Trapeziometacarpal Arthritis
Conditions
Brief summary
The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.
Detailed description
Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice. Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life. Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.
Interventions
BEHAVIORALDecision Aid
Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * English-speaking * Diagnosis of trapeziometacarpal (TMC) arthritis
Exclusion criteria
* Prior surgical intervention for trapeziometacarpal (TMC) arthritis * Previously accessed or used the online TMC arthritis Decision Aid (DA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Conflict Scale (DCS) | Day 1 | This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire | Day 1 | The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. |
| Patient Health Questionnaire-2 (PHQ-2) | Day 1 | The PHQ-2 screens for depressive mood over the past 2 weeks. The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression. |
| Consultation and Relational Empathy (CARE) Measure | Day 1 | The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit. Each item is rated on a 5-point Likert scale, yielding a total score from 0-50. A higher score indicates greater empathy. |
| 11-point Ordinal Satisfaction Scale | Day 1 | The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis. Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied. |
| Change in Decision Regret Scale After 6 Weeks and 6 Months | 6 week and 6 month follow up | Change in the Decision Regret Scale, which measures distress or remorse after a health care decision. The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Cohort that will receive a decision aid.
Decision Aid: Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them. | 45 |
| No Decision Aid (Control) One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | No Decision Aid (Control) | Total | Decision Aid |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 9.8 | 63.7 years STANDARD_DEVIATION 9.4 | 62.3 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized White | 40 Participants | 83 Participants | 43 Participants |
| Region of Enrollment United States | 45 Participants | 90 Participants | 45 Participants |
| Sex: Female, Male Female | 33 Participants | 65 Participants | 32 Participants |
| Sex: Female, Male Male | 12 Participants | 25 Participants | 13 Participants |
| Stage of Arthritis Eaton stage I | 8 Participants | 18 Participants | 10 Participants |
| Stage of Arthritis Eaton stage II | 22 Participants | 47 Participants | 25 Participants |
| Stage of Arthritis Eaton stage III | 13 Participants | 21 Participants | 8 Participants |
| Stage of Arthritis Eaton stage IV | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Decision Conflict Scale (DCS)
This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Decision Conflict Scale (DCS) | 9.3 units on a scale | Standard Error 1.9 |
| No Decision Aid (Control) | Decision Conflict Scale (DCS) | 17 units on a scale | Standard Error 2 |
Secondary
11-point Ordinal Satisfaction Scale
The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis. Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | 11-point Ordinal Satisfaction Scale | 9.5 units on a scale | Standard Error 0.13 |
| No Decision Aid (Control) | 11-point Ordinal Satisfaction Scale | 9.4 units on a scale | Standard Error 0.16 |
Secondary
Change in Decision Regret Scale After 6 Weeks and 6 Months
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision. The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret.
Time frame: 6 week and 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid | Change in Decision Regret Scale After 6 Weeks and 6 Months | Decision regret at 6 weeks | 20 units on a scale | Standard Error 2.7 |
| Decision Aid | Change in Decision Regret Scale After 6 Weeks and 6 Months | Decision regret at 6 months | 23 units on a scale | Standard Error 3.3 |
| No Decision Aid (Control) | Change in Decision Regret Scale After 6 Weeks and 6 Months | Decision regret at 6 weeks | 26 units on a scale | Standard Error 3.1 |
| No Decision Aid (Control) | Change in Decision Regret Scale After 6 Weeks and 6 Months | Decision regret at 6 months | 27 units on a scale | Standard Error 3.2 |
Secondary
Consultation and Relational Empathy (CARE) Measure
The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit. Each item is rated on a 5-point Likert scale, yielding a total score from 0-50. A higher score indicates greater empathy.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Consultation and Relational Empathy (CARE) Measure | 47 units on a scale | Standard Error 0.84 |
| No Decision Aid (Control) | Consultation and Relational Empathy (CARE) Measure | 45 units on a scale | Standard Error 1 |
Secondary
Patient Health Questionnaire-2 (PHQ-2)
The PHQ-2 screens for depressive mood over the past 2 weeks. The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Patient Health Questionnaire-2 (PHQ-2) | 0.44 units on a scale | Standard Error 0.18 |
| No Decision Aid (Control) | Patient Health Questionnaire-2 (PHQ-2) | 0.98 units on a scale | Standard Error 0.25 |
Secondary
QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire | 5.3 units on a scale | Standard Error 0.34 |
| No Decision Aid (Control) | QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire | 5.6 units on a scale | Standard Error 0.35 |