Enhanced Medical Rehabilitation for Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— EMRSCI  

Official title:

Patient Engagement Intervention in Inpatient Spinal Cord Injury Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05364151
• Other study ID #: 201803164
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2022
• Source: Shirley Ryan AbilityLab
• Contact: Wing Wong, PhD
• Phone: 3122381742
• Email: wwong[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patient engagement (or participation) is a critical cornerstone for patient-centered care, including inpatient SCI rehabilitation. Researchers have defined patient engagement as a deliberate effort and commitment to working toward the goals of rehabilitation therapy, typically demonstrated through active participation and cooperation with treatment providers. Our previous work has shown that patient engagement is an important determinant of positive rehabilitation outcomes, as higher levels of patient engagement are associated with increased functional improvement and shorter lengths of stay. In SCI research, the investigators investigated personalized trajectories of engagement in occupational therapy (OT) inpatient rehabilitation in relation to patient outcomes. The investigators found that a subgroup of patients who sustained high levels of engagement during the rehabilitation stay were more likely to have better functional, psychosocial, and participation outcomes at discharge and one-year post-injury than subgroups of patients whose levels of engagement progressively deteriorated. Other researchers found similar results for physical therapy (PT) inpatient interventions, suggesting that engagement in rehabilitation is predictive of whether the patient is discharged to home and the patient's level of involvement in work or school one-year post-injury. Given the promising results of EMR interventions in SNFs, an important step for expanding the use of EMR is to customize it to other target populations and practice settings in order to enhance its reach. The investigators propose a modification of EMR adapted for inpatient SCI rehabilitation using the Collaborative Intervention Planning Framework. The investigators will then pilot test the efficacy of EMR versus SOC rehabilitation on improving patient engagement and treatment intensity (processes), and enhancing function and psychosocial recovery (outcomes). Thus, this study aims to conduct intervention adaptations to the EMR program for patients in inpatient SCI rehabilitation and conduct a pilot RCT to demonstrate the benefits of EMR over SOC treatment in inpatient SCI rehabilitation. Despite the demonstrated relationship between patient engagement and functional outcomes/psychosocial recovery, several factors may affect engagement in rehabilitation, including goal setting, therapeutic connection, personalization, patient-centered rehabilitation, autonomy, and feedback. Many of these factors are influenced by how therapists deliver their interventions; the patient-clinician interaction is the foundation for successful engagement in rehabilitation. Thus, achieving strong patient engagement depends on a high level of targeted interaction from therapists responsible for providing rehabilitation services. Unfortunately, improving the therapist's ability to engage patients during clinical practice is challenging given the changing and competing demands of the real-world rehabilitation environment. This "environmental barrier" concurs with findings from our recent qualitative study exploring perceived barriers of patient engagement implementation in SCI rehabilitation. The investigators found that unavailability of hospital resources and insurance restrictions can undermine rehabilitation by restricting the patient's ability to reach personal treatment goals. To address these barriers, the investigators developed EMR to teach occupational and physical therapists a set of behavioral skills to engage patients and involve them in high-intensity therapy to optimize functional and psychosocial outcomes of patients in medical rehabilitation (please refer to Research Plan for details on EMR). It is important to note that EMR is a "how" intervention, not a "what" intervention. Its skill set integrates into existing OT/PT practices rather than adding new activities, exercises, or another specialist to the setting. The difference between EMR and standard of care (SOC) OT/PT is the effort necessary to engage the patient and provide high-intensity therapy. For this reason, EMR can integrate well into real-world OT/PT practices regardless of the patient's primary impairment, comorbidities, or other contextual factors. Currently, the investigators have successfully tested EMR for older adults receiving post-acute rehabilitation. In particular, the investigators found that: (1) EMR can be implemented in real-world skilled nursing facilities (SNFs). Occupational and physical therapists who were trained and supervised carried out EMR with high treatment fidelity. (2) Patients receiving services from EMR therapists demonstrated greater treatment intensity and patient engagement in rehabilitation compared to those receiving services from SOC therapists. (3) EMR improves rehabilitation outcomes. Patients randomized to EMR had better improvement in depressive symptoms and function than controls. (4) EMR overcomes barriers to rehabilitation. Those vulnerable to poor rehabilitation outcomes-patients with multiple medical comorbidities, cognitive impairment, and/or depression-benefitted the most from EMR. In spite of preliminary evidence suggesting the benefits of EMR, it remains unknown whether the EMR skills, therapist training, and coaching protocol, treatment fidelity methods, processes, and outcome measures developed for older adults in SNFs will be clinically relevant to the inpatient rehabilitation setting and acceptable to SCI populations. Thus, the investigators will utilize an established implementation science approach to customize an existing EMR program to a new patient population and a new setting. The investigators will use the Collaborative Intervention Planning Framework (CIPF) to customize the EMR program to patients with SCI in inpatient rehabilitation facilities (IRFs). This framework will help us move from intervention planning to pilot test through a randomized controlled trial (RCT) to assess the feasibility of the adapted EMR and explore its initial effects. This proposed study addresses the problem of suboptimal patient engagement in SCI rehabilitation. Most persons following SCI go to an IRF for an average of 35 days of OT/PT. This is a narrow window of opportunity for persons with SCI to regain enough function to return home and live independently. Unfortunately, "failed rehabilitation" often results because SOC therapy is not sufficiently patient centered and is of low intensity. As a result, SOC therapy does not adequately engage and benefit patients for positive rehabilitation outcomes. Post-acute OT/PT is often low in intensity. This observation may seem counterintuitive, as IRF rehabilitation involves up to three hours of daily contact. However, actual time spent on OT/PT is typically less than that. Scheduled therapy time may greatly overestimate actual active time during sessions; studies using ACTi Graph accelerometry monitors and observers counting repetitions have found a low intensity of treatment in a variety of post-acute rehabilitation settings. Two major factors may account for this low intensity of post-acute rehabilitation. First, occupational and physical therapists often do not strive for high intensity. Second, the interaction with patients may be unengaging for patients because therapists do not explicitly use principles of engagement, including patient-directed therapy and frequency feedback. The low intensity of post-acute rehabilitation has caught the attention of rehabilitation providers and policymakers, with evidence showing that rehabilitation outcomes have not significantly improved despite an increase in billed therapy hours over recent decades. Research shows a positive relationship between patient engagement and rehabilitation outcomes. Thus, to improve the outcomes of patients in inpatient SCI rehabilitation, the investigators must address the problems of low intensity and poor patient engagement in rehabilitation. EMR is an evidence-based intervention that therapists can use to engage patients participating in high-intensity therapy and that has been successfully tested in SNFs. Yet, to date, there is no data showing that EMR can work in inpatient SCI rehabilitation facilities. Thus, the overall goals of this project are to adapt the EMR intervention to a new patient population (i.e., from older adults to SCI) and new setting (i.e., from SNFs to IRFs), as well as to assess the feasibility of this adapted intervention to improve functional and psychosocial outcomes of inpatients with SCI. If the investigators demonstrate the feasibility and efficacy of adapted EMR, our next step is to conduct a full scale test of the effectiveness of the adapted EMR and its implementation in inpatient SCI rehabilitation settings. Success in this line of research will ultimately improve inpatient SCI rehabilitation, making it more patient centered, to benefit the 285,000 people currently living with SCI, people with a new injury, and their families. This application is consistent with the Foundation's mission to improve the quality of life for those affected by and living with SCI. Our study aims to develop an evidence-based intervention that teaches therapists a set of patient engagement skills with the goal of improving patient function and other rehabilitation outcomes. This intervention will establish a new standard for the delivery of SCI care, particularly in the area of rehabilitation. The investigators propose that therapists who acquire EMR skills will improve patients' engagement and the intensity of therapy, leading to better function, treatment satisfaction, and life satisfaction, and reduce depressive symptoms. Additionally, this EMR project will support the Foundation's core value of psychosocial research to inform best practices that are more patient centered by optimizing quality interactions between practitioners and individuals with SCI.

AIM 1: Conduct intervention adaptations to the EMR program for patients in inpatient SCI rehabilitation

Aim 1.1: Create a stage to foster partnership and collaboration among implementers of the EMR program Hypothesis 1.1: An SCI Community Advisory Board (SCI-CAB), including clinicians, administrators, investigators, and peer specialists/patient advocates, will be assembled to learn and review the EMR program.

Aim 1.2: Conduct needs assessment to understand the problems of current SCI practice Hypothesis 1.2: SCI-CAB members will successfully identify the engagement-related needs and areas for intervention adaptations for inpatients with SCI.

Aim 1.3: Review intervention components of the original EMR program to identify targets for adaptation Hypothesis 1.3: SCI-CAB members will successfully identify specific adaptations to intervention content or delivery, including the objectives, methods, materials, and theoretical foundations of the EMR program.

Aim 1.4: Incorporate adaptations into the EMR program for inpatient SCI rehabilitation Hypothesis 1.4: The investigators will finalize the EMR manual and materials, and train EMR supervisor and therapists.

AIM 2: Conduct a pilot RCT to demonstrate the benefits of EMR over SOC treatment in inpatient SCI rehabilitation

Aim 2.1: Examine the preliminary efficacy of EMR for improving patient engagement and treatment intensity Hypothesis 2.1: EMR will improve engagement and intensity to a greater extent than SOC rehabilitation.

Aim 2.2: Examine the preliminary efficacy of EMR for improving functional and psychosocial outcomes Hypothesis 2.2: EMR will improve functional and psychosocial outcomes to a greater extent than SOC rehabilitation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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").

Locations

Country	Name	City	State
United States	Shirley Ryan Ability Lab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bland MD, Birkenmeier RL, Barco P, Lenard E, Lang CE, Lenze EJ. Enhanced Medical Rehabilitation: Effectiveness of a clinical training model. NeuroRehabilitation. 2016 Oct 14;39(4):481-498. — View Citation

Cabassa LJ, Druss B, Wang Y, Lewis-Fernández R. Collaborative planning approach to inform the implementation of a healthcare manager intervention for Hispanics with serious mental illness: a study protocol. Implement Sci. 2011 Jul 26;6:80. doi: 10.1186/1748-5908-6-80. — View Citation

Cabassa LJ, Gomes AP, Meyreles Q, Capitelli L, Younge R, Dragatsi D, Alvarez J, Manrique Y, Lewis-Fernández R. Using the collaborative intervention planning framework to adapt a health-care manager intervention to a new population and provider group to improve the health of people with serious mental illness. Implement Sci. 2014 Nov 30;9:178. doi: 10.1186/s13012-014-0178-9. — View Citation

Hildebrand MW, Host HH, Binder EF, Carpenter B, Freedland KE, Morrow-Howell N, Baum CM, Doré P, Lenze EJ. Measuring treatment fidelity in a rehabilitation intervention study. Am J Phys Med Rehabil. 2012 Aug;91(8):715-24. doi: 10.1097/PHM.0b013e31824ad462. — View Citation

Host HH, Lang CE, Hildebrand MW, Zou D, Binder EF, Baum CM, Freedland KE, Morrow-Howell N, Lenze EJ. Patient Active Time During Therapy Sessions in Postacute Rehabilitation: Development and Validation of a New Measure. Phys Occup Ther Geriatr. 2014 Jun;32(2):169-178. — View Citation

Lenze EJ, Host HH, Hildebrand M, Morrow-Howell N, Carpenter B, Freedland KE, Baum CM, Binder EF. Enhanced medical rehabilitation is feasible in a skilled nursing facility: preliminary data on a novel treatment for older adults with depression. Am J Geriatr Psychiatry. 2013 Mar;21(3):307. doi: 10.1016/j.jagp.2012.11.006. Epub 2013 Jan 11. — View Citation

Lenze EJ, Host HH, Hildebrand MW, Morrow-Howell N, Carpenter B, Freedland KE, Baum CA, Dixon D, Doré P, Wendleton L, Binder EF. Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):708-12. doi: 10.1016/j.jamda.2012.06.014. Epub 2012 Aug 3. — View Citation

Lenze EJ, Munin MC, Quear T, Dew MA, Rogers JC, Begley AE, Reynolds CF. Significance of poor patient participation in physical and occupational therapy for functional outcome and length of stay. Arch Phys Med Rehabil. 2004 Oct;85(10):1599-601. — View Citation

Lequerica AH, Donnell CS, Tate DG. Patient engagement in rehabilitation therapy: physical and occupational therapist impressions. Disabil Rehabil. 2009;31(9):753-60. doi: 10.1080/09638280802309095. — View Citation

Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2. — View Citation

Teeter L, Gassaway J, Taylor S, LaBarbera J, McDowell S, Backus D, Zanca JM, Natale A, Cabrera J, Smout RJ, Kreider SE, Whiteneck G. Relationship of physical therapy inpatient rehabilitation interventions and patient characteristics to outcomes following spinal cord injury: the SCIRehab project. J Spinal Cord Med. 2012 Nov;35(6):503-26. doi: 10.1179/2045772312Y.0000000058. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Participation/Engagement: Change in Pittsburg Rehabilitation Participation Scale (PRPS)	A measure of patient engagement (participation) in therapy sessions. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Rehabilitation Intensity: Change in Patient Active Time	The investigators will use a stopwatch to measure patient active time as a proxy for rehabilitation intensity. The investigators will use one to record the duration of the session and the other to stop and start to measure active time. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Rehabilitation Intensity: Change in ActiGraph	Participants will wear accelerometers (ActiGraph) as a proxy for rehabilitation intensity. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Adherence/Fidelity: Change in Patient Satisfaction & Treatment Fidelity Survey	A measure of fidelity (adherence). This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Adherence/Fidelity: Change in Therapist Adherence Rating Form	A measure of fidelity (adherence). This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Work Alliance: Change in Working Alliance/Theory of Change Inventory (WATOCI)	A measure of working alliance. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Patient-Clinician Interaction: Change in Clinical Assessment of Modes Observer Form (CAM-O)	A measure of patient-clinician interaction. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Patient-Clinician Interaction: Change in Clinical Assessment of Suboptimal Interactions Short Forms (CASI-O-15)	A measure of patient-clinician interaction. This measure will be gathered 4 times during the patient's rehabilitation stay. The measure will be gathered 2 times during the admission week and 2 times during the discharge week.	1 month
Other	Baseline Comorbidity: Charlson Comorbidity Index	A measure of comorbidities	the first two weeks during patient rehabilitation stay
Other	Post-intervention Satisfaction: Modified Treatment Satisfaction Questionnaire	A measure of treatment satisfaction	the last week during patient rehabilitation stay
Primary	Function: Change in Continuity Assessment Record and Evaluation	The investigators will use the Continuity Assessment Record and Evaluation (CARE) to measure the level of independence as the primary outcome at both admission and discharge.; At admission, the investigators will use the Continuity Assessment Record and Evaluation (CARE) to measure the patient's independence before the treatment. At discharge, the investigators will use the same CARE to measure the patient's independence after the treatment. This clinician-rated measure includes tasks rated on a 6-point ordinal scale that ranges from the minimum score of 1 (dependent) to a maximum score of 6 (independent). A higher score indicates greater independence. The investigators will use CARE scores to reflect patient's ability to perform activities of daily living (ADL) or mobility tasks.	1 month
Secondary	Life Satisfaction: Change in Satisfaction with Life Scale	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 (a = 0.95).	1 month
Secondary	Depression: Change in Patient Health Questionnaire-9	A measure of psychosocial recovery; this self-report measure assesses the presence and intensity of depressive symptoms. This measure will be measured at both admission and discharge of inpatient rehabilitation. 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.	1 month