criteria:

  • younger than 18 years of age, unable to speak or read English, patient needing to be referred out at any time for different level of medical care, concurrent pregnancy or cancer diagnosis, initial treating physical therapist does not see patient for 80% of treatments during episode of care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443401


Contacts
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Contact: Kory J Zimney, DPT 6056586373 kory.zimney@usd.edu

Locations
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United States, Arizona
One Accord Physical Therapy Casa Grande Recruiting
Casa Grande, Arizona, United States, 85122
Contact: Kyle Cherney, DPT    505-879-0495    kyle.cherney@gmail.com   
Foothills Sports Medicine Physical Therapy Recruiting
Phoenix, Arizona, United States, 85044
Contact: Ted Carter, DPT         
United States, California
Butte Premier Physical Therapy Recruiting
Chico, California, United States, 95928
Contact: Leigh Langerwerf, DPT         
Signature Physical Therapy Recruiting
San Clemente, California, United States, 92673
Contact: Belinda McDonald, DPT         
United States, Illinois
Rock Valley Physical Therapy Recruiting
Silvis, Illinois, United States, 61282
Contact: Holly Wilkinson, DPT         
United States, Maryland
Active Life Sports Withdrawn
Perry Hall, Maryland, United States, 21236
United States, New Jersey
Hackensack Meridian Health-Mountainside Medical Center Recruiting
Montclair, New Jersey, United States, 07042
Contact: Edward Haddican, DPT    973-429-6712    edward.haddican@mountainsidehosp.com   
United States, Rhode Island
Miriam Hospital Outpatient Rehab Recruiting
Providence, Rhode Island, United States, 02904
Contact: Courtney Klenk, DPT         
United States, Virginia
PRO Physical Therapy Recruiting
Winchester, Virginia, United States, 22601
Contact: Aaron Hartstein, DPT         
United States, Washington
Outpatient Physical Therapy Recruiting
Kent, Washington, United States, 98032
Contact: Brett Neilson, DPT    425-226-7827    bneilson@eim.com   
Kitsap Physical Therapy and Sports Clinic Recruiting
Silverdale, Washington, United States, 98383
Contact: Steve Goldrick, DPT         
United States, Wisconsin
Phileo Health Recruiting
Altoona, Wisconsin, United States, 54720
Contact: Jessie Podolak, DPT    715-271-0388    jessiepfreedompt@gmail.com   
Sponsors and Collaborators
University of South Dakota
Iowa Physical Therapy Foundation
Investigators
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Principal Investigator: Kory J Zimney, DPT University of South Dakota
Study Chair: Emilio J Puentedura, DPT, PhD University of Nevada, Las Vegas
Study Director: Morey Kolber, PT, PhD Nova Southeastern University
Study Director: Adriaan Louw, PT, PhD International Spine and Pain Institute

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Responsible Party: Kory Zimney, Assistant Professor, University of South Dakota
ClinicalTrials.gov Identifier: NCT03443401     History of Changes
Other Study ID Numbers: 2017.154
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be used as part of research project for dissertation purposes and not shared to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms