Indiana University Dementia Screening Trial (IU-CHOICE)

Indiana University Dementia Screening Trial: The IU CHOICE Study

The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.

Study Overview

• Status: Completed
• Conditions: Dementia; Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Collaborative Dementia Care Program

Detailed Description

The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.

The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.

Primary Specific Aim 1:

Test the impact of dementia screening on health-related quality of life of the patient at 12 months.

Primary Specific Aim 2:

Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).

Secondary Aims: Estimate the cost effectiveness of dementia screening.

• Study Type: Interventional
• Enrollment (Actual): 4005
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health-Primary Care Clinics
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services-Primary Care Clinics
    • West Lafayette, Indiana, United States, 47904
      • IU Health Arnett Primary Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults age 65 and older;
• at least one office visit to their primary care physician within the previous year;
• no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
• ability to consent to participate in the study; and
• ability to communicate in English

Exclusion Criteria:

• adults who are a permanent resident of a nursing facility;
• a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
• a pre-existing diagnosis of dementia or cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Screening; Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Experimental: Screening Group; Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.	Behavioral: Collaborative Dementia Care Program; Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life (HRQOL)	The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.	1 month, 6 months, 12 months
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.	1 month, 6 months, 12 months
Generalized Anxiety Disorder Scale (GAD-7)	The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.	1 month, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Health Care Utilization	The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.	12 months
Number of Participants With an Advance Directive at 12 Months	The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.

Publications and helpful links

General Publications

• 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.
• Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.
• Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.
• Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.
• Fowler NR, Perkins AJ, Gao S, Sachs GA, Boustani MA. Risks and Benefits of Screening for Dementia in Primary Care: The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of Dementia Screening (IU CHOICE)Trial. J Am Geriatr Soc. 2020 Mar;68(3):535-543. doi: 10.1111/jgs.16247. Epub 2019 Dec 2.
• Fowler NR, Harrawood A, Frame A, Perkins AJ, Gao S, Callahan CM, Sachs GA, French DD, Boustani MA. The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial. Trials. 2014 Jun 6;15:209. doi: 10.1186/1745-6215-15-209.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 22, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 30, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Screening; Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: R01AG040220-01A1 (U.S. NIH Grant/Contract); 1R01AG040220-01A1 (U.S. NIH Grant/Contract)