Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04343534
Collaborator
Center for Survey Research, University of Massachusetts, Boston (Other)
494
1
8
61.4

Study Details

Study Description

Brief Summary

The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of psychometric performance of the scale, compare performance of different wording for items, and to extend generalizability of the findings to younger adults.

    Subjects are randomly assigned to one of the two versions of the Shared Decision Making Process scale and complete a set of measures regarding their experiences with decision making for depression, demographics, and health status. A subset of respondents will complete the Shared Decision Making Process scale and selected other items again 1 week later to examine short term test-retest reliability.

    Staff will work with a national sampling firm to recruit subjects and obtain 500 responses to the baseline survey (n=250 for each version) and a subset will complete a retest survey (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who talked with a health care provider about treatment for depression in the preceding 12 months. The sample is not a national probability sample; however, the recruitment efforts will ensure about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).

    The investigators will examine validity and reliability of the different versions. The sample size was determined to ensure sufficient power to detect differences in key subgroups, including age (younger adults vs. older adults) and version (A vs. B). To detect a difference of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per group.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    494 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
    Actual Study Start Date :
    Apr 29, 2020
    Actual Primary Completion Date :
    Jun 1, 2020
    Actual Study Completion Date :
    Dec 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Original Shared Decision Making Process scale

    Patients receive the original version of the Shared Decision Making Process scale.

    Revised Shared Decision Making Process scale

    This group completes a new version of the scale with different wording for several items.

    Outcome Measures

    Primary Outcome Measures

    1. Shared Decision Making Process Score [Baseline survey]

      The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.

    Secondary Outcome Measures

    1. Decisional Conflict tool (SURE) [Baseline survey]

      Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates high decisional conflict, 4 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict.

    2. Decision Regret Scale [Baseline survey]

      5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.

    3. Single-Item Measure of Decision Regret [Baseline survey]

      Single item asking "If you knew then what you know now, do you think you would make the same decision about depression?" Responses are definitely yes, probably yes, probably no and definitely no.

    4. Treatment Choice [Baseline survey]

      Single item asking patient "What did you want to do" in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening.

    5. Adapted Controlled Preference Scale [Baseline survey]

      Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.

    6. Shared Decision Making Process Measure retest [1 week after baseline survey]

      The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.

    7. Depression Knowledge [Baseline survey]

      Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge

    8. Adherence [Baseline survey]

      3 item measure of adherence to medication for sample participants who indicate that they are taking medicine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must have spoken to a healthcare provider about treatment for depression in the past 12 months

    • Must have started or stopped medication for depression between January 2018 and their surveyed date.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Center for Survey Research, University of Massachusetts, Boston

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04343534
    Other Study ID Numbers:
    • 2019P001434-2
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2021