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Peer Support Experience for Patients Discharged From Acute Psychiatric Care

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ClinicalTrials.gov Identifier: NCT03404882
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
The aim of the project is to conduct a four arm randomized controlled pilot trial to evaluate the effectiveness of an innovative peer support program that incorporates leadership training, mentorship, recognition, reward systems and supportive/reminder text messaging for patients discharged from acute (hospital) care. Methods and analysis: This is a prospective, rater-blinded, three arm randomized controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomized to one of four conditions: treatment as usual follow-up care, enrollment in usual follow-up care plus daily supportive/reminder text messages, enrollment in a peer support system plus daily supportive/reminder text messages or enrollment on a peer support system without daily supportive text messages. Patients in each group will complete evaluation measures (e.g., recovery, general symptomatology, functional outcomes) at baseline, six months, and 12 months. Service utilization data and data regarding the experience of the peer support workers will also be collected. Data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. We hypothesize that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. Peer support worker experience will be derived from exploratory data analysis.

Condition or disease Intervention/treatment Phase
Depression Bipolar Disorder Schizophrenia Behavioral: Supportive/reminder text messaging plus peer support Behavioral: Supportive/reminder text messaging Behavioral: Peer support only Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a longitudinal, prospective, parallel design, three arm, rater-blinded randomized clinical trial with a recruitment period of six months and an observation period of 12 months for each participant.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the database which contains the randomization code. In addition, study participants will be asked not to reveal their treatment allocation to their assessor. Moreover, these assessors will not be involved in data analysis. To test the success of blinding we will ask the assessor to guess the treatment group for each participant at six and 12-month follow-up. After data collection is complete all data will undergo a blind review for the purposes of finalizing the planned analysis.
Primary Purpose: Treatment
Official Title: Enhancing Peer-support Experience for Patients Discharged From Acute Psychiatric Care: Protocol for a Randomized Controlled Pilot Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: text messaging plus peer support arm
Patients will be assigned a peer support worker who will visit them during the last week of their inpatient stay to introduce themselves and build rapport before patients are discharged into the community. The peer support workers will visit the participants up to eight times over a six month period. The peer support workers will offer the opportunity for interactive text message support for six months. In addition to peer support, participants in this arm of the study will receive daily supportive text messages from an automated
Behavioral: Supportive/reminder text messaging plus peer support
Regular supportive/reminder text message will be delivered to patients who will also receive face to face and interactive text message support from peer support workers

Active Comparator: supportive/reminder text message only arm
Patients in the supportive/reminder text message only arm of the study will receive daily supportive text messages from the automated online application and reminder text messages for their community clinic/program appointments.
Behavioral: Supportive/reminder text messaging
Regular supportive/reminder text message will be delivered to patients who will NOT receive any face to face or interactive text message support from peer support workers

No Intervention: Control arm
Patients in the control arm of the study will receive the usual follow-up appointment offered to all patients who are discharged from acute care. However, they will not receive peer support or supportive/reminder text messages.
Active Comparator: peer support only arm
Patients will be assigned a peer support worker who will visit them during the last week of their inpatient stay to introduce themselves and build rapport before patients are discharged into the community. The peer support workers will visit the participants up to eight times over a six month period. The peer support workers will offer the opportunity for interactive text message support for six months. Patients will not receive daily supportive/reminder text messages
Behavioral: Peer support only
face to face support from peer support workers but no interactive or daily supportive/reminder text messages




Primary Outcome Measures :
  1. Changes in Health of Nations Outcome Scale (HoNOS) score from Baseline [ Time Frame: 6 & 12 Months ]
    HoNOS measures the symptom severity and social functioning across time. It has 12 items that measure behaviour, impairment, symptoms and social functioning. The items are rated on a scale of 0-4 and the results or changes in ratings are known as outcomes and may be attributed to services provided. The scores range from 0 to 48.

  2. Changes in Behavior and Symptom Identification Scale (BASIS-32) score from Baseline [ Time Frame: 6 & 12 Months ]

    BASIS-32 has 32 question measure covering 5 sub-scales

    • Relation to self and others
    • Daily living and role functioning
    • Depression and anxiety
    • Impulsive and addictive behaviour
    • Psychosis

    Sub-scale and overall mean scores also range from 0 to 4. Four of the five subscale scores and the BASIS-32 average are computed by averaging the ratings for component items using the number of non-missing items as the denominator. The score range from 0 to 128



Secondary Outcome Measures :
  1. Recovery Assessment Scale score [ Time Frame: 6 &12 Months ]
    The Recovery Assessment Scale has 38 items or statements for the consumer to rate. It is a Likert scale with 4 rating categories for consumers to select from: "untrue"; "a bit true"; "mostly true" and "completely true" which are scored 1, 2, 3 and 4 respectively giving a range of scores from 38 to 152.

  2. Perceived Discrimination Scale score [ Time Frame: 6 &12 Months ]
    This is a 7 item scale with each item scored from 1-4 making the score range from 7 to 28

  3. World Health Organization Quality of Life Brief instrument (WHOQOL-BREF) score [ Time Frame: 6 & 12 Months ]
    The WHOQOL-BREF produces a quality of life profile. It is possible to derive four domain scores. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100. Raw scores are then transformed to scores which range from 0-100 scale.

  4. Patient Satisfaction/Experience Questionnaire [ Time Frame: 6 & 12 Months ]
    This scale has 10 questions with a Liket scale with five options for each question. The score range from 10 to 50

  5. Rates of Health services utilization [ Time Frame: 6 & 12 Months ]
    Rates of use, inpatient admissions and length of stay, readmissions, completed appointments, Emergency Department presentations, Emergency Medical Services use, community services appointments, crisis and urgent service calls, no show rates.

  6. Cost of Health services utilized [ Time Frame: 6 & 12 Months ]
    Cost of use, inpatient admissions and length of stay, re-admissions, completed appointments, Emergency Department presentations, Emergency Medical Services use, community services appointments, crisis and urgent service calls, and no show cost.

  7. Peer Support Worker Effectiveness [ Time Frame: 6 & 12 Months ]
    Will be assessed through qualitative interviews of key informants and focus group discussions

  8. Peer Support Worker Job satisfaction [ Time Frame: 6 & 12 Months ]
    Will be assessed through qualitative interviews of key informants and focus group discussions

  9. Peer Support Worker Acceptability [ Time Frame: 6 & 12 Months ]
    Will be assessed through qualitative interviews of key informants and focus group discussions

  10. Recovery Assessment Scale score for Peer Support workers [ Time Frame: 6 & 12 Months ]

    The Recovery Assessment Scale has 38 items or statements for the consumer to rate. It is a Likert scale with 4 rating categories for consumers to select from: "untrue"; "a bit true"; "mostly true" and

    "completely true" which are scored 1, 2, 3 and 4 respectively giving a range of scores from 38 to 152.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are 18-65 years of age, able to provide informed written consent, have been diagnosed with an enduring mental health condition and are ready for discharge from an acute care facility within the Edmonton Zone with community mental health follow-up.
  • Patients should have a mobile handset capable of receiving text messages. Mobile phone handsets and top-up call credit of up to 10 dollars monthly will be provided to those who satisfy the inclusion criteria but do not have mobile phones.

Exclusion Criteria:

  • Patients will be ineligible if they do not meet the above inclusion criteria, if they have only an addictive disorder but no mental health diagnosis, are not capable of reading text messages from a mobile device, or will be out of town during the 12 month follow-up period.
  • Patients are also ineligible if they do not consent to take part in the study.

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): NCT03404882


Contacts
Contact: vincent I.O Agyapong, MD PhD 7807144315 agyapong@ualberta.ca
Contact: Liana Urichuck, PhD 7803427707 Liana.Urichuk@albertahealthservices.ca

Sponsors and Collaborators
University of Alberta
Alberta Health Services

Publications of Results:
Other Publications:
Alberta AH-G of. Valuing mental health: Next steps: Alberta Health website [Internet]. [cited 2018 Jan 3]. Available from: http://www.health.alberta.ca/initiatives/Mental-Health-Review.html
Edmonton C of. 2016 Municipal Census Results [Internet]. 2017 [cited 2017 Sep 14]. Available from: https://www.edmonton.ca/city_government/facts_figures/municipal-census-results.aspx
Giffort D, Schmook A, Woody C, Vollendorf C, Gervain M. Recovery Assessment Scale. Cambridge, MA: Human Services Research Institute; 1995
What is HoNOS? [Internet]. [cited 2018 Jan 4]. Available from: http://www.rcpsych.ac.uk/traininpsychiatry/conferencestraining/resources/honos/whatishonos.aspx
Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO Technical Report Series, No. 850, Annex 3 - WHO Expert Committee on Selection and Use of Essential Medicines, Sixth Report, 1993 [Internet]. [cited 2017 Nov 22]. Available from: http://apps.who.int/medicinedocs/en/d/Jwhozip13e/

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03404882     History of Changes
Other Study ID Numbers: Pro00078427
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders