A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome

June 11, 2023 updated by: Neal Chung-Jen Chen, Massachusetts General Hospital
The investigators plan a prospective randomized controlled study that compares the treatment decisions made by patients who receive decision aids, as compared to patients treated with usual care and the American Society for Surgery of the Hand brochures. The investigators expect to enroll 126 patients.

Study Overview

Detailed Description

Decision aids are tools that help patients participate in making decisions by providing detailed, specific, and personalized information regarding the benefits and risks of various potential treatment options for a diagnosis. Decision aids can reduce the level of uncertainty and mental anguish associated with choosing a particular course of action, i.e. 'decisional conflict'. The most common manifestations of decisional conflict include verbalized uncertainty about choices or undesired consequences of alternatives, vacillation between choices, and delayed decision making.

Besides the advantages of decision aids in the process of decision-making, the literature is not conclusive about the effect of decision aids on patient satisfaction. Of the 86 randomized controlled trials identified by authors Stacey et al., eleven studies measured satisfaction. Of these, four studies reported that people exposed to decision aids had higher satisfaction with their choice compared to usual care, and the remaining seven reported no statistically significant difference.

Studies that have directly investigated the effect of decision aids in orthopaedic practice are limited and further study is necessary to determine the best way to implement decision aids in a clinical orthopedic practice. 7-12 Randomized trials evaluating the impact of decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have substantial impact in hand surgery where most treatments are elective and address quality of life.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 and above
  • Diagnosis of moderate or severe:

    2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)

Exclusion Criteria:

  • Patients with previous interventions for CTS or TF
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No decision aid
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Active Comparator: Decision Aid
One cohort will receive a 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision conflict scale (DCS)
Time Frame: At enrollment
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
At enrollment
Change from baseline in Decision conflict scale (DCS) at 6 weeks
Time Frame: At 6-week follow-up
Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
At 6-week follow-up
Change from baseline Decision conflict scale (DCS) at 6 months
Time Frame: At 6 month follow-up
6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
At 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11-point ordinal satisfaction scale
Time Frame: At enrollment
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
At enrollment
11-point ordinal satisfaction scale
Time Frame: At enrollment
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
At enrollment
Knowledge questionnaire
Time Frame: At Enrollment
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
At Enrollment
Stage of decision making
Time Frame: At Enrollment
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
At Enrollment
Decision Self-efficacy Scale
Time Frame: At enrollment
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
At enrollment
Acceptability
Time Frame: At Enrollment

The Acceptability questionnaire measures the acceptability of the decision aid, including the content of the decision aid.

It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.

At Enrollment
Pain Self efficacy Questionnaire (PSEQ)
Time Frame: At enrollment
The PSEQ measures the efficacy of patients regarding pain.
At enrollment
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
Time Frame: At enrollment
The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
At enrollment
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
Time Frame: At Enrollment
EQ-5D-5L measures the health outcome of the patient.
At Enrollment
Decision Regret scale
Time Frame: At the 6-month follow-up
The Decision Regret Scale measures distress or remorse after a health care decision.
At the 6-month follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
Time Frame: At the 6 week follow-up
6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
At the 6 week follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Time Frame: At the 6 month follow-up
6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
At the 6 month follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
At the 6 week follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Time Frame: At the 6 month follow-up
6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
At the 6 month follow-up
Change from baseline in Stage of decision making at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
At the 6 week follow-up
Change from baseline in Stage of decision making at 6 months
Time Frame: At the 6 week follow-up
6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 months
Time Frame: At the 6 month follow-up
6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
At the 6 month follow-up
Change from baseline in the Decision Self-efficacy Scale at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
At the 6 week follow-up
Change from the baseline in the Decision Self-Efficacy Scale at 6 months
Time Frame: At the 6 month follow-up
6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
At the 6 month follow-up
Change from the baseline in the Acceptability questionnaire at 6 weeks
Time Frame: At the 6-week follow-up

6-week change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.

It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.

At the 6-week follow-up
Change from the baseline in the Acceptability questionnaire at 6 months
Time Frame: At the 6 month follow-up

6-month change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.

It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.

At the 6 month follow-up
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
At the 6 week follow-up
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
Time Frame: At the 6 month follow-up
6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
At the 6 month follow-up
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
At the 6 week follow-up
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months
Time Frame: At the 6 month follow-up
6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
At the 6 month follow-up
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
Time Frame: At the 6 week follow-up
6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
At the 6 week follow-up
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
Time Frame: At the 6 month follow-up
6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
At the 6 month follow-up
Change in the Decision Regret scale at 6 months
Time Frame: At the 6 month follow-up
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
At the 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Neal Chen, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2014

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimated)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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