Clinical trial NCT05335382: Implementation and Evaluation of Primary Care Behavioral Health in Sweden
Official title: Implementation and Evaluation of Primary Care Behavioral Health in Sweden - A Cluster Randomized Design for Superiority and Non-superiority Comparisons of Effects on Patient Reach, Availability, Costs, Sick-leave, Model Fidelity, and Patients' Everyday Function, Symptoms, and Experiences
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychological Distress
Life Style Induced Illness
Life Stress
Mental Health Disorder
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: The Kamprad Family Foundation for Entrepreneurship, Research & Charity
name: Karolinska Institutet
name: Capio Group
First posted: 2022-04-19
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary care centers are cluster randomized between implementing PCBH directly or implementing later. Patients seeking care at each PCC are not individually randomized, but are given the form of care that is currently offered at their PCC (pre- or post-implementation).
Primary purpose: TREATMENT

Brief summary: In this multicenter study, the investigators want to compare treatment outcomes for patients with mental and behavioral health problems in traditional primary care (Care As Usual, CAU) and primary care centres that work according to the Primary Care Behavioral Health (PCBH) model. In addition to this, the investigators want to study organisation-level outcomes, such as access to care, perceived teamwork and work environment. To achieve this, primary care centres that have expressed interest in implementing PCBH will be cluster randomised between implementing directly or waiting for implementation.

Detailed description: The overarching goal of primary care is to offer all patients individualised and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that a large proportion of patients suffer from mental and behavioural health problems, alone or in combination with one or several chronic illnesses. Despite many patients needing psychosocial interventions, there is a lack of mental health professionals as well as clear pathways for these patients.

Primary Care Behavioral Health (PCBH) is an innovative way of organising primary care, where mental health professionals have more yet shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients achieve relevant behavioral changes, so called brief interventions are used, which are based on isolated components from psychological treatments such as Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Brief interventions usually stretch over 1-4 treatment sessions. Assessments within the model are generally contextual and largely avoid psychiatric diagnostics, instead focusing on the patient's situation and their associated coping strategies - whether they be positive or negative. Although PCBH is gaining in popularity, recent reviews conclude that among the evaluation trials there are very few comparative studies. As such, there is a great need for proper evaluation of a method that is already widely implemented.

Data will be collected at 17 primary care centers (PCCs) in Västra Götalandsregionen, Sweden, that have expressed an interest in implementing PCBH. The study is looking at both patient and organizational level variables. The PCCs will be randomized between implementing PCBH immediately (December 2021) or delayed with 5-9 months (implementation in late spring or early autumn of 2022). Outcome data will be collected also from the PCCs waiting for implementation, while they apply Care as Usual (CAU). Collection of patient self-ratings will start before the first implementation of PCBH to ensure functional data collection routines and possibly create a longer baseline, but the main analysis will use data from the period from when PCCs in the Early implementation arm actually have implemented PCBH to a good enough level and until PCCs in the control group start their implementation. Data from all PCCs will be continuously be collected also during the period when the delayed group implements PCBH. For individual patients, the primary end-point for the primary outcome (everyday functioning) will be 12 weeks after the first visit. Patient outcomes are also measured after 1 year.

Outcome at the organizational level will be measured in several ways, and here the primary outcome will be two measures of waiting time between identification of patient (i.e. them self-referring for mental or behavioral health issues) and the first visit: (a) actual waiting-time and (b) Outcome at the organizational level will be measured in several ways, and here the primary outcome will be two measures of waiting time between identification of patient (i.e. them self-referring for mental or behavioral health issues) and the first visit: (a) actual waiting-time for each patient identified as relevant for inclusion and (b) Third Next Available Appointment (TNAA) for the PCC as a whole, measured at the same day and time each week.

Fidelity will be measured by an expert group as well as using four questionnaires, one for each of mental health professionals, medical doctors, registered nurses and leadership. Implementation data will also be collected from these professional groups/roles at the implementing PCCs, for example with the s-NoMAD questionnaire.

During the implementation process, all psychosocial resources (all relevant psychologists, social workers, psychotherapists and so on) will be trained in the PCBH model during 3 days. The psychosocial resources are required to already be equipped with basic training in psychotherapy, for example in CBT or psychodynamic therapies. All training will be followed up with six 4-hour group supervision sessions. PCC leaders, doctors and nurses will be included in the supervision when a need to work on inter-professional issues arises and might also receive some separate, extra supervision for up till 10 h in total if necessary. In addition to this, all PCCs will go through a half-day training of all clinical personnel at the PCC, of which 2 hours is set aside with an implementation group where all professions at the PCC are represented.

The overall main research question is:

1. Is PCBH superior to traditional primary health care in yielding the best patient outcomes regarding level of functioning (primary outcome) and symptoms, reaching the most patients, and reducing wait-times and costs?

   Secondary research questions include:
2. Is (1) true also for the sub-group of complex patients with somatic/mental comorbidities and social difficulties?
3. Is PCBH superior to traditional primary care in reducing objectively measured sick-leave? Is this, and level of functioning and symptoms, moderated by which intervention is given within PCBH? Is this true also for the sub-group of complex patients? Is this subgroup also reached by behavioral health interventions more than in traditional primary care?
4. Does the implementation of PCBH result in lower levels of prescribed pharmacological treatment for depression, anxiety, sleep, and pain?
5. What changes to group and organizational variables like teamwork, knowledge about and respect for other professions, clinical knowledge about behavior health and work environment satisfaction occur after the implementation of PCBH?
6. How does the level of fidelity, acceptability and implementation quality affect patient and implementation outcomes? Do these variables moderate results in all above research questions?
7. Which obstacles and facilitators are observed during implementation of PCBH? What factors influence fidelity and health care personnel satisfaction with PCBH?

PCBH has the potential to increase the quality and access of care for many patients with mental and behavioural health problems. This study is the first to step towards answering whether or not the effects of PCBH are large enough to merit large-scale implementation.

Eligibility criteria: Inclusion Criteria:

* All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.

Exclusion Criteria:

* Does not speak Swedish well enough to fill out questionnaires.
* Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.

Primary outcomes:
measure: WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
timeFrame: Change during the period Pre, Week 4, Week 8, and Week 12
measure: Waiting time until first appointment
timeFrame: From documented identification/self-referral to documented first visit at PCC (up to 6 months after identification)
Secondary outcomes:
measure: WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (2 domains)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Third next available appointment (TNAA)
timeFrame: Measured each week from implementation to up to 2 years
measure: Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Patient Health Questionnaire 2-Item (PHQ-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Generalized Anxiety Disorder 2-item (GAD-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Social Phobia Inventory - Abbreviated version (Mini-SPIN)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from the Swedish questionnaire 'självskattat utmattningssyndrom' (s-UMS) ['self-rated burnout-syndrome']
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Perceived Stress Scale (PSS-MINI-2) + 2 new questions
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Insomnia Severity Index 2-item (ISI-MINI-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Short Health Anxiety Inventory 3-item (SHAI-MINI-3)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Pain One-item Rating
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Total symptom index
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Brunnsviken Brief Quality of Life Questionnaire (BBQ)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Outcome Rating Scale (ORS)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Session Rating Scale (SRS)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Patient-rated perception and attitude toward care provider
timeFrame: Week 12
measure: Description of Behavioral Health Plan (PCBH) as structured note by clinician in medical record
timeFrame: Week 12
measure: Patient recollection of plan/goal/methods, descriptions of behaviour changes made
timeFrame: Week 12
measure: Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause
timeFrame: Week 12
measure: Adverse Events-9
timeFrame: Week 12
measure: Adverse Events-3
timeFrame: Week 4, Week 8
measure: Well-being Behaviors
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Long-term WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12, and 1 year
Other outcomes:
measure: Change during the period Pre, Week 12 and 1 year
timeFrame: Pre, Week 12, 1 year
measure: Availability of bookable appointments
timeFrame: Monthly from study start up to 2 years
measure: Future capacity
timeFrame: Monthly from study start up to 2 years
measure: Number of visits and phone / video contacts during treatment duration
timeFrame: All visits during Pre-Week 12
measure: Percentage of patients presenting with a new primary reason for visit or more than 6 months since last visit
timeFrame: Pre, 6 months, 1 year
measure: The number of patients seen per full time equivalent mental health professional for at least one visit in relation to all patients listed at the PCC
timeFrame: Pre, 6 months, 1 year
measure: The number of patients seen per full time equivalent mental health professional for at least one visit in relation to all patients with an ICD-10 diagnosis of F10-99, R40-45 or Z55-65
timeFrame: Pre, 6 months, 1 year
measure: PCBH Fidelity: Integrated Behaviours in Primary Care - Psychosocial Resource Edition (IBPC-PSR)
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: PCBH Fidelity: Levels of Integration Measure, Swedish version (S-LIM)
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: PCBH Fidelity: Integrated Behaviours in Primary Care - Registered Nurse Edition (IBPC-RN)
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: PCBH Fidelity: Integrated Behaviours in Primary Care - GP Edition (IBPC-GP)
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Attitudes to brief interventions
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Implementation success of PCBH
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Average number of completed visits per day to psychosocial resources
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Percentage of patients seen for more than 4 visits
timeFrame: At 1 year follow-up after implementation of PCBH
measure: Number of canceled visits and no-shows
timeFrame: At 1 year follow-up after implementation of PCBH
measure: Percentage of patients referred to specialized care, such as psychiatry or private therapy
timeFrame: At 1 year follow-up after implementation of PCBH
measure: Changes in personnel turnover rates
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Changes in number of working days with vacant positions
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Changes in number of working days covered by temporary general practitioners and nurses
timeFrame: At implementation of PCBH and 6 months and 1 year after that
measure: Subscales Meaning of Work, Work Life Conflict, Quality of Work, Work Engagement, Quantitative Demands and Sense of Community at Work from the Copenhagen Psychosocial Questionnaire III (COPSOQ-III)
timeFrame: At implementation of PCBH and 6 months and 1 year after that
Locations:
city: Angered
country: Sweden
facility: Närhälsan Hjällbo Vårdcentral
city: Bollebygd
country: Sweden
facility: Närhälsan Bollebygd Vårdcentral
city: Dalsjöfors
country: Sweden
facility: Närhälsan Dalsjöfors Vårdcentral
city: Falköping
country: Sweden
facility: Närhälsan Mösseberg Vårdcentral
city: Falköping
country: Sweden
facility: Närhälsan Oden Vårdcentral
city: Gråbo
country: Sweden
facility: Närhälsan Gråbo Vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Eriksberg Vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Gibraltargatan Vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Majorna Vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Sannegården Vårdcentral
city: Kungälv
country: Sweden
facility: Närhälsan Solgärde Vårdcentral
city: Kållekärr
country: Sweden
facility: Närhälsan Tjörn Vårdcentral
city: Lidköping
country: Sweden
facility: Närhälsan Ågårdsskogen Vårdcentral
city: Mellerud
country: Sweden
facility: Närhälsan Mellerud Vårdcentral
city: Munkedal
country: Sweden
facility: Närhälsan Munkedal Vårdcentral
city: Stenungsund
country: Sweden
facility: Närhälsan Stenungsund Vårdcentral
city: Trollhättan
country: Sweden
facility: Närhälsan Källstorp Vårdcentral
Study officials:
affiliation: Linnaeus University, Karolinska Institutet
name: Viktor Kaldo, Professor
role: PRINCIPAL_INVESTIGATOR
References: