The Supporting Patient Activation in Transition to Home Intervention ([sPATH])

• ClinicalTrials.gov Identifier: NCT02823795
• Recruitment Status: Completed
• First Posted: July 6, 2016
• Last Update Posted: September 23, 2020
• Sponsor: Karolinska Institutet
• Collaborators: Vårdalstiftelsen; Forte
• Information provided by (Responsible Party): Mirjam Ekstedt, Karolinska Institutet

Tracking Information

• First Submitted Date: July 1, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: September 23, 2020
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 5, 2016)

Re-hospitalization [ Time Frame: 90 days ]

Registry data from the Swedish Register for Health Care Encounters

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 5, 2016)

• Healthcare usage [ Time Frame: 30, 90 and 180 days ]
  Registry data from the Swedish Register for Health Care Encounters: re-hospitalization at 30 and 180 days. Emergency room and primary care visits at 30, 90 and 180 days
• Medication adherence [ Time Frame: 30, 90 and 180 days ]
  Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry
• Patient activation [ Time Frame: 30, 90 and 180 days ]
  Patient reported data using the Patient Activation Measure, 13 item
• Health related quality of life [ Time Frame: 30, 90 and 180 days ]
  Patient reported data using the EQ-5D-5L
• Basic Psychological Needs [ Time Frame: 30, 90 and 180 days ]
  Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items
• Depression [ Time Frame: 30, 90 and 180 days ]
  Patient reported data using PHQ-9 (Patient Health Questionnaire)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Supporting Patient Activation in Transition to Home Intervention
• Official Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
• Brief Summary: This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.
• Detailed Description: Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Medication Adherence
• Self-care
• Heart Failure
• Chronic Obstructive Pulmonary Disease

Intervention

Behavioral: Motivational Interviewing

Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).

Study Arms

• Experimental: sPATH
  Motivational Interviewing in five sessions post hospital discharge
  Intervention: Behavioral: Motivational Interviewing
• No Intervention: Control
  Care as usual

Publications *

• Brandberg C, Ekstedt M, Flink M. Self-management challenges following hospital discharge for patients with multimorbidity: a longitudinal qualitative study of a motivational interviewing intervention. BMJ Open. 2021 Jul 30;11(7):e046896. doi: 10.1136/bmjopen-2020-046896.
• Flink M, Brandberg C, Ekstedt M. Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing? Trials. 2019 Jan 25;20(1):82. doi: 10.1186/s13063-019-3187-9.
• Flink M, Lindblad M, Frykholm O, Kneck A, Nilsen P, Arestedt K, Ekstedt M. The Supporting Patient Activation in Transition to Home (sPATH) intervention: a study protocol of a randomised controlled trial using motivational interviewing to decrease re-hospitalisation for patients with COPD or heart failure. BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 20, 2020): 118
• Original Estimated Enrollment (submitted: July 5, 2016): 400
• Actual Study Completion Date: September 2018
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.

Exclusion Criteria:

• Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.

The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02823795
• Other Study ID Numbers: C751231003; Dnr 2014-0026 ( Other Grant/Funding Number: Vårdalsstiftelsen ); Dnr 2014-4948 ( Other Grant/Funding Number: Forte )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Mirjam Ekstedt, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current

Collaborators

• Vårdalstiftelsen
• Forte

Investigators

• Principal Investigator: Mirjam Ekstedt, Professor; LIME, Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: September 2020