Sledge 2011.
Methods | RCT Setting: Yale‐New Haven Psychiatric Hospital, acute care hospital, New Haven, Connecticut, USA. Funding: Grant M123828 Eli Lilly; Connecticut Department of Mental Health and Addiction Services; George D and Esther S Gross Professor of Psychiatry endowment. Recruitment (client): Prospective participants identified people admitted to the Yale‐New Haven Psychiatric Hospital between 1 Nov 2006 and 1 Nov 2008. Recruitment (consumer‐provider): Recruited from formal job postings. No details were provided on numbers applied, eligible, excluded, or refused participation. Training/support: Consumer‐providers received training on fundamentals of recovery philosophy and promotion practices, local resources available, boundaries, safety, cultural competence, gender factors, trauma‐informed care, motivational interviewing techniques. Training occurred over 16 days during four weeks, with homework. Received a salary from the state Department of Mental Health, under the supervision of staff at the Connecticut Department of Mental Health and Addiction Services. They did not report to or take direction from clinical staff who were directly responsible for patient care. They had ongoing supervision, including 90 minute, weekly team meeting, conducted by study supervisors and the mentors' direct supervisor. Inclusion criteria: 18 years or older; two or more psychiatric hospitalisations in previous 18 months; documented DSM‐IV diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder or major depressive disorder, and willing to accept random assignment. Exclusions: unable to give signed, written consent; unable to speak English; unavailable because of imminent incarceration; primary DM‐IV axis I diagnosis of substance abuse or dependence or an axis II diagnosis alone. |
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Participants |
Clients: 89 participants randomised, 15 withdrew consent leaving an intention to treat sample of 74 (intervention n = 38, 45% male; control n = 36, 58% male). Mean age: intervention: 42.4 years (SD 11.5); control: 38.7 years (SD 8.4) . Principal diagnoses: Main diagnoses were psychotic disorder: intervention: 68%, control: 69%, and mood disorders: intervention: 32%, control 31%. Description consumer‐providers: All 8 consumer‐providers were in recovery from a severe mental illness, openly self‐identify as having a history of mental illness, demonstrated strong interpersonal skills, and willing to work in the community and complete a paid training program. |
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Interventions |
Study aim: To determine whether recovery mentor support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalization. Intervention aim: Consumer‐provider were to deliver support for participants (peer companion model), with the aim to reduce inpatient hospitalizations. Role of consumer‐providers: Consumer‐providers gave support for clients. Consumer‐providers delivered non‐clinical activities determined by the clients' interests. Consumer‐provider caseload not described. Intervention: Mentors were instructed not to aim for any specific goal other than to support their clients (n = 38). Recovery mentors were trained to use their own first‐hand experiences as a basis on which to provide support to participants. Frequency of contact determined by mentee in collaboration with mentor. 13 of 38 intervention‐group patients had no contact with their mentee. Data for 55% of intervention‐group patients showed that mean frequency of contact was 13.43 contacts (SD 11.46), over nine months. Mean total hours of contact: 24.15 hours (SD 17.41). Control: (n = 36) Direct clinical care received by both groups consisted of what was available to them through their own efforts and resources. Most of the clinical care was delivered in the public sector via community‐based organizations that are funded by the DMHAS either through a state facility or grants to private, nonprofit community‐based, mental healthcare centres. Generally clinical care consisted of medication, psycho‐education and case management, and supportive psychotherapy. Duration: Nov 2006 to Nov 2008. Fidelity: 13 (34%) of clients had no contact with their mentor during study period despite being assigned to mentor arm. Consumer involvement outside of the intervention: None. Changes in trial protocol: None described. |
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Outcomes | Outcomes assessed at 3 and 9 months. Number of hospitalizations Number of days in hospital Trial protocol outcomes listed included: Sense of community Motivation for change Social functioning Hope Self determination Functional status Treatment relationship |
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Notes | Contacted authors regarding secondary outcomes, who advised that data were collected and authors are currently drafting a manuscript for these outcomes. Power calculation: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization scheme generated with SAS statistical software with a 50‐50 split between recovery mentor and treatment as usual for 120 participants." |
Allocation concealment (selection bias) | Low risk | "Each randomized assignment was separated and placed in consecutive order in a sealed, numbered envelope by staff (who were not directly linked to the study) at the Program for Recovery and Community Health." |
Blinding (performance bias and detection bias) Self‐reported outcomes | Unclear risk | It is unclear if participants were aware of the purpose of the study. |
Blinding (performance bias and detection bias) All other outcomes | High risk | Supervisors of mentors also participated in some follow‐up evaluations and were not blind to participants' treatment status. |
Incomplete outcome data (attrition bias) up to 6 months | Unclear risk | No 3‐month data published as yet (at January 2013). |
Incomplete outcome data (attrition bias) post 6 months | High risk | Primary outcomes have been reported, it appears that data for all participants in the intention to treat sample have been reported. Authors note, however, they did not have verifiable data on whether patients were hospitalised at other facilities during the follow up period. |
Selective reporting (reporting bias) | Unclear risk | Secondary outcomes listed in trial protocol not yet reported (at January 2013), including: Sense of community; Motivation for change; Social functioning; Hope; Self determination; Functional status; Treatment relationship. |
Groups comparable at baseline? | Low risk | "The two groups did not differ on most variables at baseline", however, marital status was different between groups (intervention: 21% currently married; control 3% currently married). |
No contamination between treatment groups? | Unclear risk | Not described. |