Clinical trial NCT00759252: Perceptions Regarding Investigational Screening for Memory Problems in Primary Care
Official title: Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: diagnosis of dementia
perceptions of risk
dementia screening
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-09-25
Enrollment: 954
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.

Detailed description: The Health Belief Model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging.

The PRISM-PC instrument includes 50 items that are organized into 8 sets of questions that cover the following areas:

A) Prior experience with AD (5 items) B) Acceptance of screening for AD (6 items) C) Acceptance of screening for other conditions (2 items) D) Benefits of screening for AD (9 items) E) Stigma of screening for AD (10 items) F) Impact of screening for AD on independence (6 items) G) Suffering of screening for AD (4 items) H) Demographics (7 items) Excluding section A and H (prior experience with AD and demographics), each item of the six other sections is rated on a 5-point Likert scale (strongly agree, agree, don't know, disagree, and strongly disagree).

Based on the previous PRISM-PC pilot study (a survey response rate of 80%) and the Dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. A random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).

Eligibility criteria: Inclusion Criteria:

* Aged 65 and older
* At least one office visit to their primary care physician within the last year
* No chart-based diagnosis of dementia or memory problem
* Willing to sign a consent form to participate in the study

Exclusion Criteria:

* Does not speak English
* Too hearing-impaired to hear the informed consent statement or the survey
* Severe mental illness based on the patient's electronic medical charts

Primary outcomes:
measure: Primary care patients' perceptions of the risks and benefits of early identification of dementia
timeFrame: Measurement will continue through the duration of the study
Secondary outcomes:
measure: Evaluation of the association between primary care patients' acceptance for early identification of dementia and their perceptions of the risks and benefits of such identification after adjusting for potential confounders such as demographics
timeFrame: Measurement will continue through the duration of the study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Group
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Center for Aging Research
name: Malaz Boustani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schubert CC, Boustani M, Callahan CM, Perkins AJ, Hui S, Hendrie HC. Acute care utilization by dementia caregivers within urban primary care practices. J Gen Intern Med. 2008 Nov;23(11):1736-40. doi: 10.1007/s11606-008-0711-0. Epub 2008 Aug 9.
citation: Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20. doi: 10.1002/gps.1983.
citation: Brayne C, Fox C, Boustani M. Dementia screening in primary care: is it time? JAMA. 2007 Nov 28;298(20):2409-11. doi: 10.1001/jama.298.20.2409. No abstract available.