Primary Health Care
Conditions
Brief summary
The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.
Interventions
OTHERIntervention
Written material provided.
Sponsors
National Institute on Aging (NIA)
Glen Taksler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Only the 2 arm round(s) will be randomized.
Intervention model description
Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Scheduled for an appointment with primary care provider during study period * Two or more of the following risk factors: * Tobacco use * Overweight/obese * Hypertension * Hyperlipidemia * Diabetes * Alcohol Misuse * Depression * History of Sexually Transmitted Infection * Being overdue for the following screenings: Colorectal, cervical, breast, lung
Exclusion criteria
\- Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interest in Individualized Preventive Care Recommendations. | Within 3 days of index primary care appointment. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Shared Decision Making. | Within 3 days of index primary care appointment. | 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) |
| Patient Readiness to Change Health Behaviors. | Within 3 days of index primary care appointment. | 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 |
| Patient Readiness to Change Health Behaviors | Within 3 days of index primary care appointment | 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 |
| Decisional Comfort. | Within 3 days of index primary care appointment. | 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) |
| Preventive Care Outcomes for Patients. | Within 1 year of index primary care appointment. | Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Individualized preventive care recommendations will be distributed to subjects.
Intervention: Written material provided. | 38 |
| Control Usual care | 32 |
| Development Phase Non-randomized receipt of individualized preventive care recommendations
Intervention: Written material provided. | 31 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Development Phase | Control |
|---|---|---|---|---|
| Age, Continuous | 55.9 years | 56.5 years | 56.9 years | 56.6 years |
| Education College degree | 3 Participants | 17 Participants | 5 Participants | 9 Participants |
| Education Doctoral or professional degree | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Education High school (diploma or GED) | 12 Participants | 32 Participants | 14 Participants | 6 Participants |
| Education Less than high school | 1 Participants | 6 Participants | 1 Participants | 4 Participants |
| Education Masters degree | 5 Participants | 8 Participants | 0 Participants | 3 Participants |
| Education Missing | 4 Participants | 8 Participants | 0 Participants | 4 Participants |
| Education Some college | 13 Participants | 29 Participants | 10 Participants | 6 Participants |
| Marital status Divorced | 7 Participants | 19 Participants | 9 Participants | 3 Participants |
| Marital status Married or civil/domestic partner | 14 Participants | 34 Participants | 8 Participants | 12 Participants |
| Marital status Never married | 12 Participants | 31 Participants | 9 Participants | 10 Participants |
| Marital status Separated | 3 Participants | 8 Participants | 2 Participants | 3 Participants |
| Marital status Widowed | 2 Participants | 9 Participants | 3 Participants | 4 Participants |
| Practice site Site 1 | 20 Participants | 51 Participants | 14 Participants | 17 Participants |
| Practice site Site 2 | 14 Participants | 43 Participants | 17 Participants | 12 Participants |
| Practice site Site 3 | 4 Participants | 7 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 80 Participants | 28 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 17 Participants | 2 Participants | 10 Participants |
| Region of Enrollment United States | 38 participants | 101 participants | 31 participants | 32 participants |
| Sex: Female, Male Female | 25 Participants | 73 Participants | 23 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 38 | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 38 | 0 / 32 | 0 / 31 |
Outcome results
Primary
Interest in Individualized Preventive Care Recommendations.
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)
Time frame: Within 3 days of index primary care appointment.
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Interest in Individualized Preventive Care Recommendations. | 8.9 score on a scale |
| Control | Interest in Individualized Preventive Care Recommendations. | NA score on a scale |
| Development Phase | Interest in Individualized Preventive Care Recommendations. | 9.0 score on a scale |
Primary
Interest in Individualized Preventive Care Recommendations.
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)
Time frame: Within 3 days of index primary care appointment.
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Interest in Individualized Preventive Care Recommendations. | 9.0 score on a scale |
| Control | Interest in Individualized Preventive Care Recommendations. | NA score on a scale |
| Development Phase | Interest in Individualized Preventive Care Recommendations. | 9.0 score on a scale |
Secondary
Decisional Comfort.
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)
Time frame: Within 3 days of index primary care appointment.
Population: Patients who completed surveys (Data not collected for Development Phase)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Decisional Comfort. | 73.2 score on a scale | Standard Error 5.3 |
| Control | Decisional Comfort. | 72.3 score on a scale | Standard Error 5.8 |
p-value: 0.91t-test, 2 sided
Secondary
Patient Readiness to Change Health Behaviors
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
Time frame: Within 3 days of index primary care appointment
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Readiness to Change Health Behaviors | 83.3 percentage of survey responses | Standard Error 7.8 |
| Control | Patient Readiness to Change Health Behaviors | 72.7 percentage of survey responses | Standard Error 9.7 |
| Development Phase | Patient Readiness to Change Health Behaviors | 86.7 percentage of survey responses | Standard Error 6.3 |
p-value: 0.39t-test, 2 sided
Secondary
Patient Readiness to Change Health Behaviors
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
Time frame: Within 3 days of index primary care appointment
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Readiness to Change Health Behaviors | 80.0 percentage of survey responses | Standard Error 10.7 |
| Control | Patient Readiness to Change Health Behaviors | 69.2 percentage of survey responses | Standard Error 13.3 |
| Development Phase | Patient Readiness to Change Health Behaviors | 82.1 percentage of survey responses | Standard Error 7.4 |
p-value: 0.53t-test, 2 sided
Secondary
Patient Readiness to Change Health Behaviors.
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
Time frame: Within 3 days of index primary care appointment
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Readiness to Change Health Behaviors. | 70.4 percentage of survey responses | Standard Error 9 |
| Control | Patient Readiness to Change Health Behaviors. | 77.8 percentage of survey responses | Standard Error 10.1 |
| Development Phase | Patient Readiness to Change Health Behaviors. | 78.6 percentage of survey responses | Standard Error 7.9 |
p-value: 0.59t-test, 2 sided
Secondary
Patient Readiness to Change Health Behaviors.
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
Time frame: Within 3 days of index primary care appointment.
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Readiness to Change Health Behaviors. | 84.6 percentage of survey responses | Standard Error 7.2 |
| Control | Patient Readiness to Change Health Behaviors. | 70.8 percentage of survey responses | Standard Error 9.5 |
| Development Phase | Patient Readiness to Change Health Behaviors. | 83.3 percentage of survey responses | Standard Error 6.9 |
p-value: 0.25t-test, 2 sided
Secondary
Preventive Care Outcomes for Patients.
Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Preventive Care Outcomes for Patients. | 31 Participants |
| Control | Preventive Care Outcomes for Patients. | 30 Participants |
| Development Phase | Preventive Care Outcomes for Patients. | 0 Participants |
Comparison: Among participants whose individualized preventive care recommendations included weight lossp-value: 0.2795% CI: [-8.18, 2.26]Mixed Models Analysis
Comparison: Among participants whose individualized preventive care recommendations included blood pressure controlp-value: 0.1995% CI: [-16.12, 3.27]Mixed Models Analysis
Comparison: Among participants whose individualized preventive care recommendations included glycemic controlp-value: 0.2495% CI: [-1.82, 0.45]Mixed Models Analysis
Comparison: Among participants whose individualized preventive care recommendations included lipids controlp-value: 0.3495% CI: [-3.65, 1.26]Generalized linear mixed regression
Comparison: Among participants whose individualized preventive care recommendations included lipids controlp-value: 0.3695% CI: [-26.63, 9.7]Mixed Models Analysis
Comparison: Among participants whose individualized preventive care recommendations included tobacco cessationp-value: 0.9295% CI: [0.03, 45.56]Mixed Models Analysis
Comparison: Among participants whose individualized preventive care recommendations included colorectal cancer screeningp-value: 0.9995% CI: [0.001, 1000]Mixed Models Analysis
Secondary
Use of Shared Decision Making.
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)
Time frame: Within 3 days of index primary care appointment.
Population: Patients who completed surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Use of Shared Decision Making. | 79.0 score on a scale | Standard Error 4.6 |
| Control | Use of Shared Decision Making. | 74.3 score on a scale | Standard Error 5.1 |
| Development Phase | Use of Shared Decision Making. | 86.4 score on a scale | Standard Error 2.6 |
p-value: 0.5t-test, 2 sided