Chronic Pain, Depression, Health Equity
Conditions
Keywords
chronic pain, depression, health equity, shared decision making, decision aid
Brief summary
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs). This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
Interventions
BEHAVIORALCoaching and Decision Aid
Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents
Sponsors
Indiana University
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients must: * have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months, * have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity, * have at least mild depression, defined as PHQ-8 score ≥5, * identify as Black or African American, * have consistent access to a telephone, * indicate openness to new pain treatments, and * have a scheduled appointment with their PCP in the next approximate 2-4 months
Exclusion criteria
Patients are excluded: * if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project, * if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or * if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months | 3 months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
| Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months | 6 months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months | 3 months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). |
| Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months | 6 months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). |
| Change From Baseline Pain Catastrophizing Scale at 3 Months | 3 months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. |
| Change From Baseline Pain Catastrophizing Scale at 6 Months | 6 months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. |
| Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months | 3 months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. |
| Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months | 6 months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. |
| Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months | 3 months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer yes will be summed for analyses. |
| Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months | 3 months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. |
| Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months | 3 months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. |
| Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months | 6 months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. |
| Change From Baseline CollaboRATE at 3 Months | 3 months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from No effort was made (0) to Every effort was made (4) for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. |
| Change From Baseline CollaboRATE at 6 Months | 6 months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from No effort was made (0) to Every effort was made (4) or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. |
| Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months | 3 months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. |
| Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months | 6 months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. |
| Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months | 6 months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer yes will be summed for analyses. |
| Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months | 6 months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. |
Countries
United States
Participant flow
Recruitment details
Potentially eligible participants (primary care patients within an academic, safety-net healthcare system) were identified through electronic medical records and sent a letter and brochure describing the study. A study team member followed up with a phone call to assess interest and, if interested, screen for eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Coaching and Decision Aid Individual coaching sessions and Decision Aid
Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents | 16 |
| Control Wait-list control group | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-months | Unable to contact for 3-month data collection | 0 | 1 |
| 3-months | Withdrawal by Subject | 2 | 0 |
| 6-months | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Coaching and Decision Aid |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 13.4 | 60.6 years STANDARD_DEVIATION 13.6 | 59.9 years STANDARD_DEVIATION 14.3 |
| Current relationship status Divorced/Separated | 7 Participants | 10 Participants | 3 Participants |
| Current relationship status Married/Domestic Partner | 1 Participants | 3 Participants | 2 Participants |
| Current relationship status Never Married | 2 Participants | 10 Participants | 8 Participants |
| Current relationship status Other | 0 Participants | 1 Participants | 1 Participants |
| Current relationship status Widowed | 4 Participants | 6 Participants | 2 Participants |
| Employment status Full-time employment | 4 Participants | 6 Participants | 2 Participants |
| Employment status Not employed | 7 Participants | 20 Participants | 13 Participants |
| Employment status Part-time employment | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 30 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest level of education completed Associate's or Technical Degree Complete | 5 Participants | 9 Participants | 4 Participants |
| Highest level of education completed College/Baccalaureate/Doctoral or Postgraduate Education | 3 Participants | 3 Participants | 0 Participants |
| Highest level of education completed High School (or Secondary School) Degree Complete | 5 Participants | 12 Participants | 7 Participants |
| Highest level of education completed Some Secondary School or High School Education | 1 Participants | 6 Participants | 5 Participants |
| Household income Comfortable | 2 Participants | 4 Participants | 2 Participants |
| Household income Just enough to make ends meet | 8 Participants | 18 Participants | 10 Participants |
| Household income Not enough to make ends meet | 4 Participants | 8 Participants | 4 Participants |
| Pain duration | 146.2 months STANDARD_DEVIATION 165.9 | 143.2 months STANDARD_DEVIATION 139.5 | 140.6 months STANDARD_DEVIATION 117.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 28 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex/Gender, Customized Female | 9 Participants | 21 Participants | 12 Participants |
| Sex/Gender, Customized Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months | -1.02 units on a scale | Standard Deviation 1.87 |
| Control | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months | -0.30 units on a scale | Standard Deviation 2.24 |
Primary
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months | -1.75 units on a scale | Standard Deviation 2.28 |
| Control | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months | -1.14 units on a scale | Standard Deviation 1.51 |
Secondary
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months
Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months | 2.64 units on a scale | Standard Deviation 8.96 |
| Control | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months | -2.04 units on a scale | Standard Deviation 9.16 |
Secondary
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months
Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months | 4.29 units on a scale | Standard Deviation 7.16 |
| Control | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months | -0.24 units on a scale | Standard Deviation 10.93 |
Secondary
Change From Baseline CollaboRATE at 3 Months
Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from No effort was made (0) to Every effort was made (4) for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline CollaboRATE at 3 Months | 0.26 units on a scale | Standard Deviation 0.47 |
| Control | Change From Baseline CollaboRATE at 3 Months | -0.13 units on a scale | Standard Deviation 0.91 |
Secondary
Change From Baseline CollaboRATE at 6 Months
Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from No effort was made (0) to Every effort was made (4) or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline CollaboRATE at 6 Months | 0.26 units on a scale | Standard Deviation 0.71 |
| Control | Change From Baseline CollaboRATE at 6 Months | -0.05 units on a scale | Standard Deviation 0.49 |
Secondary
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months
Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months | -3.29 units on a scale | Standard Deviation 5.01 |
| Control | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months | -0.08 units on a scale | Standard Deviation 6.3 |
Secondary
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months
Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months | -3.23 units on a scale | Standard Deviation 3.75 |
| Control | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months | -0.23 units on a scale | Standard Deviation 4.4 |
Secondary
Change From Baseline Pain Catastrophizing Scale at 3 Months
The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Pain Catastrophizing Scale at 3 Months | -4.31 units on a scale | Standard Deviation 11.26 |
| Control | Change From Baseline Pain Catastrophizing Scale at 3 Months | 3.54 units on a scale | Standard Deviation 8.78 |
Secondary
Change From Baseline Pain Catastrophizing Scale at 6 Months
The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Pain Catastrophizing Scale at 6 Months | -5.00 units on a scale | Standard Deviation 13.39 |
| Control | Change From Baseline Pain Catastrophizing Scale at 6 Months | -2.12 units on a scale | Standard Deviation 12.01 |
Secondary
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months
The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months | -2.36 units on a scale | Standard Deviation 5.57 |
| Control | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months | -0.77 units on a scale | Standard Deviation 4.44 |
Secondary
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months
The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months | -2.15 units on a scale | Standard Deviation 4.18 |
| Control | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months | -0.46 units on a scale | Standard Deviation 4.75 |
Secondary
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months
Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months | 0.08 score on a scale | Standard Deviation 5.45 |
| Control | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months | 2.08 score on a scale | Standard Deviation 10.9 |
Secondary
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months
Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months | 1.46 units on a scale | Standard Deviation 4.41 |
| Control | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months | 0.15 units on a scale | Standard Deviation 8.71 |
Secondary
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months
The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer yes will be summed for analyses.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months | 0.23 counts of NPTs | Standard Deviation 1.96 |
| Control | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months | -0.46 counts of NPTs | Standard Deviation 1.61 |
Secondary
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months
The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer yes will be summed for analyses.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months | 0.38 counts of NPTs | Standard Deviation 1.5 |
| Control | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months | 0.54 counts of NPTs | Standard Deviation 1.94 |
Secondary
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months
The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months | 3.67 units on a scale | Standard Deviation 13.34 |
| Control | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months | -5.54 units on a scale | Standard Deviation 13.08 |
Secondary
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months
The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching and Decision Aid | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months | 5.69 units on a scale | Standard Deviation 9.78 |
| Control | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months | -2.38 units on a scale | Standard Deviation 8.05 |