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Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD Decision Aid
Internet Based Decision Aid
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Osteoarthritis, Decision Aids, Health Literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DVD Decision Aid

Internet Based Decision Aid

Arm Description

Patient assigned to watch DVD decision aid.

Patient assigned to watch OA specific internet based decision aid.

Outcomes

Primary Outcome Measures

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.
Knowledge is a key outcome in this study because it is fundamental to informed decision making process 45. We will use the "Facts about Osteoarthritis" section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46), which includes 8 items that assess knowledge about the knee OA and its treatment options (behavioral, pharmacological, and surgical). Although this instrument was developed for knee OA, the items are also appropriate for hip OA, and it will be used for both groups.
Change in Decisional Conflict Scale at Baseline to post.
We will use the Low Literacy version of this scale, which includes 10 items with 3 response categories (yes, no, unsure), across four subscales: Informed (do patients know the different options, benefits, and risks?), Values Clarity (are patients clear about which benefits and risk matter most to them?), Support (do patients have support and advice to make a choice?), and Uncertainty (are patients clear or sure about what to choose?).
Change in Decision Self-Efficacy Scale a Baseline to post.
This is an 11-item scale that measures patients' confidence in completing various tasks related to the decision-making processes, such as getting facts about risks and benefits, asking questions, and expressing concerns. All items are measured on a scale of 0 (not confident at all) to 4 (very confident).
Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at 30 days.
Change in Decisional Conflict Scale at 30 days post.

Secondary Outcome Measures

Measurement of the Acceptability and Usability Scale post viewing of the DAs.
We will adapt a 10-item scale to assess the acceptability of this OA DAs. This tool assesses patients' opinions of general aspects of the DA (e.g., amount of information, length), as well as specific topical areas of the DA. In addition, for participants who are randomized to view the internet-based DA, we will use the Perceived Health Website Usability Questionnaire. This questionnaire includes items that assess the ease of finding information, ease of reading, appearance, and ease of learning from the website.
Semi-Structured Interviews
We will use semi-structured interviews to assess patients' perceptions and opinions of the DAs. Specific questions will be developed by the study team, covering the following topical areas: What participants liked about the DA, how well it answered questions they had about treatment options, any additional information to inform their decision-making, other suggestions for improving the DA, likelihood of using the DA to obtain information about treatment options, and how beneficial they think it would be to talk with a nurse / health educator about this information after viewing the DA.
Time spent viewing different parts of the internet-based DA
Installation of Spector Pro software onto the laptop computer on which participants will view the DA to capture information about participants' viewing of the DA. Descriptive data will be generated. Main variables we plan to evaluate are: 1.) The proportion of patients who view each page of the website. 2.) The mean or median number of minutes patients spent on each page. 3.) The proportion of patients who view video(s) within the DA. We will also compare these variables according to patient characteristics and changes in study outcomes.

Full Information

First Posted
May 29, 2012
Last Updated
March 4, 2015
Sponsor
Duke University
Collaborators
Foundation for Informed Medical Decision Making
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1. Study Identification

Unique Protocol Identification Number
NCT01618097
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Foundation for Informed Medical Decision Making

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Decision Aids, Health Literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVD Decision Aid
Arm Type
Experimental
Arm Description
Patient assigned to watch DVD decision aid.
Arm Title
Internet Based Decision Aid
Arm Type
Experimental
Arm Description
Patient assigned to watch OA specific internet based decision aid.
Intervention Type
Behavioral
Intervention Name(s)
DVD Decision Aid
Intervention Description
Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.
Intervention Type
Behavioral
Intervention Name(s)
Internet Based Decision Aid
Intervention Description
Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit
Primary Outcome Measure Information:
Title
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.
Description
Knowledge is a key outcome in this study because it is fundamental to informed decision making process 45. We will use the "Facts about Osteoarthritis" section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46), which includes 8 items that assess knowledge about the knee OA and its treatment options (behavioral, pharmacological, and surgical). Although this instrument was developed for knee OA, the items are also appropriate for hip OA, and it will be used for both groups.
Time Frame
Baseline and 1 hour
Title
Change in Decisional Conflict Scale at Baseline to post.
Description
We will use the Low Literacy version of this scale, which includes 10 items with 3 response categories (yes, no, unsure), across four subscales: Informed (do patients know the different options, benefits, and risks?), Values Clarity (are patients clear about which benefits and risk matter most to them?), Support (do patients have support and advice to make a choice?), and Uncertainty (are patients clear or sure about what to choose?).
Time Frame
Baseline and 1 hour
Title
Change in Decision Self-Efficacy Scale a Baseline to post.
Description
This is an 11-item scale that measures patients' confidence in completing various tasks related to the decision-making processes, such as getting facts about risks and benefits, asking questions, and expressing concerns. All items are measured on a scale of 0 (not confident at all) to 4 (very confident).
Time Frame
Baseline and 1 hour
Title
Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at 30 days.
Time Frame
Baseline and 30 days
Title
Change in Decisional Conflict Scale at 30 days post.
Time Frame
Baseline and 30 days
Secondary Outcome Measure Information:
Title
Measurement of the Acceptability and Usability Scale post viewing of the DAs.
Description
We will adapt a 10-item scale to assess the acceptability of this OA DAs. This tool assesses patients' opinions of general aspects of the DA (e.g., amount of information, length), as well as specific topical areas of the DA. In addition, for participants who are randomized to view the internet-based DA, we will use the Perceived Health Website Usability Questionnaire. This questionnaire includes items that assess the ease of finding information, ease of reading, appearance, and ease of learning from the website.
Time Frame
Up to 1 hour
Title
Semi-Structured Interviews
Description
We will use semi-structured interviews to assess patients' perceptions and opinions of the DAs. Specific questions will be developed by the study team, covering the following topical areas: What participants liked about the DA, how well it answered questions they had about treatment options, any additional information to inform their decision-making, other suggestions for improving the DA, likelihood of using the DA to obtain information about treatment options, and how beneficial they think it would be to talk with a nurse / health educator about this information after viewing the DA.
Time Frame
Up to 1 hour
Title
Time spent viewing different parts of the internet-based DA
Description
Installation of Spector Pro software onto the laptop computer on which participants will view the DA to capture information about participants' viewing of the DA. Descriptive data will be generated. Main variables we plan to evaluate are: 1.) The proportion of patients who view each page of the website. 2.) The mean or median number of minutes patients spent on each page. 3.) The proportion of patients who view video(s) within the DA. We will also compare these variables according to patient characteristics and changes in study outcomes.
Time Frame
Up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli D Allen, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
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Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy

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