Menopause
Conditions
Keywords
Menopause, Decision making, Decision aids, Decision quality instrument
Brief summary
The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of menopause. In particular, we will examine whether the decision aid increases knowledge about menopause/managing menopause symptoms and concordance between goals and treatment choices.
Interventions
BEHAVIORALDVD & Booklet called: Managing Menopause
DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms
Sponsors
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged 40-60 * Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year
Exclusion criteria
* Prior diagnosis of breast cancer * Surgical or medically induced menopause (ovaries removed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Knowledge | 2 weeks, on average | Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Value Concordance | 2 weeks, on average | Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C.
Pre-assignment details
Participants were randomized to receive a DVD and booklet or no DVD and to participate by phone or IVR (automated telephone survey system).
Participants by arm
| Arm | Count |
|---|---|
| Control Group not receiving the decision aid (DVD and booklet) | 213 |
| Decision Aid Group receiving the decision aid (DVD/booklet) | 188 |
| Total | 401 |
Baseline characteristics
| Characteristic | Decision Aid | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 186 Participants | 212 Participants | 398 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 5.5 | 51 years STANDARD_DEVIATION 5.1 | 51 years STANDARD_DEVIATION 5.3 |
| Region of Enrollment United States | 188 participants | 213 participants | 401 participants |
| Sex: Female, Male Female | 188 Participants | 213 Participants | 401 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 213 | 0 / 188 |
| serious Total, serious adverse events | 0 / 213 | 0 / 188 |
Outcome results
Primary
Menopause Knowledge
Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)
Time frame: 2 weeks, on average
Population: Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Menopause Knowledge | 51.3 Percentage (0-100%) | Standard Deviation 16 |
| Decision Aid | Menopause Knowledge | 55.8 Percentage (0-100%) | Standard Deviation 18.4 |
Comparison: We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.p-value: 0.0195% CI: [1.02, 7.96]t-test, 2 sided
Secondary
Value Concordance
Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs
Time frame: 2 weeks, on average