Patient Engagement, Physician-Patient Relationship, Physician's Role
Conditions
Keywords
patient engagement, physician's role, patient- centered care, communication
Brief summary
This study implements a simple evidence-based patient activation intervention - Ask 3 Questions- augmented by a novel theory-based intervention - Open Communication - aimed at activating patients and healthcare providers. The goal of this project is to increase patient and physician's preparedness for more having more questions, expressing differing opinions, and working collaboratively in making medical decisions that are both informed and responsive to patients' needs and preferences.
Detailed description
Conduct a pilot randomized controlled trial (RCT) to compare two interventions, Ask 3 Questions, Open Communication, a combination of both Ask 3 Questions and Open Communication, to a usual care control condition. These data will inform a potential future large scale evaluation of the interventions in clinical practice. Consistent with a patient-centered approach, outcome measures are selected in collaboration with a group of patient stakeholders and will include measures of patient satisfaction. The study aims to collect 75 post-visit surveys and 10 appointment audio-recordings from patients at each of 4 participating sites (a total of 300 post-visit surveys and 40 audio-recordings).
Interventions
Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare.
Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving. 2\) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet. 3\) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow.
Sponsors
Study design
Eligibility
Inclusion criteria
* Any patient with a scheduled appointment with the participating family medicine and internal medicine physicians during the study period.
Exclusion criteria
* Non-English speakers * Patients younger than 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Rating of Shared Decision Making | Day 1 (outcomes measures were assessed once for each participant) | Responses from CollaboRATE, a 3-question validated patient reported measure of shared decision making. Patients answered questions on a scale of 0 (definitely disagree) to 9 (definitely agree). The CollaboRATE questions are as follows: 1) How much effort was made to help you understand your health issues? 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next? The outcome measure was the percent of patients who gave the top score of 9 on all three questions. |
| Doctor Facilitation Subscale of the Perceived Involvement in Care Scale | Day 1 (outcomes measures were assessed once for each participant) | Responses from this patient reported measure regarding their attitudes of doctor facilitation of patient involvement for their illness management. Patients rated 5 statements on a scale of 0 (definitely disagree) to 9 (definitely agree). The statements are as follows: 1) My doctor encouraged me to talk about personal concerns related to my medical symptoms, 2) My doctor asked me what I believe is causing my medical symptoms, 3) My doctor gave me a complete explanation for my medical symptoms or treatment, 4) My doctor encouraged me to give my opinion about my medical treatment, 5) My doctor asked me whether I agree with his/her decisions. The outcome measure was the percent of patients who gave the top score of 9 on all five statements. |
| Patient Responses to Stakeholder Generated Questions | Day 1 (outcomes measures were assessed once for each participant) | Patient responses to statements that were generated by the study's patient and physicians stakeholders regarding how they felt during their appointment. Patients rated 5 statements, described below, on a scale of 0 (definitely disagree) to 9 (definitely agree). The outcome measure is the percent of patients that responded with a top score of 9. Statement 1: My doctor and I accomplished my most important goals today. Statement 2: I feel cared for. Statement 3: I feel comfortable being open with my doctor. Statement 4: I felt my doctor was open with me. Statement 5: I know what my next steps are. |
| Patients' Feeling of Respect by Their Doctor | Day 1 (outcomes measures were assessed once for each participant) | Patient responses to one statement modified from Consumer Assessment of Healthcare Providers and Systems (CAHPS) regarding the respect they felt from their doctor. Patients rated the statement My doctor showed respect for what I had to say, on a scale of 1 (definitely disagree) to 4 (definitely agree). The outcome measure was the percentage of patients that gave the top score of 4 on this statement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Option 5 Shared Decision Making Score | Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits) | Researchers measured the shared decision making process that occurs between patients and physicians during the appointment using a method called OPTION5. Researchers listened to audio-recorded patient appointments, identified any topic, defined as a health issue where alternate treatment or management option exist/where the need for a decision exists, and then measured each topic for each of the OPTION5 items on a scale of 0 (no effort: nothing observed or heard) to 20 (exemplary effort: excellent, careful attention to communication around the ideas and issues, with checks on understanding, for each of the 5 items described below. The total score is a sum of the scores from each of the 5 items at the clinic. Item 1: presenting options Item 2: establishing a partnership with the patient Item 3: describing pros and cons of options Item 4: eliciting patient preferences Item 5: integrating patient preferences into the decision |
Participant flow
Recruitment details
From May 2014 to April 2015, 75 patients were screened and enrolled for each of the 4 participating family or internal medicine clinics. Researchers met with interested patients who had a regularly scheduled appointment in order to consent and advise on how to use the study materials. After their visit, they completed a post-visit survey.
Pre-assignment details
New patients and patients with physical exams or osteopathic evaluations were initially excluded though later allowed for recruitment for some physicians at one of the participating clinics. There were 6 patients who consented to participate but did not complete the final survey when exiting their appointment.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Standard clinical care in primary care offices | 75 |
| Ask 3 Questions Patients using 3 questions to their physicians when making medical decisions during the office visit.
Ask 3 Questions: Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare. | 75 |
| Open Communication Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.
2\) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.
3\) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow. | 75 |
| Ask 3 Questions + Open Communication A combination of both the Ask 3 and Open Communication arms. | 75 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Usual Care | Ask 3 Questions | Open Communication | Ask 3 Questions + Open Communication | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 16.2 | 50.7 years STANDARD_DEVIATION 15.6 | 49.0 years STANDARD_DEVIATION 15 | 61.4 years STANDARD_DEVIATION 15.3 | 54.0 years STANDARD_DEVIATION 16.2 |
| Race/Ethnicity, Customized Asian or Pacific Islander | 15 participants | 24 participants | 20 participants | 3 participants | 62 participants |
| Race/Ethnicity, Customized Caucasian | 45 participants | 38 participants | 44 participants | 63 participants | 190 participants |
| Race/Ethnicity, Customized Other | 15 participants | 13 participants | 11 participants | 9 participants | 48 participants |
| Sex: Female, Male Female | 50 Participants | 34 Participants | 44 Participants | 54 Participants | 182 Participants |
| Sex: Female, Male Male | 25 Participants | 41 Participants | 31 Participants | 21 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 75 | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 | 0 / 75 | 0 / 75 |
Outcome results
Doctor Facilitation Subscale of the Perceived Involvement in Care Scale
Responses from this patient reported measure regarding their attitudes of doctor facilitation of patient involvement for their illness management. Patients rated 5 statements on a scale of 0 (definitely disagree) to 9 (definitely agree). The statements are as follows: 1) My doctor encouraged me to talk about personal concerns related to my medical symptoms, 2) My doctor asked me what I believe is causing my medical symptoms, 3) My doctor gave me a complete explanation for my medical symptoms or treatment, 4) My doctor encouraged me to give my opinion about my medical treatment, 5) My doctor asked me whether I agree with his/her decisions. The outcome measure was the percent of patients who gave the top score of 9 on all five statements.
Time frame: Day 1 (outcomes measures were assessed once for each participant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Doctor Facilitation Subscale of the Perceived Involvement in Care Scale | 37.3 percentage of participants | Standard Deviation 16.6 |
| Ask 3 Questions | Doctor Facilitation Subscale of the Perceived Involvement in Care Scale | 42.7 percentage of participants | Standard Deviation 11.5 |
| Open Communication | Doctor Facilitation Subscale of the Perceived Involvement in Care Scale | 45.3 percentage of participants | Standard Deviation 12.7 |
| Ask 3 Questions + Open Communication | Doctor Facilitation Subscale of the Perceived Involvement in Care Scale | 46.7 percentage of participants | Standard Deviation 14.8 |
Patient Rating of Shared Decision Making
Responses from CollaboRATE, a 3-question validated patient reported measure of shared decision making. Patients answered questions on a scale of 0 (definitely disagree) to 9 (definitely agree). The CollaboRATE questions are as follows: 1) How much effort was made to help you understand your health issues? 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next? The outcome measure was the percent of patients who gave the top score of 9 on all three questions.
Time frame: Day 1 (outcomes measures were assessed once for each participant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Rating of Shared Decision Making | 66.7 percentage of participants | Standard Deviation 17 |
| Ask 3 Questions | Patient Rating of Shared Decision Making | 72.0 percentage of participants | Standard Deviation 17.3 |
| Open Communication | Patient Rating of Shared Decision Making | 74.7 percentage of participants | Standard Deviation 14 |
| Ask 3 Questions + Open Communication | Patient Rating of Shared Decision Making | 74.7 percentage of participants | Standard Deviation 12.5 |
Patient Responses to Stakeholder Generated Questions
Patient responses to statements that were generated by the study's patient and physicians stakeholders regarding how they felt during their appointment. Patients rated 5 statements, described below, on a scale of 0 (definitely disagree) to 9 (definitely agree). The outcome measure is the percent of patients that responded with a top score of 9. Statement 1: My doctor and I accomplished my most important goals today. Statement 2: I feel cared for. Statement 3: I feel comfortable being open with my doctor. Statement 4: I felt my doctor was open with me. Statement 5: I know what my next steps are.
Time frame: Day 1 (outcomes measures were assessed once for each participant)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Patient Responses to Stakeholder Generated Questions | Statement 1 (n=75) | 86.7 percentage of participants | Standard Deviation 12.6 |
| Usual Care | Patient Responses to Stakeholder Generated Questions | Statement 2 (n=75) | 81.3 percentage of participants | Standard Deviation 10.4 |
| Usual Care | Patient Responses to Stakeholder Generated Questions | Statement 3 (n=75) | 80.0 percentage of participants | Standard Deviation 9.2 |
| Usual Care | Patient Responses to Stakeholder Generated Questions | Statement 4 (n=75) | 83.8 percentage of participants | Standard Deviation 7.7 |
| Usual Care | Patient Responses to Stakeholder Generated Questions | Statement 5 (n=75) | 82.2 percentage of participants | Standard Deviation 11.7 |
| Ask 3 Questions | Patient Responses to Stakeholder Generated Questions | Statement 3 (n=75) | 96.0 percentage of participants | Standard Deviation 6 |
| Ask 3 Questions | Patient Responses to Stakeholder Generated Questions | Statement 4 (n=75) | 90.5 percentage of participants | Standard Deviation 10.1 |
| Ask 3 Questions | Patient Responses to Stakeholder Generated Questions | Statement 2 (n=75) | 93.2 percentage of participants | Standard Deviation 8.2 |
| Ask 3 Questions | Patient Responses to Stakeholder Generated Questions | Statement 5 (n=75) | 87.7 percentage of participants | Standard Deviation 7.8 |
| Ask 3 Questions | Patient Responses to Stakeholder Generated Questions | Statement 1 (n=75) | 96.0 percentage of participants | Standard Deviation 6.3 |
| Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 4 (n=75) | 92.0 percentage of participants | Standard Deviation 9.1 |
| Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 3 (n=75) | 90.7 percentage of participants | Standard Deviation 9.4 |
| Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 1 (n=75) | 90.5 percentage of participants | Standard Deviation 11.4 |
| Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 2 (n=75) | 89.2 percentage of participants | Standard Deviation 11.5 |
| Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 5 (n=75) | 91.8 percentage of participants | Standard Deviation 8.6 |
| Ask 3 Questions + Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 4 (n=75) | 85.3 percentage of participants | Standard Deviation 11.7 |
| Ask 3 Questions + Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 3 (n=75) | 83.6 percentage of participants | Standard Deviation 12.6 |
| Ask 3 Questions + Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 1 (n=75) | 81.3 percentage of participants | Standard Deviation 10.3 |
| Ask 3 Questions + Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 5 (n=75) | 81.9 percentage of participants | Standard Deviation 12.5 |
| Ask 3 Questions + Open Communication | Patient Responses to Stakeholder Generated Questions | Statement 2 (n=75) | 81.1 percentage of participants | Standard Deviation 11.6 |
Patients' Feeling of Respect by Their Doctor
Patient responses to one statement modified from Consumer Assessment of Healthcare Providers and Systems (CAHPS) regarding the respect they felt from their doctor. Patients rated the statement My doctor showed respect for what I had to say, on a scale of 1 (definitely disagree) to 4 (definitely agree). The outcome measure was the percentage of patients that gave the top score of 4 on this statement.
Time frame: Day 1 (outcomes measures were assessed once for each participant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patients' Feeling of Respect by Their Doctor | 96.0 percentage of participants | Standard Deviation 4.6 |
| Ask 3 Questions | Patients' Feeling of Respect by Their Doctor | 98.7 percentage of participants | Standard Deviation 3 |
| Open Communication | Patients' Feeling of Respect by Their Doctor | 97.3 percentage of participants | Standard Deviation 2.4 |
| Ask 3 Questions + Open Communication | Patients' Feeling of Respect by Their Doctor | 90.7 percentage of participants | Standard Deviation 6.6 |
Option 5 Shared Decision Making Score
Researchers measured the shared decision making process that occurs between patients and physicians during the appointment using a method called OPTION5. Researchers listened to audio-recorded patient appointments, identified any topic, defined as a health issue where alternate treatment or management option exist/where the need for a decision exists, and then measured each topic for each of the OPTION5 items on a scale of 0 (no effort: nothing observed or heard) to 20 (exemplary effort: excellent, careful attention to communication around the ideas and issues, with checks on understanding, for each of the 5 items described below. The total score is a sum of the scores from each of the 5 items at the clinic. Item 1: presenting options Item 2: establishing a partnership with the patient Item 3: describing pros and cons of options Item 4: eliciting patient preferences Item 5: integrating patient preferences into the decision
Time frame: Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)
Population: From the 75 patients at each of the 4 clinics, 10 appointments were randomly selected to be audio-recordinged. The Number of Participants Analyzed reflects the number of topics identified from the 10 recordings at each clinic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Option 5 Shared Decision Making Score | Item 1 (out of 20) | 6.7 scores on a scale | Standard Deviation 2.6 |
| Usual Care | Option 5 Shared Decision Making Score | Item 2 (out of 20) | 4.1 scores on a scale | Standard Deviation 3 |
| Usual Care | Option 5 Shared Decision Making Score | Item 4 (out of 20) | 3.8 scores on a scale | Standard Deviation 3.2 |
| Usual Care | Option 5 Shared Decision Making Score | Overall Score (out of 100) | 23.9 scores on a scale | Standard Deviation 11.8 |
| Usual Care | Option 5 Shared Decision Making Score | Item 3 (out of 20) | 5.6 scores on a scale | Standard Deviation 3.6 |
| Usual Care | Option 5 Shared Decision Making Score | Item 5 (out of 20) | 3.7 scores on a scale | Standard Deviation 3.2 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Item 2 (out of 20) | 4.9 scores on a scale | Standard Deviation 3.5 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Item 3 (out of 20) | 7.2 scores on a scale | Standard Deviation 4.3 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Item 5 (out of 20) | 4.4 scores on a scale | Standard Deviation 3.7 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Item 1 (out of 20) | 7.7 scores on a scale | Standard Deviation 3.2 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Overall Score (out of 100) | 28.8 scores on a scale | Standard Deviation 16.8 |
| Ask 3 Questions | Option 5 Shared Decision Making Score | Item 4 (out of 20) | 4.5 scores on a scale | Standard Deviation 3.8 |
| Open Communication | Option 5 Shared Decision Making Score | Item 5 (out of 20) | 5.0 scores on a scale | Standard Deviation 3.8 |
| Open Communication | Option 5 Shared Decision Making Score | Item 3 (out of 20) | 6.7 scores on a scale | Standard Deviation 4.3 |
| Open Communication | Option 5 Shared Decision Making Score | Item 4 (out of 20) | 5.1 scores on a scale | Standard Deviation 3.8 |
| Open Communication | Option 5 Shared Decision Making Score | Item 2 (out of 20) | 4.9 scores on a scale | Standard Deviation 3.8 |
| Open Communication | Option 5 Shared Decision Making Score | Item 1 (out of 20) | 7.6 scores on a scale | Standard Deviation 2.9 |
| Open Communication | Option 5 Shared Decision Making Score | Overall Score (out of 100) | 29.2 scores on a scale | Standard Deviation 16.8 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Overall Score (out of 100) | 24.5 scores on a scale | Standard Deviation 14.6 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Item 3 (out of 20) | 5.8 scores on a scale | Standard Deviation 3.8 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Item 2 (out of 20) | 3.3 scores on a scale | Standard Deviation 3.1 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Item 1 (out of 20) | 6.4 scores on a scale | Standard Deviation 2.6 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Item 5 (out of 20) | 4.4 scores on a scale | Standard Deviation 3.8 |
| Ask 3 Questions + Open Communication | Option 5 Shared Decision Making Score | Item 4 (out of 20) | 4.6 scores on a scale | Standard Deviation 4 |