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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443401
• Other study ID #: 2017.154
• Status: Completed
• Start date: April 8, 2018
• Est. completion date: September 24, 2020

Study information

• Verified date: September 2020
• Source: University of South Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Physical Therapy
• Trust

Intervention

Procedure:
• Standard physical therapy care
standard plan of care delivered to patient with chronic low back within scope of licensure

Locations

Country	Name	City	State
United States	Phileo Health	Altoona	Wisconsin
United States	One Accord Physical Therapy Casa Grande	Casa Grande	Arizona
United States	Butte Premier Physical Therapy	Chico	California
United States	Outpatient Physical Therapy	Kent	Washington
United States	Hackensack Meridian Health-Mountainside Medical Center	Montclair	New Jersey
United States	Foothills Sports Medicine Physical Therapy	Phoenix	Arizona
United States	Miriam Hospital Outpatient Rehab	Providence	Rhode Island
United States	Signature Physical Therapy	San Clemente	California
United States	Kitsap Physical Therapy and Sports Clinic	Silverdale	Washington
United States	Rock Valley Physical Therapy	Silvis	Illinois
United States	PRO Physical Therapy	Winchester	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of South Dakota	Iowa Physical Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Care Assessment Survey	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.	through study completion, an average of 1 year
Primary	Change in Wake Forest Scale	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.	through study completion, an average of 1 year
Primary	Change in Trust in Physician Scale	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.	through study completion, an average of 1 year
Primary	Change in Oswestry Disability Index 2.0	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.	through study completion, an average of 1 year
Primary	Change in Numeric pain rating scale	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.	through study completion, an average of 1 year
Primary	Global rate of change	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.	through study completion, an average of 1 year
Secondary	General trust in physician scale	global trust measurement of patient	through study completion, an average of 1 year
Secondary	Change in Working alliance inventory - short revised	therapeutic alliance measurement	after initial visit and discontinuation of services, an average of 4-8 weeks.
Secondary	Change in PT survey of patient connection and engagement	Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care	after 2nd visit and discontinuation of services, an average of 4-8 weeks.
Secondary	Number of PT visits	actual number of visits seen during duration of care	discontinuation of services, an average of 4-8 weeks.
Secondary	Patient visit compliance	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	discontinuation of services, an average of 4-8 weeks.
Secondary	Discontinuation disposition	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	discontinuation of services, an average of 4-8 weeks.
Secondary	CPT codes	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.	discontinuation of services, an average of 4-8 weeks.