The Virtual Dimension: Implementing National Standards of Best-Practice Care for ALS Patients

via Telemedicine.Stephen M. Selkirk, MD,PhDNeurologist, Cleveland VA Medical Center, SCI Division. Director, Cleveland ALS Center of ExcellenceAssistant Professor, Department of Neurology, Case Western Reserve School of Medicine.

Francis McClellan, RN, MSNCleveland VA Medical Center, SCI Division. SCI Rehab Program Coordinator

Monique Washington, RN, MS, APHN-BCCleveland VA Medical Center, SCI Division. SCI Management of Information & Outcomes Coordinator

ALS and the VA

A study released by the Institute of Medicine (IOM) on November 10, 2006, Amyotrophic Lateral Sclerosis in Veterans: Review of the Scientific Literature, concluded that "there is limited and suggestive evidence of an association between military service and later development of ALS." Based upon this IOM study, and because ALS is a disease that progresses rapidly once diagnosed, VA designated ALS as a presumptively-compensable illness for all Veterans with 90 days of continuously active service in the military. 38 CFR 3.318.

The annual incidence of ALS among adults over 18 years is between 2.5 to 3.0 per 100,000. The IOM report added that the likelihood of a person dying of ALS is increased 1.5 fold if that individual is a Veteran. The IOM report did not report on factors that underlie the increased incidence of ALS. Specifically, locality of service and history of combat exposure did not show an influence on the incidence of ALS among Veterans.

1985 1995 2006 20080

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Prevalence of ALS Treated by VHA

The IOM study noted a 1.5 fold increased ALS incidence in Veterans suggesting an annual incidence rate of 4.5 per 100,000 Veterans, yielding an estimated annual incidence of 1,055 Veterans with new onset ALS and a possible Veteran prevalence of 4,220 given current life expectancy exceeding 3 years.

27 Sites of ALS Treatment Strength

The ALS Center at the Cleveland VAALS Association Certified Treatment Center of Excellence.

Referral process

-Majority of patients have been diagnosed-CCF-VA Neurology-ALSA-Spoke sites (Erie, Columbus, Dayton)

The ALS Center at the Cleveland VA

Patients are seen either in person or via telemedicine every three months

Interdisciplinary meeting (IDT) occurs prior to the actual clinic visit. Multidisciplinary team.

Phone call to patient by nurse, prior to IDT meeting.

Planned inpatient admissions for PEG/sleep studies and respite care.

Unplanned admissions to SCI service

Plan of Care Cleveland ALS Center

ALS Center of Excellence

Comprehensive management at an ALS center improves outcome measures in patients.

-Improved survival-Increased utilization of Riluzole-Increased PEG tube placement-Increased utilization of NIPPV-Fewer hospital admissions-Higher quality of life measure.

Chio et al. 2006. Positive effects of tertiary centers for amyotrophic lateral sclerosis on Outcome and use of hospital facilities. JNNP 2006; 77: 948-950.Van den Berg et al. Multidisciplinary ALS care improves quality of life in patients with ALS. Neurology 2005; 65: 1264-1267.

Cleveland ALS Center- care plan

AAN Practice ParametersQuality of LifeJoint decision making

Every patient in the VA system should have access to ALS Center care.

Cleveland ALS System of Care: Telemedicine

Use of Tele-health- CVT Provide specialty consultation closer to home with the veteran’s primary care team

Use of MOVIFollow patient at homeSecure “Skype like” systemAllows us to follow when coming to hospital for tests are no longer needed Keeps us in touch with family and patientReduces travel costs

Cleveland ALS System of Care: Telemedicine Study

Retrospective analysis of a variety of data including quality of life, care giver burden, functional rating scale, access to care, survival, weight loss.

Quality of life- McGill QOL ScaleCare Giver Burden- Zarit’s QuestionnaireALSFR- functional rating scale.

Can we deliver high quality ALS Center Care to patients via telemedicine?

Telehealth Program Evaluation

Agency for Healthcare Research and Quality (AHRQ)

Process Measures- “…assess the activities carried out by health care professionals to deliver services…often guided by evidence-based clinical guidelines”

Outcome Measures- “Measuring health outcomes is central to assessing the quality of care…..”

Process & Outcome Measures

Process Measures

RiluzoleNIPPV DieticianWeight MonitoringNutrition SupplementsHome Health CareHospice Referral Communication Device

PEG PlacementQuality of Life (McGill’s Quality of Life)Caregiver Burden (Zarit’s Short Form Survey)ALS Functional Rating Scale-RevisedSurvival WeightPatient Satisfaction

Outcome Measures

Relevant Prognostic Factors at Baseline

*Baseline Respiratory Status= (ALSFRS Orthopnea score + ALSFRS Dyspnea score)/2 at baseline, range 0-4

n=48 n=23 n=25

n=91

n=48

Total Clinic Telemedicine p-value

Distance from SCI Center (miles) 62.3 37.8 85.0 0.002

Baseline ALSFRS (mean ± SD) 34.02 ± 9.21 33.65 ± 10.59 35.12 ± 7.48

0.635

Travel and Disease Burden

n=91p=NS

Process Measures

p=NS

p=NS

p=NS

p=NS

p=NS

p=NS

p=NS

p=NS

p=NS

Outcome Measures

zarit

SIGNIFICANT AT 0.04- TELEHEALTH HAS LESS CAREGIVER STRAIN

Setting % Mean Δ SD p-value

Clinic 1% 0.09

0.54

Telemedicine 2% 0.08

Total 2% 0.19

Body Weight

% Mean Δ=(Last/Current weight-Baseline weight)/ Baseline weight

BMIEvent: Malnutrition-Defined as BMI <18.5 kg/m2

Eligibility for analysis: • ≥ 2 BMI assessments, including baseline

assessment

• BMI ≥ 18.5 kg/m2 at baseline

• Followed for at least one year

Results: • Only one event between the two groups,

one patient in the group receiving clinic visits. The incidence of malnutrition was nearly 0 in this cohort.

• The Log-Rank Test for these two survival curves was non-significant (p=.309) indicating that there is no difference in the occurrence of malnutrition between the two groups.

• There was no significant difference in the mean or the median BMI between the two groups.

ALSFRS-R

Setting % Mean Δ SD p-value

Clinic -0.22% .280.795

Telemedicine -0.24% .26

Total -0.21% .2265

% Mean Δ=(Last/Curren ALSFRS-Baseline ALSFRS)/ Baseline ALSFRS

Change in ALSFRS-REvent:

30% Decline in Baseline ALSFRS Score

Eligibility for analysis:

• ≥ 2 ALSFRS, including baseline assessment

• Followed at least one year

Results: • The results suggest that there is a positive

trend for patients receiving Telemedicine-it appears it takes longer for their ALSFRS to decline by at least 30%.

• The Log-Rank Test was non-significant (p=.309) indicating that there is no difference between the two survival curves.

• Again, there was no significant difference in the mean ALSFRS scores at baseline between the two groups.

Zarit Caregiver Burden Index (ZBI)

22-item questionnaire

Assess level of burden experienced by the principal caregivers; health, psychological well-being, finances, social life and the relationship between the caregiver and the impaired person.

Used validated 4-item screening

5-point Likert scale, higher scores reflect higher caregiver burden

Zarit Caregiver Burden Index (ZBI)

ValidWidely used in neuromuscular and neurological disordersALS population

ReliabilityCronbach’s = > 0.80

Administrationinterviewer-administered, self-administered

zarit

Zarit Caregiver Burden-Screening Form

McGill's Quality of Life (MQOL)

Measure QOL with life-threatening illnesses

16 items and a single-item global scale

Valid (Initially cancer patients), Reliable

interviewer-administered, self-administered

Total score and 4 domains of QOL:physical well being/symptomsexistential well being (assign meaning to life)psychological symptomssupport

NON-SIGNIFICANT GROUP DIFFERENCE

Setting Mean 95% CI

Clinic (n= 41) 49.8 months 35-62 months

Telemedicine(n= 48) 54.2 months 43-65 months

Survival

SurvivalEvent:

Death

Eligibility for analysis:

• Alive at Time 1• Followed for at least one year

Results:

• The results suggest that the probability of survival may be higher in patients receiving Telemedicine.

• The Log-Rank Test was non-significant (p=.297), indicating no difference.

• The median survival time for care in the clinic setting is 33.1 months.

• Telemedicine could not be calculated because 50% have not died.

SummaryThere was no significant difference between groups for delivery of services to patients.There was no significant difference between groups for outcome measures including:

SurvivalQuality of lifeWeight loss

*** Caregiver burden was less in telemedicine group. This suggests that telemedicine can be utilized to provide all ALS

patients access to ALS Center Care

Acknowledgements

Robert Ruff, MD,PhDFormer Chief of Neurology, VA.Neurology Chair, Cleveland VA

Francis McClellan, RN, MSNCleveland VA Medical Center, SCISCI Rehab Program Coordinator

Monique Washington, RN, MS, APHN-BCCleveland VA Medical Center, SCI. SCI Management of Information & Outcomes Coordinator

Richard Strozewski

ALS Association