Elders Preferences in Care Decisions

NCT ID: NCT01575990

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

Detailed Description

The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.

Conditions

Early Detection of Cancer; Colon Cancer; Decision Making; Patient-Centered Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Making A Decision About CRC Screening

A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.

Group Type: EXPERIMENTAL

Making A Decision About CRC Screening

Intervention Type: BEHAVIORAL

Targeted by age and gender with 3 components.

1. Educational component

2. Values clarification exercise

3. Individualized decision making worksheet

The intervention or control condition is administered before the index visit with the patient's provider.

Drivers 65 Plus

The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.

Group Type: PLACEBO_COMPARATOR

Drivers 65 Plus

Intervention Type: BEHAVIORAL

This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.

Interventions

Making A Decision About CRC Screening

Targeted by age and gender with 3 components.

1. Educational component

2. Values clarification exercise

3. Individualized decision making worksheet

The intervention or control condition is administered before the index visit with the patient's provider.

Intervention Type: BEHAVIORAL

Drivers 65 Plus

This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.

Intervention Type: BEHAVIORAL

Other Intervention Names

Making A Decision About Colon Cancer Screening Woman 70; Making A Decision About Colon Cancer Screening Woman 75; Making A Decision About Colon Cancer Screening Woman 80; Making A Decision About Colon Cancer Screening Men 70; Making A Decision About Colon Cancer Screening Men 75; Making A Decision About Colon Cancer Screening Men 80; Attention control; Control condition

Eligibility Criteria

Inclusion Criteria

• Men and women ages 70 to 84
• Not up to date with colon cancer screening or surveillance

Exclusion Criteria

• Men and women younger than 70 years of age or older than 84
• History of Colorectal Cancer
• Inflammatory bowel disease

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen L Lewis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Rowena J Dolor, MD, MHS

Role: STUDY_DIRECTOR

Duke University

Locations

Duke Practiced Based Research Network

Durham, North Carolina, United States

Countries

United States

References

Dalton AF, Golin CE, Morris C, Kistler CE, Dolor RJ, Bertin KB, Suresh K, Patel SG, Lewis CL. Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244982. doi: 10.1001/jamanetworkopen.2022.44982.

Reference Type: DERIVED

PMID: 36469317 (View on PubMed)

Lewis CL, Kistler CE, Dalton AF, Morris C, Ferrari R, Barclay C, Brewer NT, Dolor R, Harris R, Vu M, Golin CE. A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial. Med Decis Making. 2018 Jul;38(5):614-624. doi: 10.1177/0272989X18773713.

Reference Type: DERIVED

PMID: 29847251 (View on PubMed)

Other Identifiers

P01HS021133-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

11-1638

Identifier Type: -

Identifier Source: org_study_id