Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
- Conditions
- Physical TherapyTrustChronic Low Back Pain
- Interventions
- Procedure: Standard physical therapy care
- Registration Number
- NCT03443401
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Physical Therapy clinician participants Standard physical therapy care Licensed physical therapist that is providing standard physical therapy care for a patient participant patient participants Standard physical therapy care patients with chronic low back pain receiving standard physical therapy care
- Primary Outcome Measures
Name Time Method Change in Patient Care Assessment Survey 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.
Change in Wake Forest Scale 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.
Change in Trust in Physician Scale 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.
Change in Oswestry Disability Index 2.0 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.
Change in Numeric Pain Rating Scale 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.
Global Rate of Change 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
Name Time Method Change in Working Alliance Inventory - Short Revised after initial visit and discontinuation of services, an average of 4-8 weeks. therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance.
General Trust in Physician Scale through study completion, an average of 1 year global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales.
Change in PT Survey of Patient Connection and Engagement 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. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement.
Trial Locations
- Locations (11)
Butte Premier Physical Therapy
🇺🇸Chico, California, United States
Signature Physical Therapy
🇺🇸San Clemente, California, United States
Rock Valley Physical Therapy
🇺🇸Silvis, Illinois, United States
Miriam Hospital Outpatient Rehab
🇺🇸Providence, Rhode Island, United States
PRO Physical Therapy
🇺🇸Winchester, Virginia, United States
Outpatient Physical Therapy
🇺🇸Kent, Washington, United States
Kitsap Physical Therapy and Sports Clinic
🇺🇸Silverdale, Washington, United States
Phileo Health
🇺🇸Altoona, Wisconsin, United States
One Accord Physical Therapy Casa Grande
🇺🇸Casa Grande, Arizona, United States
Foothills Sports Medicine Physical Therapy
🇺🇸Phoenix, Arizona, United States
Hackensack Meridian Health-Mountainside Medical Center
🇺🇸Montclair, New Jersey, United States