Druss 2010.
| Methods | Randomized controlled trial | |
| Participants | The study location was an urban Community Mental Health Center (CMHC) 41 participants were randomized to the intervention group and 39 participants were randomized to the control group The inclusion criteria were to be on the active patient roster at the CMHC, have a severe mental illness, have one or more chronic medical condition, and have the capacity to provide informed consent |
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| Interventions | Intervention: HEALTH AND RECOVERY PROGRAM (HARP)
Participants in the intervention group attended up to 6 group sessions led by mental health peer specialists. Sessions covered the following topics related to chronic disease self management: 1. Overview of self management 2. Exercise and physical activity 3. Pain and fatigue management 4. Healthy eating on a limited budget 5. Medication management and 6. Finding and working with a regular doctor. During the sessions, peer educators modeled appropriate behaviors and responses, and participation from each group member helped model behavior and improve motivation for other members. Attendees are taught to develop short‐term "action plans" for choosing domains of health behavior change. This process involves identifying a problem that is of particular concern, listing ideas for solving the problem, and then developing a plan outlining specific, short‐term goals for improvement. 2 certified mental health peer specialists participated in a community‐based, 5‐day chronic disease self‐management program (CDSMP) master training course to become master trainers in the CDSMP program. Subsequently, they received 3 additional days of training from the team's principal investigator and health educator in the Health and Recovery Peer (HARP) program Control: USUAL CARE Subjects assigned to usual care continued to receive all medical, mental health, and peer‐based services that they were otherwise receiving prior to entry into the study |
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| Outcomes | The measures of adherence were a validated self report measure of problems in adherence to medication The patient outcomes were patient activation, which reflects an individual's perceived ability to manage his or her illness and health behaviors, and act as an effective patient. This construct was measured using the 13‐item Patient Activation Measure (PAM). Patient activation is calculated on a 0 to 100 score, with 100 as the highest possible degree of activation. Disease self management was assessed using questions about physical activity, health services use. Questions about physical activity and source of a primary care provider were drawn from the Behavioral Risk Factor Surveillance System (BRFSS). Health‐related quality of life (HRQOL) was measured by the SF‐36, constructed for use in the Medical Outcomes Study. A Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were constructed from the survey, scored between 0 (poor health) and 100 (perfect health) |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomization program. (pg 266) "Using a computerized algorithm, patients were randomized to the intervention or usual care group by the project manager. After randomization, interviews were administered at baseline and again at 6 months post‐baseline. Interviewers were blinded to subjects' randomization status." |
| Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment. (pg 266) "Using a computerized algorithm, patients were randomized to the intervention or usual care group by the project manager. After randomization, interviews were administered at baseline and again at 6 months post‐baseline. Interviewers were blinded to subjects' randomization status." |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | High risk | Several limitations and it is a pilot study. (pg 268) "As a pilot study, the study had several limitations, including reliance on self report outcome measures, a relatively brief follow‐up period, and lack of adequate power to assess statistical significance for many of the study outcomes. Further testing using a broader range of outcome measures, longer follow‐up periods, and larger sample sizes will be needed to establish the HARP program as an evidence‐based practice." |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORTED ADHERENCE ‐ Outcome assessors blinded. (pg 266) "Interviewers were blinded to subjects' randomization status" |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) PATIENT ACTIVATION ‐ Outcome assessors blind. (pg 266) "Interviewers were blinded to subjects' randomization status" |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORTED ADHERENCE ‐ No mention of patient blinding and this is a subjective self report measure |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) PATIENT ACTIVATION ‐ No mention of blinding of patients and subjective questionnaire |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORTED ADHERENCE ‐ No mention of blinding of other study staff |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) PATIENT ACTIVATION ‐ No mention of blinding study staff |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORTED ADHERENCE ‐ More dropouts in control group; unclear if reasons related to intervention |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) PATIENT ACTIVATION ‐ Unequal dropouts and reasons for loss to follow‐up unclear if related to intervention |