- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363746
Scool of Pain (SchooP): A Way to Create Value in Healthcare? (SchooP)
Implementation and Evaluation of a Novel Pain School Intervention Targeting Patients With Chronic Non-cancer Pain as a Tool to Achieve Value in Healthcare.
BACKGROUND: Chronic non-cancer pain (CNCP) is a disabling condition with radical consequences. Magic fix-it solutions do not exist. CNCP is a condition for life, calling for healthcare services supporting its management. Value-based healthcare is a method to work with healthcare that, in the Capital Region of Denmark, serves as a framework for clinicians, administrators, and politicians to deliver healthcare services that create value for patients within available resources. An investigation conducted in collaboration between the Danish Health Association and Danish Regions, involving patients, medical experts, municipality representatives, and general practitioners found that the following preferences should be addressed to achieve value-based healthcare in multidisciplinary treatment of CNCP: Quality of life; acceptance; maintenance, and labor market; communication; social life; sleep; physical status and energy administration; pain management and -relief; emotional status and mood.
In response to the requirement to provide value in healthcare, the Multidisciplinary Pain Centre at Rigshospitalet designed a pain school intervention based on identified preferences. Previous studies have documented the benefits of educational programs in the multidisciplinary treatment of CNCP, but also ethnic/racial and socioeconomic disparities in treatment responses. The present study AIMED to evaluate patients' experience of participating in a pain school, designed to create value in healthcare in the multidisciplinary treatment of CNCP.
Study Overview
Status
Intervention / Treatment
Detailed Description
DESIGN: The pain school intervention was evaluated using a questionnaire completed by the participants immediately after each of the seven pain school sessions. The questionnaire had two questions: 1: The topic of the pain school session was relevant for me. 2: The teachers communicated the topic of the pain school session appropriately. After the seventh and last pain school session, the participants were also asked to provide an overall evaluation of the pain school using a questionnaire with 9 questions across 4 categories.
The pain school was additionally evaluated using a qualitative design, with focus group interviews with pain school participants and individual interviews with patients who had three or more no-shows or cancellations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Multidisciplinary Paincenter, Department of Anaesthesia, Pain, and Respiratory Support, the Neuroscience Center, Copenhagen University Hospital, Rigshospitalet
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
The pain school participants were referred to the pain school by the multidisciplinary healthcare provides from the study setting in cohesion with the following criteria:
Inclusion criteria
- Patient motivation
- Ability to join a group and attend a classroom for 2 hours
- Logistical feasibility
- Sufficient energy
Exclusion cireteria
- Inability to understand and speak Danish
- Anxiety
- Depression
- Current resource-demanding opioid-tapering
- Unstable attendance to appointments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain school participants
|
The pain school intervention consists of seven sessions of two hours duration, varying between teaching, joint reflections, and exercises, carried out once a week for up to 15 patients. The pain school intervention is framed by a biopsychosocial approach, delivered by a team of by multidisciplinary pain specialists. A temporary version of the pain scholl intervention was presented for patient representatives and refined according to their comments. The topics of the final pain school sessions include: 1) Welcome and introduction, 2) Effect and side effects of medication, 3) Balancing demands and resources, 4) Social relationships, 5) Sleep, sofa, and sex, 6) Everyday life, 7) Completion and networking. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The topic of the pain school session was relevant for me?
Time Frame: Day 1.
|
The Question had five response categories ranging from zero (not at all) to four (to a very great extent).
|
Day 1.
|
|
The teachers communicated the topic of the pain school session appropriately.
Time Frame: Day 1.
|
The Question had five response categories ranging from zero (not at all) to four (to a very great extent).
|
Day 1.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall evaluation of the pain school asking nine questions within four categories.
Time Frame: Day 1.
|
Each question item has five respons categories ranging from very dissatisfied to very satisfied.
|
Day 1.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
- Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.
- Caceres-Matos R, Gil-Garcia E, Barrientos-Trigo S, Porcel-Galvez AM, Cabrera-Leon A. Consequences of Chronic Non-Cancer Pain in adulthood. Scoping Review. Rev Saude Publica. 2020 Apr 17;54:39. doi: 10.11606/s1518-8787.2020054001675. eCollection 2020.
- Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.
- Morales-Espinoza EM, Kostov B, Salami DC, Perez ZH, Rosalen AP, Molina JO, Gonzalez-de Paz L, Momblona JMS, Areu JB, Brito-Zeron P, Ramos-Casals M, Siso-Almirall A; CPSGPC Study Group. Complexity, comorbidity, and health care costs associated with chronic widespread pain in primary care. Pain. 2016 Apr;157(4):818-826. doi: 10.1097/j.pain.0000000000000440.
- Danish Regions. Værdi for patienten, et pejlemærke for fremtidens sundhedsvæsen [Value for the patient - a guiding principle for the future healthcare system]. 2019. https://www.regioner.dk/media/11352/vbspjece-marts19-tryk.pdf
- The Capital Region of Denmark. Hovedstaden, R. Model for værdibaseret sundhed i Region Hovedstaden [Model for Value-Based Healthcare in the Capital Region of Denmark]. 2020.
- Porter, ME, & Teisberg, EO. Redefining health care : creating value-based competition on results. Harvard Business School Press, 2006.
- Huffman KL, Mandell D, Lehmann JK, Jimenez XF, Lapin BR. Clinical and Demographic Predictors of Interdisciplinary Chronic Pain Rehabilitation Program Treatment Response. J Pain. 2019 Dec;20(12):1470-1485. doi: 10.1016/j.jpain.2019.05.014. Epub 2019 Jun 5.
- Turner BJ, Liang Y, Rodriguez N, Bobadilla R, Simmonds MJ, Yin Z. Randomized Trial of a Low-Literacy Chronic Pain Self-Management Program: Analysis of Secondary Pain and Psychological Outcome Measures. J Pain. 2018 Dec;19(12):1471-1479. doi: 10.1016/j.jpain.2018.06.010. Epub 2018 Aug 24.
- Turner BJ, Rodriguez N, Bobadilla R, Hernandez AE, Yin Z. Chronic Pain Self-Management Program for Low-Income Patients: Themes from a Qualitative Inquiry. Pain Med. 2020 Feb 1;21(2):e1-e8. doi: 10.1093/pm/pny192.
- Bruns EB, Befus D, Wismer B, Knight K, Adler SR, Leonoudakis-Watts K, Thompson-Lastad A, Chao MT. Vulnerable Patients' Psychosocial Experiences in a Group-Based, Integrative Pain Management Program. J Altern Complement Med. 2019 Jul;25(7):719-726. doi: 10.1089/acm.2019.0074.
- Pate JW, Tran E, Radhakrishnan S, Leaver AM. The Importance of Perceived Relevance: A Qualitative Evaluation of Patient's Perceptions of Value and Impact Following a Low-Intensity Group-Based Pain Management Program. Medicina (Kaunas). 2021 Jan 7;57(1):46. doi: 10.3390/medicina57010046.
- Clauw DJ, Essex MN, Pitman V, Jones KD. Reframing chronic pain as a disease, not a symptom: rationale and implications for pain management. Postgrad Med. 2019 Apr;131(3):185-198. doi: 10.1080/00325481.2019.1574403. Epub 2019 Feb 11.
- Suso-Ribera C, Yakobov E, Carriere JS, Garcia-Palacios A. The impact of chronic pain on patients and spouses: Consequences on occupational status, distribution of household chores and care-giving burden. Eur J Pain. 2020 Oct;24(9):1730-1740. doi: 10.1002/ejp.1616. Epub 2020 Jul 20.
- Stone AL, Wilson AC. Transmission of risk from parents with chronic pain to offspring: an integrative conceptual model. Pain. 2016 Dec;157(12):2628-2639. doi: 10.1097/j.pain.0000000000000637.
- Toye F, Seers K, Hannink E, Barker K. A mega-ethnography of eleven qualitative evidence syntheses exploring the experience of living with chronic non-malignant pain. BMC Med Res Methodol. 2017 Aug 1;17(1):116. doi: 10.1186/s12874-017-0392-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F-23056260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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