Trial Outcomes & Findings for Aligning Patients and Their Primary Care Providers (NCT NCT02707146)

Last Updated: 2019-04-30

Results Overview

All patients enrolled in the study will have one or more guideline-based care gaps at baseline. Care gaps are defined as: overdue for cancer screening (mammography, colorectal cancer), overdue for chronic disease monitoring (blood pressure, HbA1c), above goal for chronic disease (SBP \> 140, HbA1c \> 8%), or medication related (not prescribed a statin if clinically indicated, not prescribed medicine for osteoporosis if indicated, \< 80% adherence to medication for diabetes, hypertension, or hyperlipidemia), or current smoker. The investigators will assess % of patients resolving baseline clinical care gaps after 12 months. The aggregate outcome will be defined as yes/no resolution of baseline care gap. The study arms will be compared using an aggregate measure of these guideline-based clinical care gaps.

Recruitment status

COMPLETED

Study phase

Target enrollment

750 participants

Primary outcome timeframe

12 months

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tablet in the Waiting Room Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad	Health Education Handout Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle
Overall Study STARTED	359	391
Overall Study COMPLETED	359	388
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aligning Patients and Their Primary Care Providers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tablet in the Waiting Room n=359 Participants Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad	Health Education Handout n=391 Participants Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle	Total n=750 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	195 Participants n=5 Participants	212 Participants n=7 Participants	407 Participants n=5 Participants
Age, Categorical >=65 years	164 Participants n=5 Participants	179 Participants n=7 Participants	343 Participants n=5 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 12.1 • n=5 Participants	61.2 years STANDARD_DEVIATION 11.7 • n=7 Participants	60.8 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	235 Participants n=5 Participants	251 Participants n=7 Participants	486 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	140 Participants n=7 Participants	264 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · African-American	115 Participants n=5 Participants	97 Participants n=7 Participants	212 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian	20 Participants n=5 Participants	34 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	69 Participants n=5 Participants	98 Participants n=7 Participants	167 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Other (>1 race/ethnicity)	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · White	141 Participants n=5 Participants	147 Participants n=7 Participants	288 Participants n=5 Participants
Region of Enrollment United States	359 participants n=5 Participants	391 participants n=7 Participants	750 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Tablet in the Waiting Room n=359 Participants Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad	Health Education Handout n=388 Participants Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle
Aggregate Measure of Guideline-Based Clinical Care Gaps	184 Participants	210 Participants

SECONDARY outcome

Timeframe: Within 1 week of primary care study visit

Telephone survey will be conducted within 1 week of visit using validated questionnaire items that assess patient-provider communication and patient satisfaction with care

Outcome measures

Outcome measures
Measure	Tablet in the Waiting Room n=333 Participants Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad	Health Education Handout n=357 Participants Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle
Patient-reported Outcomes Prepare list of questions?	198 Participants	160 Participants
Patient-reported Outcomes Tell your doctor your top concerns at beginning o	304 Participants	297 Participants

Adverse Events

Tablet in the Waiting Room

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education Handout

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

Dr. Richard Grant

Division of Research, Kaiser Permanente Northern California

Phone: 510-891-5993

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place