Diabetes MellitusNCT02379078
Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes
A study testing Shared decision-making aid, Generic hard copy diabetes resources and Generic online diabetes resources in people with Diabetes Mellitus, run by Unity Health Toronto.
Trial summary
Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Shared decision-making aid, Generic hard copy diabetes resources and Generic online diabetes resources
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Type 1 or Type 2 diabetes and
- have 2 or more other chronic comorbidities
Who cannot join
- do not speak English
- have documented cognitive deficits
- unable to give informed consent
- have limited life expectancy (<1 year)
- not available for follow-up
- seen primarily by a resident physician
- are pregnant or considering conception
About this study
Official title: Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. On top of that, many with diabetes have other health problems, such as high blood pressure or arthritis, that make care even more complicated. Guidelines for improving the care of people with diabetes try to help by summarizing the best practices for care, but because diabetes care is so complicated, it is hard for them to be put into practice. One solution to this is a tool that can help people with diabetes set health care goals that are important to them, and participate actively in decisions about their own health care, together with health care providers. This tool would have an information booklet for patients with facts that can help them make a decision, a worksheet to help spell out what their goals are and how they want to get there, and a cheat-sheet for health care providers that gives them tips on how to do this. The purpose of this project is to find out if a tool like this would be helpful, how to make it more helpful and usable, and what the best way would be to make sure that people use it.
An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients in the intervention arm of the study will have reduced decisional conflict and diabetes distress, and improved decision-making satisfaction, chronic care delivery and quality of life.
Read the detailed description
Significance:
Diabetes is prevalent and results in major morbidity. Care of the patient with diabetes is complex and often occurs in the context of other chronic illness; this multimorbidity negatively impacts morbidity and mortality. The Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPG) are a rigorously developed knowledge tool that comprehensively address all aspects of diabetes care, conforming to AGREE II standards for guideline development. However, guideline adherence in the patient with multimorbidity is challenging both for the provider and the patient, who are overwhelmed by numerous, often conflicting recommendations. An individualized approach to the multimorbid diabetic patient using shared decision-making (SDM) and goal setting may overcome challenges to guideline adherence; however these strategies have not been taken up extensively in clinical practice. Barriers to uptake can be overcome by incorporating SDM into the context of interprofessional care: in diabetes care, role expansion, active participation by more than one discipline and adding additional team members have been demonstrated to improve clinical outcomes. While SDM and decision aids have typically focused on one issue, the precedent and potential exists for their use in the translation of the CDA CPG into practice through the prioritization of complex guideline recommendations. Given the growing prevalence of diabetes and multimorbidity in Canada, effectively bridging the knowledge to practice gap in this area has the potential to significantly improve patient-important outcomes, health care delivery and system sustainability.
Objectives:
- To enhance the implementation of a complex guidelines document (CDA 2013 CPG) by assisting in prioritizing care for patients with diabetes and multiple other comorbidities through the use of a diabetes-focused SDM intervention;
- To systematically develop, test and pilot a SDM and goal-setting intervention following the United Kingdom Medical Research Council and Knowledge to Action Frameworks;
- To build a team consisting of members of the research community, patients, health care providers, CDA, and Local Health Integration Networks of the Ministry of Health and Long-Term Care, in order to increase the relevance of research conducted and enable dissemination of these research results into practice.
Hypothesis An interprofessional SDM and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases.
Research Plan Development, testing and refinement: An evidence-based multi-component SDM intervention will be developed, framed by the Interprofessional SDM Model and based on user input from individual interviews regarding feasibility, acceptability and mediators of use. Usability testing will be done using cognitive task analysis to assess paths users take to accomplish tasks, errors made, when and where they encountered confusion or frustration, degree of satisfaction and quality of decision support. Based on feedback received, the tool will be refined through several iterative cycles of feedback and redesign.
Pilot trial: The tool kit will be piloted in a two-step parallel clustered randomized controlled trial (RCT) whose primary purpose is to assess intervention fidelity and to test the feasibility of conducting a larger RCT. The first step will be a provider-directed phase; the second step (which will occur 6 months later) will be a provider- and patient-directed phase. A secondary purpose of this study is to estimate the impact of the decision aid on decisional conflict; secondary outcomes include diabetes distress, chronic illness care and quality of life, assessed by patient-completed questionnaires of validated scales at baseline, 6 and 12 months. Analysis will be done by intention to treat. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.
- Conditions
- Diabetes Mellitus
- Being tested
- Shared decision-making aid, Generic hard copy diabetes resources, Generic online diabetes resources
- Keywords
- Shared decision-making, Priority setting, Patient decision aid, Interprofessional care, Diabetes mellitus, Patient education, Medical informatics, Toolkit development, Study protocol, User-centred design, Qualitative methods
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making aidOther
The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.
Generic hard copy diabetes resourcesOther
A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet
Generic online diabetes resourcesOther
Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website
| Study group | Role | What they receive |
|---|---|---|
| Shared decision-making aid | Experimental | At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers
At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers) Receives: Other: Shared decision-making aid |
| Generic hard-copy diabetes resources | Placebo comparator | At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers
At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients
In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website. Receives: Other: Generic hard copy diabetes resources; Other: Generic online diabetes resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict in Patients With Diabetes
Decisional conflict was chosen to allow us to assess the impact of our decision aid on the quality of the decision-making process, an important first measure of the effectiveness of a decision aid and the shared decision making process. This outcome is assessed by the Decisional Conflict Scale (DCS), a well-validated, patient-completed measure. DCS consists of 16 items, with 5 subscales (informed, values clarity, support, uncertainty, and effective decision) and an overall summary score. IT is scored on a 5-item Likert scale ranging from '0- strongly agree' to '4- strongly disagree'. It's minimum total score is 0 and it's maximum total score is 100. The higher the score, the worse the outcome. The lower the score, the better the outcome.
Measured: This outcome is measured at 0, 6 and 12 months.
Secondary outcomes (4)
Patient With Diabetes' Assessment of Their Chronic Illness Care
This outcome was selected because it is a direct measure of knowledge use by patients that will allow us to better understand mediating variables of knowledge use such as patient activation, goal-setting, problem-solving, and decision support.
This outcome is assessed by the Patient Assessment of Care for Chronic Conditions (PACIC), a well-validated patient-completed questionnaire. PACIC includes 20 items, scored on a 5 point Likert scale ranging from '1 - None of the time' to '5 - Always'. PACIC consists of 5 sub-scales (patient activation, delivery system design, goal setting, problem solving, and follow-up/coordination) and an overall summary score. The minimum total score is 0 and the maximum total score is 50. A higher score indicates a better outcome.
Measured: This outcome is measured at 0, 6 and 12 months.
Diabetes Distress in Patients With Diabetes
This outcome was selected because it is a direct measure of knowledge use by patients that will allow us to better understand mediating variables of knowledge use such as patient activation, goal-setting, problem-solving, and decision support.
This outcome is assessed by the Diabetes Distress Scale (DDS), a well-validated, patient-completed questionnaire. The DDS is a 17-item scale with 4 subscales (emotional burden, regimen distress, interpersonal distress and physician distress) with an overall summary score. It is scored on a 6-point Likert scale, ranging from '1 - no problem' to '6 - serious problem'. It's minimum total score is 0 and it's maximum total score is 6. The higher the score, the worse the outcome. The lower the score, the better the outcome.
Measured: This outcome is measured at 0, 6 and 12 months.
Health-related Quality of Life in Patients With Diabetes
Quality of life was selected to inform future sample size calculations, as more holistic and patient-centred measure of knowledge use that uniquely acknowledges patient prioritization of health care goals.
This outcome is assessed by the Short Form 12 (SF-12), a well-validated, patient-completed questionnaire. The SF-12 consists of 12 items (minimum score is 0 and maximum score is 100; the higher the score, the better the quality of life.)
Measured: This outcome is measured at 0, 6 and 12 months.
Intention to Engage in Shared Decision-making in Health Care Providers
This outcome is assessed by the Continuing Professional Development (CPD) Reaction Questionnaire, a theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions. This outcome was selected to assess provider's intention to engage in shared decision-making, as a potential facilitator or barrier to shared decision-making. The CPD Reaction Questionnaire consists of 12 items with 5 subscales (intention, social influence, beliefs about capabilities, moral norm, and beliefs about consequences) and is scored on a 7-point Likert scale. It's minimum score is 1 and it's maximum score is 7. The higher the score, the better the outcome.
Measured: This outcome is measured at 0, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Catherine H Yu, MD FRCPC, Principal investigator, St. Michael's Hospital (Unity Health Toronto)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379078
- Sponsor's protocol ID
- 13-014
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2015
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yu CH, Ivers NM, Stacey D, Rezmovitz J, Telner D, Thorpe K, Hall S, Settino M, Kaplan DM, Coons M, Sodhi S, Sale J, Straus SE. Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial. Trials. 2015 Jun 27;16:286. doi: 10.1186/s13063-015-0797-8.
PubMed 26116444Yu CH, Stacey D, Sale J, Hall S, Kaplan DM, Ivers N, Rezmovitz J, Leung FH, Shah BR, Straus SE. Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care--systematic decision aid development and study protocol. Implement Sci. 2014 Jan 22;9:16. doi: 10.1186/1748-5908-9-16.
PubMed 24450385Yu CH, Medleg F, Choi D, Spagnuolo CM, Pinnaduwage L, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi S, Stacey D, Telner D. Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial. BMC Med Inform Decis Mak. 2021 Nov 22;21(1):323. doi: 10.1186/s12911-021-01673-w.
PubMed 34809626Yu CH, McCann M, Sale J. "In my age, we didn't have the computers": Using a complexity lens to understand uptake of diabetes eHealth innovations into primary care-A qualitative study. PLoS One. 2021 Jul 7;16(7):e0254157. doi: 10.1371/journal.pone.0254157. eCollection 2021.
PubMed 34234368Yu C, Choi D, Bruno BA, Thorpe KE, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi-Helou S, Stacey D, Telner D. Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Sep 30;22(9):e16984. doi: 10.2196/16984.
PubMed 32996893Yu CH, Ke C, Jovicic A, Hall S, Straus SE; IP-SDM Team;. Beyond pros and cons - developing a patient decision aid to cultivate dialog to build relationships: insights from a qualitative study and decision aid development. BMC Med Inform Decis Mak. 2019 Sep 18;19(1):186. doi: 10.1186/s12911-019-0898-5.
PubMed 31533828
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02379078
- Acronym / sponsor ID
- 13-014
- Conditions
- Diabetes Mellitus
- Keywords
- Shared decision-making, Priority setting, Patient decision aid, Interprofessional care, Diabetes mellitus, Patient education, Medical informatics, Toolkit development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. On top of that, many with diabetes have other health problems, such as high blood pressure or arthritis, that make care even more complicated. Guidelines for improving the care of people with diabetes try to help by summarizing the best practices for care, but because diabetes care is so complicated, it is hard for them to be put into practice. One solution to this is a tool that can help people with diabetes set health care goals that are important to them, and participate actively in decisions about their own health care, together with health care providers. This tool would have an information booklet for patients with facts that can help them make a decision, a worksheet to help spell out what their goals are and how they want to get there, and a cheat-sheet for health care providers that gives them tips on how to do this. The purpose of this project is to find out if a tool like this would be helpful, how to make it more helpful and usable, and what the best way would be to make sure that people use it.
An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients in the intervention arm of the study will have reduced decisional conflict and diabetes distress, and improved decision-making satisfaction, chronic care delivery and quality of life.
Detailed description
Significance:
Diabetes is prevalent and results in major morbidity. Care of the patient with diabetes is complex and often occurs in the context of other chronic illness; this multimorbidity negatively impacts morbidity and mortality. The Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPG) are a rigorously developed knowledge tool that comprehensively address all aspects of diabetes care, conforming to AGREE II standards for guideline development. However, guideline adherence in the patient with multimorbidity is challenging both for the provider and the patient, who are overwhelmed by numerous, often conflicting recommendations. An individualized approach to the multimorbid diabetic patient using shared decision-making (SDM) and goal setting may overcome challenges to guideline adherence; however these strategies have not been taken up extensively in clinical practice. Barriers to uptake can be overcome by incorporating SDM into the context of interprofessional care: in diabetes care, role expansion, active participation by more than one discipline and adding additional team members have been demonstrated to improve clinical outcomes. While SDM and decision aids have typically focused on one issue, the precedent and potential exists for their use in the translation of the CDA CPG into practice through the prioritization of complex guideline recommendations. Given the growing prevalence of diabetes and multimorbidity in Canada, effectively bridging the knowledge to practice gap in this area has the potential to significantly improve patient-important outcomes, health care delivery and system sustainability.
Objectives:
- To enhance the implementation of a complex guidelines document (CDA 2013 CPG) by assisting in prioritizing care for patients with diabetes and multiple other comorbidities through the use of a diabetes-focused SDM intervention;
- To systematically develop, test and pilot a SDM and goal-setting intervention following the United Kingdom Medical Research Council and Knowledge to Action Frameworks;
- To build a team consisting of members of the research community, patients, health care providers, CDA, and Local Health Integration Networks of the Ministry of Health and Long-Term Care, in order to increase the relevance of research conducted and enable dissemination of these research results into practice.
Hypothesis An interprofessional SDM and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases.
Research Plan Development, testing and refinement: An evidence-based multi-component SDM intervention will be developed, framed by the Interprofessional SDM Model and based on user input from individual interviews regarding feasibility, acceptability and mediators of use. Usability testing will be done using cognitive task analysis to assess paths users take to accomplish tasks, errors made, when and where they encountered confusion or frustration, degree of satisfaction and quality of decision support. Based on feedback received, the tool will be refined through several iterative cycles of feedback and redesign.
Pilot trial: The tool kit will be piloted in a two-step parallel clustered randomized controlled trial (RCT) whose primary purpose is to assess intervention fidelity and to test the feasibility of conducting a larger RCT. The first step will be a provider-directed phase; the second step (which will occur 6 months later) will be a provider- and patient-directed phase. A secondary purpose of this study is to estimate the impact of the decision aid on decisional conflict; secondary outcomes include diabetes distress, chronic illness care and quality of life, assessed by patient-completed questionnaires of validated scales at baseline, 6 and 12 months. Analysis will be done by intention to treat. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision-making aid | Experimental | Other: Shared decision-making aidAt study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers) |
| Generic hard-copy diabetes resources | Placebo comparator | Other: Generic hard copy diabetes resources, Other: Generic online diabetes resourcesAt study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of Type 1 or Type 2 diabetes and
- have 2 or more other chronic comorbidities
Key exclusion criteria (7 listed)
- do not speak English
- have documented cognitive deficits
- unable to give informed consent
- have limited life expectancy (<1 year)
- not available for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision-making aidThe IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video. | Other | Shared decision-making aid |
| Generic hard copy diabetes resourcesA hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet | Other | Generic hard-copy diabetes resources |
| Generic online diabetes resourcesProvider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website | Other | Generic hard-copy diabetes resources |
Primary outcome
Decisional Conflict in Patients With Diabetes
Time frame: This outcome is measured at 0, 6 and 12 months.
Decisional conflict was chosen to allow us to assess the impact of our decision aid on the quality of the decision-making process, an important first measure of the effectiveness of a decision aid and the shared decision making process. This outcome is assessed by the Decisional Conflict Scale (DCS), a well-validated, patient-completed measure. DCS consists of 16 items, with 5 subscales (informed, values clarity, support, uncertainty, and effective decision) and an overall summary score. IT is scored on a 5-item Likert scale ranging from '0- strongly agree' to '4- strongly disagree'. It's minimum total score is 0 and it's maximum total score is 100. The higher the score, the worse the outcome. The lower the score, the better the outcome.
4 secondary outcomes
Patient With Diabetes' Assessment of Their Chronic Illness Care
Time frame: This outcome is measured at 0, 6 and 12 months.
Diabetes Distress in Patients With Diabetes
Time frame: This outcome is measured at 0, 6 and 12 months.
Health-related Quality of Life in Patients With Diabetes
Time frame: This outcome is measured at 0, 6 and 12 months.
Intention to Engage in Shared Decision-making in Health Care Providers
Time frame: This outcome is measured at 0, 6 and 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26116444Yu CH, Ivers NM, Stacey D, Rezmovitz J, Telner D, Thorpe K, Hall S, Settino M, Kaplan DM, Coons M, Sodhi S, Sale J, Straus SE. Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial. Trials. 2015 Jun 27;16:286. doi: 10.1186/s13063-015-0797-8.
- Background: PubMed 24450385Yu CH, Stacey D, Sale J, Hall S, Kaplan DM, Ivers N, Rezmovitz J, Leung FH, Shah BR, Straus SE. Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care--systematic decision aid development and study protocol. Implement Sci. 2014 Jan 22;9:16. doi: 10.1186/1748-5908-9-16.
- Derived from this study: PubMed 34809626Yu CH, Medleg F, Choi D, Spagnuolo CM, Pinnaduwage L, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi S, Stacey D, Telner D. Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial. BMC Med Inform Decis Mak. 2021 Nov 22;21(1):323. doi: 10.1186/s12911-021-01673-w.
- Derived from this study: PubMed 34234368Yu CH, McCann M, Sale J. "In my age, we didn't have the computers": Using a complexity lens to understand uptake of diabetes eHealth innovations into primary care-A qualitative study. PLoS One. 2021 Jul 7;16(7):e0254157. doi: 10.1371/journal.pone.0254157. eCollection 2021.
- Derived from this study: PubMed 32996893Yu C, Choi D, Bruno BA, Thorpe KE, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi-Helou S, Stacey D, Telner D. Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Sep 30;22(9):e16984. doi: 10.2196/16984.
- Derived from this study: PubMed 31533828Yu CH, Ke C, Jovicic A, Hall S, Straus SE; IP-SDM Team;. Beyond pros and cons - developing a patient decision aid to cultivate dialog to build relationships: insights from a qualitative study and decision aid development. BMC Med Inform Decis Mak. 2019 Sep 18;19(1):186. doi: 10.1186/s12911-019-0898-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine H Yu, MD FRCPC principal investigator
St. Michael's Hospital (Unity Health Toronto)
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision-making aid, Generic hard copy diabetes resources and Generic online diabetes resources in people with Diabetes Mellitus, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict in Patients With Diabetes (time frame: This outcome is measured at 0, 6 and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379078, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.