Trial Outcomes & Findings for Individualizing Disease Prevention for Middle-Aged Adults (NCT NCT03023813)

NCT ID: NCT03023813

Last Updated: 2022-04-26

Results Overview

Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: Within 3 days of index primary care appointment.
• Results posted on: 2022-04-26

Participant Flow

Participant milestones

Measure	Intervention Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control Usual care	Development Phase Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Overall Study STARTED	39	34	31
Overall Study COMPLETED	38	32	31
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Measure	Intervention Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control Usual care	Development Phase Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Overall Study Lost to Follow-up	1	2	0

Baseline Characteristics

Individualizing Disease Prevention for Middle-Aged Adults

Baseline characteristics by cohort

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.	Total n=101 Participants Total of all reporting groups
Age, Continuous	55.9 years n=5 Participants	56.6 years n=7 Participants	56.9 years n=5 Participants	56.5 years n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	80 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	38 participants n=5 Participants	32 participants n=7 Participants	31 participants n=5 Participants	101 participants n=4 Participants
Practice site Site 1	20 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	51 Participants n=4 Participants
Practice site Site 2	14 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	43 Participants n=4 Participants
Practice site Site 3	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Education Less than high school	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Education High school (diploma or GED)	12 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	32 Participants n=4 Participants
Education Some college	13 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Education College degree	3 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Education Masters degree	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Education Doctoral or professional degree	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Education Missing	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Marital status Married or civil/domestic partner	14 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	34 Participants n=4 Participants
Marital status Widowed	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Marital status Divorced	7 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Marital status Separated	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Marital status Never married	12 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 3 days of index primary care appointment.

Population: Patients who completed surveys

Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Interest in Individualized Preventive Care Recommendations.	8.9 score on a scale Interval 8.0 to 10.0	NA score on a scale Collected from intervention subjects only	9.0 score on a scale Interval 8.0 to 10.0

PRIMARY outcome

Timeframe: Within 3 days of index primary care appointment.

Population: Patients who completed surveys

Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Interest in Individualized Preventive Care Recommendations.	9.0 score on a scale Interval 9.0 to 10.0	NA score on a scale Collected from intervention subjects only	9.0 score on a scale Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment.

Population: Patients who completed surveys

Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Use of Shared Decision Making.	79.0 score on a scale Standard Error 4.6	74.3 score on a scale Standard Error 5.1	86.4 score on a scale Standard Error 2.6

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment.

Population: Patients who completed surveys

Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Patient Readiness to Change Health Behaviors.	84.6 percentage of survey responses Standard Error 7.2	70.8 percentage of survey responses Standard Error 9.5	83.3 percentage of survey responses Standard Error 6.9

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment

Population: Patients who completed surveys

Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Patient Readiness to Change Health Behaviors	83.3 percentage of survey responses Standard Error 7.8	72.7 percentage of survey responses Standard Error 9.7	86.7 percentage of survey responses Standard Error 6.3

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment

Population: Patients who completed surveys

Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Patient Readiness to Change Health Behaviors.	70.4 percentage of survey responses Standard Error 9.0	77.8 percentage of survey responses Standard Error 10.1	78.6 percentage of survey responses Standard Error 7.9

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment

Population: Patients who completed surveys

Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase n=31 Participants Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Patient Readiness to Change Health Behaviors	80.0 percentage of survey responses Standard Error 10.7	69.2 percentage of survey responses Standard Error 13.3	82.1 percentage of survey responses Standard Error 7.4

SECONDARY outcome

Timeframe: Within 3 days of index primary care appointment.

Population: Patients who completed surveys (Data not collected for Development Phase)

Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Decisional Comfort.	73.2 score on a scale Standard Error 5.3	72.3 score on a scale Standard Error 5.8	—

SECONDARY outcome

Timeframe: Within 1 year of index primary care appointment.

Population: Outcome tables are not included for specific preventive services because outcomes were not assessed by arm (instead, a statistical regression strategy was used). This outcome was not collected for participants in the Development arm.

Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.

Outcome measures

Measure	Intervention n=38 Participants Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided.	Control n=32 Participants Usual care	Development Phase Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided.
Preventive Care Outcomes for Patients.	31 Participants	30 Participants	0 Participants

Adverse Events

Development Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Glen Taksler PhD

Cleveland Clinic

Phone: 216-445-7499

Email: taksleg@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place