Clinical trial NCT03443401: Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
Official title: Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trust
Chronic Low Back Pain
Physical Therapy
Lead sponsor: University of South Dakota
Sponsor class: OTHER
Collaborators: name: Iowa Physical Therapy Foundation
First posted: 2018-02-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients coming to seek care for chronic low back at outpatient physical therapy clinics

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Patient Care Assessment Survey
timeFrame: through study completion, an average of 1 year
measure: Change in Wake Forest Scale
timeFrame: through study completion, an average of 1 year
measure: Change in Trust in Physician Scale
timeFrame: through study completion, an average of 1 year
measure: Change in Oswestry Disability Index 2.0
timeFrame: through study completion, an average of 1 year
measure: Change in Numeric Pain Rating Scale
timeFrame: through study completion, an average of 1 year
measure: Global Rate of Change
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: General Trust in Physician Scale
timeFrame: through study completion, an average of 1 year
measure: Change in Working Alliance Inventory - Short Revised
timeFrame: after initial visit and discontinuation of services, an average of 4-8 weeks.
measure: Change in PT Survey of Patient Connection and Engagement
timeFrame: after 2nd visit and discontinuation of services, an average of 4-8 weeks.
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: One Accord Physical Therapy Casa Grande
state: Arizona
city: Phoenix
country: United States
facility: Foothills Sports Medicine Physical Therapy
state: Arizona
city: Chico
country: United States
facility: Butte Premier Physical Therapy
state: California
city: San Clemente
country: United States
facility: Signature Physical Therapy
state: California
city: Silvis
country: United States
facility: Rock Valley Physical Therapy
state: Illinois
city: Montclair
country: United States
facility: Hackensack Meridian Health-Mountainside Medical Center
state: New Jersey
city: Providence
country: United States
facility: Miriam Hospital Outpatient Rehab
state: Rhode Island
city: Winchester
country: United States
facility: PRO Physical Therapy
state: Virginia
city: Kent
country: United States
facility: Outpatient Physical Therapy
state: Washington
city: Silverdale
country: United States
facility: Kitsap Physical Therapy and Sports Clinic
state: Washington
city: Altoona
country: United States
facility: Phileo Health
state: Wisconsin
Study officials:
affiliation: University of South Dakota
name: Kory J Zimney, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada, Las Vegas
name: Emilio J Puentedura, DPT, PhD
role: STUDY_CHAIR
affiliation: Nova Southeastern University
name: Morey Kolber, PT, PhD
role: STUDY_DIRECTOR
affiliation: International Spine and Pain Institute
name: Adriaan Louw, PT, PhD
role: STUDY_DIRECTOR
References: