Elders Preferences in Care Decisions

NCT01575990 | Completed

• 2 other identifiers: 11-1638P01HS021133-01
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Colon cancer screening; Decision support interventions; Health status; Patient-centered care; Age; Randomized controlled trial; Double blind; UNC

Outcome Measures

Primary Outcomes (1)

• Appropriate colorectal cancer screening

  The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

  Six months after intervention or control was adminstered

Secondary Outcomes (4)

• Appropriate colorectal cancer screening decisions

  At baseline (after intervention or control was administered)

• Appropriate screening and mediators

  Six months after intervention or control was adminstered

• Appropriate screening for health strata

  Six months after intervention or control was adminstered

• Appropriate screening for stool cards

  Six months after intervention or control was adminstered

Study Arms (2)

Making A Decision About CRC Screening

EXPERIMENTAL

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

Behavioral: Making A Decision About CRC Screening

Drivers 65 Plus

PLACEBO COMPARATOR

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

Behavioral: Drivers 65 Plus

Interventions

Making A Decision About CRC Screening 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.

Also known as: 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

Making A Decision About CRC Screening

Drivers 65 Plus 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.

Also known as: Attention control, Control condition

Drivers 65 Plus

Eligibility Criteria

• Age: 70 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Duke University: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Duke Practiced Based Research Network

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 36469317 DERIVED

• 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.

  PMID: 29847251 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Carmen L Lewis, MD, MPH

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Rowena J Dolor, MD, MHS

  Duke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 10, 2022

Record last verified: 2015-05

Locations

US (1)