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临床试验/NCT07364773
NCT07364773招募中不适用

Enhancing Rehabilitation Participation in Patients With Spinal Cord Injury or Disorder Using Motivational Interviewing

Shirley Ryan AbilityLab3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
3
主要终点
Therapy Participation Level

研究概览

简要总结

The purpose of this multi-site clinical trial is to see whether people with spinal cord injury or disorder (SCI/D) demonstrate higher level of participation in rehabilitation sessions and other outcomes when their therapists are trained in a counseling style called motivational interviewing. We want to answer the following questions:

  1. Do inpatients with SCI/D treated by physical therapists (PTs) and occupational therapists (OTs) who receive MI training and coaching demonstrate greater therapy participation compared to those treated by therapists who do not receive MI training and coaching?
  2. Do inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching demonstrate greater functional improvement at discharge from inpatient rehabilitation and greater community integration at 6 months after discharge compared to those treated by therapists who do not receive MI training and coaching?
  3. What are the potential moderators and mediators of the effect of training and coaching on MI skills on therapy participation?

Researchers will compare patient participation level and other outcomes of inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching with those treated by therapists who do not receive MI training and coaching.

Therapist participants will:

  1. Audio record 2 therapy sessions per week with each enrolled SCI patient participant
  2. Half of the therapists will attend a 16-hour training on MI skills and 2 practice therapy session

Patient participants will:

  1. Consent to audio recording of their therapy sessions
  2. Complete one brief survey near the time of their discharge and another survey 6 months later

详细描述

We plan to conduct a multi-site randomized controlled trial of motivational interviewing (MI) training for physical therapists (PTs) and occupational therapists (OTs) who treat people with SCI during inpatient rehabilitation. We will test whether patients treated by MI trained PTs and OTs demonstrate greater participation in therapy sessions and better functional, social, and educational/occupational outcomes relative to patients treated by therapists without MI training. This stage of research is appropriate because a Neilsen Foundation funded pilot study that we recently completed had promising results. Study results showed that SCI patients treated by MI trained PTs and OTs participated significantly more actively in therapy sessions compared to controls. However, the study had several limitations that need to be addressed to produce a more definitive and influential trial. First, the study was conducted at a single site and results may not generalize to other sites. Second, we did not examine whether MI training and improved participation resulted in patients having better clinically meaningful outcomes such as higher likelihood of discharge to home or superior functional, social, or educational/occupational outcomes. Third, therapists trained in MI achieved only minimal competency in MI skills. We hypothesize that if therapists received ongoing coaching to improve their MI skills during the trial the positive impact on patient participation and other outcomes might be even more robust.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patient participants and the assessor rating participation level during therapy sessions will be blinded. Therapist participants will be aware of the arm in which they will be placed through training on motivational interviewing.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Therapist Inclusion Criteria:
  • Inpatient therapist specializing in spinal cord injury patients for at least 3 months;
  • Practicing at the designated SCI inpatient units at Shirley Ryan AbilityLab, Baylor Scott & White Institute for Rehabilitation and University of Washington-Harborview Medical Center;
  • Willing to audio record conversations during regularly-scheduled rehabilitation therapy sessions with patients;
  • Willing and able to participate in 16 hours of MI training; and
  • Willing to receive feedback on MI skills.

排除标准

  • Inability to speak and understand English
  • Inpatient therapist specializing in spinal cord injury patients for less than 3 months; and
  • Unwilling or unable to follow the study protocol
  • Patient Inclusion Criteria:
  • Adults (18+)
  • Presence of a traumatic or non-traumatic spinal cord injury
  • Inpatient in the spinal cord injury unit of the three study sites
  • Has a physical or occupational therapist who is a participant in the study
  • Patient Exclusion Criteria:
  • Inability to speak and understand English
  • Cognitive deficits
  • Unwilling to allow for therapy sessions to be recorded

研究组 & 干预措施

Experimental Group: Motivational Interviewing

Experimental

Physical and Occupational Therapists in this group will receive 16 hours of training in Motivational Interviewing and use these techniques during sessions with enrolled patient participants.

干预措施: Motivational Interviewing (Behavioral)

Control Group: Standard Care

No Intervention

Therapists in this group will not participate in additional training and provide standard care to enrolled patient participants.

结局指标

主要结局

Therapy Participation Level

时间窗: From enrollment to the end of 4-week treatment

A blinded assessor will use the Pittsburgh Rehabilitation Participation Scale (PRPS) to measure therapy participation in inpatients with SCI treated by therapists trained in Motivational Interviewing (MI) compared to those treated by therapists not trained to use MI. The PRPS rating ranges from 1 (none) to 6 (excellent), with higher scores indicating higher level of participation

次要结局

  • Efficacy of Motivational Interviewing (MI) Training(During 1 year of inpatient rehabilitation)
  • Functional Abilities(At week 4)
  • Participation in the Community(At 6 months post-discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Ehrlich-Jones, PhD

Associate Director, Center for Rehabilitation Outcomes Research

Shirley Ryan AbilityLab

研究点 (3)

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