VA LOW VISION INTERVENTION TRIAL (LOVIT)

See LOVIT NEWS

[Supported by VA Rehabilitation Research and Development Service]

Estimates are that there will be 854,000 veterans with disabling chronic visual impairments in the year 2005 and 890,000 in the year 2010. Statistics based on the 2000 census suggest that it will be well into the next decade before the prevalence of blind and visually impaired veterans begins to decrease. Waiting time for admission to VA blind rehabilitation centers (BRCs) is often a year or more. Low vision services are an important aspect of blind rehabilitation because 85% of veterans admitted to BRCs have low vision. In the private sector, low vision services are provided in outpatient settings. In contrast, legally blind veterans are encouraged, if not required, to attend regional inpatient programs to obtain therapy with low vision devices because a reimbursement mechanism is not available for outpatient blind rehabilitation and few low vision outpatient clinics in the VA have rehabilitation professionals on staff who can provide this training. The VA system needs alternative service delivery options for visually impaired veterans who are unable to participate in inpatient rehabilitation. Outpatient low vision programs should provide continuity of care with the regional BRC programs and ensure local access to low vision care that is high quality, timely, and cost-effective. Currently the Veteran Equitable Resource Allocation (VERA) allocates $27,826 per blind rehabilitation admission. Outpatient low vision programs have the potential to be an alternative to inpatient low vision services, especially when more costly inpatient rehabilitation programs might not be necessary for higher functioning veterans. The objective of the LOVIT project is to measure the effectiveness of a low vision outpatient program for legally blind veterans with central field loss from macular diseases that could be provided at local VA health care facilities.

Specific Aims

• Compare the mean change in self-report of difficulty performing daily activities measured with the VA LV VFQ-48 reading domain person measures from baseline to 4 months after randomization (two months after veterans participate in a low vision outpatient program or usual care [waiting list] control group).
• Determine if the mean change in VA LV VFQ-48 visual ability and reading domain person measures from baseline to four months after randomization (two months after veterans participate in a low vision outpatient program or usual care [waiting list] control group) can be predicted by baseline measures of visual impairment, functional status and life state or explained by measures of functional status after rehabilitation.
• Perform an economic evaluation of costs and cost-effectiveness of the low vision outpatient program.
• Compare the mean change in VA LV VFQ-48 person measures from the clinical trial at baseline to 4 months after randomization (two months after veterans participate in the low vision outpatient program) to historical data on the mean change in VA LV VFQ-48 person measure scores from the Hines BRC program.

Hypothesis

Compared to the usual care (waiting list) control group, veterans in the treatment group will self-report a reduction of 0.78 logits or more in ability to perform daily living activities measured by the VA LV VFQ-48 reading domain person measures from baseline to 4 months after randomization (two months after veterans participate in the low vision outpatient program). The 0.78 logit change is clinically significant - the improvement corresponds to the change in visual ability that would accompany a 6-line improvement in visual acuity (measured on the ETDRS chart).

Research Design

LOVIT is an unmasked randomized clinical trial conducted at two sites. Subjects are 122 legally blind veterans from Hines Hospital and Hefner VA Medical Center. Veterans are randomized to treatment from a new low vision outpatient rehabilitation program or a usual care (waiting list) control group. Following a low vision evaluation, veterans in the treatment group receive 5 (2 to 2.5 hour) therapy sessions at the local VA sites and one home visit to evaluate the home environment and set up prescribed devices. The primary outcome measure is change in reading domain person measures on the VA LV VFQ-48, a telephone questionnaire for which subjects self-report their difficulty performing everyday activities at home and in the community. Other measures include instructors' ratings of veterans' skills and use of low vision devices after rehabilitation, visual skills for reading (PEPPER VSRT), health status (SF-36), and symptoms of depression (CES-D). Outcomes for the treatment and control groups will be compared with t-tests. Multiple linear regression models will be used to identify predictors and explain outcomes. Costs and cost effectiveness of outpatient treatment will be evaluated.