NCT03959696: PRIMED

Promoting Informed Decisions About Cancer Screening in Older Adults

Completed NA Results posted Last updated 6 January 2025

What this trial tests

NA trial testing Notification in Colorectal Cancer Screening in 536 participants. Completed in 30 August 2022.

Timeline

1 May 2019

Primary endpoint
30 April 2022

30 August 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	536
Start date	1 May 2019
Primary completion	30 April 2022
Estimated completion	30 August 2022
Sites	5 locations across United States

Drugs / interventions tested

• Notification
• Training

Conditions studied

• Colorectal Cancer Screening — all drugs for Colorectal Cancer Screening →

Sponsor

Massachusetts General Hospital

Who can join

21 and older, any sex, with Colorectal Cancer Screening. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Shared Decision Making Process (SDMP) Scale Score Primary · About 1 week after the physician visit

The SDMP scale is a short, patient-reported scale that asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4, with higher scores indicating more shared decision making.

Group	Value	95% CI
Notification Only Arm/ Patients	1.1	± 1.2
Training and Notification Arm/ Patients	1.5	± 1.2

Patients' Colorectal Cancer Screening Knowledge Score Secondary · 1 week after physician visit

Colorectal Cancer (CRC) Screening Knowledge will be assessed with multiple choice knowledge items adapted from the CRC Decision Quality Instrument. A total score from 0-100% will be calculated based on the number of correct answers, with higher scores indicating higher knowledge.

Group	Value	95% CI
Notification Only Arm/ Patients	61	± 18.8
Training and Notification Arm/ Patients	63	± 17.7

Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing Secondary · 1 week after physician visit (preference); 12 months after physician visit (testing)

Colorectal Cancer Screening Preference assessed with 1 item adapted from the CRC Decision Quality Instrument will be compared with the screening approach followed (assessed via chart review and patient report) to determine the percentage of patients who received preferred approach to testing.

Group	Value	95% CI
Notification Only Arm/ Patients	103
Training and Notification Arm/ Patients	115

Physician's Shared Decision Making Skills Secondary · Baseline

The transcripts from the simulated patient interactions will be scored by two coders using Braddock's Informed Decision Making framework. Total scores range from 0-9 with higher scores indicating more shared decision making elements in the interaction.

Group	Value	95% CI
Notification Only Arm/Providers	5.5	± 1.3
Training and Notification Arm/ Providers	6.1	± 1.6

Colorectal Cancer Screening Rates Secondary · 1 year

The chart review results of cancer screening rates for patients enrolled in the study.

Group	Value	95% CI
Notification Only Arm/Patients	29.1	23.3 – 35.5
Training and Notification Arm/Patients	38.6	32.3 – 45.1

Clinician Satisfaction With the Visit Secondary · 1 week post visit

The percentage of study patient visits where the clinicians' reported that they were 'extremely or very satisfied' will be compared across arms.

Group	Value	95% CI
Notification Only Arm/Patient	138
Training and Notification Arm/Patient	171

Companion SDM Process Scale Score Secondary · About a week after physician visit

Companions will complete an adapted version of the SDM Process survey to provide a different perspective on the conversation and involvement of the patient. A total score will range from 0-4, with higher scores indicating more shared decision making.

Group	Value	95% CI
Notification Only Arm/Companion	2.1	± 1.3
Training and Notification Arm/Companion	1.9	± 1.2

Clinician Attitude Toward Shared Decision Making Secondary · Baseline

The investigators will use five items to assess clinicians' confidence in Shared Decision Making Skills and Barriers to SDM. A total confidence score (0-20) with higher scores indicating higher confidence and a barrier score (0-8) higher scores indicating more barriers will be calculated.

Total Confidence

Group	Value	95% CI
Notification Only Arm/Providers	10.2	± 2.4
Training and Notification Arm/ Providers	10.7	± 1.8

Barrier Confidence

Group	Value	95% CI
Notification Only Arm/Providers	0.79	± 1.4
Training and Notification Arm/ Providers	0.88	± 1.57

Sponsor's own description

This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients in the target age group who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The investigators expect that patients seen by clinicians in the intervention arm will report more involvement in the decision making process, be more knowledgeable about the risks and benefits of CRC screening, and will have better quality decisions. Further, the investigators expect that the physicians in the intervention arm will have greater confidence in and demonstrate more skills for conducting shared decision making conversations as compared to those in the control arm.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): a Physician Cluster Randomized Trial.
   Sepucha K, Han PKJ, Chang Y, Atlas SJ, et al · · 2023 · cited 9× · PMID 35931908 · DOI 10.1007/s11606-022-07738-4
2. Shared Decision-Making in Colorectal Cancer Screening for Older Adults: A Secondary Analysis of a Cluster Randomized Clinical Trial.
   Sepucha KR, Chang Y, Valentine KD, Atlas SJ, et al · · 2024 · cited 3× · PMID 39178001 · DOI 10.1001/jamanetworkopen.2024.29645
3. Talking, not training, increased the accuracy of physicians' diagnosis of their patients' preferences for colon cancer screening.
   Valentine K, Leavitt L, Simmons L, Sepucha K, et al · · 2024 · cited 2× · PMID 37976668 · DOI 10.1016/j.pec.2023.108047
4. Exploring the Lack of Concordance between the Preferred and Actual Approach to Colorectal Cancer Screening in Older Adults: A Qualitative Study.
   Kraun L, Leavitt L, Valentine KD, Atlas SJ, et al · · 2026 · PMID 42015676 · DOI 10.1177/0272989x261441643