Inclusion Criteria
-
Alberta residents with disabilities who are coping with pain and mental health issues (see condition list from Table A1, Appendix A)
-
Have not received acupuncture treatments within the last 3 months.
Patient Recruitment
To increase the reach of the study and attract a diverse group of participants, the project will utilize various outreach strategies. These will include the use of posters and flyers distributed in public areas such as community centers, libraries, and health clinics to attract potential participants. The project will also collaborate with civil society organizations such as disability advocacy groups, community centers, and disability service providers to help spread the word about the study and recruit participants. In addition, Alberta Health Services (AHS) mail-out service in collaboration with the AHS/SPOR group at the Centre of Health Informatics (CHI) at the University of Calgary will be utilised to increase patient outreach. The AHS' Enterprise Data Warehouse (EDW) will be used to seek suitable participants. The study will concentrate on people who have recently been admitted to the hospital or attended the emergency room due to pain and/or mental health issues.
In addition, conventional medical doctors will be enlisted to help identify potential participants who may benefit from the study. The project will work with primary care physicians, psychologists, and psychiatrists to reach those in need and to ensure that the study is accessible to a wide range of individuals. This collaborative effort will help to ensure that the study is able to recruit a diverse group of participants who can benefit from the intervention.
Intervention
Participants will receive up to 12 free acupuncture treatments, with a minimum frequency of twice a week. The acupuncture treatments will focus on specific points in the body to stimulate healing and balance, and may involve the use of small needles, heat, or pressure. These treatments have been shown to alleviate pain, reduce stress, and improve overall well-being.
The treatment plan will be individualized based on their condition and will be determined after a thorough assessment. During the initial consultation, the practitioner will evaluate the participant's symptoms and lifestyle to identify the most appropriate acupuncture treatment.
To determine the most effective acupuncture treatment, the practitioner will ask questions about the participant's sleeping patterns, digestion, and diet. Physical examinations will also be conducted on areas of the body experiencing pain, and the color of the participant's tongue, face, and the strength, rhythm, and quality of the pulse in their wrist will be assessed. Based on these assessments, the practitioner will propose an individualized acupuncture treatment plan for each participant, using established treatment protocols as a guideline.
The goal of this intervention is to provide a holistic approach to improving the overall health and quality of life of participants. By tailoring the treatment plan to each participant's specific needs, the intervention aims to address both physical and mental health concerns.
Data Collection
As part of this study, we will collect comprehensive information on the well-being of participants, with their permission. This will be done using validated survey instruments that measure various aspects of health, including mental health (anxiety, depression, fatigue, anger), pain, sleep quality, quality of life, health care utilization, and return to work/school. To ensure the confidentiality and security of this information, we will be using REDCap, a secure web application for building and managing online surveys and databases. REDCap will be hosted by the Clinical Research Unit (CRU), a core research support center at the University of Calgary.
At the first consultation session, participants will be asked to answer questions from an online questionnaire on REDCap. This questionnaire will collect basic demographic information such as age and gender, as well as the participant's Alberta Personal Health Number (PHN), information on chronic pain, addiction, mental health, and quality of life. Medical records will not be accessed at this stage.
After the 6th and 12th treatment sessions, participants will be asked to answer questions from an online questionnaire on REDCap. This will help us monitor the treatment's effect and evaluate the outcome. Information on chronic pain, mental health, addiction, and quality of life will be collected. Participants will receive email invitations to complete the same surveys through REDCap three months post-treatment and six months post-treatment to understand the study's impact over the long term. This data will help us evaluate the effectiveness of the treatment and improve patient care.
Outcome Measures
The study will measure primary and secondary outcomes. The primary outcome variables include patients' productivity, pain, quality of sleep, mental health, and quality of life. Productivity will be measured using the Work Productivity and Activity Impairment questionnaire (WPAI), pain using Brief Pain Inventory (BPI) Short Form, quality of sleep using Pittsburgh Sleep Quality Index (PSQI), depression using Patient Health Questionnaire (PHQ-9), anxiety using the Generalized Anxiety Disorder 7 (GAD-7), anger using the Dimensions of Anger Reactions (DAR-5), quality of life using EQ-5D-5L, and substance use using CAGE and DAST-10 questionnaires.
The secondary outcome variables include patients' general health care utilization, which will be measured by patient self-reported inpatient, outpatient, emergency department, and prescription drug utilization. The patients will self-report the number and frequency of their medication intake, in addition to how often they had contact with different healthcare providers, hospitalizations, and ER visits in the previous week. This will help ascertain whether the visits and prescription consumption were related to the same problem for which AIDP therapy was initiated. The outcome measures are presented in Table 1.
Table 1
Outcome Measure | Instrument | Description |
Productivity | Work Productivity and Activity Impairment Questionnaire (WPAI) | A self-reported measure assessing the impact of a health condition on work productivity and daily activities over the previous seven days. It measures absenteeism (work time missed), presenteeism (reduced productivity while at work), and overall work productivity loss, as well as activity impairment outside of work. |
Pain Severity | Brief Pain Inventory (BPI) | A self-reported measure assessing the severity of pain by calculating the mean of four questions: pain at its "worst," "least," and "average" in the prior week, and pain "now." It includes numerical rating scales, ranging from 0 to 10, to quantify pain severity. |
Pain Interference | Brief Pain Inventory (BPI) | A self-reported measure assessing how much pain interferes with daily living by calculating the average of seven questions about general activity, mood, walking ability, regular work (inside and outside the home), relations, sleep, and life enjoyment. It includes numerical rating scales, ranging from 0 to 10, to quantify the degree of interference. |
Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) | A self-reported measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disruptions, usage of sleep medication, and daytime dysfunction. It includes 19 questions that generate seven component scores, with higher scores indicating worse sleep quality. |
Depression | Patient Health Questionnaire 9 (PHQ-9) | A self-reported measure assessing the frequency of nine depressive symptoms, anxiety, and alcohol use. It includes a numerical rating scale, ranging from 0 to 3, to quantify the frequency of each symptom. Scores range from 0 to 27, with higher scores indicating more severe depression. |
Anxiety | Generalized Anxiety Disorder 7 (GAD-7) | A self-reported measure assessing the severity of various generalized anxiety disorder symptoms. It includes a numerical rating scale, ranging from 0 to 3, to quantify the severity of each symptom. Scores range from 0 to 21, with higher scores indicating more severe anxiety. |
Anger | Dimensions of Anger Reactions (DAR-5) | A self-reported measure assessing the frequency, intensity, duration, level of aggression, and influence on functioning of anger over the last four weeks. It includes a numerical rating scale, ranging from 0 to 3, to quantify each aspect of anger. Scores range from 0 to 15, with higher scores indicating more severe anger. |
Substance Use | Cut, Annoyed, Guilty, and Eye (CAGE) & Drug Abuse Screening Test (DAST-10) | A screening tool for identifying alcoholism issues and involvement with substances other than alcohol. The CAGE questionnaire includes four questions that ask about the respondent's own alcohol use, while the DAST-10 includes 10 questions that ask about the respondent's use of drugs other than alcohol. |
Overall Quality of Life | EQ-5D-5L | A self-reported measure assessing mobility, self-care, routine activities, pain or discomfort, and anxiety or depression. It includes five questions, each with five response options, and generates a single score ranging from − 0.59 to 1, with higher scores indicating better quality of life. |
Healthcare Utilization | Self-reporting mechanism | A self-reported measure assessing inpatient, outpatient, emergency department, and prescription drug utilization. Participants will report their utilization of healthcare services over the previous three months, including the frequency and type of service used. |
Data Analysis
Data analysis will be conducted using STATA software to analyze the clinical outcomes of participants in the study. Descriptive statistics will be used to examine the average changes in pain, mental health, addiction, treatment quality, and healthcare use between admission and discharge. The chi-square test will be utilized to determine if there is a significant difference in these outcomes before and after treatment.
In addition to the clinical analysis, an economic evaluation will also be conducted using cost-effectiveness and cost-benefit analysis (CEA & CBA). The study will estimate the potential cost savings from integrating acupuncture into the disability service system. The first-hand data collected from the AIDP surveys will be used to estimate both direct and indirect costs associated with the AIDP program.
The cost-effectiveness analysis will estimate the cost per unit of clinical effectiveness, while the cost-benefit analysis will estimate the net economic benefits of the AIDP program. The observed impacts will be translated into cost savings measured by both reduction of direct costs (i.e. hospital, physician, drug, research, and other institutional care expenditures) and indirect costs (i.e. reduction of quality of life, lost production due to disability, and premature mortality).
By comparing the costs and benefits of the AIDP program, policymakers will be able to make informed decisions about the potential cost savings that could be realized by integrating acupuncture into the disability service system. This analysis will provide valuable insights into the cost-effectiveness and cost-benefit of the AIDP program and guide future decision-making in healthcare policies. Ultimately, the results of this study will not only contribute to improving the healthcare system but will also benefit society as a whole.
Data Confidentiality and Privacy
Our study places a high priority on ensuring the privacy of participants. We will take strict measures to keep all personal information confidential and follow a Data Management Plan to ensure that identifiable information is handled with utmost care. To this end, we will store personal contact information separately from health information and assign a unique code to replace identifiable information. All data will be accessible only to project team members, CHREB representatives, and funding agencies for quality assurance purposes. We will adhere to professional codes of ethics and legislation and keep participant information for a minimum of seven years after the study.
Additionally, our study will utilize the REDCap data platform from the Clinical Research Unit (CRU) at the University of Calgary for distribution and data storage of surveys. The CRU has all necessary data sharing and storage agreements with Alberta Health Services in place, and their server is physically located on the University of Calgary campus, ensuring participant information is not subject to other stipulations such as the US Patriot Act. The Conjoint Health Research Ethics Board (CHREB) and authorized representatives from the University of Calgary may access identifiable medical/clinical records or research records held at the University of Calgary for quality assurance purposes, with the participant's consent.
The study team will maintain the confidentiality of participant research records, except where required by law (e.g. disclosed child abuse or neglect). Access to medical/clinical records and research records will only be authorized with the participant's consent, and any legal requests will be handled accordingly.