Implementation and Evaluation of Primary Care Behavioral Health in Sweden
- Conditions
- Life StressPsychological DistressMental Health DisorderLife Style Induced Illness
- Interventions
- Behavioral: Care As Usual (CAU)Behavioral: Brief Interventions (BI)
- Registration Number
- NCT05335382
- Lead Sponsor
- Linnaeus University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 666
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed implementation of PCBH Care As Usual (CAU) PCCs randomized to this arm will have a delayed start of their PCBH implementation, waiting between 5-9 months. During this time, the same patient-level and organizational-level data will be collected from these centers while they continue to use traditional primary care / Care As Usual (CAU) . Implementing PCBH directly Brief Interventions (BI) PCCs randomized to this arm will immediately start the implementation of PCBH.
- Primary Outcome Measures
Name Time Method WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains) Change during the period Pre, Week 4, Week 8, and Week 12 The eight items constituting the four domains of Life activities, Cognition, Getting along, and Participation in the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.
Waiting time until first appointment From documented identification/self-referral to documented first visit at PCC (up to 6 months after identification) Waiting time from the patient contacting their PCC with a behavioural health concern to being seen by a physician or psychosocial resource among patients in the study
- Secondary Outcome Measures
Name Time Method Third next available appointment (TNAA) Measured each week from implementation to up to 2 years Waiting time until next available appointment for a third hypothetical patient that calls in on a given day for every clinician at the PCC, measured on the same time every week (e. g. Mondays at 9 AM), a measure of access to and and availability of care that is independent of patients own ability to show up at an offered time.
Generalized Anxiety Disorder 2-item (GAD-2) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year GAD-2 consists of two questions from the GAD-7. This will be administered as part of the GAD-7 on the above mentioned time points, and will replace the GAD-7 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.
Short Health Anxiety Inventory 3-item (SHAI-MINI-3) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of health anxiety are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 9 points. A lower score means less symptoms of health anxiety. As such, a lower score is a better outcome.
Description of Behavioral Health Plan (PCBH) as structured note by clinician in medical record Week 12 Interview form.
Patient recollection of plan/goal/methods, descriptions of behaviour changes made Week 12 Interview form.
Generalized Anxiety Disorder 7-item (GAD-7) Change during the period Pre, Week 12 and 1 year The full version of a well-validated scale for measuring anxiety symptoms. GAD-7 total score for the seven items ranges from 0 to 21. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.
Insomnia Severity Index 2-item (ISI-MINI-2) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of sleep disorders are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less sleep problems. As such, a lower score is a better outcome.
Patient-rated perception and attitude toward care provider Week 12 9-items previously used in PCBH-settings (self-report), and four items from the Client Satisfaction Questionnaire (CSQ). The scale ranges from 0 to 57 points. A lower score means less satisfaction with care. As such, a higher score is a better outcome.
Long-term WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains) Change during the period Pre, Week 4, Week 8, Week 12, and 1 year The same as Primary Outcome, but with a long-term time-frame. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (2 domains) Change during the period Pre, Week 12 and 1 year The two domains of Mobility and Self-care will be measured and the whole WHODAS will be used in some secondary analyses, but not for the primary outcome since these domains tend to form two independent factors, many patients will have initial adequate function in these domains and they are not expected to change much. The scale ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.
Social Phobia Inventory - Abbreviated version (Mini-SPIN) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Social anxiety symptoms are measured with a very short version of a well established patient-rated scale for social phobia. The scale ranges from 0 to 12 points. A lower score means less symptoms of social anxiety. As such, a lower score is a better outcome.
The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of alcohol misuse are measured with a very short version of a well established patient-rated scale for alcohol misuse. The scale ranges from 0 to 12 points. A lower score means less symptoms of alcohol misuse. As such, a lower score is a better outcome.
Pain One-item Rating Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Pain is measured on a scale from 0 to 10, where 0 is no pain and 10 is worst pain imaginable. As such, a lower score is a better outcome.
Total symptom index Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Also, a total index for level of symptoms will be calculated from all symptom items, where different weights will be used to balance the different number of questions for different domains, for example to avoid the larger number of items related to anxiety to overshadow depression ratings. The scale ranges from 0 to 20 points. A lower score means less mental health symptoms overall. As such, a lower score is a better outcome.
Brunnsviken Brief Quality of Life Questionnaire (BBQ) Change during the period Pre, Week 12 and 1 year Quality of life will be measure be the 12-item Brunnsviken Brief Quality of life (BBQ-12), asking about importance and fulfilment of six areas (e.g. spare time quality, creative work, and friendship). The scale ranges from 0 to 96 points. A lower score means lower quality of life. As such, a higher score is a better outcome.
Adverse Events-3 Week 4, Week 8 3 items asking patients to detail any adverse events that occurred as a result of treatment.
Patient Health Questionnaire 9-Item (PHQ-9) Change during the period Pre, Week 12 and 1 year The full version of a well-validated scale for measuring depressive symptoms. PHQ-9 total score for the nine items ranges from 0 to 27. A lower score means less depressive symptoms. As such, a lower score is a better outcome.
Patient Health Questionnaire 2-Item (PHQ-2) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year PHQ-2 consists of two questions from the PHQ-9. This will be administered as part of the PHQ-9 on the above mentioned time points, and will replace the PHQ-9 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less depressive symptoms. As such, a lower score is a better outcome.
Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of panic attacks are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less symptoms of panic disorder. As such, a lower score is a better outcome.
Perceived Stress Scale (PSS-MINI-2) + 2 new questions Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Stress symptoms are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. To increase face validity of the very short scale, we also added two more direct questions ("Have you been feeling stressed lately?", "Have you been feeling tense lately?"). The scale ranges from 0 to 16 points. A lower score means less stress symptoms. As such, a lower score is a better outcome.
Outcome Rating Scale (ORS) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year The ORS is a four-item measure designed to assess areas of life functioning known to change as a result of therapeutic intervention. These include symptom distress, interpersonal well-being, social role, and overall well-being, measured by four visual analogue scales. The scale ranges from 0 to 40 points. A lower score means lower satisfaction with life areas. As such, a higher score is a better outcome.
Session Rating Scale (SRS) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year The Session Rating Scale (SRS) is a four-item visual analogue scale designed to assess key dimensions of effective therapeutic relationships. These include respect and understanding, relevance of the goals and topics, client-practitioner fit and overall alliance. The scale ranges from 0 to 40 points. A lower score means lower ratings of the therapeutic alliance. As such, a higher score is a better outcome.
Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause Week 12 Interview form.
Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from the Swedish questionnaire 'självskattat utmattningssyndrom' (s-UMS) ['self-rated burnout-syndrome'] Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of stress-related exhaustion are measured with a very short version of a well established patient-rated scale and has been created by an expert group, who chose three representative questions from the original KEDS scale. To aid with diagnostics, two confirmatory questions from the Swedish s-UMS scale were added, asking for duration and presumed cause of symptoms. The scale ranges from 0 to 18 points. A lower score means less symptoms of stress-related exhaustion. As such, a lower score is a better outcome.
Obsessive Compulsive Disorder 3-Item (OCD-3-MINI) Change during the period Pre, Week 4, Week 8, Week 12 and 1 year Symptoms of obsessive compulsive disorder are measured by a very short patient-rated scale and has been created by an expert group. The scale ranges from 0 to 12 points. A lower score means less obsessive/compulsive thoughts and behaviors. As such, a lower score is a better outcome.
Adverse Events-9 Week 12 9 items asking patients to detail any adverse events that occurred as a result of treatment.
Well-being Behaviors Change during the period Pre, Week 12 and 1 year 11 items asking patients how often (number of days each week) they engage in behaviors related to maintaining physical and mental well-being, such as physical exercise and having adequate sleep hygiene. The first 10 items are summarized as an average where 0 is minimum and 7 is maximum. Higher scores indicate more well-being behaviors and better outcome.
Trial Locations
- Locations (17)
Närhälsan Sannegården Vårdcentral
🇸🇪Göteborg, Sweden
Närhälsan Solgärde Vårdcentral
🇸🇪Kungälv, Sweden
Närhälsan Tjörn Vårdcentral
🇸🇪Kållekärr, Sweden
Närhälsan Ågårdsskogen Vårdcentral
🇸🇪Lidköping, Sweden
Närhälsan Mellerud Vårdcentral
🇸🇪Mellerud, Sweden
Närhälsan Munkedal Vårdcentral
🇸🇪Munkedal, Sweden
Närhälsan Stenungsund Vårdcentral
🇸🇪Stenungsund, Sweden
Närhälsan Källstorp Vårdcentral
🇸🇪Trollhättan, Sweden
Närhälsan Hjällbo Vårdcentral
🇸🇪Angered, Sweden
Närhälsan Bollebygd Vårdcentral
🇸🇪Bollebygd, Sweden
Närhälsan Dalsjöfors Vårdcentral
🇸🇪Dalsjöfors, Sweden
Närhälsan Mösseberg Vårdcentral
🇸🇪Falköping, Sweden
Närhälsan Oden Vårdcentral
🇸🇪Falköping, Sweden
Närhälsan Gråbo Vårdcentral
🇸🇪Gråbo, Sweden
Närhälsan Eriksberg Vårdcentral
🇸🇪Göteborg, Sweden
Närhälsan Gibraltargatan Vårdcentral
🇸🇪Göteborg, Sweden
Närhälsan Majorna Vårdcentral
🇸🇪Göteborg, Sweden