Investigating the Impact of Mode of Administration on Item Response

This study has been completed.
Sponsor:
Collaborators:
QualityMetrics
NorthShore University HealthSystem Research Institute
Stanford University
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00783991
First received: October 30, 2008
Last updated: June 5, 2013
Last verified: June 2013

October 30, 2008
June 5, 2013
April 2009
December 2009   (final data collection date for primary outcome measure)
  • IRT-derived scores from two parallel static short forms containing eight items each from three PROMIS domains (emotional distress-depression, fatigue, physical function) [ Time Frame: One time assessment ] [ Designated as safety issue: No ]
  • Respondent preference and satisfaction with mode of administration [ Time Frame: One time assessment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783991 on ClinicalTrials.gov Archive Site
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Investigating the Impact of Mode of Administration on Item Response
Investigating the Impact of Mode of Administration on Item Response

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.

This study is designed to examine how differences in modes of data capture affect psychometric properties and score differences and to evaluate the consistency of these results across three PROMIS health domains: emotional distress-depression, fatigue, and physical function. Four modes of administration will be compared: interactive voice response (IVR) technology, paper and pencil questionnaire, personal computer, and personal digital assistant (PDA). A total of 800 patients will be enrolled from three diagnostic groups: chronic obstructive pulmonary disease (COPD), depression, and rheumatoid arthritis. The study will test for equivalence across modes of administration, with the hypothesis that there are no mode effects; if mode effects are found, their magnitude across modes will be estimated. This network project will result in an improved understanding of the effect of assessment mode on patient-reported outcome (PRO) data. Guidance from this project can help in planning future PROMIS activities beyond the present PROMIS program.

This study is designed to systematically test the impact of mode of administration on patient-reported outcomes measures included in the PROMIS item banks. It is designed as a randomized cross-over study. Two non-overlapping alternate forms (Form A [FA] and Form B [FB]) with eight unique items each from three of the PROMIS domains (emotional distress-depression, fatigue, physical function) will be developed. Respondents will answer one of the forms by automated phone interview using interactive voice response (IVR) technology, paper and pencil questionnaire (PP), personal computer (PC), or personal digital assistant (PDA) technology. The other form will always be answered by PC. The order in which the forms are administered will be randomized. The two assessments will be separated by a short interval (e.g., 5 to 10 minutes), but will take place on the same day. The study is powered to evaluate equivalence within a score difference of +/-2.0 on a T-score metric (standard deviation of 10) with 85% power. Data for the IVR-PC, PP-PC, and PC-PC modes will be collected via Polimetrix (n=200 per arm, with random assignment to arm); data for the PDA-PC mode will be collected via Stony Brook (n=200). Respondents will have one or more of the chronic conditions studied in other Wave 2 studies (COPD, depression, or rheumatoid arthritis).

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

Community samples with at least one of these conditions: chronic obstructive pulmonary disease (COPD), depression (DEP), or rheumatoid arthritis (RA).

  • Chronic Obstructive Pulmonary Disease
  • Depression
  • Rheumatoid Arthritis
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  • IVR-PC
    This group will have instruments administered through interactive voice response (IVR) and personal computer (PC).
  • PP-PC
    This group will have instruments administered through paper and pencil (PP) and PC.
  • PDA-PC
    This group will have instruments administered by personal digital assistant (PDA) and PC.
  • PC-PC
    This group will have all instruments administered through PC.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis given by treating physician
  • Respondents required to take one or more of the following medications for their treatment:

    1. COPD: Inhalative steroids (e.g., budesonide, beclometasone), oral medication with theophylline (dimethylxanthine), 2 mimetic (e.g., formoterol, salmeterol), leukotriene antagonists (e.g., montelukast), or oral corticosteroids (e.g., prednisolone)
    2. DEP: Anti-depressive drugs (e.g., mirtazapine, escitalopram) and/or received a recognized psychotherapeutic treatment for depression within the last year
    3. RA: Anti-inflammatory medications (e.g., Cox-2 inhibitors, acetylsalicylic acid of more than 500mg/d, diclofenac, ibuprofen), immunosuppressants (e.g., methotrexate, leflunomide), immune modulators (e.g., infliximab, etanercept), or steroids (e.g., prednisolone) for current treatment of RA
  • Fluent in English
  • Have Internet access and an e-mail address (for the IVR-PC, PP-PC and PC-PC arms)
  • Willing and able to give informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783991
07-05, 5U01AR052170-02
No
Stony Brook University
Stony Brook University
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • QualityMetrics
  • NorthShore University HealthSystem Research Institute
  • Stanford University
Principal Investigator: John E. Ware, PhD QualityMetrics
Principal Investigator: Arthur Stone, PhD Stony Brook University
Stony Brook University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP