Clinical trial NCT03052257: Improve Glaucoma Medication Adherence
Official title: Improving Glaucoma Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Disease management
Smart bottle
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Exclusion Criteria:

Exclusion criteria for patients At Screener:

* "How confident are you that you always remember to use your glaucoma medications?"

  * not at all confident
  * somewhat confident
  * very confident)
* And "In the past 4 weeks, did you ever forget to take your medicine?"

  * Veterans who respond both "very confident" and "no", respectively, will be excluded

Inclusion criteria for companions at screener:

* Willing to participate in assisting the patient with glaucoma drops and
* Willing to accompany the patient to the intervention visit for participants in the intervention arm or eye health education visit for participants in the control arm.

Exclusion criteria for companions: Unable or unwilling to attend baseline visit and intervention or control arm educational session with patient participant.

Exclusion criteria for patients or companions:

* Lacks proficiency in English,
* Lacks either a cell phone or landline phone.

Exclusion criteria for patients post randomization:

* Decision by patient and provider to cease glaucoma medication use
* Change in functional status such that the drops are no longer administered by the patient or the companion (such as nursing home care)

Primary outcomes:
measure: Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule
timeFrame: Randomization to 6 Months
Secondary outcomes:
measure: VA Medical Resource Use and Costs
timeFrame: 6 months
Other outcomes:
measure: Number of Participants With Newly Prescribed Glaucoma Therapy
timeFrame: 12 Months
measure: Total Cost at 6 Months
timeFrame: 6 months
measure: VA Healthcare Workflow Effectiveness
timeFrame: 12 months
measure: Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted
timeFrame: 12 months
measure: Within-Trial Cost-Effectiveness of Adherence
timeFrame: 6 months
measure: VA Workflow Effectiveness
timeFrame: 12 months
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kelly W. Muir, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hein AM, Rosdahl JA, Bosworth HB, Woolson SL, Olsen MK, Kirshner MA, Muir KW. The Association of an Upper Extremity Functional Survey and Glaucoma Medication Administration Success. Curr Eye Res. 2019 Oct;44(10):1150-1156. doi: 10.1080/02713683.2019.1625405. Epub 2019 Jun 11.
citation: Rosdahl JA, Hein AM, Bosworth HB, Woolson S, Olsen M, Kirshner M, Hung A, Muir KW. Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study. Clin Trials. 2021 Jun;18(3):343-350. doi: 10.1177/1740774520988291. Epub 2021 Jan 25.
citation: Muir KW, Rosdahl JA, Hein AM, Woolson S, Olsen MK, Kirshner M, Sexton M, Bosworth HB. Improved Glaucoma Medication Adherence in a Randomized Controlled Trial. Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):40-46. doi: 10.1016/j.ogla.2021.04.006. Epub 2021 Apr 20.
citation: Williams AM, Theophanous C, Muir KW, Rosdahl JA, Woolson S, Olsen M, Bosworth HB, Hung A. Within-Trial Cost-Effectiveness of an Adherence-Enhancing Educational Intervention for Glaucoma. Am J Ophthalmol. 2022 Dec;244:216-227. doi: 10.1016/j.ajo.2022.08.011. Epub 2022 Aug 21.
citation: Buehne KL, Rosdahl JA, Hein AM, Woolson S, Olsen M, Kirshner M, Sexton M, Bosworth HB, Muir KW. How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial. Ophthalmic Res. 2023;66(1):489-495. doi: 10.1159/000528857. Epub 2023 Jan 5.