Enhancing Rehabilitation Participation in Patients With SCI/D Using Motivational Interviewing

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Motivational Interviewing
  Motivational Interviewing is an evidence-based counseling style that aims to foster positive health behavior change in patients through their desires and actions.

Первичные конечные точки

• Therapy Participation Level [Срок оценки: From enrollment to the end of 4-week treatment]

Вторичные конечные точки (3)

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

Критерии участия

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.

Therapist Exclusion Criteria:

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 3 центра

• Shirley Ryan AbilityLab — Chicago
• Baylor Scott & White Institute for Rehabilitation — Dallas
• University of Washington - Harborview Medical Center — Seattle

Публикации

• Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13. PMID 26874558
• Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68. PMID 11392867
• Deci EL, Ryan RM. Self-determination theory in health care and its relations to motivational interviewing: a few comments. Int J Behav Nutr Phys Act. 2012 Mar 2;9:24. doi: 10.1186/1479-5868-9-24. PMID 22385839
• Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. Third ed. New York, NY: The Guilford Press; 2013.
• Miller WR, Rollnick S. Meeting in the middle: motivational interviewing and self-determination theory. Int J Behav Nutr Phys Act. 2012 Mar 2;9:25. doi: 10.1186/1479-5868-9-25. No abstract available. PMID 22385872
• Kramer Schmidt L, Andersen K, Nielsen AS, Moyers TB. Lessons learned from measuring fidelity with the Motivational Interviewing Treatment Integrity code (MITI 4). J Subst Abuse Treat. 2019 Feb;97:59-67. doi: 10.1016/j.jsat.2018.11.004. Epub 2018 Nov 20. PMID 30577900
• Whiteneck GG, Gassaway J, Ketchum JM. Transforming a Traumatic Brain Injury Measure of Participation Into a Psychometrically Sound Spinal Cord Injury Participation Measure. Arch Phys Med Rehabil. 2019 Dec;100(12):2293-2300. doi: 10.1016/j.apmr.2019.06.020. Epub 2019 Aug 14. PMID 31421095
• Heinemann AW, Dijkers MP, Ni P, Tulsky DS, Jette A. Measurement properties of the Spinal Cord Injury-Functional Index (SCI-FI) short forms. Arch Phys Med Rehabil. 2014 Jul;95(7):1289-1297.e5. doi: 10.1016/j.apmr.2014.01.031. Epub 2014 Mar 3. PMID 24602551

Идентификаторы

NCT: NCT07364773 · STU00219326 · 973467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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