Transition Into Primary-care Psychiatry (TIPP)

Mental Disorders Clinical Trial

Official title:

Transition Into Primary-care Psychiatry (TIPP): A Mental Health Demonstration Project.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260013
• Other study ID #: R-04-093
• Secondary ID: G03-0568710349E
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 29, 2005
• Last updated: March 22, 2010
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: March 2010
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The objective of the Transition into Primary-care Psychiatry (TIPP) project is to determine how feasible it is to conduct a study to evaluate a new primary-care focused program of mental health care delivery for people with chronic mental illness. This will be done by comparing a primary-care based collaborative, interdisciplinary model to care-as-usual on health related quality of life, client symptomatology, client's perceived need of care, participant satisfaction and cost-effectiveness.

Description:

The TIPP service will consist, at both the London and Thunder bay sites, of: (i) a mental health care nurse (B.Sc.N.) with at least several years experience as an outpatient mental health service clinician, and (ii) a psychiatrist with a license to practice medicine in the Province of Ontario and sensitivity to the issues of family physicians providing mental health services in the community

The TIPP intervention will involve a service delivery that is a modification of the Consultation Liaison in Primary-care Psychiatry (CLIPP) program

Four elements will act in synthesis and enable collaboration between the primary care and TIPP teams:

(i) Co-location of mental health services staff will involve the psychiatric nurse and psychiatrist visiting the family physicians' office at 1 and 3-month intervals, respectively. During these visits they will review and document the client's progress. This empowers the family physician as clinical manager. Treatment plans will be developed for family physicians that can be easily implemented. The family physician will monitor the client's status between the psychiatric nurse and psychiatrist's visits. At times of greater need, and/or impending crisis, increase in contact to every 14 days, with weekly or more from the family physician, and contacts with all providers adjusted to accommodate client needs. By developing linkages with area mental health services the psychiatric nurse will assist the family physician in co-coordinating access, while minimizing redundant use, to these services.

(ii) The TIPP nurse will select, prepare, and facilitate appropriate clients from the outpatient department for transfer to the family physician. The initial transfer process includes a face-to-face meeting with the client, TIPP nurse and family physician in family physician's office. Warning signs and symptoms of an impending relapse will allow for an opportunity for intervention to prevent or lessen the severity of a relapse. For each client a "relapse signature" strategy will be developed by the TIPP nurse to assist the family physician in detecting clients at high risk of mental illness relapse. Having obtained the client's permission significant caregivers will be routinely involved in the development and implementation of a clinical management plan. Standardized CLIPP based contact sheets\data sheets will promote efficient and effective communication between clinical care providers.

(iii) Client monitoring will be maintained by administrative staff support procedures targeted at ensuring a high level of retention and effective client follow up. The family physician will complete a Clinical Global Impression Scale (CGIS) (severity and change scores) every 3 months in the first year then at each visit for the remainder of the project. The CGIS will not add time to the clinical time with the clients. An administrative member of the project receiving these scales will alert the appropriate clinical providers for clients whose condition is not improving as judged by the family physician.

(iv) Telephone back up for the family physicians' whose clients are involved in the project will be provided by a project psychiatrist and/or psychiatric nurse.

The outcomes of the TIPP intervention clients will be compared to those who receive post outpatient service transfer care-as-usual from their family physician. The clients in this group will obtain any and all services normally available inside or outside their primary care service, including re-referral to specialty mental health care. No additional services will be provided for the care-as-usual group, but no usual services will be limited or withheld. Design features to ensure the interests of the control group are considered include outcomes assessment for both groups at 6, and 12 months, as well as at the projects end point. Should significant clinical concerns be noted by the rater during the assessment a systematic process will allow for the family physician to be notified so as to minimize the risk of compromised care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• (1) receiving outpatient psychiatric clinic services through the St. Joseph's Care Group Lakehead Psychiatric Hospital in the Community Mental Health Services program, Thunder Bay, Ontario or at the Regional Mental Health Care, Specialized Adult Service, London, Ontario 2) 18-65 years of age; 3) chronic moderate to severe mental illness - all scores below severe or very severe rating on the Threshold Assessment Grid; 4) duration of mental illness of at least 2 years; 5) not regularly receiving psychiatric or mental health care from another family physician, and; 6)capable of understanding the nature of the project and can give consent.

Exclusion Criteria:

• Clients will be excluded if at the time of recruitment they:

1. have an unstable mental illness;

2. had a psychiatric hospitalization admission within the last past 6 months;

3. used crisis intervention within the past 6 months (requiring subsequent contact greater than once per week);

4. had a history of self-harm over the past 6 months;

5. had a history of harm to others over the past 6 months;

6. had drug and alcohol problems over the past 6 months that would contribute significantly to clinical destabilization;

7. have unmet major psychosocial needs (including homelessness and marked poverty), and;

8. are experiencing a serious medical illness that is unstable and that contributes to instability of mental illness.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Procedure:
• program of care delivery

Locations

Country	Name	City	State
Canada	St. Joseph's Care Group Lakehead Psychiatric Hospital	Thunder Bay	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Ontario Ministry of Health and Long Term Care, St. Joseph's Care Group, St. Joseph's Health Care London

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Well Being
Secondary	Symptomatology
Secondary	Perceived need for care
Secondary	Satisfaction
Secondary	Cost Effectiveness