Enhanced Medical Rehabilitation for Spinal Cord Injury

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.

Conditions

• Spinal Cord Injuries

Interventions

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").

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• Shirley Ryan AbilityLab

  lead OTHER

Principal Investigators

• Piper Hansen, OTD · Shirley Ryan Ability Lab

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-15

Primary Completion

2024-06-15

Completion

2024-07-30

Countries

• United States

Study Locations