Trial Outcomes & Findings for Get Ready And Empowered About Treatment (NCT NCT02165735)

NCT ID: NCT02165735

Last Updated: 2019-03-15

Results Overview

Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation. LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 360 participants
• Primary outcome timeframe: Baseline and 1 year
• Results posted on: 2019-03-15

Participant Flow

Participant milestones

Measure	Patient Empowerment Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training	Standard Care Participants will be followed through usual source of care, without receiving the empowerment training.
Overall Study STARTED	180	180
Overall Study COMPLETED	164	166
Overall Study NOT COMPLETED	16	14

Reasons for withdrawal

Measure	Patient Empowerment Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training	Standard Care Participants will be followed through usual source of care, without receiving the empowerment training.
Overall Study Lost to Follow-up	12	10
Overall Study Withdrawal by Subject	3	0
Overall Study Participant indicated lack of time	1	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

Get Ready And Empowered About Treatment

Baseline characteristics by cohort

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships. Patient Empowerment and Autonomy Training	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.	Total n=359 Participants Total of all reporting groups
Age, Continuous	51.71 years STANDARD_DEVIATION 10.71 • n=5 Participants	51.24 years STANDARD_DEVIATION 11.31 • n=7 Participants	51.48 years STANDARD_DEVIATION 11 • n=5 Participants
Sex/Gender, Customized Male	112 participants n=5 Participants	101 participants n=7 Participants	213 participants n=5 Participants
Sex/Gender, Customized Female	68 participants n=5 Participants	75 participants n=7 Participants	143 participants n=5 Participants
Sex/Gender, Customized Transgender	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	47 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants	132 Participants n=7 Participants	276 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	98 Participants n=5 Participants	89 Participants n=7 Participants	187 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	41 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data

Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation.

LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Patient Activation Measure (PAM)	73.35 score on a scale Standard Deviation 1.13	70.53 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our first secondary outcome measure is eHealth literacy based on changes in the eHealth Literacy Scale or eHEALS. The eHealth Literacy Scale (eHEALS) is an 8-item measure that assesses patient comfort, knowledge, and skills at finding health information on the internet and evaluating whether or not it is reliable. People who score high on the eHEALS normally are very comfortable finding reliable information on the internet. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived skills at using online health information to help solve health problems.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in eHealth Literacy Scale (eHEALS)	29.81 score on a scale Standard Deviation 1.45	27.67 score on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our next secondary outcome measure is decision making based on changes in the Decisional Self-Efficacy Scale or DSES. The Decisional Self-Efficacy Scale (DSES) is an 11-item measure that assesses patient confidence in their ability to make health care decisions. People who score high on the DSES normally have an easier time making health care decisions. The scores for the 11-item measure range in value from 0-100, with higher scores indicating greater confidence in making an informed choice.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Decisional Self-Efficacy Scale (DSES)	91.89 score on a scale Standard Deviation 0.86	90.81 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our third secondary outcome measure is involvement in care based on changes in the Perceived Involvement in Care Scale or PICS. The Perceived Involvement in Care Scale (PICS) is an 8-item measure that assesses patient perceived proficiency in communicating concerning their health care with the doctor. People who score high on the PICS normally are satisfied with how well they feel they communicate with the doctor about their care. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived involvement in their care.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Perceived Involvement in Care Scale (PICS)	33.74 score on a scale Standard Deviation 0.94	32.47 score on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our fourth secondary outcome measure is clinician patient centeredness based on changes in the Instrument on Doctor Patient Communication Skills or IDPCS. The Instrument on Doctor Patient Communication Skills (IDPCS) is a 19-item measure that assesses patient perception of the doctor's communication proficiency with them. People who score high on the IDPCS normally are satisfied with the way the doctor speak with them about their care. The scores for the 19-item measure range in value from 19-95, with higher scores indicating greater quality communication by the doctor.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Instrument on Doctor Patient Communication Skills (IDPCS)	85.06 score on a scale Standard Deviation 1.24	83.49 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our fifth secondary outcome measure is HIV adherence self-efficacy based on changes in the HIV Adherence Self-Efficacy Scale or ASES. The HIV Adherence Self-Efficacy Scale (ASES) is a 15-item measure that assesses patient self-efficacy for adherence to HIV treatment plan including but not limited to taking HIV medications. People who score high on the ASES normally are very confident of sticking to their HIV treatment plan even when it is hard. The scores for the 15-item measure range in value from 0-150, with higher scores indicating greater adherence self-efficacy.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in HIV Adherence Self-Efficacy Scale (ASES)	102.80 score on a scale Standard Deviation 1.08	103.13 score on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our sixth secondary outcome measure is adherence to combination antiretroviral treatment (cART) based on changes on survey of recommended items for assessing self-reported antiretroviral adherence. Our survey included two recommended assessment items with the focus on one-item measure that assesses patient self-reported adherence to taking HIV medications. People who score high on the self-reported adherence cART normally are very confident of being more adherent to taking their HIV medications. The score for the one-item measure range in value from 0-100 percent, with higher scores indicating greater adherence to cART.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Self-Reported Adherence	89.33 percentage of cART adherence in past mth Standard Deviation 1.09	89.90 percentage of cART adherence in past mth Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our seventh secondary outcome measure is undetectable viral load based on changes to participants' HIV viral load. The HIV viral load measurements were abstracted from the participants' personal health record (PHR). In our study, people who had a HIV viral load of <50 were considered to have undetectable viral load.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Undetectable Viral Load	87 percentage of participants Standard Deviation 3.1	86 percentage of participants Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our eighth secondary outcome measure is prevention-seeking behavior based on chart abstracted information based on our preventive care index. We created a preventive care index for each participant by assigning one point of each intervention they received post-randomization divided by the total number of interventions for which they were eligible. The index included eleven preventive care measures: Human Papillomavirus, Influenza, Tetanus, Hepatitis A, B, C testing, Hepatitis A & B vaccinations, cervical cancer screening (PAP), mammography and any colon cancer screening. People who score high on the evidence-based preventative care normally are more able to prevent illnesses or diseases. The score for the measure range in value from 0-1, with higher scores indicating greater ability to stay healthy.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Evidence-based Preventative Care	0.35 score on a scale Standard Deviation 0.01	0.35 score on a scale Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our ninth secondary outcome measure is mental well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Short Form Health Survey: [Mental Health] (SF12)	46.38 score on a scale Standard Deviation 0.73	46.99 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Multiple imputation was used to account for those with missing or incomplete data.

Our final secondary outcome measure is physical well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.

Outcome measures

Measure	Patient Empowerment n=180 Participants Participants will take part in six 90-minute sessions focused on development of basic information technology competency within a context that supports patient autonomy, competence and human relationships. Patient Empowerment and Autonomy Training: Participants will be given supports to address patient autonomy, competence and development of provider-patient relationships.	Standard Care n=179 Participants Participants will be followed through usual source of care, without receiving the empowerment training.
Change in Short Form Health Survey: [Physical Health] (SF12)	44.83 score on a scale Standard Deviation 0.71	45.13 score on a scale Standard Deviation 0.72

Adverse Events

Patient Empowerment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

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. Kevin Fiscella, PI

University of Rochester

Phone: 5853244563

Email: kevin_fiscella@urmc.rochester.edu

Results disclosure agreements

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