Rheumatic Diseases, Physician-Patient Relations, Contraception
Conditions
Keywords
rheumatic diseases, shared decision-making, sexual and reproductive health, decision aids
Brief summary
This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care. • Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.
Detailed description
The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.
Interventions
OTHERMyVoice:Rheum
Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
OTHERPamphlet
Participants in this arm will be given a copy of an existing patient pamphlet
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE). Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed Access to a smart phone, personal computer, or tablet.
Exclusion criteria
* Women who have had prior hysterectomy or sterilization, or are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | T2 (within 24 hours of intervention and appointment) | Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses. |
| Intervention Appropriateness Measure | T2 (within 24 hours of intervention and appointment) | The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness. |
| System Usability Scale | T2 (within 24 hours of intervention and appointment) | Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow) | T2 (within 24 hours of intervention and appointment) compared to T0 (baseline) | Rheumatology-specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, pre-conception planning, medication safety, fertility; a score of nine indicates the highest level of reproductive knowledge |
| Quantity and Quality of Reproductive Health Conversation With Rheumatologist | T2 (within 24 hours of intervention and appointment) | Three-item measure. Did you talk to your rheumatologist about family planning today- yes/no; Did you make a decision related to family planning- yes/no; what was the family planning decision you made today? (Not Reported) |
| Perceived Efficacy in Patient-Physician Interactions | T2 (within 24 hours of intervention and appointment) compared to T0 (baseline) | Self-reported efficacy in communicating with providers was assessed using a modified version of the validated five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Aggregate score is calculated by taking the individual item scores together and dividing by 5, with higher score indicating higher perceived efficacy in communicating with providers. |
| Participant Number of Pregnancies During Study | T3 (three months post-intervention) | Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Users Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA). | 35 |
| Pamphlet Users Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet | 10 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Decision Aid Users | Pamphlet Users | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 10 Participants | 45 Participants |
| Age, Continuous | 33.23 years | 28.80 years | 32.825 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 10 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 7 Participants | 35 Participants |
| Region of Enrollment United States | 35 participants | 10 participants | 45 participants |
| Sex: Female, Male Female | 35 Participants | 10 Participants | 45 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 | 0 / 31 | 0 / 10 |
| other Total, other adverse events | 0 / 31 | 0 / 10 |
| serious Total, serious adverse events | 0 / 31 | 0 / 10 |
Outcome results
Primary
Acceptability of Intervention
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Time frame: T2 (within 24 hours of intervention and appointment)
Population: 30 of 31 decision aid users completed the AIM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Users | Acceptability of Intervention | 4.45 score on a scale | Standard Deviation 0.59 |
| Pamphlet Users | Acceptability of Intervention | 3.97 score on a scale | Standard Deviation 0.65 |
Primary
Intervention Appropriateness Measure
The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
Time frame: T2 (within 24 hours of intervention and appointment)
Population: 30 of the 31 Decision Aid users completed the IAM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Users | Intervention Appropriateness Measure | 4.48 score on a scale | Standard Deviation 0.61 |
| Pamphlet Users | Intervention Appropriateness Measure | 4.11 score on a scale | Standard Deviation 0.85 |
Primary
System Usability Scale
Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.
Time frame: T2 (within 24 hours of intervention and appointment)
Population: 30 of the original 31 Decision Aid Users completed the SUS Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Users | System Usability Scale | 83.06 score on a scale | Standard Deviation 15.67 |
| Pamphlet Users | System Usability Scale | 79.32 score on a scale | Standard Deviation 14.1 |
Other Pre-specified
Participant Number of Pregnancies During Study
Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.
Time frame: T3 (three months post-intervention)
Population: Pamphlet users did not complete T3 assessment. 30 Decision aids users completed T3 assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid Users | Participant Number of Pregnancies During Study | Pregnant | 1 Participants |
| Decision Aid Users | Participant Number of Pregnancies During Study | Not pregnant | 29 Participants |
| Pamphlet Users | Participant Number of Pregnancies During Study | Pregnant | 0 Participants |
| Pamphlet Users | Participant Number of Pregnancies During Study | Not pregnant | 0 Participants |
Other Pre-specified
Perceived Efficacy in Patient-Physician Interactions
Self-reported efficacy in communicating with providers was assessed using a modified version of the validated five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Aggregate score is calculated by taking the individual item scores together and dividing by 5, with higher score indicating higher perceived efficacy in communicating with providers.
Time frame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid Users | Perceived Efficacy in Patient-Physician Interactions | T2 | 4.07 score on a scale | Standard Deviation 0.82 |
| Decision Aid Users | Perceived Efficacy in Patient-Physician Interactions | T0 | 3.47 score on a scale | Standard Deviation 1.19 |
| Pamphlet Users | Perceived Efficacy in Patient-Physician Interactions | T0 | 3.73 score on a scale | Standard Deviation 0.92 |
| Pamphlet Users | Perceived Efficacy in Patient-Physician Interactions | T2 | 3.98 score on a scale | Standard Deviation 0.98 |
Other Pre-specified
Quantity and Quality of Reproductive Health Conversation With Rheumatologist
Three-item measure. Did you talk to your rheumatologist about family planning today- yes/no; Did you make a decision related to family planning- yes/no; what was the family planning decision you made today? (Not Reported)
Time frame: T2 (within 24 hours of intervention and appointment)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Decision Aid Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you talk to your Rheumatologist today about family planning? | Yes | 17 Participants |
| Decision Aid Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you talk to your Rheumatologist today about family planning? | No | 14 Participants |
| Decision Aid Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you make a decision related to family planning? | Yes | 6 Participants |
| Decision Aid Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you make a decision related to family planning? | No | 25 Participants |
| Pamphlet Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you make a decision related to family planning? | No | 8 Participants |
| Pamphlet Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you talk to your Rheumatologist today about family planning? | Yes | 4 Participants |
| Pamphlet Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you make a decision related to family planning? | Yes | 1 Participants |
| Pamphlet Users | Quantity and Quality of Reproductive Health Conversation With Rheumatologist | Did you talk to your Rheumatologist today about family planning? | No | 5 Participants |
Other Pre-specified
Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)
Rheumatology-specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, pre-conception planning, medication safety, fertility; a score of nine indicates the highest level of reproductive knowledge
Time frame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid Users | Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow) | T2 | 7.27 number of correct responses | Standard Deviation 1.17 |
| Decision Aid Users | Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow) | T0 | 5.77 number of correct responses | Standard Deviation 1.76 |
| Pamphlet Users | Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow) | T0 | 5.44 number of correct responses | Standard Deviation 2.74 |
| Pamphlet Users | Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow) | T2 | 7.11 number of correct responses | Standard Deviation 2.5 |