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Enhanced Medical Rehabilitation for Spinal Cord Injury (EMRSCI)

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ClinicalTrials.gov Identifier: NCT03952416
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Background: Patient engagement is a cornerstone of patient-centered care. Studies show that an increased level of patient engagement in medical rehabilitation is associated with greater functional recovery. To achieve higher levels of patient engagement, it is important to improve therapists' techniques for goal setting and clinician-therapist communication. Thus, we have developed a manualized intervention for post-acute rehabilitation, Enhanced Medical Rehabilitation (EMR), which is an evidence-based program to increase patient engagement and achieve a greater intensity of therapy, thereby optimizing the patient's functional and psychosocial recovery. EMR is an integrated set of skills for occupational and physical therapists that transform rehabilitation through (1) a patient-directed, interactive approach; (2) increased treatment intensity; and (3) frequent feedback to patients on effort and progress. We have developed training and supervision methods to enable therapists to carry out these skills with high fidelity. In our previous EMR study of older adults in skilled nursing facilities, patients treated by EMR-trained therapists had greater engagement in therapy, higher-intensity therapy sessions, and better functional outcomes. Due to the complexity of the inpatient spinal cord injury (SCI) rehabilitation environment, it is unknown whether the EMR program will be clinically relevant to inpatient rehabilitation settings and acceptable to SCI populations. Therefore, it is necessary to conduct a systematic adaptation approach to address all hospital- and provider-level barriers, and test this adapted program to a new setting (inpatient rehabilitation) and a new population (patients with SCI), without compromising the core elements of the original EMR.

Objective: We propose to adopt the EMR program for use in inpatient SCI rehabilitation settings using an implementation science-driven approach. We also propose a randomized trial of 80 patients with SCI to test the effects of EMR on improving engagement and treatment intensity, as well as functional and psychosocial outcomes over standard of care (SOC) rehabilitation.

Methods: We will randomize patients into EMR or SOC groups. For the EMR group, four therapists will be trained and supervised in EMR and will incorporate EMR techniques into therapy sessions. In the SOC group, four therapists will carry out therapy sessions as usual.

Expected Outcomes: With respect to EMR intervention adaptions, we hypothesize that the EMR program, including a treatment manual and other materials, will be customized with input from our Spinal Cord Injury-Community Advisory Board (SCI-CAB). Patients randomized to EMR will have greater engagement and intensity and greater functional and psychosocial recovery compared to those randomized to SOC rehabilitation.

Significance: The impact is high. EMR is patient-centered rehabilitation, and it is designed for real-world clinical practice. Success in this line of research will improve therapists' skills working with patients and optimizing patient outcomes, ensuring that inpatient SCI rehabilitation is more patient-centered, to the benefit of individuals with SCI.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Enhanced Medical Rehabilitation (EMR) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eighty participants with spinal cord injury (SCI) who are admitted to the SCI rehabilitation (at Shirley Ryan Ability Lab) will be split into two groups. This will be randomized. Group 1 will receive the intervention, enhanced medical rehabilitation (EMR) while Group 2 will receive the standard existing rehabilitation, standard of care (SOC).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The participants are masked. The care provide and investigator are not mask. Only one research assistant (outcomes assessor) will be masked.
Primary Purpose: Supportive Care
Official Title: Patient Engagement Intervention in Inpatient Spinal Cord Injury Rehabilitation
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care (SOC)
The control group for this study will receive rehabilitation therapy that is recommended and provided by the current healthcare structure. The SOC group will receive therapy only from four therapists who are not trained and supervised in EMR. These therapists will be monitored (videotaped or observed) but will not be not asked to do anything differently with their patients. The investigators recognize that spillover of therapist EMR training to untrained therapists is a concern. Thus, the investigators will ask therapists in the EMR group to agree not to share any of the training with non-trained therapists over the course of the study, and the investigators will provide free EMR training to the non-trained therapists once the treatment phase of the study is complete.
Experimental: Enhanced Medical Rehabilitation (EMR)
Patients in the EMR group will also receive the recommended rehabilitation therapy, but they will receive therapy only from four therapists who are trained and supervised in EMR. The therapy sessions will follow EMR protocol. EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation.
Behavioral: Enhanced Medical Rehabilitation (EMR)
EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation. EMR was built on theories of behavior change, including social cognitive theory and self-regulatory theory, and their applications to patient engagement, such as the Health Action Process Approach and motivational interviewing. It has three foci: (1) a patient-directed, interactive approach stemming from patient-centered goals ("Patient as boss"); (2) frequent feedback to patients on their efforts and progress ("Link activities to personal goals"); and (3) increased rehabilitation intensity ("Optimize intensity").




Primary Outcome Measures :
  1. Function: Functional Independence Measure [ Time Frame: 1 Month ]

    The investigators will use the Functional Independence Measure (FIM) to measure the level of independence as the primary outcome at both admission and discharge.

    At admission, the investigators will use the Functional Independence Measure (FIM) to measure the patient's independence before the treatment. At discharge, the investigators will use the same FIM to measure the patient's independence after the treatment. This clinician-rated measure contains 18 items composed of 13 motor and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from the minimum score of 1 (total assistance) to a maximum score of 7 (complete independence). A higher score indicates greater independence. The investigators will use FIM motor scores to reflect patient's ability to perform activities of daily living (ADL) or mobility tasks.



Secondary Outcome Measures :
  1. Life Satisfaction: Satisfaction with Life Scale [ Time Frame: 1 Month ]

    The investigators will use the Satisfaction with Life Scale to measure the psychological functioning as the secondary outcome. This measure will be measured at both admission and discharge of inpatient rehabilitation.

    At admission, the investigators will use the Satisfaction with Life Scale to measure the patient's psychological functioning before the treatment. At discharge, the investigators will use the same Satisfaction with Life Scale to measure the patient's psychological functioning after the treatment. This self-report measure contains a single item assessing overall life satisfaction, along with eight additional items that are domain specific (e.g., self-care, vocational situation). Items are answered on a 6-point scale that ranges from 1 (very dissatisfied) to 6 (very satisfied). A higher score indicates greater life satisfaction. It has been tested and validated in SCI, with adequate internal consistency of items (α = 0.95).


  2. Depression: Patient Health Questionnaire-9 [ Time Frame: 1 Month ]
    A measure of psychosocial recovery; this self-report measure assesses the presence and intensity of depressive symptoms. It contains 9 questions rated based on the frequency of occurrence of symptoms in the past 2 weeks (from 0 = "Not at all" to 3 = "Nearly every day"). A higher score indicates greater symptomatology. PHQ-9 has been shown as a promising tool to identify probable major depressive disorder (MDD) in people with SCI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) inpatient therapists specializing in SCI patients for at least six months
  • (2) practicing on one of two SCI units at the SRAL
  • (3) willing to collect study measures
  • (4) willing to be videotaped for therapy sessions with patients
  • (5) willing and able to participate in EMR training and supervision sessions.

Exclusion Criteria:

  • (1) inpatient therapists specializing in SCI for less than six months
  • (2) not willing/able to follow study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952416


Locations
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United States, Illinois
Shirley Ryan Ability Lab
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Washington University School of Medicine
Shirley Ryan AbilityLab
Investigators
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Study Director: Piper Hansen, OTD Shirley Ryan Ability Lab

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03952416     History of Changes
Other Study ID Numbers: 201803164
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Occupational Therapy
Spinal Cord Injury
Rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System