Trial Outcomes & Findings for Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening (NCT NCT00324753)

Last Updated: 2018-11-29

Results Overview

A survey collected data on patient demographic characteristics, family history of colorectal cancer or polyp, and provider recommendation for colorectal cancer screening, if any. In addition, we asked patients whether colorectal cancer screening was discussed at the visit. If the response was yes, we then asked patients how satisfied they were with the PCP communication during the visit in general using a 5-point Likert scale to a number of items describing the communication. A medical record review was conducted to collect data on provider ordering and patient completion of the following colorectal cancer screening tests during the study period (i.e., 6 months from the time of the clinical encounter): fecal occult blood testing, sigmoidoscopy, or colonoscopy.

Recruitment status

COMPLETED

Study phase

Target enrollment

454 participants

Primary outcome timeframe

6-12 months

Results posted on

2018-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Intervention arm- Prompting by prevention nurses and a communication sheet provided A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter.	Control Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
Overall Study STARTED	190	264
Overall Study COMPLETED	190	264
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=190 Participants Intervention arm- Prompting by prevention nurses and a communication sheet provided A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter.	Control n=264 Participants Standard of care brochures Standard of care: Standard of care brochures	Total n=454 Participants Total of all reporting groups
Age, Customized Age (years) · 50-59	114 Participants n=93 Participants	160 Participants n=4 Participants	274 Participants n=27 Participants
Age, Customized Age (years) · 60-69	67 Participants n=93 Participants	96 Participants n=4 Participants	163 Participants n=27 Participants
Age, Customized Age (years) · 70 and older	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	22 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	153 Participants n=93 Participants	242 Participants n=4 Participants	395 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=93 Participants	18 Participants n=4 Participants	33 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=93 Participants	241 Participants n=4 Participants	413 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	68 Participants n=93 Participants	82 Participants n=4 Participants	150 Participants n=27 Participants
Race/Ethnicity, Customized Race · African American	103 Participants n=93 Participants	166 Participants n=4 Participants	269 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other	14 Participants n=93 Participants	9 Participants n=4 Participants	23 Participants n=27 Participants
Race/Ethnicity, Customized Race · Not Answered	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Charlson Comorbidity Index 0	75 Participants n=93 Participants	137 Participants n=4 Participants	212 Participants n=27 Participants
Charlson Comorbidity Index 1	62 Participants n=93 Participants	61 Participants n=4 Participants	123 Participants n=27 Participants
Charlson Comorbidity Index 2 or more	53 Participants n=93 Participants	66 Participants n=4 Participants	119 Participants n=27 Participants
Family History of Colorectal Cancer or Polyps History of Colorectal Cancer	20 Participants n=93 Participants	26 Participants n=4 Participants	46 Participants n=27 Participants
Family History of Colorectal Cancer or Polyps History of Polyps only	16 Participants n=93 Participants	18 Participants n=4 Participants	34 Participants n=27 Participants
Family History of Colorectal Cancer or Polyps History of Neither	154 Participants n=93 Participants	220 Participants n=4 Participants	374 Participants n=27 Participants
Education < High School Graduate	16 Participants n=93 Participants	160 Participants n=4 Participants	176 Participants n=27 Participants
Education High School Graduate	52 Participants n=93 Participants	96 Participants n=4 Participants	148 Participants n=27 Participants
Education Post High School	120 Participants n=93 Participants	8 Participants n=4 Participants	128 Participants n=27 Participants
Education Not Answered	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Site Chicago	72 Participants n=93 Participants	116 Participants n=4 Participants	188 Participants n=27 Participants
Site Houston	49 Participants n=93 Participants	61 Participants n=4 Participants	110 Participants n=27 Participants
Site Pittsburgh	69 Participants n=93 Participants	87 Participants n=4 Participants	156 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6-12 months

Outcome measures

Outcome measures
Measure	Intervention n=190 Participants Communication sheet Communication: Communication sheet	Control n=264 Participants Standard of care brochures Standard of care: Standard of care brochures
Completion of Colorectal Cancer Screening Tests CRC Test Completed	102 Participants	142 Participants
Completion of Colorectal Cancer Screening Tests CRC Test Not Completed	88 Participants	122 Participants

PRIMARY outcome

Timeframe: immediate after the patient visit

Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).

Outcome measures

Outcome measures
Measure	Intervention n=190 Participants Communication sheet Communication: Communication sheet	Control n=264 Participants Standard of care brochures Standard of care: Standard of care brochures
Quality of Communication A lot of satisfaction	149 Participants	193 Participants
Quality of Communication Some/Little Satisfaction	30 Participants	58 Participants
Quality of Communication Missing/Unknown/No Discussion	11 Participants	13 Participants

PRIMARY outcome

Timeframe: immediately after the patient visit

PCP Explains CRC screening to my satisfaction

Outcome measures

Outcome measures
Measure	Intervention n=190 Participants Communication sheet Communication: Communication sheet	Control n=264 Participants Standard of care brochures Standard of care: Standard of care brochures
Communication Content Strongly Agree	152 Participants	203 Participants
Communication Content Somewhat Agree/Neither	30 Participants	50 Participants
Communication Content Missing/Unknown/Did not Discuss	8 Participants	11 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria K. Mor

Center for Health Equity Research and Promotion (VAPHS)

Phone: (412) 360-2240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place