Development and evaluation effectiveness of interprofessional service package for promoting social participation of patients with Severe Mental Disorders (BARAMA): A protocol for mixed methods study

Abstract

BACKGROUND:

Mental disorders are the leading cause of disability worldwide. This disability is more important in patients with severe mental disorders due to the gradual onset and progression, tendency to relapse, and reduced functioning. Considering these factors affect reentry of these patients into society, social participation is an important issue in most countries. For this purpose, this study will be carried out with the aim of developing and evaluation effectiveness of an interprofessional service package for promoting social participation of patients with severe mental disorders (SMD).

METHODS:

This mixed-methods sequential exploratory study will be conducted in three phases. In the first phase, analysis the situation will be done through literature review and interviews with patients, family caregivers, and mental health professionals. At the end of this phase components the initial draft of the service package will be designed. In the second phase, the final version of the service package will be determined through Delphi method. In the third phase, effectiveness of implementing the service package for promoting social participation of SMD patients will be evaluated by conducting a Randomized Controlled Trial (RCT) study (42 patients in each group). Data gathering tools will be ICF-APP and (WHOQOL-BREF) instruments in the time intervals of one week, 8 weeks and three and six months after being discharged from psychiatric wards. Data will be analyzed by using t-test and ANOVA through IBM SPSS Statistics, Version 26.0.

CONCLUSION:

Implementing this service package and its integration into decision-making and policymaking processes will take a significant step toward improving the quality of life for individuals with mental disorders and their caregivers after discharge from psychiatric wards.

Background

Mental disorders are among the leading causes of disability worldwide. According to recent research, the global prevalence of psychiatric disorders ranges from 11% to 23.8% across different populations,[1,2] and adults suffer from these diseases by 12.6% to 48.6%.[1] In addition, the one-year prevalence of psychiatric disorders ranges from 3.4% to 26.4% globally, with the highest rates reported in the Eastern Mediterranean region, ranging from 15.6% to 35.5%.[3] In Iran, studies show that about 7 million people are suffering from some kind of psychiatric disorder, and the results of a survey showed that 31.03% of the Iranian population is suffering from some kind of psychiatric disorder.[4,5] Mental disorders vary in severity and range, from mild disorders in the patient’s thinking and/or behavior to more severe mental disorders (SMD), such as schizophrenia, bipolar disorder, and depression with psychotic features. SMD represents a group of psychotic disorders with non-organic origins that are both stable (i.e., treatment duration of 2 years or more) and lead to significant functional impairment.[1]

Patients with SMD, diagnosed with schizophrenia or mood disorder, often experience a complex and distressing period of illness characterized by severe and sometimes debilitating symptoms, including delusions, hallucinations, and social withdrawal.[5] These patients are at high risk of recurrence and have significant disabilities in social, family, and occupational functioning, even after controlling for acute episodes and partial improvement of symptoms.[6] While the effectiveness of drugs in controlling symptoms of psychosis has caused many patients to live in society, the reality is that drugs cannot create and promote coping skills that patients need to enter society, lonely.[7]

In addition to the individual, family, and social dysfunction of SMD patients, the burden of these disorders on society is really important, in such a way that the World Economic Forum has estimated that by 2030, suffering from mental disorders will constitute more than half of the world’s economic burden attributed to non-communicable diseases.[8] In general, this group of patients is at higher risk of poverty, unemployment, and poor housing conditions, which negatively affect social participation of these patients and lead to the worsening of their disease status. In this situation, experts and politicians are making efforts to improve the social consequences related to this group.[9]

Chang et al.[10] presented a conceptual model of social participation, based on that, the definition of participation is “engagement in life situations”, which is according to the World Health Organization’s International Classification of Functioning, Disability and Health (ICF). Chang’s model includes participation in the areas of social life (for example, participating in social groups and maintaining contact with family and friends), leisure time (such as going to the club, cinema, restaurant), and the area of productive activities (participating in learning activities and work for wages). In another research, social participation is defined as engaging in activities and jobs with or without pay and other daily activities such as education, which leads to facilitate the rehabilitation process of these patients.[6] Promotion of social participation leads to improvement of self-esteem, increased feeling of self-efficacy, reduced severity of symptoms, higher quality of life, and improvement in the SMD patients’ rehabilitation process.[11,12] Burns-Lynch et al.[6] found a positive relationship between higher levels of rehabilitation and well-being of SMD patients, and the number of days of participation (intensity of participation) and the range of participation (extent of participation). They concluded that a greater number of participations in the range that patients considered important and indicated a desire was associated with their higher rehabilitation and well-being.[6] In another study, most people with chronic psychiatric disorders, 50-60%, tend to work and other daily activities, and this statistic reaches 97% in some other studies, but these patients often have fewer opportunities for social participation.[10] In this regard, the action planning of the World Health Organization (2013-2030) specifically emphasizes the need to implement comprehensive, integrated and responsive mental health services and social care services in community-based centers so that “people affected by these disorders can enjoy what is called human rights and access to high-quality and culturally appropriate health and social care in a way that leads to promote rehabilitation process and they can reach the highest possible level of health and full participation in society free from stigma and discrimination.[13] In Iran, according to the executive regulations of the third plan of economic, social, and cultural development, a headquarters should be established for SMD patients that adopts a coordinated, coherent, and integrated manner to provide all services at the level of prevention, treatment, and rehabilitation of these patients. The purpose of rehabilitation is to provide all the necessary services in order to empower SMD patients to achieve an independent and self-sufficient life, which includes medical, psychological, social, and professional rehabilitation.[14] However, despite concerted efforts of various departments to develop measures that can enable SMD patients to participate in society, these patients are still marginalized in society.[15]

Considering the frequency of SMD recurrence and re-hospitalization of SMD patients, on the one hand, and evidence, confirming the role of interprofessional cooperation in improving patients’ participation in society,[15,16,17] on the other hand, the need to design and implement a service package that helps patients to have a social and independent life is perceived. So, this study will be conducted with the aim of developing and evaluating the effectiveness of an interprofessional service package for promoting social participation of SMD patients (BARAMA).

Materials and Methods

This mixed-methods sequential exploratory study will be conducted in three phases with the permission of the Ethics Committee of Isfahan University of Medical Sciences in Isfahan, Iran. In the first phase, an analysis of the situation will be done through literature review and interviews with patients, family caregivers, and mental health professionals. At the end of this phase components the initial draft of the service package will be designed. In the second phase, the final version of the service package will be determined through Delphi method. In the third phase effectiveness of the service package for promoting social participation of SMD patients will be evaluated by conducting a Randomized Controlled Trial (RCT) study [Figure 1].

Figure 1.

Flow diagram illustrating mixed methods approach to the development and evaluation the service package

First Phase: Designing the Initial Draft of the Social Participation Service Package for SMD Patients

Aim

This stage will be aimed at analyzing the situation through literature review and interviews with patients, family caregivers, and mental health professionals.

Literature review

Reviewing guidelines and protocols will help to investigate the needs, challenges, obstacles, and possible solutions in the field of social participation of SMD patients after discharging from the psychiatric wards. For this purpose, a matrix of the keywords “social participation”, “community participation”, “severe psychiatric disorder patient”, “community-based”, “social networks”, “psychosocial support”, “follow-up”, and “post-discharge” by using AND, OR Boolean operators, as well as quotation marks and star sign will be used. In this review, databases, ProQuest, Cochrane, Library, PubMed, UpToDate, ScienceDirect, Scopus, Ovid, Springer, and Medline will be evaluated. In this review and evaluation, English protocols and guidelines with full text accessibility and without time limitation will be studied.

Interview

Interviews with patients, family caregivers, and mental health professionals will be done for having a comprehensive view of patients’ needs for social participation, strengthening factors and barriers to patients’ participation in society after discharge from psychiatric wards.

Participants and settings

In this phase, participants will be SMD patients and their family caregivers, psychiatric nurses, psychiatrists, psychologists, occupational therapists, social workers, and mental health policymakers. The inclusion criteria for patients will include diagnoses of one of the mental disorders (mood, anxiety, schizophrenia, and bipolar disorders) based on mental status examination and psychiatrist approval according to DSM-5-TR, being able to communicate and interview, living with family, and not having a substance-induced mental disorder will be included in the study. Also, family caregivers with characteristics like lacking psychiatric diseases and caring for one psychiatric patient in the family will participate in the study. The inclusion criteria for mental health service providers will include psychologists, psychiatric nurses, psychiatrists, occupational therapists, social workers, and policymakers with at least 5 years of work experience.

Data collection

Participants will be selected using the purposeful sampling method. Research environment will be psychiatry wards of hospitals affiliated to Isfahan University of Medical Sciences, including Farabi and Khorshid hospitals, and the mental health office of the health department of the province and the rehabilitation department of the welfare organization of Isfahan province. The researcher will obtain informed consent from participants, and the time and place of the interview will be arranged with them. The semi-structured interview will continue until the saturation of the data occurs, and simultaneous analysis enables access to key people for the next interview, which will result in richer information. Saturation occurs when no new information is obtained during the data analysis and coding process. Data collection process will be done for patients and their families, upon interview individually, and for mental health professionals as a focus group. Some of the interview guide questions for SMD patients include “What things are you self-sufficient in or need support to do?”, “What is your plan after being discharged from the hospital?” and about family caregivers, “How do you think patients can continue their activities after being discharged from the psychiatric ward? What is your role in that?”, “What do you want to know about interaction with these patients after discharge?”, “What social and supporting resources are you familiar with? What conditions do you think should be provided in this field?” and finally, Mental health professionals include “How is the service provision infrastructure in the country for providing social services after discharge?”, “What are the opportunities and challenges in the field of re-entering patients into society after being discharged from psychiatric wards?”.

Data analysis

These data will be inductively analyzed using content analysis, a conventional type. Data analysis will be done simultaneously with the data collection. In this way, after recording each individual interview, the researcher will listen to the interviews several times and write them down verbatim. Then the texts will be read line by line, and important sentences and phrases will come in the form of a compact semantic unit. After that, each semantic unit will be coded with a shorter phrase, and then similar codes will be merged, and more comprehensive and abstract sub-sub categories will be formed. Then, sub-sub-categories will form sub-categories, and then the main categories will appear. The data will be analyzed through MAXQDA. the data will be examined based on Guba and Lincoln’s criteria.[18] To ensure the credibility of the study, in-depth interviews at different times and places, selection of participants with maximum variety, peer debriefing, and member checking will be used. To ensure the dependability of the findings, all the activities and steps of the work will be described in detail. Also, the external observer will be used to check his/her possible similar understanding with the researchers and search for discrepancies. To confirm the transferability, the research results will be presented to four people with the profiles of the participants who did not participate in the research. For conformability, the extracted codes will be given to several faculty members who are familiar with the method of qualitative research analysis and did not participate in the research team, so that the correctness of the coding and class extraction process can be checked.

Second Phase: Delphi Method

Aim

This phase will be aimed at emerging the information obtained from the previous step. The expert’s consensus about the final version of the service package will be done through Delphi method.

Participants and settings

Participants in this phase will be psychiatric nurse, psychologist, mental health office manager of the health deputy, rehabilitation manager deputy of the welfare organization, psychiatrist, social worker, and occupational therapist. The inclusion criteria will be at least 5 years of work experience in the field of providing care and treatment for SMD patients and completing informed consent to participate in the sessions.

Data collection and analysis

At this stage, the initial draft of the service package for promoting social participation of SMD patients will be confirmed and validated. In the first round, the researcher-made checklist, based on the priorities in the previous stage, will be provided through email. The applicability of the service package will be evaluated by using this checklist, which will be rated on a scale of 1–9. The mean score of 7 to 9 will be labeled as “appropriate”, the mean score of 1–3, “inappropriate”, and the mean score of 4–6, “undetermined”. Also, experts will be allowed to add recommendations to this list, based on their own knowledge and experience. Data will be analyzed using IBM SPSS Statistics, Version 26.0.

In the second round, after coordination and sending invitations to the experts, the panel members will come together with the research team in a meeting and will hold a group discussion. The experts will discuss the scoring of each recommendation, especially on the uncertain scores. The focus will be on the conflicting cases, and there is an opportunity to revise services, and the final decision will be made. In the end, considering the conclusions of the experts’ opinions and performing necessary revisions, the final version of the interprofessional service package for promoting social participation of SMD patients will be developed. The checklist will be designed from the service packages recommendations, with a score of feasibility of recommendation of 0 to 100. Recommendations that achieve a score above 70% are unchanged in the service packages, and recommendations that score below 70% are reviewed by experts.[19]

In conclusion, through the first and second rounds of the Delphi process, a series of measures will be designed to enhance the social participation of SMD patients based on follow-up periods would be set at one week, eight weeks, three months, and six months after discharge. These measures will be implemented in collaboration with a charitable organization specializing in rehabilitation services. The planned interventions will consist of interprofessional group-based educational interventions for the patients and their caregivers, as well as referral services for these clients to facilitate their greater presence in society, enable them to benefit from urban services as citizens, and improve their access to counseling services in the city during the time intervals, will be determined by expert consensus.

Third Phase: A Randomized Field Trial Study

Aim

In this part, researchers will evaluate the effectiveness of implementing a service package for promoting social participation of SMD patients, by conducting an RCT study.

Participants and setting

This study will be a 1:1 parallel cluster RCT with a duration of 6 months. Study population will consist of all patients with severe psychiatric disorder who are hospitalized in one of the psychiatric wards of Farabi and Khorshid hospitals, and meet the inclusion criteria include willing to participate in the study, age 20–55 years, not suffering from chronic physical diseases, no mental retardation, reading and writing literacy, having psychiatric disorders (schizophrenic, mood, bipolar or anxiety) according the mental status examination and psychiatrist approval based on DSM-5-TR, not being in the acute phase of the disease, being able to participate in educational sessions, living in Isfahan city and not having substance-induced mental disorder. The exclusion criteria will include unwillingness to be followed by the center and participate in the study. The research environment will be the support and care center for Iranian terminally ill patients (Iranian HAMD Charity Foundation). This center, with the permission of the Iranian Ministry of Health, aims to increase the quality of life of patients with incurable diseases and their families. In this regard, in order to improve their quality of life, a series of physical, psychological, social, and spiritual support and care is provided.

Sample size

Samples estimated by considering mean difference and reliability of 95% (1.96), power of 80% (0.84), minimum acceptable difference of 0.61 s, 12% possibility of sampling attrition.[20] So, 48 patients will be allocated to each of the intervention and control group. The sampling method will be done conveniently at first, and then samples will be allocated to the intervention and control groups randomly.

Recruitment

Patient’s eligibility assessment will be performed by the Ph.D. candidate of nursing, and informed consent will be obtained from eligible patients. After determining the eligible patients, the study objectives and the way of participating in the study will be explained to the patients who accept the invitation. During the interview, the levels of social participation and quality of life of patients will be evaluated using validated questionnaires. The representative of the Ethics Committee of the Isfahan University of Medical Sciences will supervise all stages of the research and will decide to end the trial.

Sampling and data collection

After determining the eligible patients and giving Oral and written information about the study and the informed consent form, assessment of social participation restriction (Mini-ICF-APP¹) and quality of life (WHOQOL-BREF²) Questionnaires will be completed by the researcher, interviewing with the patients and their caregivers. Participants will be allocated to the intervention and control groups based on the random number table. Researchers will register patients, eligible with inclusion criteria, in the Iranian HAMD Charity Foundation system upon discharge from the psychiatric ward. Also, the psychosocial assessment checklist of each patient, eligible to enter the study, will be completed by the interprofessional team consisting of a psychologist, nurse, psychiatrist, occupational therapist, and social worker during the patient’s hospitalization.

Intervention

The intervention will begin with the researcher’s telephone follow-up a week after discharge from the psychiatric ward in the HAMD center. In the intervention group, the researcher will plan a related service package intervention based on the level of social participation from Mini-ICF-APP, which will be obtained upon discharge from the hospital, for each patient. Group training for patients and their family caregivers, counseling and referring will be done for patients in the intervention group by an interprofessional team in the HAMD center. The number, duration, and intervals of the sessions for the intervention group will be set identically. It is estimated that the training program will be scheduled for 6 groups, and for each group, twice a week. In the control group, telephone follow-up will be done routinely according to the follow-up nursing protocol.[21] Researchers will bear the intervention and transportation costs for intervention groups. Participants should not participate in any other research or psychotherapy programs during the intervention. The research is expected to proceed without any harm; however, in case of harm, the main researcher will be responsible for compensating for the reparable harm.

Outcomes

The outcome will be the level of patients social participation and quality of life and the magnitude of their change at three time points for both groups and based on related protocol and guidelines[22,23]: one week after discharge (t₁), 8 weeks after discharging (t₂), 3 months after discharging (t₃) and 6 months after discharging (t₄) from psychiatry wards. Figure 2 shows the study flow based on the Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

Figure 2.

The study flow based on the Consolidated Standards of Reporting Trials (CONSORT) flow diagram

Data collection tools

The data collection tool will be ICF-APP in the time intervals, which will be determined. It is an instrument for the assessment of psychosocial functioning in people with mental health problems, regardless of the type of diagnosis. Also, it describes and classifies disorders of activity and capacity, which may lead to restrictions in social participation.[24] This instrument was designed in Germany, and its validity and reliability have been confirmed.[25] Molodynski et al.[26] also showed the good validity and reliability of this tool in community-based mental healthcare centers in England. In a pilot study with 40 Iranian individuals, the questionnaire showed good internal consistency (Cronbach’s alpha = 0.85) and acceptable validity. The mini-ICF-APP consists of thirteen items, each one evaluating one capacity or domain of functioning: (1) adherence to regulations and routines; (2) planning and structuring of tasks; (3) flexibility; (4) competency/efficacy; (5) endurance; (6) assertiveness; (7) contact with others; (8) group integration; (9) family and intimate relationships; (10) leisure activities; (11) self-care; (12) mobility; and (13) competence to judge and decide. scoring this instrument is based on the five-point Likert scale from 0 (no disability) to 4 (total disability). The sum score of the mini-ICF-APP ranges from 0 to 52 points, with cut-off values defining severity: mild from 3 to 7 points; moderate from 8 to 15 points; marked from 16 to 24 points; severe from 25 to 37; and extremely severe 38 or more points.[27]

Another dependent variable will be WHOQOL-BRFE with 26 items, measuring the physical health, psychological state, social relations, and environment perspectives. To measure the physical health domain of the WHOQOL-BRFE, sleep pattern, working capacities, energy, and medication use items are used. Person’s thinking, body image, and spiritual aspect items are used to assess the psychological state, whereas the social domain was assessed by asking participants about their sexual relations and relationship with families. Moreover, the environmental domain addressed the safety, leisure, finance, home, and information aspects. This tool is a cross-culturally validated instrument to measure the quality of life in healthcare settings with good sensitivity and specificity, and in a study of patients with severe mental illness, the Cronbach alpha was 0.88.[28] The tool raw scores are transformed into a range between 0 and 100, and they are scaled in a positive direction (i.e., higher scores related to a better health-related quality of life and vice versa.[29]

Confidentiality

Researchers will be directly accountable for relevant information about the trial to the potential participants. When entering data in the datasheet, participants’ details will be removed, and the code will be assigned.

Data management and analysis

Data will be analyzed using the SPSS 19 software and statistical tests, including the independent t-test, paired t-test, Chi-square, and repeated measures analysis of variance (RM ANOVA). If the measurements at the enrollment phase appear differently in the groups, analysis of covariance (ANCOVA), controlling for baseline data and independent variables (group as a fixed parameter and enrollment mean scores as a covariate), will be used. Also, the baseline value of outcome variables and potential confounding variables, which are different between the two groups will be adjusted to avoid potential risk of bias and detect independent results. The data normality will be evaluated through the Kolmogorov-Smirnov test. If the data are not normally distributed, nonparametric tests such as the Wilcoxon will be used. In the case of missing data, we will utilize the last value carried forward method to impute missing values.

Presentation of the results

All results of the trial without any restrictions will be published.

Discussion

This study will be conducted with the aim of developing and evaluating the effectiveness of an interprofessional service package for promoting social participation of SMD patients. In this regard, there is a need for models, for policymakers and mental health professionals to facilitate the transition of patients from inpatient settings to society. Among the efficient models, the Transitional Discharge Model (TDM) has been introduced as a comprehensive community participation program, which was evaluated for the first time in Canada by Forchuk et al. (1998).[30] According to this model, the early stage consists of establishing healing relationships that activate the clients for a safe transition to the community. Next, the established relationships facilitate mental state changes. Furthermore, mental state changes facilitate successful community integration.[31] Another presented model is based on the results of a study by Damari et al.[32] This action research with the collaborative study showed that the SERAJ protocol has considered both preventive and treatment measures for mental and social health disorders and their risk factors. Moreover, by implementing this protocol, the entire population can have access to primary and secondary services, which can reduce rehospitalization risk factors. In the process of SMD patients’ participation in society, the role of non-governmental organizations as a link is crucial. In fact, NGOs can help clients by supporting them to access a wide range of social services (in the field of guiding daily activities at home, leisure time, participation in groups and community, finance issues, education, and work).[33] In the current research, researchers will try to design a service package in an interprofessional manner by using the above-mentioned models and through steps related to the health planning cycle, and with the help of NGOs, including the Iranian HAMD Charity Foundation. We hope that by providing this service package and including it in decisions and policymaking, an important step will be taken to improve the quality of life of SMD patients and their family caregivers after discharge from psychiatric wards.

Consent for publication

Not applicable.

Abbreviations

SMD: Severe Mental Disorder; ICF: International Classification of Functioning, Disability and Health; ICF-APP: Mini-ICF-Rating for limitations of Activities and Participation in Psychological disorders; TDM: Transitional Discharge Model; NGO: non-governmental organizations.

Ethics approval and consent to participate

Ethical approval for this study has been obtained by the ethics committee affiliated with Isfahan University of Medical Sciences, Isfahan, Iran (IR.MUI.NUREMA.REC.1402.046). All the procedures for the participants will be in accordance with the ethical standards of the Isfahan University of Medical Sciences. It will also be explained that their refusal to participate in the study would have no effect on their routine care. At all stages, informed consent will be obtained from the participants by the researchers. The trial was registered in the Iranian Registry of Clinical Trials (IRCT20150127020833N4).

Author’s contributions

SA was involved in designing the protocol. She will be involved in designing the intervention, interpretation of the data, writing, and editing of the manuscript. Also, she will coordinate the meetings with stakeholders, record the meeting reports, identify the potential recruits, and take consent. AI was involved in the project development and in designing the protocol. He will be involved in designing the intervention, data collection, supervising, acquisition of analysis, interpretation of the study results, manuscript writing, and supervising the implementation steps of the trial. He will be responsible for all aspects of the Ethics Committee of the Isfahan University of Medical Sciences and Research Board of University of Isfahan and report the information to the Trial Steering Committee every 6 months. FGH and SGM will be involved in designing the intervention and meet over the course of the trial to oversee the conduct and progress. The authors read and approved the final manuscript.

Availability of data and materials

The datasets will be available from the corresponding author upon reasonable request.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

This study is financially supported by the Isfahan University of Medical Sciences (Grant number: 3402139). The Institutional Review Board of the funding body reviewed and approved the study. The Ethics Committee of Isfahan University of Medical Sciences will supervise the intervention. The funding body was involved in the design of the study. The researchers will be independent from the sponsor and competing interests. The funding body will not be involved in the data collection, analysis, interpretation of the data, and writing of the manuscript. A representative of the ethics committee of the funding body will supervise the research process.