Trial Outcomes & Findings for The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis (NCT NCT03181724)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

Day 1

Results posted on

2019-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	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.	No Decision Aid (Control) One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.	Total n=90 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 8.8 • n=5 Participants	65.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	63.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Stage of Arthritis Eaton stage I	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Stage of Arthritis Eaton stage II	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Stage of Arthritis Eaton stage III	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Stage of Arthritis Eaton stage IV	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Decision Conflict Scale (DCS)	9.3 units on a scale Standard Error 1.9	17 units on a scale Standard Error 2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire	5.3 units on a scale Standard Error .34	5.6 units on a scale Standard Error .35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Patient Health Questionnaire-2 (PHQ-2)	0.44 units on a scale Standard Error 0.18	0.98 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Consultation and Relational Empathy (CARE) Measure	47 units on a scale Standard Error 0.84	45 units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
11-point Ordinal Satisfaction Scale	9.5 units on a scale Standard Error 0.13	9.4 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=45 Participants 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.	No Decision Aid (Control) n=45 Participants One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
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	26 units on a scale Standard Error 3.1
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	27 units on a scale Standard Error 3.2

Adverse Events

Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Decision Aid (Control)

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. Neal Chen

Massachusetts General Hospital

Phone: 617-726-4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place