Clinical trial NCT01618097: Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
Official title: Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Decision Aids
Health Literacy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2012-06-13
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to advance the evidence base regarding methods for facilitating informed decisions among patients with knee and hip osteoarthritis by comparing DVD and online formats of decision aids for these conditions. The project will assess how these different formats impact key outcomes including: patient knowledge about treatment options, decisional conflict, preparation for decision making, decision self-efficacy, stage of decision making, and acceptability and usability of the decision aids.

Detailed description: Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability. Many patients with OA know very little about treatment options and are not well equipped to make informed decisions regarding these treatments. Further, there are racial and gender disparities in perceptions of the risks and benefits of total joint replacement, which also highlights the need to improve facilitation of informed treatment choices in these patients. Decision aids have great potential to improve patient satisfaction, safety, and outcomes for patients with OA, but there is no evidence base regarding best formats for delivering this information. This project will compare patient decision-making outcomes immediately following viewing of DVD and web-based versions of the Health Dialog DAs for hip and knee OA, as well as three days and one month later. Patients with symptomatic knee and hip OA (n=200) will be enrolled from a primary care and orthopedic clinics. Participants will be randomized, with stratification according to health literacy level, to view the DVD or web-based DA. Outcomes will include: Knowledge about OA and Treatments, Decisional Conflict, Preparation for Decision-Making, Decision Self-Efficacy, Stage of Decision Making, Acceptability and Usability of the DA, and home use of the DA. This project will make a novel contribution with direct clinical applicability, providing information regarding best methods for disseminating tools to enhance informed decision-making among patients with hip and knee OA, with particular attention to patients with low literacy.

Eligibility criteria: Inclusion Criteria:

* Clinician diagnosis of knee/hip OA, based on radiographic evidence in Duke medical records.
* Moderate or worse current joint symptoms, assessed at telephone screening using standard items.

Exclusion Criteria:

* Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease.
* Active diagnosis of psychosis or dementia, or other cognitive impairment.
* Severe hearing or visual impairment that would prohibit effective use of the DAs.
* Planning, scheduled for or on a wait list for joint replacement surgery.
* Had a prior hip or knee joint replacement surgery.
* Inability to read English, since the DAs are in English.
* Current participation in another OA interventional study.

Primary outcomes:
measure: Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at Baseline to post.
timeFrame: Baseline and 1 hour
measure: Change in Decisional Conflict Scale at Baseline to post.
timeFrame: Baseline and 1 hour
measure: Change in Decision Self-Efficacy Scale a Baseline to post.
timeFrame: Baseline and 1 hour
measure: Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at 30 days.
timeFrame: Baseline and 30 days
measure: Change in Decisional Conflict Scale at 30 days post.
timeFrame: Baseline and 30 days
Secondary outcomes:
measure: Measurement of the Acceptability and Usability Scale post viewing of the DAs.
timeFrame: Up to 1 hour
measure: Semi-Structured Interviews
timeFrame: Up to 1 hour
measure: Time spent viewing different parts of the internet-based DA
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen, K.D., Sanders, L. Olsen, M., Bowlby, L., Katz, J.N., Mather, R.C., Powers, B., Sperber, N., Voils, C.I., Williams, J.W. Effectiveness of Internet and DVD Decision Aids for Patients with Hip and Knee Osteoarthritis. April 2014 World Congress on Osteoarthritis. Paris, France.