Psychiatric DisordersNCT06681727
Feasibility of Accessible Video Mental Healthcare Triage and Assessment
An observational study of Psychiatric Disorders, run by Region Stockholm at 2 sites in Sweden.
Trial summary
This study aims to describe the immediate psychiatry (IP) service, patient population, and patient flow, as well as investigate the experiences, acceptability, and feasibility of the IP triage service implemented in Region Stockholm, Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- Accessible Video Mental Healthcare Triage and Assessment (IP)
- How many people
- 172 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Dec 2022to 30 Jun 2023
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients belonging to primary care in Southwest of Stockholm who seek help for acute psychiatric symtoms.
Who may be able to join
- Adult patients
- Knowledge of Swedish language
- Access to internet
- Belonging to Primary care in Southwest of Stockholm Region
- Seeking help for acute psychiatric symptoms
Who cannot join
- Younger than 18 years old
- Not meeting inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Psychiatry Southwest
Stockholm, 11486
Psychiatry Southwest,
Stockholm, 14186
About this study
Official title: Feasibility of Accessible Video Mental Healthcare Triage and Assessment - A Clinical Pilot Study
This study aims to describe the immediate psychiatry (IP) service, patient population, and patient flow, as well as investigate the experiences, acceptability, and feasibility of the IP triage service implemented in Region Stockholm, Sweden.
Patients aged 18 years and older who were registered at participating primary care centers were eligible to access the IP through a regional healthcare app. IP comprised a brief digital screening followed by a 45-minute video consultation with a mental health professional. The study will employ a mixed methods design with data from medical records, patient surveys, interviews with the IP team, and clinician acceptability questionnaires. The quantitative data will be analyzed via descriptive statistics, and the qualitative data will be analyzed via content analysis.
Read the detailed description
Study Design, Setting, and Ethical Considerations This pilot study, initiated in May 2022, was conducted at a psychiatric clinic affiliated with Karolinska Huddinge Hospital, in collaboration with eight primary care centers in southern Stockholm, Sweden. Data collection occurred from December 19, 2022, to June 30, 2023. The study was ethically approved by the Swedish Ethical Review Authority (2022-03893-01) and adhered to ethical guidelines. Participants were informed about the study's purpose and procedures, with an option to opt out at any time without affecting their care.
The specific research questions were as follows:
- How many patients received IP, on the basis of the selected recruitment strategy?
- What were the subsequent care needs in primary and psychiatric care settings identified for patients after using the service?
- What were the demographics of participants included in the study, such as age, gender, type of psychiatric problems?
- How did the participants rate their psychiatric concerns in terms of the type of symptoms, symptom severity, symptom onset, and symptom duration?
- How did the IP team assess patients' psychiatric symptoms and suicidality?
- How did the participants rate their satisfaction with the IP?
- Did patient groups recommended for subsequent care in primary and psychiatric care differ in terms of demographics and clinical aspects explored in C-F?
- How did the IP team experience their work with the intervention?
- How did participating primary care centers rate the acceptability of IP?
Recruitment Process Participants were recruited through multiple channels including information on the participating primary healthcare websites, posters, verbal information from healthcare providers, and local advertisements. Recruitment was limited to Swedish speakers due to the app's language and logistical issues with interpreter availability.
Participants Inclusion criteria required participants to be 18 years or older and registered with one of the eight participating primary healthcare centers. No exclusion criteria were applied, enabling the study to include patients with both subclinical and severe psychiatric symptoms.
Intervention and Procedure The Immediate Psychiatry (IP) service was delivered entirely through the "Alltid Öppet" app, which provided patients with a digital pathway to book consultations and complete brief screenings. After consultations, patients were invited to fill out a satisfaction survey. A flowchart of the patient journey was developed to visualize the process. The service was developed through an agile, collaborative approach and monitored weekly by a multidisciplinary team. A detailed service manual was produced, covering protocols for risk assessment, consultation procedures, and patient referrals.
Intake, Screening, and Patient Satisfaction Patients completed a brief psychiatric screening upon registration. After the screening, they could schedule a 45-minute video consultation with a mental health professional, without specific professional matching. Post-consultation, patients were provided with a link to an anonymous satisfaction survey.
Team Organization and Competencies The IP team was multidisciplinary, consisting of psychiatrists, psychologists, psychiatric nurses, a mental health therapist, and administrators. The team had a wide range of experience in general psychiatric care, social psychiatry, and suicide prevention.
Consultation Consultations were guided by a semi-structured interview process adapted for this study. Professionals gathered patient histories, screened for psychiatric symptoms, domestic violence, suicidality, and substance use, and collaboratively developed preliminary care plans with patients.
Clinical Documentation Each consultation was documented in a semi-structured format in the electronic medical record system. Preliminary diagnoses, care plans, suicide risk assessments, and other relevant information, such as experiences of abuse, were recorded following the clinic's standard procedures.
Subsequent Care and Referrals Consultations resulted in referrals to primary or psychiatric care, self-help recommendations, or no further action. Patients were responsible for scheduling follow-up appointments, with support from the healthcare system via the app.
Data Collection and Patient Flow Patient data, including demographic information, preliminary diagnoses, and actions taken, were collected through self-reports and medical records. Patient flow was monitored through the app and medical records.
Screening of Psychiatric Concerns A brief 9-item screening tool was used to assess psychiatric symptoms, history, and current use of medications. This tool was developed to facilitate early information gathering and reduce patient burden during intake.
Medical Records and Data Exports The Operational Support team within Region Stockholm Healthcare provided data exports from medical records, which included patients' demographic information, diagnoses, and suicide risk assessments.
Patient Satisfaction Survey The satisfaction survey utilized a 5-point Likert scale to assess multiple dimensions, including the ease of consultation, staff competence, and likelihood of recommending the service.
IP Team Interviews To capture staff experiences, three semi-structured interviews were conducted with IP team members at the end of the intervention period. These interviews focused on roles, patient interactions, and decision-making processes.
Clinician Acceptability at Primary Care Centers Healthcare professionals who received referred patients were surveyed using the Acceptability of Intervention Measure (AIM) to assess the acceptance and perceived usefulness of the IP service.
Data Analysis Descriptive statistics will be used to summarize patient characteristics. Fisher's Exact Test and the Mann-Whitney U Test will be applied for group comparisons. Missing data will be handled through imputation based on mean values. Qualitative content analysis will be used for interview data, involving systematic coding and theme development.
- Conditions
- Psychiatric Disorders
- Being tested
- Accessible Video Mental Healthcare Triage and Assessment (IP)
- Keywords
- Telepsychiatry, Mental Health Triage, Implementation, Primary care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accessible Video Mental Healthcare Triage and Assessment (IP)Other
Also called Immediate psychiatry (IP)
Patients aged 18 years and older who were registered at participating primary care centers were eligible to access the IP through a regional healthcare app. IP comprised a brief digital screening followed by a 45-minute video consultation with a mental health professional. Eligible patients could thereafter schedule appointments at cooperating healthcare centers and clinics through the app used for video consultations.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients belonging to Primary care with help seeking for acute psychiatric symptoms Receives: Other: Accessible Video Mental Healthcare Triage and Assessment (IP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics
Patient characteristics and patient flow Data on patient characteristics were collected through self-reported psychiatric concerns as well as preliminary diagnoses and actions initiated by the IP team, as indicated by information from the medical records. Patient flow was monitored through patient medical records.
Measured: Study period of 7 months
Brief screening of psychiatric concerns
The 9-item brief self-reported screening of psychiatric concerns (Supplement A) was used to gather initial information from patients (patient-rated symptoms and the impact of these symptoms on daily life and relationships via a combination of multiple-choice and open-ended questions.) It assesses a range of psychiatric symptoms, including those related to mood disorders, anxiety disorders, stress-related disorders, obsessive-compulsive disorders, and psychotic disorders. Additionally, it screens for self-harm or suicidal thoughts, psychiatric history, and current use of psychopharmaceuticals. The scale is descriptive without numeric score.
Measured: Study period of 7 months
Secondary outcomes (5)
Patients demographics
Data exports from medical journals and questionnaires were provided by the operational support team within Region Stockholm Healthcare. The information retrieved from the consultation medical records included patients' legal sex and age
Measured: Pre intervention
Clinical assessments
Data exports from medical journals were provided by the operational support team within Region Stockholm Healthcare. The descriptive information retrieved from the consultation medical records included patients' preliminary diagnoses, suicide risk level, number of historic suicide attempts, and current and planned actions based on the consultation.
Measured: Study period of 7 months]
Patient satisfaction
The survey utilized a 5-point Likert scale ranging from 1 ("No, not at all") to 5 ("Yes, completely") to measure various dimensions of patient satisfaction. These dimensions included ease of establishing contact, comfort in sharing health-related experiences, satisfaction with the self-care advice received, perceived effectiveness of the consultation, perceived competence of the staff, respectfulness and considerateness of the treatment, involvement in care or treatment decisions, satisfaction with the choice of receiving clinic for subsequent care, and the likelihood of recommending the service to others. The survey items were based on national and regional Swedish patient surveys used in primary and psychiatric healthcare.
Measured: Study period of 7 months
Interviews with the IP Team
Experiences working with the IP were explored through interviews with the IP team. Three 90-minute semistructured retrospective interviews based on 15 questions were conducted with staff who had provided consultations to patients. The interviews were audio recorded and conducted by a psychologist in training, with experience in interview techniques and who was unaffiliated with the project. These interviews took place during the final month of the intervention period with the three remaining staff members-two mental health nurses and one mental health therapist. The topics covered included healthcare professionals' roles, task management, patient interaction strategies, guiding principles, and decision-making processes.
Measured: Study period of 7 months
Clinician acceptability at primary care centers
The mental and medical healthcare professionals who received referred patients were identified through medical records, contacted by email, and asked to complete the anonymous four-item survey "Acceptability of Intervention Measure" (AIM, Weiner et al., 2017) at the end of the study period. The survey evaluated the receiving clinicians' acceptance of the IP intervention via a five-item Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), assessing the approval, appeal, personal liking, and general welcoming of the intervention.
Measured: Study period of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 172 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Lina Martinsson, MD PhD, Principal investigator, Centre for Psychiatry Research, Dept. Clinical Neuro Science. Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681727
- Sponsor's protocol ID
- PD pilot
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Accessible Video Mental Healthcare Triage and Assessment - A Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06681727
- Acronym / sponsor ID
- PD pilot
- Conditions
- Psychiatric Disorders
- Keywords
- Telepsychiatry, Mental Health Triage, Implementation, Primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe the immediate psychiatry (IP) service, patient population, and patient flow, as well as investigate the experiences, acceptability, and feasibility of the IP triage service implemented in Region Stockholm, Sweden.
Patients aged 18 years and older who were registered at participating primary care centers were eligible to access the IP through a regional healthcare app. IP comprised a brief digital screening followed by a 45-minute video consultation with a mental health professional. The study will employ a mixed methods design with data from medical records, patient surveys, interviews with the IP team, and clinician acceptability questionnaires. The quantitative data will be analyzed via descriptive statistics, and the qualitative data will be analyzed via content analysis.
Detailed description
Study Design, Setting, and Ethical Considerations This pilot study, initiated in May 2022, was conducted at a psychiatric clinic affiliated with Karolinska Huddinge Hospital, in collaboration with eight primary care centers in southern Stockholm, Sweden. Data collection occurred from December 19, 2022, to June 30, 2023. The study was ethically approved by the Swedish Ethical Review Authority (2022-03893-01) and adhered to ethical guidelines. Participants were informed about the study's purpose and procedures, with an option to opt out at any time without affecting their care.
The specific research questions were as follows:
- How many patients received IP, on the basis of the selected recruitment strategy?
- What were the subsequent care needs in primary and psychiatric care settings identified for patients after using the service?
- What were the demographics of participants included in the study, such as age, gender, type of psychiatric problems?
- How did the participants rate their psychiatric concerns in terms of the type of symptoms, symptom severity, symptom onset, and symptom duration?
- How did the IP team assess patients' psychiatric symptoms and suicidality?
- How did the participants rate their satisfaction with the IP?
- Did patient groups recommended for subsequent care in primary and psychiatric care differ in terms of demographics and clinical aspects explored in C-F?
- How did the IP team experience their work with the intervention?
- How did participating primary care centers rate the acceptability of IP?
Recruitment Process Participants were recruited through multiple channels including information on the participating primary healthcare websites, posters, verbal information from healthcare providers, and local advertisements. Recruitment was limited to Swedish speakers due to the app's language and logistical issues with interpreter availability.
Participants Inclusion criteria required participants to be 18 years or older and registered with one of the eight participating primary healthcare centers. No exclusion criteria were applied, enabling the study to include patients with both subclinical and severe psychiatric symptoms.
Intervention and Procedure The Immediate Psychiatry (IP) service was delivered entirely through the "Alltid Öppet" app, which provided patients with a digital pathway to book consultations and complete brief screenings. After consultations, patients were invited to fill out a satisfaction survey. A flowchart of the patient journey was developed to visualize the process. The service was developed through an agile, collaborative approach and monitored weekly by a multidisciplinary team. A detailed service manual was produced, covering protocols for risk assessment, consultation procedures, and patient referrals.
Intake, Screening, and Patient Satisfaction Patients completed a brief psychiatric screening upon registration. After the screening, they could schedule a 45-minute video consultation with a mental health professional, without specific professional matching. Post-consultation, patients were provided with a link to an anonymous satisfaction survey.
Team Organization and Competencies The IP team was multidisciplinary, consisting of psychiatrists, psychologists, psychiatric nurses, a mental health therapist, and administrators. The team had a wide range of experience in general psychiatric care, social psychiatry, and suicide prevention.
Consultation Consultations were guided by a semi-structured interview process adapted for this study. Professionals gathered patient histories, screened for psychiatric symptoms, domestic violence, suicidality, and substance use, and collaboratively developed preliminary care plans with patients.
Clinical Documentation Each consultation was documented in a semi-structured format in the electronic medical record system. Preliminary diagnoses, care plans, suicide risk assessments, and other relevant information, such as experiences of abuse, were recorded following the clinic's standard procedures.
Subsequent Care and Referrals Consultations resulted in referrals to primary or psychiatric care, self-help recommendations, or no further action. Patients were responsible for scheduling follow-up appointments, with support from the healthcare system via the app.
Data Collection and Patient Flow Patient data, including demographic information, preliminary diagnoses, and actions taken, were collected through self-reports and medical records. Patient flow was monitored through the app and medical records.
Screening of Psychiatric Concerns A brief 9-item screening tool was used to assess psychiatric symptoms, history, and current use of medications. This tool was developed to facilitate early information gathering and reduce patient burden during intake.
Medical Records and Data Exports The Operational Support team within Region Stockholm Healthcare provided data exports from medical records, which included patients' demographic information, diagnoses, and suicide risk assessments.
Patient Satisfaction Survey The satisfaction survey utilized a 5-point Likert scale to assess multiple dimensions, including the ease of consultation, staff competence, and likelihood of recommending the service.
IP Team Interviews To capture staff experiences, three semi-structured interviews were conducted with IP team members at the end of the intervention period. These interviews focused on roles, patient interactions, and decision-making processes.
Clinician Acceptability at Primary Care Centers Healthcare professionals who received referred patients were surveyed using the Acceptability of Intervention Measure (AIM) to assess the acceptance and perceived usefulness of the IP service.
Data Analysis Descriptive statistics will be used to summarize patient characteristics. Fisher's Exact Test and the Mann-Whitney U Test will be applied for group comparisons. Missing data will be handled through imputation based on mean values. Qualitative content analysis will be used for interview data, involving systematic coding and theme development.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Accessible Video Mental Healthcare Triage and Assessment (IP)Patients belonging to Primary care with help seeking for acute psychiatric symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients belonging to primary care in Southwest of Stockholm who seek help for acute psychiatric symtoms.
Key inclusion criteria (5 listed)
- Adult patients
- Knowledge of Swedish language
- Access to internet
- Belonging to Primary care in Southwest of Stockholm Region
- Seeking help for acute psychiatric symptoms
Key exclusion criteria (2 listed)
- Younger than 18 years old
- Not meeting inclusion criteria
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 |
|---|---|---|
| Accessible Video Mental Healthcare Triage and Assessment (IP)Also: Immediate psychiatry (IP)Patients aged 18 years and older who were registered at participating primary care centers were eligible to access the IP through a regional healthcare app. IP comprised a brief digital screening followed by a 45-minute video consultation with a mental health professional. Eligible patients could thereafter schedule appointments at cooperating healthcare centers and clinics through the app used for video consultations. | Other | Patients |
Primary outcome
Patient characteristics
Time frame: Study period of 7 months
Patient characteristics and patient flow Data on patient characteristics were collected through self-reported psychiatric concerns as well as preliminary diagnoses and actions initiated by the IP team, as indicated by information from the medical records. Patient flow was monitored through patient medical records.
Brief screening of psychiatric concerns
Time frame: Study period of 7 months
The 9-item brief self-reported screening of psychiatric concerns (Supplement A) was used to gather initial information from patients (patient-rated symptoms and the impact of these symptoms on daily life and relationships via a combination of multiple-choice and open-ended questions.) It assesses a range of psychiatric symptoms, including those related to mood disorders, anxiety disorders, stress-related disorders, obsessive-compulsive disorders, and psychotic disorders. Additionally, it screens for self-harm or suicidal thoughts, psychiatric history, and current use of psychopharmaceuticals. The scale is descriptive without numeric score.
5 secondary outcomes
Patients demographics
Time frame: Pre intervention
Clinical assessments
Time frame: Study period of 7 months]
Patient satisfaction
Time frame: Study period of 7 months
Interviews with the IP Team
Time frame: Study period of 7 months
Clinician acceptability at primary care centers
Time frame: Study period of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- 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.
Lina Martinsson, MD PhD principal investigator
Centre for Psychiatry Research, Dept. Clinical Neuro Science. Karolinska Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorders, run by Region Stockholm at 2 sites in Sweden.
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 5 inclusion and 2 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 19 Nov 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient characteristics (time frame: Study period of 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2024.