A home-based comprehensive care model in patients with Multiple Sclerosis: A study pre-protocol

Study design

The study is a prospective, two-group, randomized experimental design with nine data collection points (baseline and every three months). MS patients recruited from a neurology clinic will be randomized into two groups: the intervention or usual care group. The usual care group receives the current standardized MS care, while the intervention group receives usual care plus 24-months of the MAHA intervention provided by a transdisciplinary team led by a MS-Comprehensivist. The usual care group will receive the intervention at the end of the 24-month period if the intervention is found to be effective by our a priori criteria. The study is subject to review and approval by the University of Nebraska Medical Center Institutional Review Board (IRB) and informed consent will be obtained from all participants prior to the study.

Study settings

Potential subjects will be identified and recruited from the University of Nebraska Medical Center (UNMC) neurology clinic, where the principle investigator, who has ethical access at the clinic site, will be responsible for identifying the potential participants, screening for eligibility and referring eligible subjects for recruitment.

Study participants

Inclusion criteria. Patients are eligible for the study if they: 1) have a diagnosis of progressive MS; 2) receive a Kurtzke Expanded Disability Status Scale (EDSS) score ≥6.5 (requires bilateral assist for ambulation and cannot walk > 120 meters; http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/10-2-3-29-EDSS_Form.pdf); and 3) have a home residence located within 60 miles of the Omaha metropolitan area.

Sample size

The sample size estimation is computed based on Specific Aim 1: the increased score of quality of life (QoL) and Specific Aim 2: the reduced number of unplanned healthcare utilizations associated with complications. An estimated 50 patients per group will provide 80% power to detect a 5-point difference [Usual Care mean (SD): 45(8.6), MAHA mean (SD) 50(8.6)] between groups in the SF-36 Mental Health Component Score QoL. This sample size also provides 80% power at a 5% significance level to detect a 34% reduction in unplanned visits/admits (from 2.5 per person per year to 1.65, using the Poisson distribution, which is most appropriate for count/rate data). These are feasible and clinically important differences. Based on our preliminary analyses, 125 patients are currently expected to meet these criteria. Furthermore, based on our previous patient survey results, a high proportion of patients (~80% or n = 100) have expressed a genuine interest in participating in MS research for the benefit of others with this disabling disease. Furthermore, we estimate 50 patients will be a reasonable panel size for the MS-Comprehensivist or care team leader (CTL) in the MAHA model (unpublished report).

MAHA intervention

The MAHA model is a patient- and family-centered system in which care is tailored around the complex, chronic needs of those with progressive disabling MS. The intervention program is designed to address a fundamental question: “how will this affect the patient and/or family?” The majority of care and medical services will be provided at home, thus avoiding frequent and cumbersome clinic visits. The intervention strategies were developed based on the frequent requests and suggestions from patients with progressive MS, along with caregivers and providers experiencing daily struggles with fragmented care. Furthermore, the model is also supported by initiatives from the health policy literature developed by the National Multiple Sclerosis Society (NMSS), emphasizing the need for home- and community-based services (http://www.nationalmssociety.org/Treating-MS/Comprehensive-Care).

MAHA Team Structure. The intervention will be delivered by a transdisciplinary team led by a MS-Comprehensivist, also referred to as Care Team Leader (CTL). The care provided is comprehensive and holistic, addressing patient/family physical, emotional and spiritual, and social needs. The transdisciplinary team includes the core team partners and “neighbors and best friends” (Figure 2). The CTL role will be filled by a nurse practitioner (NP) with specialty training in MS and extensive experience managing patients with chronic illness. The core team partners include the CTL, MS neurologist, primary care provider (PCP), and selected home health agencies. To address MS patients’ complex needs and reduce unplanned healthcare services, the CTL will closely collaborate with patients and family, the MS neurologist and the PCP to develop patient-centered care plans and goals, and to co-manage symptoms and complications. The selected home health agencies will provide nursing and personal care staff, physical and occupational therapists (PT/OT), and social work services. They are responsible for carrying out the care plan and conducting collaborative, on-going evaluation of the care plan with the CTL. Given MS patients’ limitations in mobility, PT/OTs will also be involved in plans of care to facilitate the restoration and maintenance of function oriented toward activities of daily living (ADLs). PTs from the home health agencies will be trained by physical therapists who have extensive experience in the education and care of MS patients. “Neighbors & Best Friends” represent subspecialty providers and community resources. The “neighbors”, or subspecialty providers (e.g., urologist, rehabilitative professionals, palliative care specialist, ophthalmologist, wound care specialist, etc.) provide consultation services and advise the CTL in preventative and treatment strategies for common complications or issues not responsive to standard strategies. The “Best Friends”, include community resources, including clergy, respite services, the MS Society, League of Human Dignity, and Office on Aging, among others.

Figure 2. MAHA Model.

MAHA Team Processes (10 C’s). The MS-Comprehensivist or CTL will be responsible to: 1) provide regular and frequent visits to patients’ homes using a pre-planned schedule based on each individual’s care needs; 2) coordinate patients’ care by collaborating and communicating closely with the core team partners, and “neighbors and best friends”; and 3) train the home health staff in the specialty care of MS patients. In the process of care, the MAHA model stresses patient/family engagement (i.e., informed and activated) and productive interaction between patients and providers through ten fundamental elements (10 Cs; Figure 3).

Figure 3. Ten fundamental elements guiding the care process.

Data collection, instruments and sources of data

Key data collection instruments, assessments, and measures are summarized in Table 1. This information will be collected from three data sources: 1) patient reports to CRC personnel, 2) patient reports to the CTL or other MAHA team member at each home visit, and 3) medical record review.

Data analysis

Specific Aim 1 and 2. The data analysis will follow the intention-to-treat (ITT) protocol. To ensure groups are comparable, descriptive analyses, including t-tests and Chi-square tests will be conducted to compare the characteristics of each group at baseline. The occurrence of complications and other self-reported measures, such as ADLs, Multiple Sclerosis QoL Inventory (MSQLI), CSQ-8, and Caregiver Burden Inventory (CBI) will be compared between groups using a linear mixed model to account for the repeated measurements over time and adjust for baseline scores of the respective measures. To determine if differences exist between groups after adjusting for potential confounding variables, such as age, gender, comorbidity, etc. or imbalances between groups, unplanned healthcare utilization (i.e., visits/admissions) will be analyzed using Poisson regression models. The proportion of any versus no use of each health service (e.g., proportion with any inpatient admissions versus the proportion with no admissions) will be compared between groups using Chi-square tests. The time-by-group interaction will be investigated to determine if any changes over time are consistent between groups.

Specific Aim 3. To assess the acceptability, utility, implementation and adaptation of the program, we will create a toolkit that comprehensively describes our program structure, processes, patients/provider/system outcomes, as well as lessons learned. This toolkit will serve to evaluate the MAHA program and identify system-, provider-, and patient-levels of barriers and facilitators. To evaluate financial sustainability, we will specifically track the Current Procedural Terminology (CPT) codes for evaluation and management visits (clinic and home visits), care coordination, and care plan oversight. Reimbursement amounts associated with these codes will be summed for each study group at six and 12 months. T-tests and log transformed linear regression models will be used to compare total reimbursement amounts between groups. Also, staffing and associated salary estimates will be computed based on home visit time logs maintained by the MAHA team members, on-call activity logs, and number of home visits in the intervention group. We will project the necessary percent FTE and salary to execute the intervention model based on a range of panel sizes (e.g., 25, 50, 100 patients) per MS-Comprehensivist/CTL. The ratio of total salary costs-to-reimbursement amount for a given number of patients will be calculated for each group and compared using t-tests.