Social Determinants of HealthNCT02959866
Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security
A study testing online income tool in people with Social Determinants of Health and Poverty, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
We will evaluate the acceptability, feasibility and impact of an online tool that helps patients identify financial benefits that they are entitled to at six clinic sites over a three month period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health, Poverty, Social Isolation
- What is being tested?
- online income tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesCanada
- Study dates
- May 2016to Jun 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Used the online income tool with their health provider
- Able to provide consent
- Able to converse in English
- Able to be reached by telephone or email
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Department of Family Medicine, Faculty of Medicine, University of Manitoba
Winnipeg, Manitoba, R3E 3P5
About this study
Official title: Evaluating the Implementation and Impact of an Online Tool Used Within Primary Care to Improve the Income Security of Patients With Complex Health and Social Needs in Ontario and Manitoba
We will evaluate the acceptability, feasibility and impact of an online tool that helps patients identify financial benefits that they are entitled to at six clinic sites over a three month period. We will answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact?
Read the detailed description
Addressing the social determinants of health of patients has been identified as a key way to achieve health system goals. However, few evidence-based interventions exist. This study emerges from an ongoing collaboration between family physicians, researchers and a charitable financial literacy organization. This study aims to answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact? We will recruit six primary care sites in Toronto and Winnipeg that serve low-income communities. We will introduce clinicians to screening for poverty and increasing access to additional income sources via government benefits. Following an initial orientation session, health providers will be encouraged to use the tool with any patient seen. The health provider and patient will complete the online tool together, generating a tailored list of financial benefits, along with local community resources to assist with obtaining these benefits. A brief survey on this experience will be administered to patients after they complete the tool, as well as a request to contact them in one month. Those who agree to be contacted will be interviewed on whether the intervention impacted their knowledge and ability to access benefits. We will administer an online survey to providers and conduct provider focus groups at each site at the end of study. An advisory group made up of patients living on low incomes and representatives from community agencies will support this study. An online tool could help health providers in improving the income security of their patients. Strengths of this study include that it involves a diverse set of clinics and that the tool has been implemented pragmatically, in the real world of busy primary care clinics. Limitations include the convenience sampling method, that the selected clinics may not be representative of all primary care providers and the relatively short follow-up period. Our findings will provide insight into the potential of electronic tools that assist providers address the social determinants of health.
- Being tested
- online income tool
- Medical subject headings
- Social Isolation, Social Marginalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online income toolOther
Also called benefits screening tool
An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.
| Study group | Role | What they receive |
|---|---|---|
| Online income tool | Experimental | Patients who complete the online income tool with their health provider during the study period. Receives: Other: online income tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of Financial Benefits
Self-reported awareness of at least one financial benefit
Measured: 4 weeks
Secondary outcomes (1)
Increase in Income
Self-reported increase in income through accessing a financial benefit
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJun 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Pinto, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959866
- Sponsor's protocol ID
- SMH2016
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2016
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aery A, Rucchetto A, Singer A, Halas G, Bloch G, Goel R, Raza D, Upshur REG, Bellaire J, Katz A, Pinto AD. Implementation and impact of an online tool used in primary care to improve access to financial benefits for patients: a study protocol. BMJ Open. 2017 Oct 22;7(10):e015947. doi: 10.1136/bmjopen-2017-015947.
PubMed 29061603
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation and Impact of an Online Tool Used Within Primary Care to Improve the Income Security of Patients With Complex Health and Social Needs in Ontario and Manitoba
- ClinicalTrials.gov ID
- NCT02959866
- Acronym / sponsor ID
- SMH2016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 27 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will evaluate the acceptability, feasibility and impact of an online tool that helps patients identify financial benefits that they are entitled to at six clinic sites over a three month period. We will answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact?
Detailed description
Addressing the social determinants of health of patients has been identified as a key way to achieve health system goals. However, few evidence-based interventions exist. This study emerges from an ongoing collaboration between family physicians, researchers and a charitable financial literacy organization. This study aims to answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact? We will recruit six primary care sites in Toronto and Winnipeg that serve low-income communities. We will introduce clinicians to screening for poverty and increasing access to additional income sources via government benefits. Following an initial orientation session, health providers will be encouraged to use the tool with any patient seen. The health provider and patient will complete the online tool together, generating a tailored list of financial benefits, along with local community resources to assist with obtaining these benefits. A brief survey on this experience will be administered to patients after they complete the tool, as well as a request to contact them in one month. Those who agree to be contacted will be interviewed on whether the intervention impacted their knowledge and ability to access benefits. We will administer an online survey to providers and conduct provider focus groups at each site at the end of study. An advisory group made up of patients living on low incomes and representatives from community agencies will support this study. An online tool could help health providers in improving the income security of their patients. Strengths of this study include that it involves a diverse set of clinics and that the tool has been implemented pragmatically, in the real world of busy primary care clinics. Limitations include the convenience sampling method, that the selected clinics may not be representative of all primary care providers and the relatively short follow-up period. Our findings will provide insight into the potential of electronic tools that assist providers address the social determinants of health.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online income tool | Experimental | Other: online income toolPatients who complete the online income tool with their health provider during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Used the online income tool with their health provider
- Able to provide consent
- Able to converse in English
- Able to be reached by telephone or email
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| online income toolAlso: benefits screening toolAn online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for. | Other | Online income tool |
Primary outcome
Awareness of Financial Benefits
Time frame: 4 weeks
Self-reported awareness of at least one financial benefit
1 secondary outcome
Increase in Income
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29061603Aery A, Rucchetto A, Singer A, Halas G, Bloch G, Goel R, Raza D, Upshur REG, Bellaire J, Katz A, Pinto AD. Implementation and impact of an online tool used in primary care to improve access to financial benefits for patients: a study protocol. BMJ Open. 2017 Oct 22;7(10):e015947. doi: 10.1136/bmjopen-2017-015947.
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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.
Andrew D Pinto, MD MSc principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online income tool in people with Social Determinants of Health and Poverty, run by Unity Health Toronto at 2 sites in Canada.
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 4 inclusion and 1 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 27 Sep 2019). 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?
Awareness of Financial Benefits (time frame: 4 weeks). 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 NCT02959866, which also lists 1 linked publication.
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 27 Sep 2019.