Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 11
- 主要终点
- Change in Patient Care Assessment Survey
研究概览
简要总结
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.
详细描述
- 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.
- 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.
- 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.
- The patient then will receive a normal physical therapy initial evaluation and treatment as directed by the physical therapist based on the patient presentation.
- 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.
- 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.
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Patient Care Assessment Survey
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- General Trust in Physician Scale(through study completion, an average of 1 year)
- Change in Working Alliance Inventory - Short Revised(after initial visit and discontinuation of services, an average of 4-8 weeks.)
- Change in PT Survey of Patient Connection and Engagement(after 2nd visit and discontinuation of services, an average of 4-8 weeks.)
研究者
Kory Zimney, PT, DPT, PhD
Assistant Professor
University of South Dakota