BACKGROUND/RATIONALE:
Gout is the most common inflammatory arthritis that affects 4% of U.S. adults and 5% of Veterans. Gout is more common in African-Americans who have worse outcomes compared to Caucasians. Medication adherence of >80% to urate-lowering therapy (ULT), the cornerstone of gout treatment, in the first year is only 37%. This medication adherence for gout was the lowest as compared to medication adherence of 55-72% in six other chronic disease, including hypertension, hypothyroidism, type 2 diabetes, seizure disorders, hypercholesterolemia and osteoporosis.. We recently found that the total charges for admissions for gout as primary or secondary diagnosis for hospital admission increased from $14.3 billion/year in 2009 to $18 billion/year in the U.S. in 2012 based on national inpatient sample, a U.S. representative study . Gout is common in Veterans, affecting up to 5% of all Veterans. Thus, gout-related healthcare utilization and cost, especially emergency department and inpatient costs, constitute a huge burden for the VA. A recent study found that 89% of gout hospitalizations were preventable, many related to poor medication adherence . This indicates that a significant proportion of this health care costs and patient suffering due to gout is likely preventable.

Compared to Caucasians, AAs have lower rates of ULT prescription (42% vs. 80%) and 1.86-times odds of inadequate ULT adherence (<0.80, 64% vs. 77%).Optimal ULT adherence is key to gout management, since it improves the ability to achieve the target serum urate <6 mg/dl, and is associated with lower medical care costs and risk of gout flares. This treatment goal is also recommended by gout treatment guidelines. A patient-centered intervention is highly appropriate in gout, since a lack of knowledge and misconceptions regarding ULT use are common among patients, similar to other chronic conditions. Thus, gout is a very useful test case for chronic symptomatic diseases.

With VA HSR&D pilot funding (PPO 14-111), we have completed the development of the storytelling intervention. The purpose of developing the Storytelling Intervention Video in the pilot study was to test it with our subsequent study, which is this fully funded HSR&D merit review. The veterans participating in the intervention video signed the HIPAA Authorization and consent for use of picture and voice. These documents stated that the video recordings will be "analyzed for effectiveness"(as stated in the video recording consent document). The proposed study is to analyze the effectiveness of the intervention video that will "disseminated to other gout patients" (as stated in both HIPAA and Video recording consent documents- Appendix 1- highlighted). We will determine the effectiveness of the intervention compared to usual care by conducting a 12-month multicenter randomized controlled trial (RCT) among 150 AA Veterans with gout with a ULT adherence of <0.80 at Birmingham VAMC (total 300 AA Veterans at the 3 proposed VA sites- Birmingham, St. Louis, and Philadelphia VA Medical Centers).


OBJECTIVE(S):
Our objective is to test the effectiveness of a patient-centered, culturally relevant narrative intervention, or "storytelling," based on the solid conceptual foundation of the narrative communication theory and the constructs of the Health Belief Model, (HBM) to improve medication adherence and outcomes in chronic diseases among African-Americans (AA), using gout as an example. Gout is a chronic disease associated with chronic symptoms and disability interrupted by intermittent acute flares, similar to Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction if not treated appropriately. Due to the intermittently symptomatic nature of chronic conditions patients, often don't perceive disease severity and susceptibility to disease complications, and, therefore, may not balance the barriers and benefits to medication adherence. Storytelling in the patients' own voice has the power to directly and more effectively confront a patient's barriers to medication adherence, reinforce the benefits and provide useful cues to action. Storytelling promotes patient engagement when the patient identifies with the storyteller and can lead to a patient's recognition of the need to treat the condition and improve health outcomes, as shown by a meaningful improvement in blood pressure in a recent clinical trial in AA with hypertension. The success of this project, combined with other published data, will represent a major step toward demonstrating the effectiveness of storytelling to improve medication adherence in chronic diseases and will address two VA research priority areas, i.e., health care disparities and health care delivery.

METHODS:
Study Population.
This is a prospective randomized study of AA Veterans with gout and low adherence to urate-lowering therapy (ULT), the cornerstone of gout treatment. The intervention being tested is a series of three videos shown at baseline, 2, and 4-months post-enrollment with follow up assessments completed at 3, 6, 9, and 12 months. We anticipate 150 Veterans to be enrolled from rheumatology and primary care clinics within the Birmingham VA Medical Center and its affiliated community-based outpatient clinics (CBOCs). Detailed patient recruitment plan is provided in Appendix 2, a flow chart (Appendix 3) and related details in Appendix 4. Data sources include administratively collected data from the electronic health record and the Corporate Data Warehouse (CDW), patient interviews, medication usage from MEMSCap, and a usual care blood draw to assess serum urate.

The storytelling intervention has been developed to be generalizable to all gout patients and thus we plan to recruit a representative sample at the Birmingham VA. Gout patients seen at referral clinics such as rheumatology are often selected for worse or more advanced disease and thus not representative of general patients with gout. Patients in primary care clinics are more representative and therefore, we plan to recruit across all Birmingham VA primary care clinics and rheumatology clinics.

Intervention.
The intervention being tested is a series of three videos shown at baseline, 2, and 4 months post-enrollment. The baseline video will be shown at the Birmingham VA using VA-approved iPADs and the follow up videos will be distributed to patients as DVDs via mail. We chose the platform of touchscreen computer (e.g., iPAD) for the baseline video for two reasons: (1) the patients will be in the clinic for the baseline visit, and this would ensure that every patient gets the complete intervention in both groups at baseline; and (2) patients will be interacting with the touchscreen technology, which is the proposed platform for the future implementation. To ensure data security, the iPADs will be set up by the Office of Information Technology and will be encrypted prior to use by the study team personnel (FIPS 140-2).

Throughout the study, each video will either have the gout storytelling intervention with patient narrated stories and "Learn More" gout material in a patient's own voice or the stress management video. The duration of the videos is the same (15-20 minutes based on previous experience). DVDs will have new stories from our storytelling stars but will be similar to those presented at the baseline visit.

Outcomes.
-Primary outcome: Adherence to ULT as assessed directly with MEMSCap
-Secondary outcomes: Adherence to ULT as assessed indirectly by the following improved outcomes. These secondary outcomes will be assessed from patient surveys and by using the VA laboratory and other relevant data collected by the Corporate Data Warehouse.
a.Frequency of gout flares requiring treatment
b.Patient satisfaction with treatment
c.Achieving target serum urate (sUA) <6 mg/dl

-Exploratory outcomes will be assessed with surveys (HRQOL, self-reported ULT adherence, alcohol use) or from the VA database (BMI, healthcare utilization). Additional exploratory outcomes will focus on taking advantage of the detailed MEMS Caps data to examine the temporal relationships between medication adherence and specific research study events, e.g., the initial study visit, telephone survey, each DVD mailing, the 6 month research visit, and clinical events (e.g., an acute gout exacerbation or hospitalization).



FINDINGS/RESULTS:
There are no findings to date. All Patients have been enrolled and we are no longer collecting any data. Trial analyses are currently underway.

IMPACT:
The success of this project, combined with other published data, will represent a major step toward demonstrating the effectiveness of storytelling to improve medication adherence in chronic diseases including gout and will address two VA research priority areas, i.e., health care disparities and health care delivery. The experiences and stories from Veterans recorded during our recent pilot study demonstrate the significance of this proposal and the impact of this extremely painful, destructive and deforming arthritis on the quality of life and function in Veterans. The trial analysis is currently underway.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001461-01A1
Link: https://reporter.nih.gov/project-details/9085817

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PUBLICATIONS:

None at this time.

DRA: Health Systems, Autoimmunity, Allergy, and Inflammation
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Adherence, Ethnicity/Race, Outcomes - Patient
MeSH Terms: none