Glaucoma
Conditions
Keywords
Glaucoma, Disease management, Smart bottle
Brief summary
The proposed study is a randomized controlled trial enrolling Veterans with medically treated glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants will be randomized to receive either a one-on-one session with a member of the research team discussing the disease process and strategies for administering eye drops (intervention) or a one-on-one session with a member of the research team discussing general eye health (control). All participants will be provided with a smart bottle to house their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder function will be activated. The proportion or prescribed doses taken according to the monitor will be compared for the two groups.
Detailed description
The purpose if this study is to improve glaucoma medication adherence in Veterans with medically-treated glaucoma. The study design is a single-site randomized controlled trial. Specific Aim 1. Evaluate the impact of an intervention to improve glaucoma medication adherence among Veterans at 6-month follow up. Hypothesis 1: Veterans randomized to the intervention will have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm. The primary outcome for hypothesis 1A is the proportion of prescribed doses taken according to the electronic monitor. Participants in both arms will receive the electronic monitor or smart bottle, which wirelessly transmits the date and time of opening of the smart bottle to the study team. From these medication events, the proportion of prescribed doses will be derived, defined as the ratio of the number of times the smart bottle was opened to the required number of doses prescribed according to the medical record over the period of time that the bottle is in use. For example, if a participant is advised to take his or her glaucoma drop twice a day for the 180 days that the bottle is in use and the smart bottle reveals 135 openings over the same time period, the proportion of prescribed doses taken is 37.5%. Specific Aim 2. Evaluate the impact of the intervention on intensification of glaucoma therapy among Veterans at 12-month follow-up. Hypothesis 2: The proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy, defined as addition of adjuvant glaucoma medication or recommendation for laser or glaucoma surgery will be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention. Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit . The investigators will collect these data at 12 months because the Metrics study suggested that 55% of participants in the control arm will have intensification of therapy within one year. Specific Aim 3. Evaluate the incremental cost-effectiveness and budget and workflow impacts of the intervention compared to usual care. Hypothesis 3: The intervention will be cost-effectiveness for the following ratios: 1) cost per percentage improvement in medication adherence; 2) cost per blindness averted; and 3) cost per quality-adjusted-life years saved. A direct measurement approach will be used to estimate per-patient intervention and control arm costs. Glaucoma-related health care utilization costs will be derived from VA administrative datasets. The cost estimates will be combined with observed improvement in medication adherence and reduction in escalation in therapy to estimate the first two incremental cost effectiveness ratios. Simulation using Markov modeling will be used to estimate the incremental cost per blindness averted and quality-adjusted life years (QALYs) gained. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall budget and workload impacts to the VA healthcare system.
Interventions
BEHAVIORALEducational - glaucoma
Discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, Provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation. An individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES).
BEHAVIORALDose monitoring and reminder
Participants will be provided with a smart bottle to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through AdhereTech will be activated.
BEHAVIORALEducational - general
The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma.
BEHAVIORALDose monitoring
Participants will be provided with a smart bottle to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open angle glaucoma \[primary open angle glaucoma, pigment dispersion glaucoma, pseudoexfoliation glaucoma, combined mechanism glaucoma, low tension glaucoma\] recorded in the medical record * Prescribed glaucoma eye drops, * Visual field performed within the last 9 months. * As visual field testing is standard care glaucoma and the investigators wish to establish baseline glaucoma severity, the investigators will require that subjects have a visual field test documented in the chart within 9 months of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule | Randomization to 6 Months | Will veterans randomized to the intervention have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm? The electronic bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through the electronic bottle will be activated. The outcome measure is the proportion of prescribed doses taken with a minimum of Zero and a maximum of One; where higher scores indicate more adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VA Medical Resource Use and Costs | 6 months | The investigators will investigate the overall budget impacts to the VA healthcare system. The main intervention costs are labor inputs, consisting of the one-time fixed labor cost of training and the variable labor cost of conducting the adherence intervention. The VA healthcare system also incurs costs, such as administration, utilities, and custodial services that cannot be directly attributed to a given health care service but nonetheless should be included in the cost analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| VA Healthcare Workflow Effectiveness | 12 months | The investigators will investigate the overall workload impacts to the VA healthcare system. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall workload impacts to the VA healthcare system. |
| Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted | 12 months | Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted |
| Number of Participants With Newly Prescribed Glaucoma Therapy | 12 Months | Will the proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention? Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit . |
| VA Workflow Effectiveness | 12 months | The investigators will investigate the overall workload impacts to the VA healthcare system. |
| Within-Trial Cost-Effectiveness of Adherence | 6 months | Will the intervention be cost-effectiveness compared to usual care? Total cost was calculated by adding the mean medical resource cost per patient to the cost of the intervention ($549) or the control ($48), then multiplying the total by the number of patients per group (100) |
| Total Cost at 6 Months | 6 months | The proportion of participants attaining equal or \>80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost effectiveness ratios comparing intervention to control at 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES). Participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated. | 100 |
| Control Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a smart bottle to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 8.6 | 67.1 years STANDARD_DEVIATION 8.1 | 67.5 years STANDARD_DEVIATION 8.33 |
| Companion Status Companion at Randomization | 20 Participants | 21 Participants | 41 Participants |
| Companion Status No Companion at Randomization | 80 Participants | 79 Participants | 159 Participants |
| Doses Per Day of Monitored Medication More Than One Dose Per Day | 56 Participants | 57 Participants | 113 Participants |
| Doses Per Day of Monitored Medication One Dose Per Day | 44 Participants | 43 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 4 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 96 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 73 Participants | 139 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 30 Participants | 21 Participants | 51 Participants |
| Region of Enrollment United States | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 96 Participants | 91 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 100 | 2 / 100 |
| other Total, other adverse events | 1 / 100 | 0 / 100 |
| serious Total, serious adverse events | 3 / 100 | 2 / 100 |
Outcome results
Primary
Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule
Will veterans randomized to the intervention have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm? The electronic bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through the electronic bottle will be activated. The outcome measure is the proportion of prescribed doses taken with a minimum of Zero and a maximum of One; where higher scores indicate more adherence.
Time frame: Randomization to 6 Months
Population: 95 Intervention: Of the 100 randomized to Intervention - 2 subjects withdrew after randomization and 3 subjects excluded for not having at least 25 weeks of adherence data 97 Control: Of the 100 randomized to Control - 1 subject excluded by PI for not taking medication and 2 subjects excluded for not having at least 25 weeks of adherence data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intervention | Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule | .84 proportion of doses |
| Control | Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule | 0.62 proportion of doses |
p-value: <0.000195% CI: [0.15, 0.3]Regression, Linear
Secondary
VA Medical Resource Use and Costs
The investigators will investigate the overall budget impacts to the VA healthcare system. The main intervention costs are labor inputs, consisting of the one-time fixed labor cost of training and the variable labor cost of conducting the adherence intervention. The VA healthcare system also incurs costs, such as administration, utilities, and custodial services that cannot be directly attributed to a given health care service but nonetheless should be included in the cost analysis.
Time frame: 6 months
Population: 100 Intervention 100 Control
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | VA Medical Resource Use and Costs | 10947 USD | Standard Deviation 19341 |
| Control | VA Medical Resource Use and Costs | 12939 USD | Standard Deviation 25199 |
Other Pre-specified
Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted
Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted
Time frame: 12 months
Population: While the long-term goal of this research program is to reduce glaucoma-related blindness in Veterans; in the course of the study period no participants went blind. We were unable to calculate this hypothesized outcome.
Other Pre-specified
Number of Participants With Newly Prescribed Glaucoma Therapy
Will the proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention? Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit .
Time frame: 12 Months
Population: 200 randomized Veterans who are patients of the Durham VA Eye Clinic with medically-treated glaucoma.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Newly Prescribed Glaucoma Therapy | 23 Participants |
| Control | Number of Participants With Newly Prescribed Glaucoma Therapy | 24 Participants |
Other Pre-specified
Total Cost at 6 Months
The proportion of participants attaining equal or \>80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost effectiveness ratios comparing intervention to control at 6 months.
Time frame: 6 months
Population: 100 Intervention (hypothetical cohort) 100 Control (hypothetical cohort)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Total Cost at 6 Months | 1,149,600 USD |
| Control | Total Cost at 6 Months | 1,298,700 USD |
Other Pre-specified
VA Healthcare Workflow Effectiveness
The investigators will investigate the overall workload impacts to the VA healthcare system. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall workload impacts to the VA healthcare system.
Time frame: 12 months
Population: Workflow changed significantly over the course of the study such that this outcome became not feasible to assess. Over the time that participants were enrolled, we had multiple staff and doctor changes, not to mention the pandemic.
Other Pre-specified
VA Workflow Effectiveness
The investigators will investigate the overall workload impacts to the VA healthcare system.
Time frame: 12 months
Population: Workflow changed significantly over the course of the study such that this outcome became not feasible to assess. Over the time that participants were enrolled, we had multiple staff and doctor changes, not to mention the pandemic.
Other Pre-specified
Within-Trial Cost-Effectiveness of Adherence
Will the intervention be cost-effectiveness compared to usual care? Total cost was calculated by adding the mean medical resource cost per patient to the cost of the intervention ($549) or the control ($48), then multiplying the total by the number of patients per group (100)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Within-Trial Cost-Effectiveness of Adherence | 1,149,600 USD |
| Control | Within-Trial Cost-Effectiveness of Adherence | 1,298,700 USD |