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Self-admission: A New Treatment Approach for Patients With Severe Eating Disorders

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ClinicalTrials.gov Identifier: NCT02937259
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Yvonne von Hausswolff-Juhlin, Karolinska Institutet

Brief Summary:
Self-admission is a novel treatment tool whereby patients who are well-known to a service who have high previous utilization of health care are offered the possibility of self-admission to the inpatient ward for up to seven days without having their motive for admission questioned. Patients are free to admit themselves because of deteriorating mental health, acute stress, lack of structure in their everyday life, loneliness, boredom, or any other reason. The patients decide when they want to admit themselves and can discharge themselves at any time. The purpose behind the self-admission model is to increase the availability of inpatient care for severely ill patients, to avoid stressful and possibly destructive visits to the emergency service, and to decrease total inpatient care utilization. Patients offered a contract for self-admission usually have a history of repeated and prolonged hospitalizations. By encouraging them to monitor their own mental health status and allowing them to seek help swiftly when they are feeling poorly, the delay from first signs of deterioration to admission can be minimized and full-blown relapse can be avoided, ultimately reducing the total time spent in hospital. Until now, projects of self-admission have mainly targeted patients with long-standing psychotic disorders, such as schizophrenia, or bipolar disorder. Starting in August 2014, a four-year clinical project at the Stockholm Centre for Eating Disorders began offering self-admission to patients with severe and enduring eating disorders. The purpose of this study is to determine whether this model is viable in a specialized eating disorders treatment setting, if it does lead to increased patient participation and agency and a reduction of the total time spent hospitalized for this particular patient group, and if it is cost-effective.

Condition or disease Intervention/treatment Phase
Eating Disorders Anorexia Nervosa Bulimia Nervosa Other: Patient self-admission to inpatient treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-admission: A New Treatment Approach for Patients With Severe Eating Disorders
Study Start Date : August 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-admission
Participants are given a contract whereby they are offered the possibility to admit themselves at will to the inpatient ward at the Stockholm Centre for Eating Disorders for a maximum of seven consecutive days at a time. They are also free to discharge themselves at any time. The participants may use this opportunity as often as they want to for a period of one year, or longer if the contract is renewed after one year.
Other: Patient self-admission to inpatient treatment
Participants are given a contract whereby they are offered the possibility to admit themselves at will to the inpatient ward at the Stockholm Centre for Eating Disorders for a maximum of seven consecutive days at a time. They are also free to discharge themselves at any time. The participants may use this opportunity as often as they want to for a period of one year, or longer if the contract is renewed after one year.
Other Name: Patient-controlled hospital admission




Primary Outcome Measures :
  1. Change in days spent in inpatient treatment [ Time Frame: 1 year ]
    The number of days the participants spend in inpatient treatment at a) a specialized eating disorders clinic, b) a psychiatric hospital, and c) a somatic hospital during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.


Secondary Outcome Measures :
  1. Change in days spent in inpatient treatment [ Time Frame: 3 years ]
    The number of days the participants spend in inpatient treatment at a) a specialized eating disorders clinic, b) a psychiatric hospital, and c) a somatic hospital during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.

  2. Change in days spent in involuntary inpatient treatment [ Time Frame: 1 year ]
    The number of days the participants spend in involuntary inpatient treatment at a) a specialized eating disorders clinic, and b) a psychiatric hospital during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.

  3. Change in days spent in involuntary inpatient treatment [ Time Frame: 3 years ]
    The number of days the participants spend in involuntary inpatient treatment at a) a specialized eating disorders clinic, and b) a psychiatric hospital during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.

  4. Change in number of outpatient or day-patient visits [ Time Frame: 1 year ]
    The number of visits the participants have at an outpatient or day-patient unit at a) a specialized eating disorders clinic, b) a psychiatric clinic, and c) at a somatic clinic during the time they have a contract for self-admission will be compared with the number of visits during the same time period before receiving their contracts.

  5. Change in number of outpatient or day-patient visits [ Time Frame: 3 years ]
    The number of visits the participants have at an outpatient or day-patient unit at a) a specialized eating disorders clinic, b) a psychiatric clinic, and c) at a somatic clinic during the time they have a contract for self-admission will be compared with the number of visits during the same time period before receiving their contracts.

  6. Change in BMI [ Time Frame: 1 year ]
    The participants' body mass index (BMI) at inclusion will be compared with their BMI at follow-up.

  7. Change in BMI [ Time Frame: 3 years ]
    The participants' body mass index (BMI) at inclusion will be compared with their BMI at follow-up.

  8. Change in eating disorder diagnosis [ Time Frame: 1 year ]
    Diagnosis according to SEDI (Structured Eating Disorder Interview).

  9. Change in eating disorder diagnosis [ Time Frame: 3 years ]
    Diagnosis according to SEDI (Structured Eating Disorder Interview).

  10. Change in severity of symptoms according to EDE-Q [ Time Frame: 1 year ]
    Severity of symptomatology as measured by EDE-Q (Eating Disorder Examination Questionnaire).

  11. Change in severity of symptoms according to EDE-Q [ Time Frame: 3 years ]
    Severity of symptomatology as measured by EDE-Q (Eating Disorder Examination Questionnaire).

  12. Change in severity of symptoms according to CIA [ Time Frame: 1 year ]
    Severity of symptomatology as measured by CIA (Clinical Impairment Assessment questionnaire).

  13. Change in severity of symptoms according to CIA [ Time Frame: 3 years ]
    Severity of symptomatology as measured by CIA (Clinical Impairment Assessment questionnaire).

  14. Change in GAF score [ Time Frame: 1 year ]
    Global Assessment of Functioning.

  15. Change in GAF score [ Time Frame: 3 years ]
    Global Assessment of Functioning.

  16. Change in quality of life as measured by EQ-5D [ Time Frame: 1 year ]
    Patient-reported quality of life as measured by EQ-5D at inclusion will be compared with quality of life at follow-up.

  17. Change in quality of life as measured by EQ-5D [ Time Frame: 3 years ]
    Patient-reported quality of life as measured by EQ-5D at inclusion will be compared with quality of life at follow-up.

  18. Change in quality of life as measured by RAND-36 [ Time Frame: 1 year ]
    Patient-reported quality of life as measured by RAND-36 at inclusion will be compared with quality of life at follow-up.

  19. Change in quality of life as measured by RAND-36 [ Time Frame: 3 years ]
    Patient-reported quality of life as measured by RAND-36 at inclusion will be compared with quality of life at follow-up.

  20. Change in medication [ Time Frame: 1 year ]
    The number and types of medication prescribed for the participants at inclusion will be compared to number and types of medication and 1 year and 3 years.

  21. Change in medication [ Time Frame: 3 years ]
    The number and types of medication prescribed for the participants at inclusion will be compared to number and types of medication and 1 year and 3 years.

  22. Change in number of days in sick leave [ Time Frame: 1 year ]
    The number of days the participants are absent from work or school, as measured by different types of public health insurance benefits, during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.

  23. Change in number of days in sick leave [ Time Frame: 3 years ]
    The number of days the participants are absent from work or school, as measured by different types of public health insurance benefits, during the time they have a contract for self-admission will be compared with the number of days during the same time period before receiving their contracts.

  24. Cost-effectiveness [ Time Frame: 1 year ]
    Cost-effectiveness of the model will be calculated at 1 year and 3 years using the outcome measures described above.

  25. Cost-effectiveness [ Time Frame: 3 years ]
    Cost-effectiveness of the model will be calculated at 1 year and 3 years using the outcome measures described above.

  26. Patient experiences [ Time Frame: 6 months ]
    Semi-structured interviews about participants' experiences of the self-admission model are conducted at 6 months and 3 years.

  27. Patient experiences [ Time Frame: 3 years ]
    Semi-structured interviews about participants' experiences of the self-admission model are conducted at 6 months and 3 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Having been admitted to the inpatient treatment ward for adults at the Stockholm Centre for Eating Disorders at least once before.
  • Being able to follow the routines and rules and partake in the treatment at the inpatient ward.

Exclusion criteria:

  • Active and untreated substance use disorder.
  • Active suicidal ideation.

No BMI criteria will be applied.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937259


Locations
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Sweden
Stockholm Centre for Eating Disorders
Stockholm, Sweden, 11850
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Yvonne von Hausswolff-Juhlin, M.D, Ph.D. Karolinska Institutet

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yvonne von Hausswolff-Juhlin, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02937259     History of Changes
Other Study ID Numbers: Self-Admission
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia