Enhanced Medical Rehabilitation for Spinal Cord Injury (EMRSCI Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

Trial Summary

What is the purpose of this trial?To achieve higher levels of patient engagement, it is important to improve therapists' techniques for goal setting and clinician-therapist communication. Thus, the investigators 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. The investigators have developed training and supervision methods to enable therapists to carry out these skills with high fidelity. 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 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: The investigators propose to adopt the EMR program for use in inpatient SCI rehabilitation settings using an implementation science. The investigators 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: The investigators 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. Outcomes: With respect to EMR intervention adaptions, the investigators 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: Success in this research will improve therapists' skills working with patients and optimizing patient outcomes

Eligibility Criteria

This trial is for inpatient therapists with at least six months of experience specializing in spinal cord injury (SCI) patients. They must be willing to undergo EMR training, participate in supervision sessions, collect study measures, and consent to being videotaped during therapy sessions.

Exclusion Criteria

I have been a therapist for SCI patients for less than 6 months.

I am unable or unwilling to follow the study's requirements.

Participant Groups

The trial tests Enhanced Medical Rehabilitation (EMR), a program designed to boost patient engagement and the intensity of therapy for better functional and psychosocial recovery from SCI. It compares EMR's effectiveness against standard care by randomly assigning patients to either approach.

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Medical Rehabilitation (EMR)Experimental Treatment1 Intervention

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.

Group II: Standard of Care (SOC)Active Control1 Intervention

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.