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Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation

Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01947283
Acronym
PCORI
Enrollment
481
Registered
2013-09-20
Start date
2013-09-30
Completion date
2016-10-31
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

Patient-Provider Relationship, Shared Decision Making, Therapeutic Alliance, Mental Health, Minority Health, Patient Activation, Communication

Brief summary

The purpose of this study is to learn more about how patients and healthcare providers interact in order to improve shared decision making. The investigators plan to test an intervention with two separate educational components-one for patients and one for providers-designed to encourage patients to ask questions and increase their level of involvement in their own care, while simultaneously training providers to be more receptive to patients' questions and concerns. Patients in the intervention group will receive three short (30-45 minute) trainings focused on developing and asking questions and will be interviewed three times over the course of the intervention to see how it has affected the quality of their care. Providers receiving the intervention will participate in three separate trainings, including a 12-hour group workshop, an additional two hour training, and six hours of individual instruction, including personalized feedback based on three audio-recorded patient visits. Previous studies looking at patient engagement and involvement in decision-making have shown that increased engagement is linked with improved outcomes, but that providers are sometimes not prepared to develop a collaborative relationship with patients. The investigators think that training both patients and providers to work together and communicate more effectively will improve quality of care and increase patient satisfaction more than interventions that focus on only one side of the clinical encounter. One of the major goals in studying patient-provider communication is to improve shared decision-making and see how it contributes to racial and ethnic disparities in mental health care, since minority patients have been shown to be less involved in care and have been shown to be perceived and treated differently by providers.

Detailed description

The Center for Multicultural Mental Health Research (CMMHR) at Cambridge Health Alliance has recently been selected for funding by the Patient Centered Outcomes Research Institute (PCORI) to address the importance of patient-provider communication, shared decision making, and therapeutic alliance. Our research team demonstrated that a psycho-educational intervention (DECIDE-PA) improves patient activation and self-management in behavioral health care. However, the investigators found that providers were unresponsive or reacted negatively to patients' activation. In response, the investigators propose to combine DECIDE-PA with provider coaching (DECIDE-PC) to increase providers' receptivity to patient activation, and improve Shared Decision Making (SDM). The investigators also focus on quality of care, responding to clinic administrators who require interventions that improve quality of behavioral health care (mental health and substance treatments). Aims: 1) Test the effectiveness of DECIDE PA+PC compared to usual care in improving SDM and patient-perceived quality of behavioral health care; 2) Test whether patient-centered communication and therapeutic alliance mediate the effect of the DECIDE PA+PC intervention on SDM; 3) Explore whether ethnic/racial or language matching between patient and provider moderates the effect of DECIDE PA+PC on SDM and quality of behavioral health care. Intervention: The DECIDE PA+PC intervention is designed to improve the quality of mental health care for adult behavioral health patients by engaging minority participants in asking questions about their treatment. The intervention is administered to patients and providers and is designed to improve patient activation, self-management, and therapeutic alliance. For patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in concordant and discordant ethnic/racial dyads. The DECIDE PC training for providers consists of 1.5 days of training which focuses on augmenting patient-centered communication and therapeutic alliance as a possible underlying pathway by which SDM can take place. The training also addresses 1) lack of perspective taking; 2) frequent attributional errors that providers make; and 3) decreased receptivity to patient participation and collaboration in decision making. The training includes provider coaching totaling 15-20 hours. Methods: For Aim 1, implement a randomized controlled trial comparing DECIDE-PA+PC with usual care on Shard Decision Making (SDM) and perceived quality of care. Identify treatment effects using multi-level models that account for nesting of observations, patients, providers, and clinics. For Aim 2, identify underlying mechanisms of the effect of the DECIDE-PA+PC intervention on SDM. Mediation analysis techniques are used that allow for rigorous testing of causal pathways and statistical adjustment for spurious correlation is used in instances where mediators and SDM measurement are contemporaneous. For Aim 3, expand Aim 1 models to test whether DECIDE-PA+PC impacts SDM and perceived quality differentially by ethnic/racial concordant/discordant dyads. Usual Care: Usual care across clinics is described by clinicians as answering their patients' questions during the clinical encounter. Clinicians report that on average they perceive their patients as having limited involvement in decision-making. No DECIDE training for patients or providers will be applied to the control condition while the control provider and control patient are participating in the study. Once the control provider and control patient complete their participation in the study, they will be offered the DECIDE trainings. Participating Sites: The investigators plan to administer the intervention to patients and providers at four participating Cambridge Health Alliance clinics, along with Beth Israel Deaconess Medical Center, Boston Children's Hospital, South Cove Community Health Center, Edward M Kennedy Health Center (Great Brook Valley Health Center), and two community health centers through Harbor Health Services (Neponset Health Center and Geiger Gibson Community Health Center).

Interventions

BEHAVIORALDECIDE-PA

The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.

BEHAVIORALDECIDE-PC

The DECIDE-PC intervention trains providers in patient-centered communication techniques and encourages providers to be receptive to patients who take a more active role during the clinical encounter in order to improve shared decision making.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria: -Patients ages 18-80 who are receiving mental health treatment at one of the collaborating clinics. Patient

Exclusion criteria

-Patients will be excluded if they screen with mania, psychosis, or suicidality to ensure their safety and minimize the stress of receiving the intervention. Patients over the age of 65 will be assessed with a cognitive functioning screening instrument and excluded if possible cognitive impairment is indicated. Provider Inclusion Criteria: -Providers will be permitted to participate in this study if they are regular, paid staff that provide behavioral health services at any of the participating clinics. No other criteria will be required.

Design outcomes

Primary

MeasureTime frameDescription
Shared Decision Making (OPTION) Independent Blind Coder Assessment ScoresFollow-up assessment (2 months)12 items designed to assess SDM quality in medical visit. Rated on 5 point Likert scales ranging from 0 (behavior not observed) -- 4 (clinician exhibited behavior to high standard). Final scores are the sum of the rating and range from 0-44. Final scores were transformed to a scale that ranges from 0 (lowest SDM) - 100 (highest SDM).
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)End-of-intervention Assessment (5 months)Evaluates patient SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).
Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider VersionFollow-up Assessment (2 months)The 10 items was developed by research team to evaluate provider SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the provider.
Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)Follow-up Assessment (2 months)Evaluates provider SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)End-of-intervention Assessment (5 months)Assesses patient perceptions of care in psychiatric settings. Includes 3 items, final scores are scored externally, and range from 0 (lowest quality) to 100 (highest quality).
Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient VersionEnd-of-intervention Assessment (5 months)The 10 items was developed by research team to evaluate patient SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the patient.

Countries

United States

Participant flow

Recruitment details

Recruitment began in August 2014 and ended in September 2016. Participants were recruited at behavioral health community clinics and psychiatric outpatient clinics in Massachusetts. Participants were assessed for eligibility and then randomized into a study arm.

Pre-assignment details

Patients were excluded due to ineligibility (positive screening for mania, psychosis, and/or active suicidal ideation) or treatment discontinuation. Providers were excluded due to a lack of patients enrolled in the study. Both patient and provider study participants were excluded if they withdrew before randomization into a study arm.

Participants by arm

ArmCount
Intervention Providers & Patients
Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
89
Intervention Patients, Control Providers
Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.
68
Control Patients, Intervention Providers
Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called Managing Your Mental Health Care. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
83
Control Patients & Providers
Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called Managing Your Mental Health Care.
72
Non Randomized Controlled Trial Patients
Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
95
Control Providers
Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
34
Intervention Providers
Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
40
Total481

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyDeath1110000
Overall StudyLost to Follow-up4655025
Overall StudyMissing Follow-up Assessment2230020
Overall StudyNo Clinical Recording126810000
Overall StudyNon-coding Clinical Recording language0001000
Overall StudyNo patients were enrolled in study0000031
Overall StudyWithdrawal by Subject10841002

Baseline characteristics

CharacteristicIntervention Providers & PatientsIntervention Patients, Control ProvidersControl Patients, Intervention ProvidersControl Patients & ProvidersNon Randomized Controlled Trial PatientsControl ProvidersIntervention ProvidersTotal
Age, Customized
<=18 years
1 Participants1 Participants2 Participants0 Participants2 Participants0 Participants0 Participants6 Participants
Age, Customized
>=65 years
5 Participants7 Participants6 Participants7 Participants5 Participants2 Participants2 Participants34 Participants
Age, Customized
Between 18 and 65 years
83 Participants60 Participants75 Participants65 Participants88 Participants31 Participants38 Participants440 Participants
Age, Customized
Missing
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
41 Participants26 Participants34 Participants29 Participants38 Participants8 Participants7 Participants183 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants42 Participants49 Participants43 Participants57 Participants26 Participants33 Participants298 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Patient Shared Decision Making in Behavioral Health (SDM-BH) Patient Version49.35 units on a scale
STANDARD_DEVIATION 8.91
46.23 units on a scale
STANDARD_DEVIATION 8.26
48.58 units on a scale
STANDARD_DEVIATION 7
47.76 units on a scale
STANDARD_DEVIATION 9.3
48.18 units on a scale
STANDARD_DEVIATION 8.39
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)90.78 units on a scale
STANDARD_DEVIATION 10.44
88.29 units on a scale
STANDARD_DEVIATION 12.33
90.74 units on a scale
STANDARD_DEVIATION 9.9
88.32 units on a scale
STANDARD_DEVIATION 12.45
92.75 units on a scale
STANDARD_DEVIATION 8.74
90.39 units on a scale
STANDARD_DEVIATION 10.77
Provider Shared Decision Making in Behavioral Health (SDM-BH) Provider Version46.29 units on a scale
STANDARD_DEVIATION 4.91
46.85 units on a scale
STANDARD_DEVIATION 3.97
46.60 units on a scale
STANDARD_DEVIATION 4.37
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
7 Participants5 Participants9 Participants5 Participants7 Participants5 Participants6 Participants44 Participants
Race (NIH/OMB)
Black or African American
14 Participants6 Participants12 Participants6 Participants9 Participants2 Participants1 Participants50 Participants
Race (NIH/OMB)
More than one race
2 Participants15 Participants0 Participants6 Participants3 Participants2 Participants2 Participants30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants2 Participants1 Participants1 Participants0 Participants0 Participants6 Participants
Race (NIH/OMB)
Unknown or Not Reported
28 Participants10 Participants28 Participants21 Participants32 Participants3 Participants1 Participants123 Participants
Race (NIH/OMB)
White
36 Participants32 Participants31 Participants33 Participants43 Participants22 Participants30 Participants227 Participants
Region of Enrollment
United States
89 participants68 participants83 participants72 participants95 participants34 participants40 participants481 participants
Sex: Female, Male
Female
58 Participants47 Participants56 Participants51 Participants57 Participants24 Participants32 Participants325 Participants
Sex: Female, Male
Male
31 Participants21 Participants27 Participants21 Participants38 Participants10 Participants8 Participants156 Participants
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)77.15 units on a scale
STANDARD_DEVIATION 20.31
76.31 units on a scale
STANDARD_DEVIATION 18.27
77.82 units on a scale
STANDARD_DEVIATION 17.54
74.24 units on a scale
STANDARD_DEVIATION 21.04
75.4 units on a scale
STANDARD_DEVIATION 23.57
76.23 units on a scale
STANDARD_DEVIATION 20.32

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
1 / 891 / 681 / 830 / 720 / 950 / 340 / 40
other
Total, other adverse events
0 / 890 / 680 / 830 / 720 / 950 / 340 / 40
serious
Total, serious adverse events
0 / 890 / 680 / 830 / 720 / 950 / 340 / 40

Outcome results

Primary

Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version

The 10 items was developed by research team to evaluate patient SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the patient.

Time frame: End-of-intervention Assessment (5 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. SDM-BH patient version was not administered to providers. Measure was not assessed for Non-RCT patients.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersPatient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version51.46 units on a scaleStandard Deviation 6.63
Intervention Patients, Control ProvidersPatient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version47.14 units on a scaleStandard Deviation 10.54
Control Patients, Intervention ProvidersPatient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version50.28 units on a scaleStandard Deviation 7.85
Control Patients & ProvidersPatient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version48.67 units on a scaleStandard Deviation 7.89
Primary

Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)

Assesses patient perceptions of care in psychiatric settings. Includes 3 items, final scores are scored externally, and range from 0 (lowest quality) to 100 (highest quality).

Time frame: End-of-intervention Assessment (5 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. PoC was not administered to providers. Measure was not assessed for Non-RCT patients.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersPerceptions of Care Survey - Global Evaluation of Care Scale (PoC)94.60 units on a scaleStandard Deviation 7.64
Intervention Patients, Control ProvidersPerceptions of Care Survey - Global Evaluation of Care Scale (PoC)91.15 units on a scaleStandard Deviation 9.48
Control Patients, Intervention ProvidersPerceptions of Care Survey - Global Evaluation of Care Scale (PoC)90.50 units on a scaleStandard Deviation 12.45
Control Patients & ProvidersPerceptions of Care Survey - Global Evaluation of Care Scale (PoC)89.00 units on a scaleStandard Deviation 13.06
Primary

Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version

The 10 items was developed by research team to evaluate provider SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the provider.

Time frame: Follow-up Assessment (2 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. Each enrolled provider completed a follow-up assessment for each of their enrolled patients, following the audio recording of their clinical session.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersProvider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version41.26 units on a scaleStandard Deviation 6.57
Intervention Patients, Control ProvidersProvider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version40.10 units on a scaleStandard Deviation 7.45
Control Patients, Intervention ProvidersProvider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version41.96 units on a scaleStandard Deviation 5.53
Control Patients & ProvidersProvider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version38.41 units on a scaleStandard Deviation 7.11
Primary

Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores

12 items designed to assess SDM quality in medical visit. Rated on 5 point Likert scales ranging from 0 (behavior not observed) -- 4 (clinician exhibited behavior to high standard). Final scores are the sum of the rating and range from 0-44. Final scores were transformed to a scale that ranges from 0 (lowest SDM) - 100 (highest SDM).

Time frame: Follow-up assessment (2 months)

Population: All participants who enrolled in the study after the baseline interview and whose data was analyzed. Measure for Control Providers and Intervention Providers is the average across all of their RCT patients, irrespective of whether they were intervention or control patients. Differences from overall numbers are due to missing observations.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores36.31 units on a scaleStandard Deviation 11.77
Intervention Patients, Control ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores29.78 units on a scaleStandard Deviation 10.53
Control Patients, Intervention ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores34.50 units on a scaleStandard Deviation 14.96
Control Patients & ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores30.37 units on a scaleStandard Deviation 13.54
Non Randomized Controlled Trial PatientsShared Decision Making (OPTION) Independent Blind Coder Assessment Scores32.37 units on a scaleStandard Deviation 12.96
Control ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores30.09 units on a scaleStandard Deviation 12.12
Intervention ProvidersShared Decision Making (OPTION) Independent Blind Coder Assessment Scores35.39 units on a scaleStandard Deviation 13.48
Primary

Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)

Evaluates patient SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

Time frame: End-of-intervention Assessment (5 months)

Population: All participants who enrolled in the study after the baseline interview and whose data was analyzed. SDM-Q-9 patient version was not administered to providers. Measure was not assessed for Non-RCT patients.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersShared Decision Making Questionnaire (SDM-Q-9 Patient Version)81.10 units on a scaleStandard Deviation 17.77
Intervention Patients, Control ProvidersShared Decision Making Questionnaire (SDM-Q-9 Patient Version)77.5 units on a scaleStandard Deviation 17.86
Control Patients, Intervention ProvidersShared Decision Making Questionnaire (SDM-Q-9 Patient Version)75.85 units on a scaleStandard Deviation 19.91
Control Patients & ProvidersShared Decision Making Questionnaire (SDM-Q-9 Patient Version)76.75 units on a scaleStandard Deviation 20.52
Primary

Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)

Evaluates provider SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

Time frame: Follow-up Assessment (2 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. Each enrolled provider completed a follow-up assessment for each of their enrolled patients, following the audio recording of their clinical session.

ArmMeasureValue (MEAN)Dispersion
Intervention Patients & ProvidersShared Decision Making Questionnaire (SDM-Q-9 Provider Version)69.03 units on a scaleStandard Deviation 12.51
Intervention Patients, Control ProvidersShared Decision Making Questionnaire (SDM-Q-9 Provider Version)69.60 units on a scaleStandard Deviation 14.3
Control Patients, Intervention ProvidersShared Decision Making Questionnaire (SDM-Q-9 Provider Version)69.85 units on a scaleStandard Deviation 10.14
Control Patients & ProvidersShared Decision Making Questionnaire (SDM-Q-9 Provider Version)68.46 units on a scaleStandard Deviation 16.97

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026